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Human Research Ethics

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(China & Australia) ANU study says China deliberately falsifying data on organ transplants – The Canberra Times (Kirsten Lawson | November 2019)

Published/Released on November 15, 2019 | Posted by Admin on February 21, 2020 | Keywords: , , , , , ,

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Friday afternoon’s funny – Reasons for refusal

Published/Released on February 21, 2020 | Posted by Admin on February 21, 2020 | Keywords: , , , ,

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Clinical trials: how to make informed consent more ethical – The Conversation (Jeremy Howick | February 2020)

It has been illegal to treat humans like guinea pigs since the Nuremberg trials, in which Nazi doctors were punished for doing unspeakable things to prisoners. These days, we have to explain the experiment to the people taking part in trials for new treatments and get their permission (their... More

It has been illegal to treat humans like guinea pigs since the Nuremberg trials, in which Nazi doctors were punished for doing unspeakable things to prisoners. These days, we have to explain the experiment to the people taking part in trials for new treatments and get their permission (their “informed consent”). [colored_box]Specifically, we have to tell them about the risks of taking part. So in a trial of a new drug, we have to tell patients about all the possible side-effects. In ethical geek-speak, we have to preserve patients’ autonomy by giving them enough information to make an autonomous decision. Which is fine, up to a point. . It is also an ethical requirement to avoid unnecessarily harming patients. A recent study published in the BMJ Journal for Medical Ethics shows that the relatively recent discovery of so-called nocebo effects – a result of the patient’s expectation that the treatment will harm them – means that harm is being done by the way we inform patients about the trial in which they are taking part. .

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Flying Blind – the Australian Health Data Series: Human Research Ethics Committees (HRECs) (Nadia Levin | September 2017)

Flying Blind is a series of three reports dedicated to uncovering the acute levels of data fragmentation existing at all levels of Australia’s health landscape.

In our previous blog, The Ethics Quagmire: Case Studies you might have read the case study by... More

Flying Blind is a series of three reports dedicated to uncovering the acute levels of data fragmentation existing at all levels of Australia’s health landscape.

In our previous blog, The Ethics Quagmire: Case Studies you might have read the case study by Kathy Tannous concerning the difficulties she has faced getting ethics approval from three ethics committees. But are there problems closer to home for researchers, in their own institutions, even when only one HREC is involved? We think so. But the solution may also lie with these institutions, in the better application of existing guidelines. We explain how below. [colored_box]Earlier this year, the Productivity Commission handed the Australian Government its report on Data Availability and Use and Research Australia is working with the Taskforce within the Prime Minister’s Department who is developing the Government’s response. A particular area of focus for us, as the national peak body for the medical research pipeline, is the Productivity Commission’s recommendations on Human Research Ethics Committees (HRECs). . HRECs are responsible for providing ethics approval for most publicly funded human research in Australia that involves people; the research can’t proceed without it. This includes research as diverse as a clinical trial, where patients are receiving experimental new medications and treatments, to surveys and research using existing datasets- the types of data based research considered by the Productivity Commission. .

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Flying Blind – the Australian Health Data Series: Ethics Reviews, Trust and Mutual Acceptance (Divya Ramachandran | January 2018)

Flying Blind is a series of three reports dedicated to uncovering the acute levels of data fragmentation existing at all levels of Australia’s health landscape.

Our earlier blog posts highlighted the irony of numerous ethical reviews for the same research project, which makes us... More

Flying Blind is a series of three reports dedicated to uncovering the acute levels of data fragmentation existing at all levels of Australia’s health landscape.

Our earlier blog posts highlighted the irony of numerous ethical reviews for the same research project, which makes us wonder about the validity of multiple opinions, besides creating huge administrative burdens and wasted time and costs for the researcher as well as the ethics committees themselves. This is especially the case in studies that evaluate service quality, interventions and outcomes, as they are required to follow patients across several hospitals, health services, local health districts and across jurisdictions, and call for utilizing data from different data collections. Obtaining ethics approvals for such ‘multi-centre’ health research continues to be an onerous exercise for researchers, as they navigate the varying, and sometimes inconsistent requirements of multiple HRECS for the same project.  One recent study described an Australian multi-centre project in which the cost of ethics approvals alone accounted for 38% of the project budget. For a study involving 50 centres the mean cost per site was $6960. In the same study, 75% of time was estimated to have been spent on repeated tasks as well as tasks that were time-intensive, such as re-formatting documents that “did nothing to improve study design or participant safety.” This is just one example of a reality that the health and medical research sector has been dealing with for over two decades. Researchers expressed such frustrations in a 1996 report to the then Federal Minister of Health, claiming that the ethics approval processes existed in isolation from one another, increasing workloads for both researchers and ethics committees.

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Flying Blind – the Australian Health Data Series: The Ethics Quagmire: Case Studies (Uma Srinivasan | August 2017)

Flying Blind is a series of three reports dedicated to uncovering the acute levels of data fragmentation existing at all levels of Australia’s health landscape.

In Flying Blind 2, we have been highlighting the tortuous route of the researcher’s journey, as... More

Flying Blind is a series of three reports dedicated to uncovering the acute levels of data fragmentation existing at all levels of Australia’s health landscape.

In Flying Blind 2, we have been highlighting the tortuous route of the researcher’s journey, as they negotiate the ethics processes and the myriad data sources required for their research. In the next few blogs, Australian health and medical researchers who have been through the journey, present real-life case studies and  back-of-the-envelope calculations of what it takes to identify existing data sets and negotiating the ethics processes, to link the data sets to support their research. What is sad for Australian health research is that these numbers do not reflect reseachers' time spent in actually performing research! We hope the case studies will shine a light on the complexities and the lack of efficiency and transparency around tapping into de-identified pre-existing administrative data sets from multiple states and federal health data sources.

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Friday afternoon’s funny – Peril ahead?

Published/Released on February 14, 2020 | Posted by Admin on February 14, 2020 | Keywords: , , ,

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‘Evidence-Based Medicine’ and the Expulsion of Peter Gøtzsche – Medscape (Daniel Kolitz | December 2019)

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Ethical Procedures? A Critical Intervention: The sacred, the profane, and the planet (Papers: Keyan Tomaselli | 2017))

Published/Released on January 01, 2016 | Posted by Admin on February 13, 2020 | Keywords: , , , , , , , , , ,

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Global Code of Conduct for Research in Resource-Poor Settings (TRUST Resource | May 2018)

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The battle for ethical AI at the world’s biggest machine-learning conference – Nature (Elizabeth Gibney | January 2020)

Bias and the prospect of societal harm increasingly plague artificial-intelligence research — but it’s not clear who should be on the lookout for these problems.

Diversity and inclusion took centre stage... More

Bias and the prospect of societal harm increasingly plague artificial-intelligence research — but it’s not clear who should be on the lookout for these problems.

Diversity and inclusion took centre stage at one of the world’s major artificial-intelligence (AI) conferences in 2018. But once a meeting with a controversial reputation, last month’s Neural Information Processing Systems (NeurIPS) conference in Vancouver, Canada, saw attention shift to another big issue in the field: ethics. [colored_box]The focus comes as AI research increasingly deals with ethical controversies surrounding the application of its technologies — such as in predictive policing or facial recognition. Issues include tackling biases in algorithms that reflect existing patterns of discrimination in data, and avoiding affecting already vulnerable populations. “There is no such thing as a neutral tech platform,” warned Celeste Kidd, a developmental psychologist at University of California, Berkeley, during her NeurIPS keynote talk about how algorithms can influence human beliefs. At the meeting, which hosted a record 13,000 attendees, researchers grappled with how to meaningfully address the ethical and societal implications of their work. . Ethics gap Ethicists have long debated the impacts of AI and sought ways to use the technology for good, such as in health care. But researchers are now realizing that they need to embed ethics into the formulation of their research and understand the potential harms of algorithmic injustice, says Meredith Whittaker, an AI researcher at New York University and founder of the AI Now Institute, which seeks to understand the social implications of the technology. At the latest NeurIPS, researchers couldn’t “write, talk or think” about these systems without considering possible social harms, she says. “The question is, will the change in the conversation result in the structural change we need to actually ensure these systems don’t cause harm?” .

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Friday afternoon’s funny – The specifics of recruitment

Published/Released on February 07, 2020 | Posted by Admin on February 7, 2020 | Keywords: , , , ,

Cartoon by Don Mayne www.researchcartoons.com Full-size image for printing (right mouse click and save file) [colored_box]

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(China) ANU study says China deliberately falsifying data on organ transplants – The Canberra Times (Kirsten Lawson | November 2019)

Published/Released on November 15, 2019 | Posted by Admin on January 31, 2020 | Keywords: , , , , , ,

New research blows the lid on China's claim to have stopped using prisoners and groups such as Falun Gong for organ donation, finding that China appears to have systematically falsified its official data. The Australian National University research, published on Friday, said analysis of the data implied "deliberate human intervention",... More

New research blows the lid on China's claim to have stopped using prisoners and groups such as Falun Gong for organ donation, finding that China appears to have systematically falsified its official data. The Australian National University research, published on Friday, said analysis of the data implied "deliberate human intervention", showing centrally coordinated data falsification "has clearly taken place". Simply, the rise in the numbers of transplants was "too neat to be true" and appeared to be generated using a simple quadratic equation, familiar to high school students.

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Friday afternoon’s funny – Simple language

Published/Released on January 31, 2020 | Posted by Admin on January 31, 2020 | Keywords: , , , ,

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(China) Publishers urged to take stronger stance on Uighur persecution – Times Higher Education (Ellie Bothwell | January 2020)

Scholars say ensuring vulnerable minorities have given consent to use of their data does not go far enough

Academics are pushing journal publishers to take more drastic action in response to China’s crackdown on minority Muslims in the wake of increasing scrutiny over the... More

Scholars say ensuring vulnerable minorities have given consent to use of their data does not go far enough

Academics are pushing journal publishers to take more drastic action in response to China’s crackdown on minority Muslims in the wake of increasing scrutiny over the global science community’s role in the continued persecution. There have been rising concerns over Western journals’ publication of papers focusing on the DNA of minority ethnic groups by Chinese scientists affiliated with the country’s surveillance agencies. More than 1 million Uighurs and other members of predominantly Muslim minority groups are believed to have been locked up in internment camps and there are worries that this research is being used to build databases, facial recognition systems and other methods for monitoring these groups.

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Australian biobank repatriates hundreds of ‘legacy’ Indigenous blood samples – Science (Dyani Lewis | December 2019)

Published/Released on December 23, 2019 | Posted by Admin on January 28, 2020 | Keywords: , , , , , , , , , ,

The return is part of a groundbreaking approach that could inspire other institutions grappling with how to use historical samples ethically in research.

Last month, the Galiwin’ku community of Elcho Island off the coast of northern Australia celebrated the return of more than 200... More

The return is part of a groundbreaking approach that could inspire other institutions grappling with how to use historical samples ethically in research.

Last month, the Galiwin’ku community of Elcho Island off the coast of northern Australia celebrated the return of more than 200 vials of blood that were collected from their ancestors half a century ago, before modern research principles on informed consent existed. Unbeknownst to the Galiwin’ku community, the blood vials had been in freezers at the Australian National University in Canberra ever since. [colored_box]Many Indigenous Australian communities believe that the remains of their people, including blood and hair, must return to their ancestral home, or Country, to be at peace. Having the blood vials returned “meant a lot to us”, says Ross Mandi Wunungmurra, chair of the Yalu Aboriginal Corporation, the community organization that helped negotiate the samples’ return. Mandi is one of several hundred living community members whose own blood was collected after a typhoid outbreak in 1968. ' Before the samples of the deceased were repatriated, the relatives gave permission for DNA to be extracted from the blood, while those still alive offered fresh samples. The genetic information will be stored in the biobank of the National Centre for Indigenous Genomics (NCIG), which the Australian National University (ANU) established specifically to manage its historical samples. .

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The Secretive Company That Might End Privacy as We Know It – New York Times (Kashmir Hill | January 2020)

Published/Released on January 18, 2020 | Posted by Admin on January 26, 2020 | Keywords: , , , , , ,

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Evaluating ethics oversight during assessment of research integrity (Papers: Andrew Grey, et al | November 2019)

Published/Released on January 24, 2020 | Posted by Admin on January 24, 2020 | Keywords: , , , , , ,

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Friday afternoon’s funny – Consent… b o r i n g

Published/Released on January 24, 2020 | Posted by Admin on January 24, 2020 | Keywords: , , , , ,

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There’s ‘consent’ and then there’s consent: Mobilising Māori and Indigenous research ethics to problematise the western biomedical model (Papers: Kiri West-McGruer | January 2020)

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(US) FDA and NIH let clinical trial sponsors keep results secret and break the law – Science (Charles Piller | January 2020)

Published/Released on January 13, 2020 | Posted by Admin on January 21, 2020 | Keywords: , , , , , , ,

For 20 years, the U.S. government has urged companies, universities, and other institutions that conduct clinical trials to record their results in a federal database, so doctors and patients can see whether new treatments are safe and effective. Few trial sponsors have consistently done so, even after a 2007... More

For 20 years, the U.S. government has urged companies, universities, and other institutions that conduct clinical trials to record their results in a federal database, so doctors and patients can see whether new treatments are safe and effective. Few trial sponsors have consistently done so, even after a 2007 law made posting mandatory for many trials registered in the database. In 2017, the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) tried again, enacting a long-awaited “final rule” to clarify the law’s expectations and penalties for failing to disclose trial results. The rule took full effect 2 years ago, on 18 January 2018, giving trial sponsors ample time to comply. But a Science investigation shows that many still ignore the requirement, while federal officials do little or nothing to enforce the law. [colored_box]Science examined more than 4700 trials whose results should have been posted on the NIH website ClinicalTrials.gov under the 2017 rule. Reporting rates by most large pharmaceutical companies and some universities have improved sharply, but performance by many other trial sponsors—including, ironically, NIH itself—was lackluster. Those sponsors, typically either the institution conducting a trial or its funder, must deposit results and other data within 1 year of completing a trial. But of 184 sponsor organizations with at least five trials due as of 25 September 2019, 30 companies, universities, or medical centers never met a single deadline. As of that date, those habitual violators had failed to report any results for 67% of their trials and averaged 268 days late for those and all trials that missed their deadlines. They included such eminent institutions as the Harvard University–affiliated Boston Children’s Hospital, the University of Minnesota, and Baylor College of Medicine—all among the top 50 recipients of NIH grants in 2019. . The violations cover trials in virtually all fields of medicine, and the missing or late results offer potentially vital information for the most desperate patients. For example, in one long-overdue trial, researchers compared the efficacy of different chemotherapy regimens in 200 patients with advanced lymphoma; another—nearly 2 years late—tests immunotherapy against conventional chemotherapy in about 600 people with late-stage lung cancer. .

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Research Ethics in an Unethical World: The Politics and Morality of Engaged Research (Claudio Morrison and Devi Sacchetto | October 2017)

Abstract This article explores ethical dilemmas in researching the world of work. Recent contributions to Work, employment and society have highlighted challenges for engaged research. Based on the emancipatory epistemologies of Bourdieu, Gramsci and Burawoy, the authors examine moral challenges in workplace fieldwork, question the assumptions... More

Abstract This article explores ethical dilemmas in researching the world of work. Recent contributions to Work, employment and society have highlighted challenges for engaged research. Based on the emancipatory epistemologies of Bourdieu, Gramsci and Burawoy, the authors examine moral challenges in workplace fieldwork, question the assumptions of mainstream ethics discourses and seek to identify an alternative approach. Instead of an ethics premised on a priori, universal precepts that treasure academic neutrality, this article recognises a morality that responds to the social context of research with participation and commitment. The reflection in this study is based on fieldwork conducted in the former Soviet Union. Transformation societies present challenges to participatory ethnography but simultaneously provide considerable opportunities for developing an ethics of truth. An approach that can guide engaged researchers through social conflict’s ‘messy’ reality should hinge on loyalty to the emancipation struggles of those engaged in it. Keywords business and management research, ethics, materialism, post-socialism, qualitative fieldwork, workplace morality

Morrison, C., & Sacchetto, D. (2018). Research Ethics in an Unethical World: The Politics and Morality of Engaged Research. Work, Employment and Society, 32(6), 1118–1129. https://doi.org/10.1177/0950017017726947 Publisher: https://journals.sagepub.com/doi/abs/10.1177/0950017017726947#articleCitationDownloadContainer

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Google health-data scandal spooks researchers – Science (Heidi Ledford | November 2019)

Scientists fear the controversy over the Nightingale project will undermine trust in research.

Google and one of the largest health-care networks in the United States are embroiled in a data-privacy controversy that researchers fear could jeopardize public trust in data-sharing practices and, potentially, academic... More

Scientists fear the controversy over the Nightingale project will undermine trust in research.

Google and one of the largest health-care networks in the United States are embroiled in a data-privacy controversy that researchers fear could jeopardize public trust in data-sharing practices and, potentially, academic studies. At issue is a project dubbed Nightingale that gives Google access to the health-care information, including names and other identifiable data, of tens of millions of people without their knowledge. The people were treated at facilities run by the health network Ascension, which is based in St Louis, Missouri. Google says that Nightingale, first reported in The Wall Street Journal on 11 November, is meant to develop technology that would enable Ascension to deliver improved health care.

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Friday afternoon’s funny – Research during a disaster

Published/Released on January 10, 2020 | Posted by Admin on January 10, 2020 | Keywords: , , , , , , ,

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China Uses DNA to Map Faces, With Help From the West – New York Times ( Sui-Lee Wee & Paul Mozur | December 2019)

TUMXUK, China — In a dusty city in the Xinjiang region on China’s western frontier, the authorities are testing the rules of science.

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TUMXUK, China — In a dusty city in the Xinjiang region on China’s western frontier, the authorities are testing the rules of science.

[colored_box]With a million or more ethnic Uighurs and others from predominantly Muslim minority groups swept up in detentions across Xinjiang, officials in Tumxuk have gathered blood samples from hundreds of Uighurs — part of a mass DNA collection effort dogged by questions about consent and how the data will be used. .

In Tumxuk, at least, there is a partial answer: Chinese scientists are trying to find a way to use a DNA sample to create an image of a person’s face. .

The technology, which is also being developed in the United States and elsewhere, is in the early stages of development and can produce rough pictures good enough only to narrow a manhunt or perhaps eliminate suspects. But given the crackdown in Xinjiang, experts on ethics in science worry that China is building a tool that could be used to justify and intensify racial profiling and other state discrimination against Uighurs. .

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Misrepresenting “Usual Care” in Research: An Ethical and Scientific Error (Papers: Ruth Macklin, Charles Natanson | January 2020)

Abstract Comparative effectiveness studies, referred to here as "usual-care" trials, seek to compare current medical practices for the same medical condition. Such studies are presumed to be safe and involve only minimal risks. However, that presumption may be flawed if the trial design contains "unusual" care,... More

Abstract Comparative effectiveness studies, referred to here as "usual-care" trials, seek to compare current medical practices for the same medical condition. Such studies are presumed to be safe and involve only minimal risks. However, that presumption may be flawed if the trial design contains "unusual" care, resulting in potential risks to subjects and inaccurately informed consent. Three case studies described here did not rely on clinical evidence to ascertain contemporaneous practice. As a result, the investigators drew inaccurate conclusions, misinformed research participants, and subjects' safety was compromised. Before approving usual-care protocols, IRBs and scientific review committees should evaluate the quality and completeness of information documenting usual-care practices. Guidance from governmental oversight agencies regarding evidence-based documentation of current clinical practice could prevent similar occurrences in future usual-care trials. Accurate information is necessary to ensure that trials comply with government regulations that require minimizing research risks to subjects and accurate informed consent documents. KEYWORDS: Human subjects research; IRB (Institutional Review Board); informed consent; risk/benefit analysis

Macklin, R. & Natanson, C. (2019) Misrepresenting “Usual Care” in Research: An Ethical and Scientific Error. Americaan Journal of Bioethics. 20(1):31-39. doi: 10.1080/15265161.2019.1687777. Publisher: https://www.tandfonline.com/doi/full/10.1080/15265161.2019.1687777

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Reasoning “Uncharted Territory”: Notions of Expertise Within Ethics Review Panels Assessing Research Use of Social Media (Papers: Chelsea Sellers, et al | February 2019 )

Published/Released on February 14, 2019 | Posted by Admin on January 5, 2020 | Keywords: , , ,

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(China/Gene) Chinese scientist who produced genetically altered babies sentenced to 3 years in jail – Science (Dennis Normile | December 2019)

He Jiankui, the Chinese researcher who stunned the world last year by announcing he had helped produce genetically edited babies, has been found guilty of conducting “illegal medical practices” and sentenced to 3 years in prison. [colored_box]A court in Shenzhen found that He and two collaborators forged... More

He Jiankui, the Chinese researcher who stunned the world last year by announcing he had helped produce genetically edited babies, has been found guilty of conducting “illegal medical practices” and sentenced to 3 years in prison. [colored_box]A court in Shenzhen found that He and two collaborators forged ethical review documents and misled doctors into unknowingly implanting gene-edited embryos into two women, according to Xinhua, China’s state-run press agency. One mother gave birth to twin girls in November 2018; it has not been made clear when the third baby was born. The court ruled that the three defendants had deliberately violated national regulations on biomedical research and medical ethics, and rashly applied gene-editing technology to human reproductive medicine. . All three pleaded guilty, according to Xinhua. The court also fined He, formerly of the Southern University of Science and Technology (SUSTech) and known as JK to friends and colleagues, 3 million Chinese yuan ($429,000). His collaborators were identified as Zhang Renli, of a medical institution in Guangdong province, and Qin Jinzhou, from a Shenzhen medical institution; Zhang received a 2-year prison sentence and was fined 1 million yuan, according to Xinhua, whereas Qin was given 18 months in prison with a 2-year reprieve, and a 500,000 yuan fine. .

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Sample and data sharing barriers in biobanking: consent, committees, and compromises (Paper: Flora Colledge MA, et al | December 2013)

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(China) Academic misconduct standards to be tightened – China Daily Global (Li Yan | October 2019)

China has strengthened its fight against academic misconduct by publishing new standards defining plagiarism, fabrication, falsification and other violations of research integrity. Experts believe the clarity will make it easier to discipline researchers who violate the rules. The document, issued by the Ministry of Science and Technology, has been adopted... More

China has strengthened its fight against academic misconduct by publishing new standards defining plagiarism, fabrication, falsification and other violations of research integrity. Experts believe the clarity will make it easier to discipline researchers who violate the rules. The document, issued by the Ministry of Science and Technology, has been adopted by 20 government agencies ranging from China's Supreme People's Court to the Chinese Academy of Sciences. Depending on the severity of the offense, punishments can range from canceling a project's funding to revoking the offender's titles and permanently banning them from promotion or other research positions. Institutes that connive with or shield violators will also be punished with budget cuts or judicial action.

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How about personally optimized treatment? – The Ethics Blog (Pär Segerdahl | March 2019)

Published/Released on March 06, 2019 | Posted by Admin on December 31, 2019 | Keywords: , , , , , , ,

It is well known that patients who are asked to participate in cancer trials are tempted by the therapeutic misconception. They believe they are offered a newer and better treatment, when in fact it is about research into an untested treatment. When researchers use genetic tests to develop personalized... More

It is well known that patients who are asked to participate in cancer trials are tempted by the therapeutic misconception. They believe they are offered a newer and better treatment, when in fact it is about research into an untested treatment. When researchers use genetic tests to develop personalized oncology, even more misconceptions can arise. I will soon explain. But first, what is personalized cancer treatment? Here is an example. Patients whose tumor is to be operated may undergo preparatory radiation or chemotherapy. Since the preparatory therapy has severe side effects, one wants to avoid giving it to patients whose tumors do not respond to it. The challenge is to distinguish patients who respond to treatment from patients who do not. This is to be accomplished through, among other things, genetic tests on the tumor cells. If this works, you can develop personalized cancer treatment. Patients with the “right” tumor cell genetics receive the preparatory therapy, while patients who, according to the genetic tests, only get the side effects, with no effect on tumor growth, do not receive the therapy. What are the misconceptions that can arise in patients who are asked to participate in research on personalized cancer treatment? Here are some examples.

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Holiday funny – New Years resolutions for your research ethics committee

Published/Released on December 31, 2019 | Posted by Admin on December 31, 2019 | Keywords: , , ,

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(US) This Researcher Exploited Prisoners, Children, and the Elderly. Why Does Penn Honor Him? – The Chronicle of Higher Education (Alexander Kafka, | November 2019)

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(China) Science publishers review ethics of research on Chinese minority groups – Nature (Richard Van Noorden & Davide Castelvecchi | December 2019)

Springer Nature and Wiley have concerns about lack of consent in genetics and facial-recognition papers.

Two science publishers are reviewing the ethics of research papers in which scientists backed by China’s government used DNA or facial-recognition technology to study minority groups in the country,... More

Springer Nature and Wiley have concerns about lack of consent in genetics and facial-recognition papers.

Two science publishers are reviewing the ethics of research papers in which scientists backed by China’s government used DNA or facial-recognition technology to study minority groups in the country, such as the predominantly Muslim Uyghur population. Springer Nature (which publishes Nature) and Wiley want to check that the study participants gave informed consent, after researchers and journalists raised concerns that the papers were connected to China’s heavy surveillance operations in the northwestern province of Xinjiang. China has attracted widespread international condemnation — and US sanctions — for mass detentions and other human-rights violations in the province. The Chinese government says that it is conducting a re-education campaign in the region to quell what it calls a terrorist movement. “We are very concerned about research which involves consent from vulnerable populations,” says a spokesperson from Springer Nature (Nature’s news team is editorially independent of its publisher).

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(Europe) Psychology researcher committed misconduct, says university – Retraction Watch (Adam Marcus | December 2019)

Published/Released on December 24, 2019 | Posted by Admin on December 24, 2019 | Keywords: , , , , , , , ,

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Friday afternoon’s funny – Disaster recovery plan

Published/Released on December 20, 2019 | Posted by Admin on December 20, 2019 | Keywords: , , ,

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International Policy Frameworks for Consent in Minimal-risk Pragmatic Trials (Papers: Tanya J. Symons, et al | November 2019)

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‘A long and lonely process:’ Whistleblowers in a misconduct case speak out – Retraction Watch (Ivan Oransky | )

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(China) Ideological ‘rectification’ hits social sciences research – University World News (Yojana Sharma | December 2019)

Social sciences research in China, not as well funded in the past as the hard sciences, is undergoing an even further narrowing so that research more closely serves the purposes of the state, experts have said, with some going as far as to say social sciences in China have... More

Social sciences research in China, not as well funded in the past as the hard sciences, is undergoing an even further narrowing so that research more closely serves the purposes of the state, experts have said, with some going as far as to say social sciences in China have undergone political rectification under Chinese leader Xi Jinping. As part of China’s control over the intelligentsia, there has been greater focus on moulding the social sciences, including law, economics, political science, sociology and ethnic studies, to be politically correct, according to Carl Minzner, professor of law at Fordham University, New York, and an expert on Chinese law and politics. “In the past four or five years they [the Chinese leadership] have been in an effort to politically sanitise the social sciences in China,” Minzner told University World News. “They were worried that they had lost control over the narrative, and that there were too many critical voices emerging within university classrooms in China.”

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(China) China’s Genetic Research on Ethnic Minorities Sets Off Science Backlash – New York Times (By Sui-Lee Wee and Paul Mozur | December 2019)

Published/Released on December 04, 2019 | Posted by Admin on December 12, 2019 | Keywords: , , , , , , , , , , , ,

Scientists are raising questions about the ethics of studies backed by Chinese surveillance agencies. Prestigious journals are taking action.

BEIJING — China’s efforts to study the DNA of the country’s ethnic minorities have incited a growing backlash from the global scientific community, as a... More

Scientists are raising questions about the ethics of studies backed by Chinese surveillance agencies. Prestigious journals are taking action.

BEIJING — China’s efforts to study the DNA of the country’s ethnic minorities have incited a growing backlash from the global scientific community, as a number of scientists warn that Beijing could use its growing knowledge to spy on and oppress its people. Two publishers of prestigious scientific journals, Springer Nature and Wiley, said this week that they would re-evaluate papers they previously published on Tibetans, Uighurs and other minority groups. The papers were written or co-written by scientists backed by the Chinese government, and the two publishers want to make sure the authors got consent from the people they studied. Springer Nature, which publishes the influential journal Nature, also said that it was toughening its guidelines to make sure scientists get consent, particularly if those people are members of a vulnerable group.

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Disaster-zone research needs a code of conduct – Nature (JC Gaillard & Lori Peek | November 2019)

Published/Released on November 20, 2019 | Posted by Admin on December 10, 2019 | Keywords: , , , , , , , , , , ,

Study the effects of earthquakes, floods and other natural hazards with sensitivity to ethical dilemmas and power imbalances.

A magnitude-7.0 earthquake rocked Anchorage, Alaska, in late November 2018. Roads buckled and chimneys tumbled from rooftops. Business operations were disrupted. Schools were damaged across the... More

Study the effects of earthquakes, floods and other natural hazards with sensitivity to ethical dilemmas and power imbalances.

A magnitude-7.0 earthquake rocked Anchorage, Alaska, in late November 2018. Roads buckled and chimneys tumbled from rooftops. Business operations were disrupted. Schools were damaged across the district. This was the largest earthquake to shake the region in a generation, and there was much to learn. What was the state of the infrastructure? Might further quakes occur? How did people respond? Teams of scientists and engineers from across the United States mobilized to conduct field reconnaissance in partnership with local researchers and practitioners. These efforts were coordinated through the clearing house set up by the Earthquake Engineering Research Institute in Oakland, California, which provided daily in-person and online briefings, as well as a web portal for sharing data. [colored_box]But researchers are not always so welcome in disaster zones. After the deadly Indian Ocean earthquake and tsunami on 26 December 2004, hundreds of academics from countries including Japan, Russia, France and the United States rushed to the region to collect perishable data. This influx of foreign scientists angered and fatigued some locals; many declined researchers’ requests for interviews. The former governor of Aceh province, Indonesia, where more than 128,000 people died, described foreign researchers as “guerrillas applying hit-and-run tactics”1. Yet research on tsunami propagation and people’s response to the event has led to improved warnings and emergency-response plans. . When, on 28 September 2018, an earthquake and tsunami hit the Indonesian island of Sulawesi, dozens of researchers found themselves unable to enter the country2. Indonesian law now requires foreign scientists to obtain a special visa before they can begin research. Data-collection protocols must be submitted to the government in advance and projects must have an Indonesian partner. Violators could face criminal charges and even prison. .

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Friday afternoon’s funny – Santa and the future study coordinator

Published/Released on December 06, 2019 | Posted by Admin on December 6, 2019 | Keywords: , , , ,

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Disgraced tracheal transplant surgeon is handed 16 month prison sentence in Italy (Papers: Michael Day | November 2019)

Disgraced surgeon Paolo Macchiarini, who faked research relating to dangerous and largely discredited tracheal transplants, has been handed a 16 month prison sentence in Italy for forging documents and abuse of office. Macchiarini made headlines around the world after claiming a major breakthrough for patients with failing windpipes, by “seeding”... More

Disgraced surgeon Paolo Macchiarini, who faked research relating to dangerous and largely discredited tracheal transplants, has been handed a 16 month prison sentence in Italy for forging documents and abuse of office. Macchiarini made headlines around the world after claiming a major breakthrough for patients with failing windpipes, by “seeding” an artificial scaffold with a patient’s own stem cells, to generate a functioning trachea. But excitement at the prospect of a genuine medical advance turned to scandal when it emerged that Macchiarini had falsified results and misled hospital authorities regarding the health of those receiving the experimental procedures. The revelation prompted his research centre, the Karolinska Institute, to eventually disown his …

Day, M. (2019) Disgraced tracheal transplant surgeon is handed 16 month prison sentence in Italy. BMJ. 367:l6676. doi: 10.1136/bmj.l6676. No abstract available. PMID: 31767600 Publisher: https://www.bmj.com/content/367/bmj.l6676

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What’s the Harm? The Coverage of Ethics and Harm Avoidance in Research Methods Textbooks (Papers: Shane Dixon and Linda Quirke | June 2017)

Published/Released on June 02, 2017 | Posted by Admin on December 3, 2019 | Keywords: , , , , , , , ,

Abstract Methods textbooks play a role in socializing a new generation of researchers about ethical research. How do undergraduate social research methods textbooks portray harm, its prevalence, and ways to mitigate harm to participants? We conducted a content analysis of ethics chapters in the 18 highest-selling... More

Abstract Methods textbooks play a role in socializing a new generation of researchers about ethical research. How do undergraduate social research methods textbooks portray harm, its prevalence, and ways to mitigate harm to participants? We conducted a content analysis of ethics chapters in the 18 highest-selling undergraduate textbooks used in sociology research methods courses in the United States and Canada in 2013. We found that experiments are portrayed as the research design most likely to harm participants. Textbooks overwhelmingly referred to high-profile, well-known examples of harmful research. Chapters primarily characterize participants as at risk for psychological and physical harm. Textbooks engage in detailed discussions of how to avoid harm; informed consent figures prominently as an essential way to mitigate risk of harm. We conclude that textbooks promote a procedural rather than nuanced approach to ethics and that content in ethics chapters is out of step with scholarly research in research ethics. Keywords ethics, research methods, textbooks, harm, participants

Dixon, S., & Quirke, L. (2018). What’s the Harm? The Coverage of Ethics and Harm Avoidance in Research Methods Textbooks. Teaching Sociology, 46(1), 12–24. https://doi.org/10.1177/0092055X17711230 Publisher (Open Access): https://journals.sagepub.com/doi/10.1177/0092055X17711230

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Participant understanding and recall of informed consent for induced pluripotent stem cell biobanking (Papers: Tristan McCaughey, et al | 2016)

Published/Released on June 14, 2016 | Posted by Admin on December 1, 2019 | Keywords: , , , ,

Abstract The ability to generate human induced pluripotent stem cells (iPSCs) has opened new avenues for human disease modelling and therapy. The aim of our study was to determine research participants’ understanding of the information given when donating skin biopsies for the generation of patient-specific iPSCs.... More

Abstract The ability to generate human induced pluripotent stem cells (iPSCs) has opened new avenues for human disease modelling and therapy. The aim of our study was to determine research participants’ understanding of the information given when donating skin biopsies for the generation of patient-specific iPSCs. A customised 35-item questionnaire based on previous iPSC consent guidelines was sent to participants who had previously donated samples for iPSC research. The questionnaire asked pertinent demographic details, participants' motivation to take part in iPSC research and their attitudes towards related ethical issues. 234 participants were contacted with 141 (60.3 %) complete responses received. The median duration between recruitment and follow-up questioning was 313 days (range 10–573 days). The majority of participants (n = 129, 91.5 %) believed they understood what a stem cell was; however, only 22 (16.1 %) correctly answered questions related to basic stem cell properties. We found no statistically significant difference in responses from participants with different levels of education, or those with a health sciences background. The poor understanding amongst participants of iPSC research is unlikely to be unique to our study and may impact future research if not improved. As such, there is a need to develop an easily understood yet comprehensive consent process to ensure ongoing ethical progress of iPSC biobanking. Keywords Stem cell, Informed consent, HeLa, Biobank

McCaughey T., Chen C.Y., De Smit E., Rees G., Fenwick E., Kearns L.S., Mackey D.A., MacGregor C., Munsie M., Cook A.L., Pébay A. & Hewitt A.W. (2016) Participant understanding and recall of informed consent for induced pluripotent stem cell biobanking. Cell and Tissue Banking. 17: 449. https://doi.org/10.1007/s10561-016-9563-8 Publisher: https://link.springer.com/article/10.1007%2Fs10561-016-9563-8
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Breakthrough Gene Therapy Clinical Trial is the World’s First That Aims to Reverse 20 Years of Aging in Humans – CISION (Osvaldo R. Martinez-Clark | November 2019)

Published/Released on November 21, 2019 | Posted by Admin on November 28, 2019 | Keywords: , , , , , , , ,

This is the world's first IRB-approved clinical trial aimed at reversing aging by at least 20 years; it is also the world's most expensive pay-to-play trial with a one million price tag to enroll.

[colored_box]MANHATTAN, Kan., Nov. 21, 2019 /PRNewswire/ -- Libella Gene Therapeutics,... More

This is the world's first IRB-approved clinical trial aimed at reversing aging by at least 20 years; it is also the world's most expensive pay-to-play trial with a one million price tag to enroll.

[colored_box]MANHATTAN, Kan., Nov. 21, 2019 /PRNewswire/ -- Libella Gene Therapeutics, LLC ("Libella") announces an institutional review board (IRB)-approved pay-to-play clinical trial in Colombia (South America) using gene therapy that aims to treat and ultimately cure aging. This could lead to Libella offering the world's only treatment to cure and reverse aging by 20 years. . Under Libella's pay-to-play model, trial participants will be enrolled in their country of origin after paying $1 million. Participants will travel to Colombia to sign their informed consent and to receive the Libella gene therapy under a strictly controlled hospital environment. . Traditionally, aging has been viewed as a natural process. This view has shifted, and now scientists believe that aging should be seen as a disease. The research in this field has led to the belief that the kingpin of aging in humans is the shortening of our telomeres. . Telomeres are the body's biological clock. Every time a cell divides, telomeres shorten, and our cells become less efficient at dividing again. This is why we age. A significant number of scientific peer-reviewed studies have confirmed this. Some of these studies have shown actual age reversal in every way imaginable simply by lengthening telomeres. .

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Holiday funny – Potential participant duped

Published/Released on November 28, 2019 | Posted by Admin on November 28, 2019 | Keywords: , , , , ,

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Wildlife Cameras Are Accidentally Capturing Humans Behaving Badly – Nature (James Dinneen | November 2019)

Published/Released on November 14, 2019 | Posted by Admin on November 25, 2019 | Keywords: , , , , , , , , ,

Scientists face an ethical dilemma over what to do with their ‘human bycatch’

To study wildlife, Dr. Nyeema Harris, an assistant professor in the Ecology and Evolutionary Biology Department at the University of Michigan, uses camera traps — remotely triggered cameras that take pictures when... More

Scientists face an ethical dilemma over what to do with their ‘human bycatch’

To study wildlife, Dr. Nyeema Harris, an assistant professor in the Ecology and Evolutionary Biology Department at the University of Michigan, uses camera traps — remotely triggered cameras that take pictures when they detect movement and body heat. Harris, a wildlife biologist, is not typically interested in humans, but sometimes they still end up in her photographs.

[colored_box]Between 2016 and 2018, Harris led the first published camera trap survey ever conducted in Burkina Faso and Niger, originally conceived to focus on the critically endangered West African lion. But Harris ended up capturing so much human activity that she expanded the focus of her study to include how humans were using the area. Research on human activity in the wildlife preserve had typically relied on humans reporting their own actions, but with the cameras, Harris could see what they were actually doing. “The data emerged to be a really interesting story that I felt compelled to tell,” Harris says. .

Even in studies conducted in remote nature reserves, meant to capture wildlife at its wildest, people showed up. .

When camera traps inadvertently capture human activity, it’s called “human bycatch.” And according to a 2018 University of Cambridge study, Harris is far from the only researcher to have ended up with humans in the data. The study included a survey of 235 scientists across 65 countries about their experiences with human bycatch, and 90% of them reported capturing some images of people in their most recent projects. Even in studies conducted in remote nature reserves, meant to capture wildlife at its wildest, people showed up. .

As in Harris’s study, this human data doesn’t always stay “bycatch.” Nearly half of respondents to the Cambridge survey said they had used images of people apparently involved in illegal activity to inform wildlife management efforts. Many of them had reported images to law enforcement, others to conservation staff, and some to the media. All this, despite only 8% of projects having set out to capture images of people. .

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(Australia) Skin cancer doctor in hot water after papers retracted – The Age (Liam Mannix and Tom Cowie | November 2019)

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23andMe, moving beyond consumer DNA tests, is building a clinical trial recruitment business – STAT (Rebecca Robbins | September 2019)

S... More

SAN FRANCISCO — Consumer genetics giant 23andMe announced Thursday that it would move deeper into the business of clinical trial recruitment, partnering with a fast-growing startup to help match its customers with nearby study sites based on their diseases, demographics, and DNA. [colored_box]The Silicon Valley company has for months been quietly making inroads into clinical trial recruitment by emailing customers who’ve opted in with recommendations about studies that might be appropriate for them. It has recruited for studies, both interventional and observational, in disease areas including Alzheimer’s, Parkinson’s, attention-deficit hyperactivity disorder, eczema, and liver disease, a spokesperson for the company confirmed. . But the new partnership with TrialSpark, which offers a tech-powered alternative to traditional contract research organizations, may help 23andMe address one of the biggest challenges in clinical trial recruitment: geography. The idea is that patients who want to enroll in a clinical trial centered out of, say, Memorial Sloan Kettering Cancer Center, won’t have to fly to New York and can instead participate by visiting their local doctor’s office. .

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Involve (NIHR | Established 1996, latest news August 2019)

INVOLVE was established in 1996 and is part of, and funded by, the National Institute for Health Research, to support active public involvement in NHS, public health and social care research. It is one of the few government funded programmes of its kind... More

INVOLVE was established in 1996 and is part of, and funded by, the National Institute for Health Research, to support active public involvement in NHS, public health and social care research. It is one of the few government funded programmes of its kind in the world. As a national advisory group our role is to bring together expertise, insight and experience in the field of public involvement in research, with the aim of advancing it as an essential part of the process by which research is identified, prioritised, designed, conducted and disseminated. The Impact of public involvement in NIHR health and social care research is defined as: “The changes, benefits and learning gained from the insights and experiences of patients, carers and the public when working in partnership with researchers and others involved in NIHR initiatives”

Supporting statement: By public involvement we mean research being carried out ‘with’ or ‘by’ members of the public rather than ‘to’, ‘about’ or ‘for’ them as defined by NIHR INVOLVE.

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The female problem: how male bias in medical trials ruined women’s health – The Guardian (Gabrielle Jackson | November 2019)

Centuries of female exclusion has meant women’s diseases are often missed, misdiagnosed or remain a total mystery

From the earliest days of medicine, women have been considered inferior versions of men. In On the Generation of Animals, the Greek philosopher Aristotle characterised... More

Centuries of female exclusion has meant women’s diseases are often missed, misdiagnosed or remain a total mystery

From the earliest days of medicine, women have been considered inferior versions of men. In On the Generation of Animals, the Greek philosopher Aristotle characterised a female as a mutilated male, and this belief has persisted in western medical culture. [colored_box]“For much of documented history, women have been excluded from medical and science knowledge production, so essentially we’ve ended up with a healthcare system, among other things in society, that has been made by men for men,” Dr Kate Young, a public health researcher at Monash University in Australia, tells me. . Young’s research has uncovered how doctors fill knowledge gaps with hysteria narratives. This is particularly prevalent when women keep returning to the doctor, stubbornly refusing to be saved. . “The historical hysteria discourse was most often endorsed when discussing ‘difficult’ women, referring to those for whom treatment was not helpful or who held a perception of their disease alternative to their clinician,” Young wrote in a research paper published in the journal Feminism & Psychology. .

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Ethical research — the long and bumpy road from shirked to shared – Nature (Sarah Franklin | October 2019)

Published/Released on October 29, 2019 | Posted by Admin on November 10, 2019 | Keywords: , , , , , ,

From all too scarce, to professionalized, the ethics of research is now everybody’s business, argues Sarah Franklin in the sixth essay in a series on how the past 150 years have shaped science, marking Nature’s anniversary.

In the autumn of 1869, Charles Darwin was... More

From all too scarce, to professionalized, the ethics of research is now everybody’s business, argues Sarah Franklin in the sixth essay in a series on how the past 150 years have shaped science, marking Nature’s anniversary.

In the autumn of 1869, Charles Darwin was hard at work revising the fifth edition of On The Origin of Species and drafting his next book, The Descent of Man, to be published in 1871. As he finished chapters, Darwin sent them to his daughter, Henrietta, to edit — hoping she could help to head off the hostile responses to his debut, including objections to the implication that morality and ethics could have no basis in nature, because nature had no purpose. That same year, Darwin’s cousin Francis Galton published Hereditary Genius, a book that recast natural selection as a question of social planning1. Galton argued that human abilities were differentially inherited, and introduced a statistical methodology to aid “improvement of the race”. Later, he coined the term ‘eugenics’ to advocate selective reproduction through application of the breeder’s guiding hand. Darwin’s transformative theory inspired modern biology; Galton’s attempt to equate selection and social reform spawned eugenics. The ethical dilemmas engendered by these two late-nineteenth-century visions of biological control proliferate still. And, as older quandaries die out, they are replaced by more vigorous descendants. That there has never been a border between ethics and biology remains as apparent today as it was 150 years ago. The difference is that many of the issues, such as the remodelling of future generations or the surveillance of personal data, have become as everyday as they are vast in their implications. To work out how to move forward, it is worth looking at how we got here.

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Data Management Expert Guide (Guidance: CESSDA | December 2017)

This guide is designed by European experts to help social science researchers make their research data Findable, Accessible, Interoperable and Reusable (FAIR). You will be guided by different European experts who are - on a daily basis - busy ensuring long-term access to valuable social science datasets, available for discovery... More

This guide is designed by European experts to help social science researchers make their research data Findable, Accessible, Interoperable and Reusable (FAIR). You will be guided by different European experts who are - on a daily basis - busy ensuring long-term access to valuable social science datasets, available for discovery and reuse at one of the CESSDA social science data archives. Target audience and mission This guide is written for social science researchers who are in an early stage of practising research data management. With this guide, CESSDA wants to contribute to professionalism in data management and increase the value of research data.

Overview If you follow the guide, you will travel through the research data lifecycle from planning, organising, documenting, processing, storing and protecting your data to sharing and publishing them. Taking the whole roundtrip will take you approximately 15 hours, however you can also hop on and off at any time.

CESSDA Training Working Group (2017 - 2018). CESSDA Data Management Expert Guide. Bergen, Norway: CESSDA ERIC. Retrieved from https://www.cessda.eu/DMGuide

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Former GP Spurs 20+ Retractions Over Forced Transplants From Chinese Prisoners – Medspace (Diana Swift | October 2019)

In her second career as a bioethicist, a former ge... More

In her second career as a bioethicist, a former general practitioner is reshaping the scientific literature of organ transplantation. From 1983 to 2000, Wendy Rogers, BMBS, practiced primary care medicine in different settings in the United Kingdom and Australia. In the latter country, the single mother of two grew disillusioned with the fee-for-service system, so while she was pondering her future, she decided to change course, leaving practice to take a degree in English literature and philosophy that led to a doctorate in philosophy. Medicine's loss was medical ethics' gain. Now a professor of clinical ethics at Macquarie University in Sydney, Australia, Rogers' work to draw attention to scientific research that used organ transplants from executed prisoners in China have led to at least 20 retractions, and counting.

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Why research ethics should add retrospective review (Papers: Angus Dawson, et al | October 2019)

Published/Released on October 10, 2019 | Posted by Admin on October 26, 2019 | Keywords: , , , ,

Abstract Research ethics is an integral part of research, especially that involving human subjects. However, concerns have been expressed that research ethics has come to be seen as a procedural concern focused on a few well-established ethical issues that researchers need to address to obtain ethical... More

Abstract Research ethics is an integral part of research, especially that involving human subjects. However, concerns have been expressed that research ethics has come to be seen as a procedural concern focused on a few well-established ethical issues that researchers need to address to obtain ethical approval to begin their research. While such prospective review of research is important, we argue that it is not sufficient to address all aspects of research ethics. We propose retrospective review as an important complement to prospective review. We offer two arguments to support our claim that prospective review is insufficient. First, as currently practiced, research ethics has become for some a ‘tick box’ exercise to get over the ‘hurdle’ of ethics approval. This fails to capture much of what is important in ethics and does not promote careful reflection on the ethical issues involved. Second, the current approach tends to be rules-based and we argue that research ethics should go beyond this to develop people’s capacity to be sensitive to the relevant moral features of their research, their ethical decision-making skills and their integrity. Retrospective review of a project’s ethical issues, and how they were addressed, could help to achieve those aims better. We believe that a broad range of stakeholders should be involved in such retrospective review, including representatives of ethics committees, participating communities and those involved in the research. All stakeholders could then learn from others’ perspectives and experiences. An open and transparent assessment of research could help to promote trust and understanding between stakeholders, as well as identifying areas of agreement and disagreement and how these can be built upon or addressed. Retrospective review also has the potential to promote critical reflection on ethics and help to develop ethical sensitivity and integrity within the research team. Demonstrating this would take empirical evidence and we suggest that any such initiatives should be accompanied by research into their effectiveness. Our article concludes with a discussion of some possible objections to our proposal, and an invitation to further debate and discussion.

Dawson, A., Lignou, S., Siriwardhana, C. and O’Mathúna, D.P. (2019) Why research ethics should add retrospective review. BMC Medical Ethics 20: 68 Publisher (Open Access): https://bmcmedethics.biomedcentral.com/articles/10.1186/s12910-019-0399-1

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Scientists ‘may have crossed ethical line’ in growing human brains – The Guardian (Ian Sample | )

Debate needed over research with ‘potential for something to suffer’, neuroscientists say

Neuroscientists may have crossed an “ethical rubicon” by growing lumps of human brain in the lab, and in some cases transplanting the tissue into animals, researchers warn. The creation of mini-brains or brain... More

Debate needed over research with ‘potential for something to suffer’, neuroscientists say

Neuroscientists may have crossed an “ethical rubicon” by growing lumps of human brain in the lab, and in some cases transplanting the tissue into animals, researchers warn. The creation of mini-brains or brain “organoids” has become one of the hottest fields in modern neuroscience. The blobs of tissue are made from stem cells and, while they are only the size of a pea, some have developed spontaneous brain waves, similar to those seen in premature babies. Many scientists believe that organoids have the potential to transform medicine by allowing them to probe the living brain like never before. But the work is controversial because it is unclear where it may cross the line into human experimentation.

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Can dynamic consent facilitate the protection of biomedical big data in biobanking in Malaysia? (Papers: Mohammad Firdaus Abdul Aziz & Aimi Nadia Mohd Yusof | May 2019)

Abstract As with many other countries, Malaysia is also developing and promoting biomedical research to increase the understanding of human diseases and possible interventions. To facilitate this development, there is a significant growth of biobanks in the country to ensure continuous collection of biological samples for... More

Abstract As with many other countries, Malaysia is also developing and promoting biomedical research to increase the understanding of human diseases and possible interventions. To facilitate this development, there is a significant growth of biobanks in the country to ensure continuous collection of biological samples for future research, which contain extremely important personal information and health data of the participants involved. Given the vast amount of samples and data accumulated by biobanks, they can be considered as reservoirs of precious biomedical big data. It is therefore imperative for biobanks to have in place regulatory measures to ensure ethical use of the biomedical big data. Malaysia has yet to introduce specific legislation for the field of biobanking. However, it can be argued that its existing Personal Data Protection Act 2010 (PDPA) has laid down legal principles that can be enforced to protect biomedical big data generated by the biobanks. Consent is a mechanism to enable data subjects to exercise their autonomy by determining how their data can be used and ensure compliance with legal principles. However, there are two main concerns surrounding the current practice of consent in biomedical big data in Malaysia. First, it is uncertain that the current practice would be able to respect the underlying notion of autonomy, and second, it is not in accordance with the legal principles of the PDPA. Scholars have deliberated on different strategies of informed consent, and a more interactive approach has recently been introduced: dynamic consent. It is argued that a dynamic consent approach would be able to address these concerns. Keywords Biobanking, Autonomy, Data protection, Informed consent, Dynamic consent

Abdul Aziz, Mohammad Firdaus, and Aimi Nadia Mohd Yusof. 2019. Can dynamic consent facilitate the protection of biomedical big data in biobanking in Malaysia? Asian Bioethics Review 11 (2) 1-14.  https://doi.org/10.1007/s41649-019-00086-2. Publisher: https://link.springer.com/article/10.1007%2Fs41649-019-00086-2
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(US) Google and the University of Chicago Are Sued Over Data Sharing – New York Times (Daisuke Wakabayashi | June 2019)

SAN FRANCISCO — When the University of Chicago Medical Center announced a partnership to share patient data with Google in 2017, the alliance was promoted as a way to unlock information trapped in electronic health records and improve predictive analysis in medicine.

On Wednesday, the... More

SAN FRANCISCO — When the University of Chicago Medical Center announced a partnership to share patient data with Google in 2017, the alliance was promoted as a way to unlock information trapped in electronic health records and improve predictive analysis in medicine.

On Wednesday, the University of Chicago, the medical center and Google were sued in a potential class-action lawsuit accusing the hospital of sharing hundreds of thousands of patients’ records with the technology giant without stripping identifiable date stamps or doctor’s notes.

The suit, filed in United States District Court for the Northern District of Illinois, demonstrates the difficulties technology companies face in handling health data as they forge ahead into one of the most promising — and potentially lucrative — areas of artificial intelligence: diagnosing medical problems.

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Personality and fatal diseases: Revisiting a scientific scandal (Papers: Anthony J Pelosi | February 2019)

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Work of renowned UK psychologist Hans Eysenck ruled ‘unsafe’ – The Guardian (Sarah Boseley | October 2019)

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(US) NIH must better protect research from foreign influence, federal watchdog says – STAT (Lev Facher | September 2019)

Published/Released on September 27, 2019 | Posted by Admin on October 13, 2019 | Keywords: , , , , , , ,

WASHINGTON — Foreign governments and corporations could profit from American academic institutions’ failure to safeguard taxpayer-funded biomedical research, according to a set of new reports from a federal watchdog. [colored_box]The reports, issued by the Department of Health and Human Services inspector general, show that 54% of research institutions funded by... More

WASHINGTON — Foreign governments and corporations could profit from American academic institutions’ failure to safeguard taxpayer-funded biomedical research, according to a set of new reports from a federal watchdog. [colored_box]The reports, issued by the Department of Health and Human Services inspector general, show that 54% of research institutions funded by the National Institutes of Health — some 1,013 universities and academic centers — failed to publish financial conflict-of-interest policies online. In 2018, according to the report, the NIH conducted just three audits to determine grantee institutions’ own efforts to safeguard their research — down from 28 in 2012. . “The concern, generally speaking, is whether financial interests threaten or distort the use of NIH funds for their intended research purpose or the results of that scientific research,” Erin Bliss, an assistant HHS inspector general, said in an interview. “There are also concerns around the diversion of intellectual property, which could be an economic or a national security risk, and the potential for distortion or inappropriate influence of funding decisions.” .

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(Australia) Unauthorised survey asked students to rate Chinese people out of seven – Sydney Morning Herald (Nick Bonyhady | September 2019)

An unauthorised survey delivered to students at the University of Sydney under the university's official logo asked them to rate the attractiveness and intelligence of Chinese people out of seven.
[colored_box]The survey was delivered by both paid and volunteer pollsters to students voting in student representative council elections at the university... More

An unauthorised survey delivered to students at the University of Sydney under the university's official logo asked them to rate the attractiveness and intelligence of Chinese people out of seven.
[colored_box]The survey was delivered by both paid and volunteer pollsters to students voting in student representative council elections at the university this week. It claimed to be "approved in principle by the University of Sydney's ethics committee" and "endorsed by the political science department." . A University of Sydney spokeswoman said the university had "very strong concerns" about the content of the survey, which it was not aware of until contacted by the Herald on Wednesday, and how it was delivered. . "An initial inquiry indicates ethics approval was not obtained for the study and our logo has been used without permission," the spokeswoman said. "We are formally contacting the staff and student involved today to advise them the matter may be subject to disciplinary proceedings." .

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 For Vulnerable Populations, the Thorny Ethics of Genetic Data Collection – UnDark (Adrian Pecotic | September 2019)

Published/Released on September 30, 2019 | Posted by Admin on October 10, 2019 | Keywords: , , , , , , , ,

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How to Boost Racial, Ethnic and Gender Diversity in Clinical Research (Report – Syneos: September 2019)

Why All Stakeholders Must OWN The Mission Healthcare transformations take time—and the time lag has consequences.

[colored_box]It has been 25 years since Congress passed the National Institutes of Health Revitalization Act requiring federally funded clinical research programs to prioritize... More

Why All Stakeholders Must OWN The Mission Healthcare transformations take time—and the time lag has consequences.

[colored_box]It has been 25 years since Congress passed the National Institutes of Health Revitalization Act requiring federally funded clinical research programs to prioritize inclusion of women and minorities. Since then, both the NIH and the Food and Drug Administration have mounted numerous initiatives, including regulatory guidance aimed at shoring up the law’s intent. ,

Despite parallel efforts by biopharmaceutical innovators, the demographics of clinical trials today still do not reflect the racial, ethnic or gender diversity of target patient populations around the world. This is true for trial subjects, of whom an estimated 83 percent are white. And it’s true for the race/ethnicity/gender representation of investigators at many trial sites as well.

As advanced health systems around the world enter an era of genomic and precision medicine, lack of diversity across the clinical research landscape is a daunting obstacle.

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Payment of participants in research: information for researchers, HRECs and other ethics review bodies (NHMRC | September 2019)

Published/Released on September 26, 2019 | Posted by Admin on October 3, 2019 | Keywords: , , , , , , ,

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Pay-to-Participate Trials and Vulnerabilities in Research Ethics Oversight – JAMA Network (Holly Fernandez Lynch, et al | September 2019)

Published/Released on September 23, 2019 | Posted by Admin on October 2, 2019 | Keywords: , , , , ,

Faced with the prospect of death or debilitating disease, patients and their families may be willing to try almost any treatment. A number of systems exist to help prevent this understandable desperation from resulting in serious harm, including standards of medical professionalism, requirements for product approval by the US... More

Faced with the prospect of death or debilitating disease, patients and their families may be willing to try almost any treatment. A number of systems exist to help prevent this understandable desperation from resulting in serious harm, including standards of medical professionalism, requirements for product approval by the US Food and Drug Administration (FDA), and oversight of research by institutional review boards (IRBs). There are gaps in this safety net, however, that become particularly evident in the context of clinical trials that require patients to pay to participate. Although these trials may sometimes satisfy the standards of ethical research, the research oversight system in the United States is not sufficiently robust to ensure that this will always be the case. Pay-to-Participate Trials Clinical research is typically funded by governments, charitable foundations, and private companies. Built into this traditional funding system are review mechanisms intended to select for high-priority, high-quality studies. These mechanisms can often prevent the initiation of low-value studies, but they may also limit innovation by prioritizing incremental progress over bold ideas or deprioritizing research with little commercial promise. Inevitably, limited resources may force funders to forgo important studies. One response is to seek out alternative funding sources, including study participants. Short of fraud protections, there is no legal prohibition against asking patients to pay to participate in research. The FDA explicitly permits charging for investigational products under certain circumstances, while regulations governing research consent simply call for disclosure of any “additional costs” that may result from participation.

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What’s next for Registered Reports? – Nature (Chris Chambers | September 2019)

Published/Released on September 10, 2019 | Posted by Admin on September 19, 2019 | Keywords: , , , , , , , , ,

Reviewing and accepting study plans before results are known can counter perverse incentives. Chris Chambers sets out three ways to improve the approach.

What part of a research study — hypotheses, methods, results, or discussion — should remain beyond a scientist’s control? The answer,... More

Reviewing and accepting study plans before results are known can counter perverse incentives. Chris Chambers sets out three ways to improve the approach.

What part of a research study — hypotheses, methods, results, or discussion — should remain beyond a scientist’s control? The answer, of course, is the results: the part that matters most for publishing in prestigious journals and advancing careers. This paradox means that the careful scepticism required to avoid massaging data or skewing analysis is pitted against the drive to identify eye-catching outcomes. Unbiased, negative and complicated findings lose out to cherry-picked highlights that can bring prominent articles, grant funding, promotion and esteem. The ‘results paradox’ is a chief cause of unreliable science. Negative, or null, results go unpublished, leading other researchers into unwittingly redundant studies. Ambiguous or otherwise ‘unattractive’ results are airbrushed (consciously or not) into publishable false positives, spurring follow-up research and theories that are bound to collapse. Clearly, we need to change how we evaluate and publish research. For the past six years, I have championed Registered Reports (RRs), a type of research article that is radically different from conventional papers. The 30 or so journals that were early adopters have together published some 200 RRs, and more than 200 journals are now accepting submissions in this format (see ‘Rapid rise’). When it launched in 2017, Nature Human Behaviour became the first of the Nature journals to join this group. In July, it published its first two such reports1. With RRs on the rise, now is a good time to take stock of their potential and limitations

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Why We Need Guidelines for Brain Scan Data – Wired (Evan D. Morris | September 2019)

Published/Released on September 17, 2019 | Posted by Admin on September 18, 2019 | Keywords: , , , ,

Your brain is a lot like your DNA. It is, arguably, everything that makes you uniquely you. Some types of brain scans are a lot like DNA tests. They may reveal what diseases you have (Parkinson’s, certainly; depression-possibly), what happened in your past (drug abuse,... More

Your brain is a lot like your DNA. It is, arguably, everything that makes you uniquely you. Some types of brain scans are a lot like DNA tests. They may reveal what diseases you have (Parkinson’s, certainly; depression-possibly), what happened in your past (drug abuse, probably; trauma, maybe), or even what your future may hold (Alzheimer’s, likely; response to treatment, hopefully). Many people are aware—and properly protective—of the vast stores of information contained in their DNA. When DNA samples were collected in New York without consent, some went to great lengths to have their DNA expunged from databases being amassed by the police. Fewer people are aware of the similarly vast amounts of information in a brain scan, and even fewer are taking steps to protect it. My colleagues and I are scientists who use brain imaging (PET and fMRI) to study neuropsychiatric diseases. Based on our knowledge of the technologies we probably ought to be concerned. And yet, it is rare that we discuss the ethical implications of brain imaging. Nevertheless, by looking closely, we can observe parallel trends in science and science policy that are refining the quality of information that can be extracted from a brain scan, and expanding who will have access to it. There may be good and bad reasons to use a brain scan to make personalized predictions. Good or bad, wise or unwise, the research is already being conducted and the brain scans are piling up. PET (Positron Emission Tomography) is commonly used, clinically, to identify sites of altered metabolism (e.g., tumors). In research, it can be used to identify molecular targets for treatment. A recent PET study of brain metabolism in patients with mild cognitive impairment predicted who would develop Alzheimer’s disease. In our work at Yale, we have used PET images of a medication that targets an opioid receptor to predict which problem drinkers would reduce their drinking while on the medication.

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(China) A 10-year follow up of publishing ethics in China: what is new and what is unchanged (Papers: Katrina A. Bramstedt & Jun Xu | September 2019)

Abstract Background Organ donation and transplantation in China are ethically complex due to questionable informed consent and the use of prisoners as donors. Publishing works from China can be problematic. The objective of this study was to perform a 10-year follow up on... More

Abstract Background Organ donation and transplantation in China are ethically complex due to questionable informed consent and the use of prisoners as donors. Publishing works from China can be problematic. The objective of this study was to perform a 10-year follow up on Chinese journals active in donation and transplant publishing regarding the evolution of their publishing guidelines. Methods Eleven Chinese journals were analyzed for 7 properties: (1) ethics committee approval; (2) procedure consent; (3) publishing consent; (4) authorship criteria; (5) conflict of interest; (6) duplicate publication; and (7) data integrity. Results were compared with our 2008 study data. Additionally, open access status, impact factor, and MEDLINE-indexing were explored. Results Most journals heightened the ethical requirements for publishing, compared to the results of 2008. All 11 now require their published manuscripts to have data integrity. Ten of 11 require ethics committee approval and informed consent for the publication of research studies, whereas in the original study only 2 journals evidenced these requirements. Nine of 11 have criteria for authorship, require conflict of interest disclosure, and forbid duplicate publishing. None of the journals have a policy to exclude data that was obtained from unethical organ donation practices. Nine of 11 journals are MEDLINE-indexed but only 2 are open-access. Conclusions Most journals have improved their general ethical publishing requirements but none address unethical organ donation practices. Keywords: China; Informed consent; Organ donation; Publishing; Research ethics; Research integrity

Bramstedt, K. and Xu, J. (20019) (China) A 10-year follow up of publishing ethics in China: what is new and what is unchanged. Research Integrity and Peer Review 4(17) https://doi.org/10.1186/s41073-019-0077-3. Publisher (Open Access): https://researchintegrityjournal.biomedcentral.com/articles/10.1186/s41073-019-0077-3

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European universities dismal at reporting results of clinical trials – Nature (Nic Fleming | April 2019)

Analysis of 30 leading institutions found that just 17% of study results had been posted online as required by EU rules.

[colored_box]Many of Europe’s major research universities are ignoring rules that require them to make... More

Analysis of 30 leading institutions found that just 17% of study results had been posted online as required by EU rules.

[colored_box]Many of Europe’s major research universities are ignoring rules that require them to make public the results of clinical trials. A report published on 30 April found that the results of only 162 of 940 clinical trials (17%) that were due to be published by 1 April had been posted on the European Union’s trials register. The 30 universities surveyed are those that sponsor the most clinical trials in the EU. Fourteen of these institutions had failed to publish a single results summary. If three high-performing UK universities are excluded from the figures, the results of just 7% of the trials were made public on time. Campaigners say the resulting lack of transparency harms patients by undermining the efforts of doctors and health authorities to provide the best treatments, slows medical progress and wastes public funds.

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Study pulls back curtain on contracts between Coca-Cola and the researchers it funds – STAT (Andrew Josep | May 2019)

When it funds scientific research, Coca-Cola includes a provision in its contracts with academic institutions that allows the beverage giant to pull its funding for a study at any point, according to a group of researchers who obtained several such agreements. The policies could pressure recipients of the... More

When it funds scientific research, Coca-Cola includes a provision in its contracts with academic institutions that allows the beverage giant to pull its funding for a study at any point, according to a group of researchers who obtained several such agreements. The policies could pressure recipients of the funding to pursue research that dovetails with Coca-Cola’s goals out of fear of having their project canceled, the researchers said in a paper published Tuesday, though they added that they found no example of that occurring. The paper, which was published in the Journal of Public Health Policy, comes amid increasing scrutiny of the food and beverage industry’s funding of and influence over academic research. The industry has taken a number of steps to improve transparency and safeguard the independence of studies it sponsors. Notably, Coca-Cola in 2015 started listing on its website the institutions and researchers it funded and the following year outlined principles that would guide its support for scientific research.

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Data sharing and how it can benefit your scientific career – Nature (Gabriel Popkin | May 2019)

Published/Released on May 13, 2019 | Posted by Admin on September 5, 2019 | Keywords: , , , , ,

Open science can lead to greater collaboration, increased confidence in findings and goodwill between researchers.

Ecologist Thomas Crowther knew that scientists had already collected a vast amount of field data on forests worldwide. But almost all of those data were sequestered in researchers’ notebooks... More

Open science can lead to greater collaboration, increased confidence in findings and goodwill between researchers.

Ecologist Thomas Crowther knew that scientists had already collected a vast amount of field data on forests worldwide. But almost all of those data were sequestered in researchers’ notebooks or personal computers, making them unavailable to the wider scientific community. In 2012, Crowther, then a postdoctoral researcher at Yale University in New Haven, Connecticut, began to e-mail and cold-call researchers to request their data. He started to assemble an inventory, now hosted by the Global Forest Biodiversity Initiative, an international research collaboration, that contains data on more than 1 million locations. Data are stored in CSV files (plain-text files that contain a list of data) on servers at Crowther’s present laboratory at the Swiss Federal Institute of Technology in Zurich and on those of a collaborator at Purdue University in West Lafayette, Indiana; he hopes to outsource database storage to a third-party organization with expertise in archiving and access. After years of courting and cajoling, Crowther has persuaded about half of the data owners to make their data public. The other half, he laments, say that they support open data in principle, but have specific reasons for keeping their data sets private. Mainly, he explains, they want to use their data to conduct and publish their own studies. Crowther’s database challenges reflect the current state of science: partly open, partly closed, and with unclear and inconsistent policies and expectations on data sharing that are still in flux. High-level bodies such as the US National Academies of Sciences, Engineering, and Medicine and the European Commission have called for science to become more open and endorsed a set of data-management standards known as the FAIR (findable, accessible, interoperable and reusable) principles. Government funding agencies in the United States, Europe and Australia require researchers to devise plans for data management and, in some cases, data sharing; some private funders also require them. Many journals, including Nature, have adopted policies that encourage or require authors to make data available. A plethora of open-access repositories host data sets from almost all fields, and scientists have been publicly criticized by colleagues for not sharing data.

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Better Metadata Could Help Save The World! – Scholarly Kitchen (Alice Meadows | June 2019)

Published/Released on June 11, 2019 | Posted by Admin on September 4, 2019 | Keywords: , , , , ,

The title of this post may seem like a farfetched claim, however, no one can deny that we are currently faced with increasingly critical challenges — climate crisis, shrinking biodiversity, hunger, poverty, disease, and more. I think most of us would agree this means it’s essential for the research... More

The title of this post may seem like a farfetched claim, however, no one can deny that we are currently faced with increasingly critical challenges — climate crisis, shrinking biodiversity, hunger, poverty, disease, and more. I think most of us would agree this means it’s essential for the research findings that could help address these challenges to be shared as quickly and widely as possible — and for the data behind those findings to be FAIR (findable, accessible, interoperable, and reusable). And that means…metadata! As a community, we have a collective responsibility for sharing research outputs, including their metadata. That’s why Metadata 2020 is so timely and important (disclaimer: I am co-chair of their Researcher Communications project group). This community-led initiative aims to improve metadata in order to enhance discoverability, encourage new services, create efficiencies, and — ultimately — accelerate scholarly research. Lofty goals, to be sure! Which means that to succeed in achieving them we need the support of everyone who is involved in creating, curating, and consuming metadata. Per the FAIR principles, “Metadata and data should be easy to find for both humans and computers.  Machine-readable metadata are essential for automatic discovery of datasets and services.” Building on this, the Metadata 2020 project group on Best Practices and Principles has developed a set of draft principles, which were recently released for community comment. They state that for metadata to support the community, they should be:

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Enhancing ethics review of social and behavioral research: developing a review template in Ethiopia (Papers: Liya Wassie, et al | August 2019)

Abstract Background: Africa is increasingly becoming an important region for health research, mainly due to its heavy burden of disease, socioeconomic challenges, and inadequate health facilities. Regulatory capacities, in terms of ethical review processes, are also generally weak. The ethical assessment of social... More

Abstract Background: Africa is increasingly becoming an important region for health research, mainly due to its heavy burden of disease, socioeconomic challenges, and inadequate health facilities. Regulatory capacities, in terms of ethical review processes, are also generally weak. The ethical assessment of social and behavioral research is relatively neglected compared to the review of biomedical and clinical studies, which led us to develop an ethics review assessment tool for use in the review of social and behavioral research in Ethiopia, which could potentially be of value in low- and middle-income settings. Methods: Initially, we did a comprehensive literature review on principles, guidelines, and practices of research ethics, on social and behavioral studies, from which we extracted query terms to explore the opinions of selected key informants and focus groups in Ethiopia. The discussants and informants were selected using a convenience sampling method to evaluate an ethics review template, which integrated issues that commonly arise in social and behavioral studies. Finally, we directly solicited opinions from the discussants about the desirability, feasibility, acceptability, and relevance of the ethics review assessment tool and used the resulting data to refine our initial draft. Results and conclusion: Although the same basic ethics principles govern all research studies, social and behavioral research have some disciplinary particularities that may require reviewers to exercise a different orientation of ethical attention in some cases. Using a qualitative approach, we developed a review assessment tool that could potentially be useful to raise awareness, focus attention, and strengthen the review of social and behavioral studies by ethics review committees, particularly in settings without a long-standing tradition of reviewing such research. This process also exposed some areas where further capacity building and discussion of ethical issues may be necessary among stakeholders in the review of social and behavioral research. Keywords Behavioral, social, qualitative, biomedical research, ethics review, low and middle income

Liya Wassie, Senkenesh Gebre-Mariam, Geremew Terekegne et al. (2019) Enhancing ethics review of social and behavioural research: Developing a review template in Ethiopia. Research Ethics 15(4) 1–23. Publisher (Open Access): https://journals.sagepub.com/doi/full/10.1177/1747016119865731

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Expression of Interest: Consumer Inclusive Research – Consumer Reference Group

Published/Released on August 27, 2019 | Posted by Admin on August 26, 2019 | Keywords: , , , , , ,

The Hopkins Centre is recruiting 8 consumer representatives on a Consumer Inclusive Research - Consumer Reference Group.

The Hopkins Centre is conducting research on “Supporting the ethical inclusion of people with acquired disability in research: Consumer informed approaches”. We invite consumers and community members... More

The Hopkins Centre is recruiting 8 consumer representatives on a Consumer Inclusive Research - Consumer Reference Group.

The Hopkins Centre is conducting research on “Supporting the ethical inclusion of people with acquired disability in research: Consumer informed approaches”. We invite consumers and community members to join a reference group which will support and guide us in this project. We cannot and should not do our research without including you, so we are asking for your help. This opportunity would suit a consumer who has a particular interest in research. Membership We are recruiting 8 consumers or carers from a variety of backgrounds to participate in a maximum of 4 meetings to be held over approximately 6 months via teleconference or web based. Applications from a range of people and groups is encouraged. How to apply Please complete the Expression of Interest form below and return to Dr Gary Allen at The Hopkins Centre via g.allen@griffith.edu.au by 9am Friday 20 September 2019. For queries relating to the Reference Group or assistance completing this Expression of Interest, please contact Gary Allen at The Hopkins Centre via g.allen@griffith.edu.au or by phone on c/o 07 3735 2069.

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Open consent, biobanking and data protection law: can open consent be ‘informed’ under the forthcoming data protection regulation? (Papers: Dara Hallinan & Michael Friedewald | 2015)

Published/Released on January 24, 2015 | Posted by Admin on August 22, 2019 | Keywords: , , , , , , , , , ,

Abstract This article focuses on whether a certain form of consent used by biobanks – open consent – is compatible with the Proposed Data Protection Regulation. In an open consent procedure, the biobank requests consent once from the data subject for all future research uses of... More

Abstract This article focuses on whether a certain form of consent used by biobanks – open consent – is compatible with the Proposed Data Protection Regulation. In an open consent procedure, the biobank requests consent once from the data subject for all future research uses of genetic material and data. However, as biobanks process personal data, they must comply with data protection law. Data protection law is currently undergoing reform. The Proposed Data Protection Regulation is the culmination of this reform and, if voted into law, will constitute a new legal framework for biobanking. The Regulation puts strict conditions on consent – in particular relating to information which must be given to the data subject. It seems clear that open consent cannot meet these requirements. 4 categories of information cannot be provided with adequate specificity: purpose, recipient, possible third country transfers, data collected. However, whilst open consent cannot meet the formal requirements laid out by the Regulation, this is not to say that these requirements are substantially undebateable. Two arguments could be put forward suggesting the applicable consent requirements should be rethought. First, from policy documents regarding the drafting process, it seems that the informational requirements in the Regulation are so strict in order to protect the data subject from risks inherent in the use of the consent mechanism in a certain context – exemplified by the online context. There are substantial differences between this context and the biobanking context. Arguably, a consent transaction in the biobanking does not present the same type of risk to the data subject. If the risks are different, then perhaps there are also grounds for a reconsideration of consent requirements? Second, an argument can be made that the legislator drafted the Regulation based on certain assumptions as to the nature of ‘data’. The authors argue that these assumptions are difficult to apply to genetic data and accordingly a different approach to consent might be preferable. Such an approach might be more open consent friendly.

Hallinan, D. and M. Friedewald (2015). "Open consent, biobanking and data protection law: can open consent be ‘informed’ under the forthcoming data protection regulation?" Life Sciences, Society and Policy 11(1): 1. Publisher (Open Access): https://lsspjournal.biomedcentral.com/articles/10.1186/s40504-014-0020-9

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International Association for the Study of Forced Migration (IASFM) Code of ethics: Critical reflections on research ethics in situations of forced migration

Context: Research with people in situations of forced migration poses particular ethical challenges because of unequal power relations, legal precariousness, extreme poverty, violence, the criminalization of migration, politicized research contexts, the policy relevance of our research and/or dependence on government and non-governmental services and funding. However,... More

Context: Research with people in situations of forced migration poses particular ethical challenges because of unequal power relations, legal precariousness, extreme poverty, violence, the criminalization of migration, politicized research contexts, the policy relevance of our research and/or dependence on government and non-governmental services and funding. However, Research Ethics Boards (REBs) are not always aware of these particular ethical issues; some countries and institutions do not have REBs; and some kinds of research are not subject to REB approval. In this context of heightened risks of research, and uneven institutional accountability for research ethics, the International Association for the Study of Forced Migration (IASFM) hereby proposes this code of ethics for research with people in situations of forced migration. Similarly to how Indigenous research methodologies incorporate a broad, engaged and critical notion of ethics that recognizes power differentiations and the agency of the participants within exploitive research histories, this document sets forth principles that are starting points for respectful research.1 It is intended to reflect the broad diversity of our membership, including those involved in gathering information – whether in an academic or community setting – as well as those who are asked to take part in research. That being said, we acknowledge that this is not a comprehensive nor exhaustive document, but rather a starting point for active, critical engagement with ethical issues.

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How to organize a conference that’s open to everyone – Nature (Nic Fleming | July 2019)

Published/Released on July 24, 2019 | Posted by Admin on August 17, 2019 | Keywords: , , ,

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Journals retract more than a dozen studies from China that may have used executed prisoners’ organs – Retraction Watch (Ivan Oransky | August 2017)

In the past month, PLOS ONE and Transplantation have retracted fifteen studies by authors in China because of suspicions that the authors may have used organs from executed prisoners. All of the original studies — seven in Transplantation, and eight in PLOS ONE — were published between 2008 and 2014.... More

In the past month, PLOS ONE and Transplantation have retracted fifteen studies by authors in China because of suspicions that the authors may have used organs from executed prisoners. All of the original studies — seven in Transplantation, and eight in PLOS ONE — were published between 2008 and 2014. Two involved kidney transplants, and the rest involved liver transplants. Two other journals, the Clinical Journal of the American Society of Nephrology and Kidney International, have recently issued expressions of concern for the same reason. In an editorial explaining the seven retractions from its journal, the editors of Transplantation write:

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Long-Term Agreement for Services (LTAS) for the Provision of Global Research Quality Assurance Services and an Ethical Review Facility for Evidence Generation (Request for proposal | August 2019)

Published/Released on August 10, 2019 | Posted by Admin on August 13, 2019 | Keywords: , , , , ,

UNICEF is putting out a call for tenders for a Global Ethical Review Facility for the organisation. This would entail undertaking ethical reviews of evidence generation projects across the organization and providing advice on possible mitigation strategies. Information can be found here: https://www.ungm.org/public/Notice/95212 Gabrielle Berman, PhD Senior Advisor... More

UNICEF is putting out a call for tenders for a Global Ethical Review Facility for the organisation. This would entail undertaking ethical reviews of evidence generation projects across the organization and providing advice on possible mitigation strategies. Information can be found here: https://www.ungm.org/public/Notice/95212 Gabrielle Berman, PhD Senior Advisor - Ethics in Evidence Generation UNICEF Innocenti Via degli Alfani, 58 Firenze, Italia 50122 Skype: gabrielle.berman Less

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China approves ethics advisory group after CRISPR-babies scandal – Nature (Hepeng Jia | August 2019)

Bioethicists hope a national committee will help close loopholes in the country’s biomedical ethics regulations.

China will establish a national committee to advise the government on research-ethics regulations. The decision comes less than a year after a Chinese scientist sparked an international outcry over... More

Bioethicists hope a national committee will help close loopholes in the country’s biomedical ethics regulations.

China will establish a national committee to advise the government on research-ethics regulations. The decision comes less than a year after a Chinese scientist sparked an international outcry over claims that he had created the world’s first genome-edited babies. The country's most powerful policymaking body, the Central Comprehensively Deepening Reforms Commission of the ruling Chinese Communist Party, headed by President Xi Jinping, approved at the end of last month a plan to form the committee. According to Chinese media, it will strengthen the coordination and implementation of a comprehensive and consistent system of ethics governance for science and technology. The government has released few details on how the committee will work. But Qiu Renzong, a bioethicist at the Chinese Academy of Social Science in Beijing, says it could help to reduce the fragmentation in biomedical ethics regulations across ministries, identifying loopholes in the enforcement of regulations and advise the government on appropriate punishments for those who violate the rules.

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(Australia) Materials scientist up to five retractions as publishers investigate dozens of his papers – Retraction Watch (Ivan Oransky | August 2019)

Published/Released on August 06, 2019 | Posted by Admin on August 9, 2019 | Keywords: , , , , , , , , ,

A materials scientist in Australia, by way of Iran, has recently had five papers retracted for duplicating his prior work, and the reader who brought the issue to publishers’ attention says it could affect some 100 articles. Ali Nazari, now of Swinburne University of Technology in... More

A materials scientist in Australia, by way of Iran, has recently had five papers retracted for duplicating his prior work, and the reader who brought the issue to publishers’ attention says it could affect some 100 articles. Ali Nazari, now of Swinburne University of Technology in Australia, was at Islamic Azad University in Iran when he published the five papers in Energy and Buildings, an Elsevier title, in 2010 and 2011. The retractions came sometime after January of this year, when an anonymous reader contacted Elsevier about dozens of Nazari’s papers. A typical notice, for “Physical, mechanical and thermal properties of concrete in different curing media containing ZnO2 nanoparticles,” reads:

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Using ASCO’s Clinical Database for Commercial Research Raises Questions, Ethicists Say – Medscape (Ellie Kincaid | May 2019)

Eleven abstracts of the thousands accepted for publication at this year's annual meeting of the American Society of Clinical Oncology (ASCO), one of the largest cancer research conferences in the world, draw upon data collected through a nonprofit subsidiary of ASCO that in 4 years has brought together the... More

Eleven abstracts of the thousands accepted for publication at this year's annual meeting of the American Society of Clinical Oncology (ASCO), one of the largest cancer research conferences in the world, draw upon data collected through a nonprofit subsidiary of ASCO that in 4 years has brought together the electronic health records (EHRs) of 1.2 million patients. The ASCO subsidiary — CancerLinQ — will have its own 1200 square foot booth in prime real estate at the entrance to the meeting's exhibit hall. It has received data from 48 healthcare institutions to help them improve care for patients and has compiled a treasure trove of data for researchers studying how expensive cancer drugs work for patients in the real world. But ethicists are concerned that CancerLinQ is allowing companies to sell access to the data after they have been stripped of patient identifiers, without asking for patients' permission. "I think that the ethics of profiting off of someone else's information is dicey and at the very least the patient should go in with their eyes open, and that requires informing them," said Robert Field, PhD, MPH, JD, a professor of law and public health at Drexel University, Philadelphia, Pennsylvania.

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Participants’ Understanding of Informed Consent for Biobanking: A Systematic Review (Papers: Elizabeth R. Eisenhauer, et al | 2017)

Abstract Nurses are increasingly asked to obtain consent from participants for biobanking studies. Biobanking has added unique complexities to informed consent. The purpose of this systematic review was to evaluate participants’ level of understanding of the information presented during the informed consent process unique to the... More

Abstract Nurses are increasingly asked to obtain consent from participants for biobanking studies. Biobanking has added unique complexities to informed consent. The purpose of this systematic review was to evaluate participants’ level of understanding of the information presented during the informed consent process unique to the donation of biological specimens for research. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were utilized to conduct the review. PubMed, EMBASE, CINAHL, PsycINFO, Scopus, Web of Science, and ProQuest bibliographic databases were searched. Results indicated that elements of informed consent unique to biobanking were poorly understood. Most studies had authors or funding associated with a biobank. Only one study disclosed and assessed participants’ understanding of moral risks. Increased disclosures, values-clarification, and presenting information via multiple modalities may facilitate understanding. There is a need to improve the quality of informed consent for biobanking studies by utilizing standardized instruments, definitions, and encouraging research about informed choice outside the biobanking industry. Keywords biological specimen banks, biobanking, informed consent, moral risks, understanding

Eisenhauer, E. R., Tait, A. R., Rieh, S., Y. & Arslanian-Engoren, C., M. (2017) Participants' understanding of informed consent for biobanking: a systematic review. Clinical Nursing Research. 28(1) pp30-51 Publisher: https://journals.sagepub.com/doi/10.1177/1054773817722690

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Incorporating Exclusion Clauses into Informed Consent for Biobanking (Papers: Zubin Master and David B. Resnik)

Published/Released on March 14, 2013 | Posted by Admin on August 7, 2019 | Keywords: , , , , , ,

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Does psychology have a conflict-of-interest problem? – Nature (Tom Chivers | July 2019)

Published/Released on August 02, 2019 | Posted by Admin on August 5, 2019 | Keywords: , , , , , , ,

Some star psychologists don’t disclose in research papers the large sums they earn for talking about their work. Is that a concern?

Generation Z has made Jean Twenge a lot of money. As a psychologist at San Diego State University in California, she studies... More

Some star psychologists don’t disclose in research papers the large sums they earn for talking about their work. Is that a concern?

Generation Z has made Jean Twenge a lot of money. As a psychologist at San Diego State University in California, she studies people born after the mid-1990s, the YouTube-obsessed group that spends much of its time on Instagram, Snapchat and other social-media platforms. Thanks to smartphones and sharing apps, Generation Z has grown up to be more narcissistic, anxious and depressed than older cohorts, she argues. Twenge calls them the ‘iGen’ generation, a name she says she coined. And in 2010, she started a business, iGen Consulting, “to advise companies and organizations on generational differences based on her expertise and research on the topic”. Twenge has “spoken at several large corporations including PepsiCo, McGraw-Hill, nGenera, Nielsen Media, and Bain Consulting”, one of her websites notes. She delivers anything from 20-minute briefings to half-day workshops, and is also available to speak to parents’ groups, non-profit organizations and educational establishments. In e-mail exchanges, she declined to say how much she earns from her advisory work, but fees for star psychologists can easily reach tens of thousands of dollars for a single speech, and possibly much more, several experts told Nature. Twenge’s academic papers don’t mention her paid speeches and consulting. Yet that stands in stark contrast to the conflict-of-interest (COI) guidelines issued by the International Committee of Medical Journal Editors (ICMJE), an influential organization whose standards have been widely adopted by many medical and some psychology journals. Those guidelines say that such ‘personal fees’ should be declared as potential COIs in research papers because readers should be made aware of any financial interests that they might perceive as potentially influencing the findings.

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Mice are not people: Fighting spin in medical science – CBC (Kelly Crowe | June 2019)

Published/Released on June 29, 2019 | Posted by Admin on August 4, 2019 | Keywords: , , , , , ,

There was big news in baldness this week — for some furry rodents

"A cure for baldness could be on the way." That was the big news in baldness this week as headlines announced a "critical breakthrough," along with photos of More

There was big news in baldness this week — for some furry rodents

"A cure for baldness could be on the way." That was the big news in baldness this week as headlines announced a "critical breakthrough," along with photos of hairless human heads. It was exciting news — for a mouse. The baldness breakthrough was unpublished research by a commercially sponsored group that used stem cells to grow new hair through the skin of mice.

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(Australia) Medicare data used to recruit people with bipolar for research – Sydney Morning Herald (Kate Aubusson | July 2019)

Published/Released on July 29, 2019 | Posted by Admin on July 29, 2019 | Keywords: , , , ,

A letter sent to almost 50,000 patients prescribed lithium inviting them to take part in a bipolar study has raised questions about how Medicare stores and uses private healthcare information. [colored_box]UNSW psychiatrist Professor Gordon Parker first became aware of a study investigating the genetics of bipolar when a former patient... More

A letter sent to almost 50,000 patients prescribed lithium inviting them to take part in a bipolar study has raised questions about how Medicare stores and uses private healthcare information. [colored_box]UNSW psychiatrist Professor Gordon Parker first became aware of a study investigating the genetics of bipolar when a former patient sent him an angry email accusing him of breaching her privacy. . “She was furious with me, believing that she was contacted by Medicare because I had blown her confidentiality,” he said. . But the letter had been sent by the Department of Health Services (DHS) on behalf of a research team at QIMR Berghofer Medical Research Institute inviting recipients to participate in a study exploring potential biomarkers for bipolar disorder. .

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Conducting Accessible Research: Including People With Disabilities in Public Health, Epidemiological, and Outcomes Studies (Papers: Dianne Rios, et al | November 2016)

Published/Released on December 01, 2016 | Posted by Admin on July 25, 2019 | Keywords: , , , , ,

Abstract People with disabilities are largely absent from mainstream health research. Exclusion of people with disabilities may be explicit, attributable to poorly justified exclusion criteria, or implicit, attributable to inaccessible study documents, interventions, or research measures. Meanwhile, people with disabilities experience poorer health, greater incidence of... More

Abstract People with disabilities are largely absent from mainstream health research. Exclusion of people with disabilities may be explicit, attributable to poorly justified exclusion criteria, or implicit, attributable to inaccessible study documents, interventions, or research measures. Meanwhile, people with disabilities experience poorer health, greater incidence of chronic conditions, and higher health care expenditure than people without disabilities. We outline our approach to “accessible research design”—research accessible to and inclusive of people with disabilities. We describe a model that includes 3 tiers: universal design, accommodations, and modifications. Through our work on several large-scale research studies, we provide pragmatic examples of accessible research design. Making efforts to include people with disabilities in public health, epidemiological, and outcomes studies will enhance the interpretability of findings for a significant patient population. Rios, D., Magasi, S., Novak, C. & Harniss, M. Conducting Accessible Research: Including People With Disabilities in Public Health, Epidemiological, and Outcomes Studies, American Journal of Public Health 106, no. 12 (December 1, 2016): pp. 2137-2144. https://doi.org/10.2105/AJPH.2016.303448 Publisher: https://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2016.303448 Less

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Journal Publishes Concern About Study Using Forced Organ Donation – Medscape (Diana Swift | June 2019)

The Clinical Journal of the American Society of Nephrology (CJASN) recently issued an "Expression of Concern" regarding a 2008 article on renal allograft recipients written by Chinese researchers. The Expression of Concern stems from an Australian report More

The Clinical Journal of the American Society of Nephrology (CJASN) recently issued an "Expression of Concern" regarding a 2008 article on renal allograft recipients written by Chinese researchers. The Expression of Concern stems from an Australian report published online in February in BMJ Open, which urged the repudiation by English-language journals of more than 445 studies involving 85,477 organ transplants done in China. The reason? Many of the organs used were likely forcibly harvested from Chinese prisoners of conscience, such as practitioners of Falun Gong, Uyghurs, Tibetans, and underground Christians. "We reached out for clarification of the organ source to the senior authors, but one was deceased and the other had left the institution where the research was done," said CJASN Editor-in-Chief Rajnish Mehrotra, MD, MBBS, a professor of medicine at the David Geffen School of Medicine at University of California Los Angeles.

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A Russian Biologist Wants To Create More Gene-Edited Babies – NPR (Rob Stein | June 2019)

A Russian scientist says he wants to create more genetically modified babies, flouting international objections that such a step would be premature, unethical and irresponsible. Denis Rebrikov, a molecular biologist who heads a gene-editing lab at the Kulakov National Medical Research Center... More

A Russian scientist says he wants to create more genetically modified babies, flouting international objections that such a step would be premature, unethical and irresponsible. Denis Rebrikov, a molecular biologist who heads a gene-editing lab at the Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology in Moscow, claims he has developed a safe — and therefore acceptable — way to create gene-edited babies. "How it can be unethical if we will make [a] healthy baby instead of diseased?" Rebrikov told NPR during his first broadcast interview. "Why? Why [is it] unethical?"

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Alarmed by new ‘CRISPR babies’ plan, top science figures say they’re powerless to stop it – STAT (Rick Berke | June 2019)

Published/Released on June 24, 2019 | Posted by Admin on July 19, 2019 | Keywords: , , , , , ,

ASPEN, Colo. — Two influential leaders in science for the first time publicly condemned a Russian biologist who said he plans to produce gene-edited babies but conceded that it was beyond their organizations’ authority to halt him from doing so. In separate interviews with STAT over the weekend,... More

ASPEN, Colo. — Two influential leaders in science for the first time publicly condemned a Russian biologist who said he plans to produce gene-edited babies but conceded that it was beyond their organizations’ authority to halt him from doing so. In separate interviews with STAT over the weekend, Margaret Hamburg, co-chair of an international advisory committee on human genome-editing, and Victor Dzau, president of the U.S. National Academy of Medicine, said they were deeply concerned by the plans outlined by Russian scientist Denis Rebrikov. Still, said Hamburg, “I don’t know where we get the teeth to do some of what may ultimately need to be done’’ to respond in such situations.

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Tell the World – Exposing how China is creating the world’s largest prison – ABC Four Corners (July 2019)

On 15th July, ABC 4Corners ran a documentary examining develop the use of AI to profile and track activities non-Han populations in China. One Australian commentator argued that, in providing technical assistance, Australian universities were being ‘complicit in the human rights abuses’ (Assoc Prof James Leibold, La Trobe University). UTS told 4Corners... More

On 15th July, ABC 4Corners ran a documentary examining develop the use of AI to profile and track activities non-Han populations in China. One Australian commentator argued that, in providing technical assistance, Australian universities were being ‘complicit in the human rights abuses’ (Assoc Prof James Leibold, La Trobe University). UTS told 4Corners that it was reviewing its relationships with a Chinese state-owned military tech company while Curtin is reviewing its research approval procedures. Other universities may want to consider the mechanisms that they have that allow them to explore the ethics of the end use of technology that they develop and the degree to which it might be intended for or repurposed for the use of state security or military purposes. The biomedical literature has explored the dangers of dual use, but the 4Corners investigation pointed to problems that are much easier to anticipate, in this case work contracted directly with Australian university partners by Chinese state enterprises with military connections. ASSOC PROF. JAMES LEIBOLD, ethnic policy in China, La Trobe University: I think… universities here in Australia that have connections with any Party State company, particularly in the military or security sector, needs to end those contracts, and to pull out of those collaborative arrangement. I mean, essentially by doing that, we're being complicit in the human rights abuses that are occurring in Xinjiang and in China more widely. EXCERPT FROM THE ITEM

"People started to literally disappear, communities were being emptied of adult men and women." China researcher

It's a remote corner of the world, but what is taking place there is nothing short of breathtaking. "My older brother, younger brothers and two younger sisters, five siblings were all taken by... masked police. Heavily armed Special Forces police raided their home and taken (sic) them by covering their face and shackling them in front of the kids." Australian Uyghur Xinjiang province is a vast area of deserts and mountains where the ancient Silk Road once ran. Today its Uyghur population is being systematically rounded up with estimates of as many as a million citizens being held in detention.

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Credit data generators for data reuse – Nature (Heather H. Pierce, et al | June 2019)

To promote effective sharing, we must create an enduring link between the people who generate data and its future uses, urge Heather H. Pierce and colleagues.

Much effort has gone towards crafting mandates and standards for researchers to share their data1–3. Considerably less time... More

To promote effective sharing, we must create an enduring link between the people who generate data and its future uses, urge Heather H. Pierce and colleagues.

Much effort has gone towards crafting mandates and standards for researchers to share their data1–3. Considerably less time has been spent measuring just how valuable data sharing is, or recognizing the scientific contributions of the people responsible for those data sets. The impact of research continues to be measured by primary publications, rather than by subsequent uses of the data. To incentivize the sharing of useful data, the scientific enterprise needs a well-defined system that links individuals with reuse of data sets they generate4. To further this goal, the Association of American Medical Colleges (where H.H.P. and A.D. work) and the Multi-Regional Clinical Trials Center at Brigham and Women’s Hospital and Harvard Medical School (where E.S. and B.E.B. work), along with The New England Journal of Medicine, convened a 2018 workshop of representatives from 50 organizations to discuss and validate such a system. The workshop included major journals, funders, data-citation groups and academic centres (see Supplementary Information, Participant list) and was preceded by numerous meetings. Here we propose a system for leveraging existing initiatives and infrastructure to track the use, reuse and impact of scientific data through the consistent adoption of unique identifiers. Our system begins when researchers deposit a data set that they have generated. It then links every use and published analysis of that data set back to the original researchers (see ‘Virtuous cycle’).

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Pragmatic trials without informed consent? – The Ethics Blog (Pär Segerdahl | April 2019)

Published/Released on April 08, 2019 | Posted by Admin on July 9, 2019 | Keywords: , , , , , , ,

Randomized controlled trials (RCTs) are considered to be the gold standard for determining a causal effect of medical interventions. To achieve this aim, possible confounding factors must be avoided. This implies excluding many patients from participating in the trial, for example, patients with concomitant conditions. A negative consequence of... More

Randomized controlled trials (RCTs) are considered to be the gold standard for determining a causal effect of medical interventions. To achieve this aim, possible confounding factors must be avoided. This implies excluding many patients from participating in the trial, for example, patients with concomitant conditions. A negative consequence of these exclusions, however, is limited generalizability. Studying the artificially uniform participant group, you will be able to determine a causal effect, but you will know much less about real-life treatment outcomes in the population where the intervention actually will be used. [colored_box]Further artificiality is created by the written informed consent procedure, which excludes even further patients from participating in the trial. Moreover, because they know they participate in a clinical trial, participants may change their behavior. All this points to the importance of so-called pragmatic randomized controlled trials. In such trials, the effectiveness of two approved and routinely prescribed medicines are compared in normal clinical practice. This avoids most of the artificiality of RCTs and significantly improves generalizability and practical clinical relevance. Randomization is still required for scientific purposes, however, and written informed consent is an ethical obligation.

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Ethical Considerations for Disseminating Research Findings on Gender-Based Violence, Armed Conflict, and Mental Health: A Case Study from Rural Uganda (Papers: Jennifer J. Mootz, et al | June 2019)

Published/Released on July 12, 2019 | Posted by Admin on July 8, 2019 | Keywords: , , , , , , ,

Abstract Gender-based violence (GBV) is a major public health problem that is exacerbated in armed conflict settings. While specialized guidelines exist for conducting research with GBV, guidance on disseminating findings from GBV research is scant. This paper describes ethical considerations of designing and disseminating research findings... More

Abstract Gender-based violence (GBV) is a major public health problem that is exacerbated in armed conflict settings. While specialized guidelines exist for conducting research with GBV, guidance on disseminating findings from GBV research is scant. This paper describes ethical considerations of designing and disseminating research findings on GBV, armed conflict, and mental health (including alcohol misuse) in conflict-affected settings in Northeastern Uganda. Following completion of two research studies, we conducted a half-day dissemination meeting with local community professionals (n=21) aged 24 to 60. Attendees were divided into small groups and given a quiz-style questionnaire on research findings to prompt discussion. Two primary ethical tensions arose. One ethical consideration was how to disseminate research findings equitably at the participant level after having taken care to collect data using safe and unharmful methods. Another ethical issue concerned how to transparently share findings of widespread problems in a hopeful and contextualized way in order to facilitate community response. We recommend planning for dissemination a priori, engaging with partners at local levels, and grounding dissemination for action in evidence-based practices.

Mootz, J. J., Taylor, L., Milton L. Khoshnood, W. & Khoshnood, K. (2019) Ethical Considerations for Disseminating Research Findings on Gender-Based Violence, Armed Conflict, and Mental Health: A Case Study from Rural Uganda. Health and Human Rights Journal. Publisher (Open Access): https://www.hhrjournal.org/2019/06/ethical-considerations-for-disseminating-research-findings-on-gender-based-violence-armed-conflict-and-mental-health-a-case-study-from-rural-uganda/

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Debriefing for ego threat may require more than we thought – Psychology & More (Dana C. Leighton, Ph.D. | July 2019)

Published/Released on July 04, 2019 | Posted by Admin on July 7, 2019 | Keywords: , , , , , , ,

When social psychologists manipulate a participant’s attitudes or beliefs, we have an ethical obligation to undo that manipulation. I explain it to my students as “putting the participant back the way we found them.” We frequently use a debriefing procedure, in the form of a written and/or (as in... More

When social psychologists manipulate a participant’s attitudes or beliefs, we have an ethical obligation to undo that manipulation. I explain it to my students as “putting the participant back the way we found them.” We frequently use a debriefing procedure, in the form of a written and/or (as in the case of my lab) verbal notice something to the effect of “yuk yuk, gosh, ya know what? we were just kidding. the thing you (read/did) was fake, we made it up, and it doesn’t mean anything.” Here is an example from the verbal debriefing script I used in a study several years ago that presented participants with a fake newspaper article about vandalism by University of Texas students.

I want to thank you for your participation here today and for your contribution to this project. We really appreciate your help with this work. Let me tell you a little bit about what we are trying to study.

First, we want to assure you that the incident you read about never happened on the campus. We created a fake newspaper article about it in order to better understand how people respond to these kinds of situations. To our knowledge, no University of Texas students have ever been involved in such an incident.

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The full article is behind a paywall, but here's the reference: Miketta, S., & Friese, M. (2019). Debriefed but still troubled? About the (in)effectiveness of postexperimental debriefings after ego threat. Journal of Personality and Social Psychology. Advance online publication. http://dx.doi.org/10.1037/pspa0000155 Less

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Not Reporting Results of a Clinical Trial Is Academic Misconduct – ACP (Editorial | Joshua D. Wallach, MS, PhD; Harlan M. Krumholz, MD, SM | May 2019)

Failure to report the results of clinical trials threatens the public's trust in research and the integrity of the medical literature, and should be considered academic misconduct at the individual and institutional levels. According to the ethical principles for research outlined in the Declaration of Helsinki, researchers “have a... More

Failure to report the results of clinical trials threatens the public's trust in research and the integrity of the medical literature, and should be considered academic misconduct at the individual and institutional levels. According to the ethical principles for research outlined in the Declaration of Helsinki, researchers “have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports” (1). When participants volunteer to take part in clinical trials, and expose themselves to interventions with unknown safety and efficacy profiles, they have a tacit assumption, based on trust, that the evidence generated will inform clinical science (2). Health care providers and medical societies, who are responsible for evaluating and synthesizing evidence and filling the gap between research and practice, need for investigators to fully report their results in a timely manner. The utility of the diligent search for truth in the medical literature depends on its completeness. However, when research findings are not consistently disseminated, the literature provides a skewed view of the science, which may bias reviews of the evidence. During the past 2 decades, efforts have been increasing to promote the reporting of clinical trial results. After the creation of ClinicalTrials.gov, a public registration database, the United States moved to establish consequences of not reporting clinical trial results. In particular, the U.S. Food and Drug Administration Amendments Act (FDAAA) of 2007 created legal requirements for certain intervention studies of FDA-regulated...

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Forced Migration Review – Issue 61 (Papers: Marion Couldrey and Jenny Peebles Editors | June 2019)

the ETHICS issue exploring ethical questions that confront us in our work

We each live according to our own personal code of ethics but what moral principles guide our work? The 19... More

the ETHICS issue exploring ethical questions that confront us in our work

We each live according to our own personal code of ethics but what moral principles guide our work? The 19 feature theme articles in this issue debate many of the ethical questions that confront us in programming, research, safeguarding and volunteering, and in our use of data, new technologies, messaging and images. Prepare to be enlightened, unsettled and challenged. This issue is being published in tribute to Barbara Harrell-Bond, founder of the Refugee Studies Centre and FMR, who died in July 2018. Forced Migration Review issue 61 www.fmreview.org/ethics PDF copy of this edition Contents
  • 4 Big data, little ethics: confidentiality and consent Nicole Behnam and Kristy Crabtree
  • 7 New technologies in migration: human rights impacts Petra Molnar
  • 9 Social media screening: Norway’s asylum system Jan-Paul Brekke and Anne Balke Staver
  • 12 Developing ethical guidelines for research Christina Clark-Kazak
  • 15 ‘Over-researched’ and ‘under-researched’ refugees Naohiko Omata
  • 18 Research fatigue among Rwandan refugees in Uganda Cleophas Karooma
  • 20 Over-researching migration ‘hotspots’? Ethical issues from the Carteret Islands Johannes M Lutz
  • 23 Ethics and accountability in researching sexual violence against men and boys Sarah Chynoweth and Sarah Martin
  • 26 Ethics and consent in settlement service delivery Carla Nayton and Sally Baker
  • 28 Ethical primary research by humanitarian actors Prisca Benelli and Tamara Low
  • 30 EU migration strategy: compromising principled humanitarian action Anaïs Faure Atger
  • 33 A humanitarian approach to travel medicine? Marta Aleksandra Balinska
  • 36 Principled humanitarian assistance and non-State armed groups Ruta Nimkar, Viren Falcao, Matthew Tebbutt and Emily Savage
  • 39 Ethical dilemmas posed by unethical behaviour by persons of concern Anna Turus
  • 41 Ethical quandaries in volunteering Ashley Witcher
  • 44 The ethical use of images and messaging Dualta Roughneen
  • 47 Representing refugees in advocacy campaigns Natalie Slade
  • 49 Putting safeguarding commitments into practice Agnes Olusese and Catherine Hingley
  • 52 Safeguarding in conflict and crisis Sarah Blakemore and Rosa Freedman Tribute to Barbara Harrell-Bond
  • 55 A Life Not Ordinary: our colleague Barbara Harrell-Bond Matthew Gibney, Dawn Chatty and Roger Zetter
  • 56 A lifelong commitment to justice HRH Prince El Hassan bin Talal of Jordan
  • 58 A refugee-centred perspective Anita H Fábos
  • 60 Building expert witness reports: Barbara’s legacy Maja Grundler
  • 62 The helpfulness of Imposing Aid: a tribute from the Refugee Law Project Chris Dolan
  • 65 Barbara’s ethics of antagonism Joshua Craze
  • 67 AMERA: delivering a refugee-centred approach to protection Sarah Elliott and Megan Denise Smith
  • 69 From a critique of camps to better forms of aid Alyoscia D’Onofrio
  • 72 Resist injustice Olivier Rukundo
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Infecting healthy people in vaccine research can be ethical and necessary – The Conversation (Michael Selgelid & Euzebiusz Jamrozik | June 2019)

Medical experiments involving intentionally infecting people with bacteria, viruses, and parasites are surprisingly common. And they are becoming more common worldwide, particularly in developing countries. The ultimate aim of these “human challenge studies” is usually to test potential new vaccines. However, because of the risks involved, this kind of research raises... More

Medical experiments involving intentionally infecting people with bacteria, viruses, and parasites are surprisingly common. And they are becoming more common worldwide, particularly in developing countries. The ultimate aim of these “human challenge studies” is usually to test potential new vaccines. However, because of the risks involved, this kind of research raises difficult ethical questions. For example, who should be infected? And which pathogens would be too dangerous to use?

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(US) Rounding up the Belmont Report Retrospectives – Amp@sand (May 2019)

Last month brought the 40th anniversary of the publishing of the Belmont Report, and along with that milestone came a reflection on how its values, conclusions, and imperatives have changed in the intervening years. A celebration of its durability has been accompanied by a necessary reckoning with the ways... More

Last month brought the 40th anniversary of the publishing of the Belmont Report, and along with that milestone came a reflection on how its values, conclusions, and imperatives have changed in the intervening years. A celebration of its durability has been accompanied by a necessary reckoning with the ways that a 40-year-old document may be ill-equipped to process the ethical issues brought about by technological, cultural, and political changes. Here, we’ve gathered a range of resources that look back on 40 years of the Belmont Report. Safeguards for human studies can’t cope with big data Nature This provocative piece explores the ways in which the Belmont Report is insufficient for dealing with revolutionary digital technologies, arguing that “data science overlooks risks to human participants by default” and that it is “past time for a Belmont 2.0.” That new summit, the author argues, would need to engage with the currently “poorly understood risks and harms” that big data researches poses to humans. A Belmont Report for Health Data (abstract available) The New England Journal of Medicine HIPAA offers robust protection of a limited range of data, but in 2019, the demands on humans’ health data come from far more directions than the 1996 legislation could anticipate. The authors of this NEJM piece call for a coordinated expansion of the scope of ethical review of the gathering, use, and manipulation of health data to account for sources such as “social-media platforms, health and wellness apps, smartphones [and] life insurers,” citing concerns about reidentification of deidentified data, discrimination, health profiling, and more.

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Misreporting the science of lab-made organs is unethical, even dangerous – The Conversation (Cathal D. O’Connell | May 2019)

I work in the field of bioprinting, where the aim is to build biological tissues by printing living cells into 3D structures. Last month I found my Facebook news feed plastered with an amazing story about “the first 3D printed heart using a patient’s own cells”. A More

I work in the field of bioprinting, where the aim is to build biological tissues by printing living cells into 3D structures. Last month I found my Facebook news feed plastered with an amazing story about “the first 3D printed heart using a patient’s own cells”. A video showed a beautiful, healthy-looking heart apparently materialising inside a vat of pinkish liquid. Big news. According to an impact tracking algorithm, the story has been picked up by 145 news outlets, tweeted 2,390 times to 3.8 million followers (as of May 27, 2019). Articles on Facebook have at least 13,000 shares, and videos about the story have been viewed well over 3 million times.

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(US) FDA says HCMC doctors kept ketamine study going after pledging to stop – Star Tribune (Andy Mannix | June 2019)

Medical staff at HCMC continued to sedate people with ketamine and collect data for a study for months after the hospital’s leadership told elected officials they had voluntarily halted the research in response to questions over ethics and patient safety. New inspection reports from federal regulators also say that doctors... More

Medical staff at HCMC continued to sedate people with ketamine and collect data for a study for months after the hospital’s leadership told elected officials they had voluntarily halted the research in response to questions over ethics and patient safety. New inspection reports from federal regulators also say that doctors involved in the research failed to disclose incidents of patients suffering serious medical complications — such as trouble breathing or high blood pressure — to the committee in charge of keeping study subjects safe. HCMC officials have already responded to the reports, vigorously rebutting many of the findings.

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(US) UCSD has not told women with HIV of data breach, despite researchers’ pleas – inewsource (Jill Castellano & Brad Racino | May 2019)

University of California San Diego officials stonewalled attempts to notify women in an HIV research study that their confidential data was breached more than seven months ago, an inewsource investigation has found. [colored_box]UCSD researchers conducting the EmPower Women study told university officials in October that participants’... More

University of California San Diego officials stonewalled attempts to notify women in an HIV research study that their confidential data was breached more than seven months ago, an inewsource investigation has found. [colored_box]UCSD researchers conducting the EmPower Women study told university officials in October that participants’ names, audio-taped conversations and other sensitive materials were made accessible to everyone working at Christie’s Place, a San Diego nonprofit supporting women with HIV and AIDS. They called the situation “very serious” and said the women affected are “within one of the most vulnerable and marginalized populations.” . But internal emails, reports and meeting minutes chronicle months of communication between lead researcher Jamila Stockman — who pushed for telling two dozen women enrolled in the project about the breach — and UCSD officials concerned about the consequences. .

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Hyped-up science erodes trust. Here’s how researchers can fight back – Vox (Brian Resnick | June 2019)

Published/Released on June 11, 2019 | Posted by Admin on June 18, 2019 | Keywords: , , , ,

Science is often poorly communicated. Researchers can fight back.

In 2018, psychology PhD student William McAuliffe co-published a paper in the prestigious journal Nature Human Behavior. The study’s conclusion — that people become less generous over time when... More

Science is often poorly communicated. Researchers can fight back.

In 2018, psychology PhD student William McAuliffe co-published a paper in the prestigious journal Nature Human Behavior. The study’s conclusion — that people become less generous over time when they make decisions in an environment where they don’t know or interact with other people — was fairly nuanced.

But the university’s press department, perhaps in an attempt to make the study more attractive to news outlets, amped up the finding. The headline of the press release heralding the publication of the study read “Is big-city living eroding our nice instinct?

From there, the study took on a new life as stories in the press appeared with headlines like “City life makes humans less kind to strangers.”

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People want to be able to influence the risk – The Ethics Blog (Pär Segerdahl | May 2019)

Published/Released on May 27, 2019 | Posted by Admin on June 16, 2019 | Keywords: , , , , , , ,

We need to do research to know what people think is important in genetic risk information. What they prefer to know. But how do we find out? One way is to ask people to answer questionnaires. One problem with questionnaires is that they ask one thing at a time. Do... More

We need to do research to know what people think is important in genetic risk information. What they prefer to know. But how do we find out? One way is to ask people to answer questionnaires. One problem with questionnaires is that they ask one thing at a time. Do you prefer a hotel room with a sea view when you are on vacation? You probably answer yes. But do you prefer the sea view even if the room is above the disco, or costs 500 EUR per night? If you only ask one thing at a time, then it is difficult to know how different factors interact, how important they are relative to each other. One way to get past this limitation is to ask people to choose between two alternatives, where the alternatives have several different attributes.

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How Do You Publish the Work of a Scientific Villain? – WIRED (Megan Molteni | December 2018)

HOW DO YOU handle the data of a scientist who violates all the norms of his field? Who breaches the trust of a community that spans the entire globe? Who shows a casual disregard for the fate of the whole... More

HOW DO YOU handle the data of a scientist who violates all the norms of his field? Who breaches the trust of a community that spans the entire globe? Who shows a casual disregard for the fate of the whole human species? On the one hand, you might want to learn from such a person’s work; to have a full and open dissection of everything that went wrong. Because, spoiler, there was a lot that went wrong in the case in question. But rewarding such “abhorrent” behavior, as one scientist put it, with a publication—the currency of the scientific world—would send a message that ethical rules only exist to be broken.

This is the precarious situation in which we find ourselves today, as scientists hash out the next chapter of the human gene-editing scandal that erupted two weeks ago, when the Chinese scientist He Jiankui revealed that for the last two years he has been working in secret to produce the world’s first Crispr-edited babies. Scientists denounced the work with near-unanimous condemnation, citing its technical failures as well as its deep breaches of ethical (and possibly legal) lines. What’s much less certain is what should happen to the work, now that it’s been done.

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(US) ‘Banished’ blood, stool samples from San Diego veterans used in research article, despite federal probe – ienewsource (Brad Racino & Jill Castellano | May 2019)

Two prominent doctors associated with the University of California San Diego and the local VA used blood and stool samples taken from sick veterans to bolster a paper published this month in an academic research journal. The specimens were not supposed to be used, according to... More

Two prominent doctors associated with the University of California San Diego and the local VA used blood and stool samples taken from sick veterans to bolster a paper published this month in an academic research journal. The specimens were not supposed to be used, according to the project’s lead researcher, because they were part of a study that unethically collected biological samples from living subjects without their consent, which investigators called "serious noncompliance." When people volunteer to be human research subjects, they accept potential health risks in order to contribute to a growing bank of scientific and medical knowledge.

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(Japan) 158 ethics violations found in research by Japan’s NCVC medical institute – The Japan Times (May 2019)

SUITA, OSAKA PREF. - The National Cerebral and Cardiovascular Center said Thursday it has found 158 cases of research that was conducted in violation of the country’s ethical standards. The violations include the use of patients’ information without their consent, the NCVC said. There have been no reports of health... More

SUITA, OSAKA PREF. - The National Cerebral and Cardiovascular Center said Thursday it has found 158 cases of research that was conducted in violation of the country’s ethical standards. The violations include the use of patients’ information without their consent, the NCVC said. There have been no reports of health damage linked to these cases that involved follow-up research, the institute said. “We deeply apologize for the misconduct,” NCVC President Hisao Ogawa said at a news conference in Suita, where the institute is based.

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Research Ethics Governance – An African Perspective (Chapter: Marelize I. Schoeman | May 2019)

Abstract Governance structures in research are generally a retrospective response to unethical research practices. Similar to the international research landscape Africa has not been immune to human research abuses inclusive of unethical experimentation and clinical trials. An increase in research was... More

Abstract Governance structures in research are generally a retrospective response to unethical research practices. Similar to the international research landscape Africa has not been immune to human research abuses inclusive of unethical experimentation and clinical trials. An increase in research was noted in Africa this past decade in response to serious psychosocial and health-related challenges the continent faced. This increase in research has not necessarily brought about improvements in the governance and oversight of human research practices. In contrast, it increased the risk of exploitative research funded by resource-rich countries who conducted studies in Africa that would be difficult to conduct in countries with more established and strict research regulatory frameworks.

Even though the impact colonialism and the internationalisation of research had on ethics governance is recognised, African scholars is of the opinion that the debate about research ethics governance largely represents the opinions of scholars from Euro-western countries, with little contribution being made by African scholars. Against this background, the chapter presents an Afrocentric viewpoint of research ethics governance. In addition, Westernised and African research ethics practices and oversight structures were compared to identify challenges and guidelines. The research ethics governance landscape is to a large extent still an uncharted landscape creating the opportunity to develop a research ethics governance framework that acknowledges the unique humanistic morality and normative set of social rules and principles that guide the conduct of people in African societies. The chapter aims to make a significant contribution by stimulate critical discourse about the relevance of ethical principles and governance structures currently used in Africa.

Keywords Research ethics governance, Research ethics committees, Biomedical research, Social science research 

Schoeman M.I. (2019) Research Ethics Governance – An African Perspective. In: Nortjé N., Visagie R., Wessels J. (eds) Social Science Research Ethics in Africa. Research Ethics Forum, vol 7. Springer, Cham Publisher: https://www.springer.com/978-3-030-15401-1?wt_mc=ThirdParty.SpringerLink.3.EPR653.About_eBook
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Friday afternoon’s funny – Data Food Chain

Published/Released on May 31, 2019 | Posted by Admin on May 31, 2019 | Keywords: , , , ,

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German ethics council expresses openness to eventual embryo editing – STAT (Sharon Begley | May 2019)

Published/Released on May 13, 2019 | Posted by Admin on May 30, 2019 | Keywords: , , , , , , ,

panel of government-appointed experts in Germany agreed unanimously that the human germline — DNA that is inherited by children from their parents — “is not inviolable,” rejecting one objection to using genome editing technologies such as CRISPR to make heritable changes in the DNA of human embryos,... More

panel of government-appointed experts in Germany agreed unanimously that the human germline — DNA that is inherited by children from their parents — “is not inviolable,” rejecting one objection to using genome editing technologies such as CRISPR to make heritable changes in the DNA of human embryos, sperm, or eggs. [colored_box]In a 47-page report made public on Monday, the independent German Ethics Council concluded that the power of CRISPR, and the announcement last November that a scientist in China had used it to edit two IVF embryos that resulted in the birth of twin girls, means that “the possibility of intervening more easily and precisely in the human germline is drawing closer and closer.” . Although the council’s 26 ethicists, legal scholars, scientists, and other experts agreed unanimously that there are no compelling philosophical arguments against altering human germlines, they also concluded that it is ethically irresponsible to do so now. .

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Thinking about ethics in Burma research (Papers: Lisa Brooten & Rosalie Metro | 2014)

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(US/China) When DNA science goes down an unethical path in China, who is responsible? – Medical Xpress (Brittany Meiling, et al | February 2019)

Published/Released on February 28, 2019 | Posted by Admin on May 24, 2019 | Keywords: , , , , , , ,

New reports that China is using DNA science developed in San Diego County for widespread ethnic surveillance raise ethical questions about who is responsible for how that technology is used. The New York Times reported recently that Chinese authorities are building a DNA database of the country's Uighur minority, a... More

New reports that China is using DNA science developed in San Diego County for widespread ethnic surveillance raise ethical questions about who is responsible for how that technology is used. The New York Times reported recently that Chinese authorities are building a DNA database of the country's Uighur minority, a predominantly Muslim ethnic group blamed for a series of terrorist attacks in northwestern China. Since 2016, there have been regular reports of authorities taking blood samples in the Xinjiang region, where ethnic tensions have been rising. The situation has evolved into a Muslim crackdown in China, with nearly one million Uighurs and other minorities reportedly held in "re-education" camps bent on making Muslims more subservient to the Communist Party. There, Uighurs are being forced to hand over genetic samples, which activists worry could later be used by authorities to chase down any Uighurs who resist the indoctrination.

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Friday afternoon’s funny – Participant betrayal

Published/Released on May 23, 2019 | Posted by Admin on May 23, 2019 | Keywords: , , ,

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The ethics of New Development Economics: is the Experimental Approach to Development Economics morally wrong? (Papers: Stéphane J. Baele)

Published/Released on November 19, 2013 | Posted by Admin on May 21, 2019 | Keywords: , , , , , , , , ,

Abstract: The 2000s have witnessed the arrival and growing popularity of randomized controlled experiments (RCTs) in Development Economics. Whilst this new way of conducting research on development has unfolded important insights, the ethical challenge it provokes has not yet been... More

Abstract: The 2000s have witnessed the arrival and growing popularity of randomized controlled experiments (RCTs) in Development Economics. Whilst this new way of conducting research on development has unfolded important insights, the ethical challenge it provokes has not yet been systematically examined. The present article aims at filling this gap by providing the first ad hoc discussion of the moral issues that accompany the use of RCTs in Development Economics. Claiming that this new research agenda needs its own, specific set of ethical guidelines, we expose the six ethical problems that these experiments potentially provoke and that should therefore be carefully assessed by ethics committees before an RCT is launched and by scholarly journals before its results are published. Keywords: Development Economics, ethics, RCTs, experiments

Baele, Stéphane J. (2013) ‘The ethics of New Development Economics: is the Experimental Approach to Development Economics morally wrong?’, The Journal of Philosophical Economics, VII:1 Publisher (Open Access): https://jpe.ro/?id=revista&p=291&cuprins=vizibil

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The Ethics of Social Research with Children and Families in Young Lives: Practical Experiences (Book: Virginia Morrow | 2009)

Published/Released on January 01, 2012 | Posted by Admin on May 19, 2019 | Keywords: , , , , ,

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China tightens its regulation of some human gene editing, labeling it ‘high-risk’ – Science (Dennis Normile | February 2019)

In the wake of the shocking news that one of its scientists had produced genetically altered babies, the Chinese government this week issued draft regulations that would require national approval for clinical research involving gene editing and other “high-risk biomedical technologies.” Although some Chinese researchers welcome the move to... More

In the wake of the shocking news that one of its scientists had produced genetically altered babies, the Chinese government this week issued draft regulations that would require national approval for clinical research involving gene editing and other “high-risk biomedical technologies.” Although some Chinese researchers welcome the move to tighten oversight, there are worries that the rules could impose a burden on areas of genetic research that are not so controversial. “I am happy to see the national regulations regarding new biomedical technologies; I think this makes relevant policy more clear,” says Wei Jia, a medical oncologist who is involved with an ongoing trial using gene editing to modify cancer patient T-cells at the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School in China. The regulations are in response to the late November 2018 claim by He Jiankui, then of Southern University of Science and Technology in Shenzhen, China, that he had altered the DNA embryos in a way that would give the babies and their descendants resistance to HIV. This approach is called germline engineering—it can involve changing DNA in embryos or sperm or eggs—and is banned in many countries, by law or regulation. He’s effort, using a technique called CRISPR, resulted in twin girls born last fall; one more baby, he said, is on the way. The experiment earned He worldwide condemnation for prematurely using a still glitchy technique that might negatively affect the babies’ development and health in a medically unnecessary and unjustified intervention.

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Chinese government funding may have been used for ‘CRISPR babies’ project, documents suggest – STAT (Jane Qiu | February 2019)

Published/Released on February 25, 2019 | Posted by Admin on May 19, 2019 | Keywords: , , , , , , ,

BEIJING — Three government institutions in China, including the nation’s science ministry, may have funded the “CRISPR babies” study that led to the birth last November of two genetically modified twin girls, according to documents reviewed by STAT.

These findings appear to support what many... More

BEIJING — Three government institutions in China, including the nation’s science ministry, may have funded the “CRISPR babies” study that led to the birth last November of two genetically modified twin girls, according to documents reviewed by STAT.

These findings appear to support what many researchers inside and outside China have suspected since scientist He Jiankui revealed the births in late November, sparking international condemnation for violating scientific guidelines against the use of gene-edited human embryos to start pregnancies. “I don’t think He Jiankui could have done it without the government encouragement to press ahead” with research they thought would merit a Nobel Prize, said Jing-Bao Nie, a bioethicist at the University of Otago in New Zealand.

If the documents are correct, they would suggest China is supporting research that the U.S. and other countries consider unethical, and raise doubts about the preliminary conclusion of a government investigation that He acted mostly on his own. That inquiry, which was led by the Guangdong provincial health commission and involved the science ministry and the National Health Commission, determined that He raised funding for the experiment on his own without official endorsement. It also concluded that He forged an informed-consent form and violated scientific ethics and Chinese regulations, according to the official Xinhua News Agency.

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Trump’s science adviser on research ethics, immigration and presidential tweets – Science (Sara Reardon | April 2019)

Five months into the job, Kelvin Droegemeier tells Nature what it’s like to work with the US president.

When meteorologist Kelvin Droegemeier was sworn in as director of the White House Office of Science and Technology Policy (OSTP) in February, he inherited More

Five months into the job, Kelvin Droegemeier tells Nature what it’s like to work with the US president.

When meteorologist Kelvin Droegemeier was sworn in as director of the White House Office of Science and Technology Policy (OSTP) in February, he inherited an office that had been without a leader for two years — and became the top science adviser to President Donald Trump. Trump's push to cut government spending on research, and his policies on issues such as immigration, have caused controversy in science. Nature spoke to Droegemeier in mid-April — two months into his tenure — about these policies, his plans and what it’s like to work with the president. The interview has been edited for length and clarity. The number of OSTP staff dropped precipitously during Trump’s first two years in office. What is the situation now? The lights were definitely on, and there was a lot of work actually getting done. We have people cycle through. Some of them are on detail for a year, so there’s kind of a constant refresh. I have brought additional people on board in some of the areas that I’m going to be working on a little bit more.

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Remains of dissected Nazi prisoners to be laid to rest in Berlin – The Guardian (Philip Oltermann | May 2019)

Microscopic tissue samples, kept by controversial anatomist, were found in 2016

The microscopic remains of political prisoners executed by the Nazis and dissected by a controversial anatomist are to be buried in Berlin on Monday, more than seven decades after the end of the... More

Microscopic tissue samples, kept by controversial anatomist, were found in 2016

The microscopic remains of political prisoners executed by the Nazis and dissected by a controversial anatomist are to be buried in Berlin on Monday, more than seven decades after the end of the second world war. About 300 tissue samples, each one no more than a hundredth of a millimetre thin and one square centimetre in size, were discovered in 2016 by descendants of Hermann Stieve, a former director of the Berlin Institute of Anatomy who specialised in research into the female reproductive system. Though Stieve was not a member of the Nazi party, he developed a relationship with the regime whereby he was allowed to do research on recently executed political prisoners in return for helping to obliterate any traces of their remains.

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Aboriginal genome analysis comes to grips with ethics – Nature (Ewen Callaway | September 2011)

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Friday afternoon’s funny – Faster recruitment

Published/Released on May 10, 2019 | Posted by Admin on May 10, 2019 | Keywords: , , , , ,

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Indigenous groups look to ancient DNA to bring their ancestors home – Nature (Nicky Phillips – April 2019)

Published/Released on May 9, 2019 | Posted by Admin on May 9, 2019 | Keywords: , , , , , ,

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Australian Mental Health Consumer and Carer Perspectives on Ethics in Adult Mental Health Research (Papers: Alyssa R. Morse, et al | April 2019)

Abstract Barriers to research arise when national ethical guidelines governing the inclusion of consumers in mental health research are implemented at the local level. Equivalent guidelines for research involving carers are not available. A social science investigation of Australian mental health consumer and carer perspectives... More

Abstract Barriers to research arise when national ethical guidelines governing the inclusion of consumers in mental health research are implemented at the local level. Equivalent guidelines for research involving carers are not available. A social science investigation of Australian mental health consumer and carer perspectives on research ethics procedures was conducted in two interlinked stages: (a) a discussion forum with consumers, carers, and lived-experience researchers and (b) in-depth interviews with consumers and carers. Data collection and analysis drew strongly on methodological features of grounded theory. Privacy, confidentiality, and stigmatizing ethics procedures were key issues for consumer and carer participants. Recommendations for research practice include the following: considering the impact of information sharing on participants' relationships and adopting individual-focused approaches to managing research risks.
Keywords: caregiver; carer involvement; consumer involvement; mental health; research ethics; service user

Morse, A. R., Forbes, O., Jones, B. A., Gulliver, A., & Banfield, M. (2019). Australian Mental Health Consumer and Carer Perspectives on Ethics in Adult Mental Health Research. Journal of Empirical Research on Human Research Ethics. https://doi.org/10.1177/1556264619844396 Publisher: https://journals.sagepub.com/doi/abs/10.1177/1556264619844396

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Research: Data Protection Impact Assessment (DPIA) (Guidance: SOAS UL | November 2018)

Published/Released on November 14, 2018 | Posted by Admin on May 2, 2019 | Keywords: , , , ,

Table of Contents Research: Data Protection Impact Assessment (DPIA) .... 1 1. Requirement .... 3 2. The Nature of the DPIA .... 3 3. Screening Evaluation .... 4 4. Content and scope .... 4 5. Process .... 5 6. Unmitigated High-Risks .... 5 Appendix 1: Screening Evaluation .... 7 Appendix 2: Data Protection Impact... More

Table of Contents Research: Data Protection Impact Assessment (DPIA) .... 1 1. Requirement .... 3 2. The Nature of the DPIA .... 3 3. Screening Evaluation .... 4 4. Content and scope .... 4 5. Process .... 5 6. Unmitigated High-Risks .... 5 Appendix 1: Screening Evaluation .... 7 Appendix 2: Data Protection Impact Assessment (DPIA) Template ....8 [colored_box]1. Requirement 1.1 The Data Protection Impact Assessment (DPIA) is a requirement that is set out in both the General Data Protection Regulation (GDPR) and the Data Protection Act (DPA) 2018.1 . 1.2 The Research Office has prepared the guide set out here as it relates to Research and it forms part of the overall Research Ethics process. It is formulated in line with SOAS’ corporate approach as set out in the Data Protection Impact Assessment Guide. .

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Guidance for Researchers on the Implications of the General Data Protection Regulation and the Data Protection Act 2018 (Guidance: UCL | May 2018)

Published/Released on May 30, 2018 | Posted by Admin on April 30, 2019 | Keywords: , , , , , , ,

Introduction This guidance note has been compiled to provide an overview of data protection key points for researchers, in line with the General Data Protection Regulation (GDPR) and the new UK Data Protection Act 2018. When referring to both, this guidance note will use the term... More

Introduction This guidance note has been compiled to provide an overview of data protection key points for researchers, in line with the General Data Protection Regulation (GDPR) and the new UK Data Protection Act 2018. When referring to both, this guidance note will use the term ‘new data protection legislation’. This document was last updated on 24 May 2018. It may be updated further as relevant guidance on the issues raised is published by the UK Information Commissioner’s Office (ICO). A. Scope This guidance applies to researchers who are processing personal data, i.e. information relating to an identified or identifiable living person. Note that ‘processing’ means any operation - collecting, storing, using, transferring, disclosing or destroying - performed on personal data.

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‘They’re not property’: the people who want their ancestors back from British museums – The Guardian (David Shariatmadari | Apr 2019)

Published/Released on April 23, 2019 | Posted by Admin on April 25, 2019 | Keywords: , , , , ,

The remains of indigenous people from all over the world have ended up in various British institutions. Why do their descendants have so much trouble getting them returned?

In November 2011, Ned David travelled the 8,500 miles from his home on Thursday... More

The remains of indigenous people from all over the world have ended up in various British institutions. Why do their descendants have so much trouble getting them returned?

In November 2011, Ned David travelled the 8,500 miles from his home on Thursday Island, off the tip of Queensland, Australia, to the Natural History Museum in London. He was on a mission to collect the bones of his ancestors. The material included skulls, a jawbone and other fragments from the Torres Strait archipelago, collected by Europeans in the 19th century as scientific specimens and anthropological curios. The museum had agreed that the remains should be given back to their “originating community”, and it was finally time to take them home. A private ceremony was held – David is reluctant to share the details with outsiders – and afterwards he and his fellow islanders went back to their hotel. But the mood wasn’t celebratory. “Mate,” he says, “it was sombre with a capital ‘S’. There was sort of this eerie feeling after all the hoo-ha and the media, and whatever. We sat around and no one spoke. I think it took a long time to realise the significance of what we had done.” The handover had followed a consultation in which islanders were asked what they wanted to do about body parts that were sitting in collections on the other side of the world. Feelings ran high. “It’s probably one of those rare exercises we have done as a nation in which we were in total agreement with each other,” says David, who chairs the Gur A Baradharaw Kod, or Torres Strait Sea and Land council. “As one elder said: ‘How would you feel knowing that one of your family members is in some strange place and, more importantly, hasn’t been afforded the right burial?’ That has an impact on the psyche of a group.”

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African governments need to fund research ethics training – University World News (Paul Ndebele | April 2019)

Published/Released on April 20, 2019 | Posted by Admin on April 24, 2019 | Keywords: , , , , ,

There has been significant growth in international collaborative research implemented in Sub-Saharan Africa over the past three decades – funded mainly by the United States, United Kingdom, Germany, Japan and other nations. This growth has in part led to debates about the ethics of some of the research. For example,... More

There has been significant growth in international collaborative research implemented in Sub-Saharan Africa over the past three decades – funded mainly by the United States, United Kingdom, Germany, Japan and other nations. This growth has in part led to debates about the ethics of some of the research. For example, during the late 1990s there were serious debates regarding use of placebos in research on HIV treatment when treatment outcomes were already known. Some commentators accused researchers from rich countries of using poor African countries to conduct research which they could not conduct in their own countries due to the stringent protections already in place. Additionally, several papers described the weak research oversight systems in several African countries. In response, several research ethics capacity development programmes were initiated across Sub-Saharan Africa with the support of the World Health Organization, US National Institutes of Health, Wellcome Trust, Erasmus Mundus programme, pharmaceutical companies and others.

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U.S. Public Health Service STD Experiments in Guatemala (1946–1948) and Their Aftermath – Ethics and Human Research (Kayte Spector‐Bagdady Paul A. Lombardo | March 2019)

ABSTRACT The U.S. Public Health Service’s sexually transmitted disease (STD) experiments in Guatemala are an important case study not only in human subjects research transgressions but also in the response to serious lapses in research ethics. This case study describes how individuals in the STD experiments... More

ABSTRACT The U.S. Public Health Service’s sexually transmitted disease (STD) experiments in Guatemala are an important case study not only in human subjects research transgressions but also in the response to serious lapses in research ethics. This case study describes how individuals in the STD experiments were tested, exposed to STDs, and exploited as the source of biological specimens—all without informed consent and often with active deceit. It also explores and evaluates governmental and professional responses that followed the public revelation of these experiments, including by academic institutions, professional organizations, and the U.S. federal government, pushing us to reconsider both how we prevent such lapses in the future and how we respond when they are first revealed.

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(US) Safeguards for human studies can’t cope with big data – Nature (Nathaniel Raymond | April 2019)

Forty years on from a foundational report on how to protect people participating in research, cracks are showing, warns Nathaniel Raymond.

One of the primary documents aiming to protect human research participants was published in the US Federal Register 40 years ago this week.... More

Forty years on from a foundational report on how to protect people participating in research, cracks are showing, warns Nathaniel Raymond.

One of the primary documents aiming to protect human research participants was published in the US Federal Register 40 years ago this week. The Belmont Report was commissioned by Congress in the wake of the notorious Tuskegee syphilis study, in which researchers withheld treatment from African American men for years and observed how the disease caused blindness, heart disease, dementia and, in some cases, death. [colored_box]The Belmont Report lays out core principles now generally required for human research to be considered ethical. Although technically governing only US federally supported research, its influence reverberates across academia and industry globally. Before academics with US government funding can begin research involving humans, their institutional review boards (IRBs) must determine that the studies comply with regulation largely derived from a document that was written more than a decade before the World Wide Web and nearly a quarter of a century before Facebook. . It is past time for a Belmont 2.0. We should not be asking those tasked with protecting human participants to single-handedly identify and contend with the implications of the digital revolution. Technological progress, including machine learning, data analytics and artificial intelligence, has altered the potential risks of research in ways that the authors of the first Belmont report could not have predicted. For example, Muslim cab drivers can be identified from patterns indicating that they stop to pray; the Ugandan government can try to identify gay men from their social-media habits; and researchers can monitor and influence individuals’ behaviour online without enrolling them in a study. .

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The Ethics of Learning Analytics in Australian Higher Education. A Discussion Paper (The University of Melbourne | March 2019)

Overview This project brought together learning analytics experts from across Australia to explore key ethical issues relating to the development and use of learning analytics in higher education. The result of these discussions was a discussion paper that provides an outline of seven ethical principles as... More

Overview This project brought together learning analytics experts from across Australia to explore key ethical issues relating to the development and use of learning analytics in higher education. The result of these discussions was a discussion paper that provides an outline of seven ethical principles as well as practical considerations associated with the use of learning analytics.

Objective

The ever-increasing availability of data about student activities in educational environments presents many opportunities for the improvement of learning and teaching through the use of learning analytics. In applying analytics, there is an obligation that educators and institutions ensure that data and analysis techniques are used appropriately. The range of ethical considerations that educational institutions must face is complex, and many institutions are still formulating their approach to ensuring ethical practice in this field. The objective of this project was to draw together contemporary research and current practice in the area of ethics and learning analytics, and use this to produce a discussion paper that provides guidance to a range of higher education stakeholders including students, educators, researchers, and senior leaders.

Corrin, L., Kennedy, G., French, S., Buckingham Shum S., Kitto, K., Pardo, A., West, D., Mirriahi, N., & Colvin, C. (2019). The Ethics of Learning Analytics in Australian Higher Education. A Discussion Paper. https://melbourne-cshe.unimelb.edu.au/research/research-projects/edutech/the-ethical-use-of-learning-analytics

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(US/UK) Data suggest US, UK universities fall woefully short on reporting clinical trial results – Endpoints News (Natalie Grover | March 2019)

Published/Released on March 26, 2019 | Posted by Admin on April 9, 2019 | Keywords: , , , , , , ,

Clinical trial data are used by patients, doctors and policymakers to make informed choices about the benefits and safety of interventions — while the methods and results of all trials are crucial to the pace and direction of scientific progress. However, there is a large body of evidence that... More

Clinical trial data are used by patients, doctors and policymakers to make informed choices about the benefits and safety of interventions — while the methods and results of all trials are crucial to the pace and direction of scientific progress. However, there is a large body of evidence that suggests that completed clinical trials are commonly left unreported, and educational institutions in the United States and the United Kingdom — arguably the two biggest regions that breed the bulk of medical innovation — have emerged as one of the key culprits guilty of these violations. In the United States, Congress passed a law in 2007 requiring trial sponsors — including universities — to post the results of certain clinical trials on clinicaltrials.gov within a year of trial completion, and a decade later in January 2017 the rule was finalized. Since 2017, 40 leading US universities should have posted the results of 450 clinical trials — but over a third (31%) of those results are missing, according to an analysis by Universities Allied for Essential Medicines (UAEM) in partnership with non-profit research advocacy group TranspariMED. The violators include some of the most active trial sponsors: For example the MD Anderson Cancer Center, which has only reported 77% of due trials, Mayo Clinic (42%), UC San Francisco (37%), New York University (21%), and Columbia University (17%).

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Genomic Research Through an Indigenous Lens: Understanding the Expectations (Nanibaa’ A. Garrison, et al | August 2019)

Published/Released on August 15, 2019 | Posted by Admin on April 2, 2019 | Keywords: , , , , , , ,

Abstract Indigenous scholars are leading initiatives to improve access to genetic and genomic research and health care based on their unique cultural contexts and within sovereign-based governance models created and accepted by their peoples. In the past, Indigenous peoples’ engagement with genomic research was hampered by... More

Abstract Indigenous scholars are leading initiatives to improve access to genetic and genomic research and health care based on their unique cultural contexts and within sovereign-based governance models created and accepted by their peoples. In the past, Indigenous peoples’ engagement with genomic research was hampered by a lack of standardized guidelines and institutional partnerships, resulting in group harms. This article provides a comparative analysis of research guidelines from Canada, New Zealand, Australia, and the United States that pertain to Indigenous peoples. The goals of the analysis are to identify areas that need attention, support Indigenous-led governance, and promote the development of a model research policy framework for genomic research and health care that has international relevance for Indigenous peoples. Expected final online publication date for the Annual Review of Genomics and Human Genetics Volume 22 is August 30, 2019. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.

Garrison, N. A., Hudson, M., L. Ballantyne, LL., Garba, I. Martinez, A., Taualii, M., Arbour L., Caron, NR. and Rainie, SC. (2019). Genomic Research Through an Indigenous Lens: Understanding the Expectations. Annual Review of Genomics and Human Genetics 20(1) https://www.annualreviews.org/doi/abs/10.1146/annurev-genom-083118-015434

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(US) University of Illinois at Chicago Missed Warning Signs of Research Going Awry, Letters Show – Propublica Illinois (Jodi S. Cohen | March 2019)

Published/Released on February 28, 2019 | Posted by Admin on March 31, 2019 | Keywords: , , , , , , , , ,

UIC has played down its shortcomings in overseeing the work of a prominent child psychiatrist, but newly obtained documents show that the school acknowledged its lapses to federal officials.

This story was co-published with The Chronicle of... More

UIC has played down its shortcomings in overseeing the work of a prominent child psychiatrist, but newly obtained documents show that the school acknowledged its lapses to federal officials.

This story was co-published with The Chronicle of Higher Education and the Chicago Sun-Times.

For a year, the University of Illinois at Chicago has downplayed its shortcomings in overseeing the work of a prominent child psychiatrist who violated research protocols and put vulnerable children with bipolar disorder at risk.

But documents newly obtained by ProPublica Illinois show that UIC acknowledged to federal officials that it had missed several warning signs that Dr. Mani Pavuluri’s clinical trial on lithium had gone off track, eventually requiring the university to pay an unprecedented $3.1 million penalty to the federal government.

UIC’s Institutional Review Board, the committee responsible for protecting research subjects, improperly fast-tracked approval of Pavuluri’s clinical trial, didn’t catch serious omissions from the consent forms parents had to sign and allowed children to enroll in the study even though they weren’t eligible, the documents show.

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On “truly” understanding the risk – The Ethics Blog (Pär Segerdahl | March 2019)

Pär SegerdahlIt is a well-known psychological fact that people have great difficulties to understand probabilistic risks. What does it actually mean that the risk of developing breast cancer the next ten years is fifteen percent? In addition to the difficulties of... More

Pär SegerdahlIt is a well-known psychological fact that people have great difficulties to understand probabilistic risks. What does it actually mean that the risk of developing breast cancer the next ten years is fifteen percent? In addition to the difficulties of understanding probabilities, mathematical expressions can cause a false appearance of exactitude and objectivity. It is often about uncertain evaluations, but expressed in seemingly definitive figures. At our Monday seminar, Ulrik Kihlbom discussed another difficulty with understanding risk information. It can be difficult to understand not only the probabilities, but also what it is you risk experiencing. Sometimes, people face enormously complex choices, where the risks are high, but also the benefits. Perhaps you suffer from a serious disease from which you will die. However, there is a treatment, and it may work. It is just that the treatment has such severe side effects that you may die even from the treatment. Ulrik Kihlbom interviewed physicians treating patients with leukemia. The doctors stated that patients often do not understand the risks of the treatment they are offered. The difficulty is not so much about understanding the risk of dying from the treatment. The patients understand that risk. However, the doctors said, no one who has not actually seen the side effects understand that the treatment can make you so incredibly ill.

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Academic Behind Cambridge Analytica Data Mining Sues Facebook for Defamation – New York Times (Matthew Rosenberg | March 2019)

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The Foundation of Knowledge Production: Research Ethics Education in Taiwan (PowerPoint: Chien Chou | September 2018)

Outline

1. The Importance of Research Ethics 2. Researchers’Needs for Education 3. Education and Implementation Mechanism of Research Ethics in Taiwan’s Higher Education 4. Concluding Remarks

The Importance of research ethics

• Presents a baseline for all research behaviors • Protects others, minimizes harm... More

Outline

1. The Importance of Research Ethics 2. Researchers’Needs for Education 3. Education and Implementation Mechanism of Research Ethics in Taiwan’s Higher Education 4. Concluding Remarks

The Importance of research ethics

• Presents a baseline for all research behaviors • Protects others, minimizes harm and increases the sum of good • Supports trust among researchers and between research communities and the public • Ensures research integrity and quality • Satisfies organizational and professional demands • Copes with new and more challenging problems

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China to tighten rules on gene editing in humans – Nature (David Cyranoski | March 2019)

In the wake of the gene-edited-baby scandal, scientists and institutions could face tough penalties for breaking the rules.

China’s health ministry has issued draft regulations that will restrict the use of gene editing in humans, just three months after Chinese researcher He Jiankui announced... More

In the wake of the gene-edited-baby scandal, scientists and institutions could face tough penalties for breaking the rules.

China’s health ministry has issued draft regulations that will restrict the use of gene editing in humans, just three months after Chinese researcher He Jiankui announced that twin girls had been born with edited genomes. The proposal includes severe penalties for those who break the rules. If approved, scientists say the policy could have gains and drawbacks for research. The draft regulations, issued by the National Health Commission on 26 February, state that gene editing in any type of cell that will end up in humans, including embryos, will need the commission’s approval, as will other high-risk biomedical procedures. The regulations come in response to He’s claim, in late November, that he used the gene-editing technology CRISPR–Cas9 to alter the genomes of embryos — a process known as germline editing — to make them resistant to HIV. He then implanted the edited embryos into women. News that twin girls had been born as a result of these experiments prompted an international outcry about He’s use of a risky and unproven technology.

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Major medical journals don’t follow their own rules for reporting results from clinical trials – Science (Jocelyn Kaiser | February 2019)

Published/Released on February 15, 2019 | Posted by Admin on March 19, 2019 | Keywords: , , , , ,

It’s a well-known problem with clinical trials: Researchers start out saying they will look for a particular outcome—heart attacks, for example—but then report something else when they publish their results. That practice can make a drug or treatment look like it’s safer or more effective than it actually is.... More

It’s a well-known problem with clinical trials: Researchers start out saying they will look for a particular outcome—heart attacks, for example—but then report something else when they publish their results. That practice can make a drug or treatment look like it’s safer or more effective than it actually is. Now, a systematic effort to find out whether major journals are complying with their own pledge to ensure that outcomes are reported correctly has found many are falling down on the job—and both journals and authors are full of excuses. [colored_box]When journals and researchers were asked to correct studies, the responses “were fascinating, and alarming. Editors and researchers routinely misunderstand what correct trial reporting looks like,” says project leader Ben Goldacre, an author and physician at the University of Oxford in the United Kingdom and a proponent of transparency in drug research. . Starting 4 years ago, his team’s Centre for Evidence-Based Medicine Outcome Monitoring Project (COMPare) project examined all trials published over 6 weeks in five journals: Annals of Internal Medicine, The BMJ, JAMA, The Lancet, and The New England Journal of Medicine (NEJM). The study topics ranged from the health effects of drinking alcohol for diabetics to a comparison of two kidney cancer drugs. All five journals have endorsed long-established Consolidated Standards of Reporting Trials (CONSORT) guidelines. One CONSORT rule is that authors should describe the outcomes they plan to study before a trial starts and stick to that list when they publish the trial. .

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New call to ban gene-edited babies divides biologists – Science (Jon Cohen | March 2019)

A prominent group of 18 scientists and bioethicists from seven countries has called for a global “moratorium” on introducing heritable changes into human sperm, eggs, or embryos—germline editing—to make genetically altered children. The group, which published a commentary in Nature today, hopes to influence a long-standing debate that dramatically... More

A prominent group of 18 scientists and bioethicists from seven countries has called for a global “moratorium” on introducing heritable changes into human sperm, eggs, or embryos—germline editing—to make genetically altered children. The group, which published a commentary in Nature today, hopes to influence a long-standing debate that dramatically intensified after China’s He Jiankui announced in November 2018 that he used the genome editor CRISPR to try to alter the genes of babies to be resistant to the AIDS virus. [colored_box]Their call, which is endorsed in the same issue of Nature by Francis Collins, director of the U.S. National Institutes of Health, is a departure from statements issued by two global summits on genome editing in 2015 and 2018, a 2017 report from the U.S. National Academies of Sciences, Engineering, and Medicine (NASEM), and a 2018 report from the United Kingdom’s Nuffield Council on Bioethics. None has banned human germline editing, and most have stressed that it holds promise to help correct some heritable diseases. All have warned against using germline editing for cognitive or physical “enhancement” of people. Scientists including Nobel laureate David Baltimore of the California Institute of Technology in Pasadena remain opposed to a moratorium. Even in the wake of the He incident, Baltimore, who helped organize the summits, denounced such a ban as “draconian” and “antithetical to the goals of science.” . Any nation that wants to greenlight a human germline edit by its scientists, the 18 authors declare, should have to give public notice, engage in an international and transparent assessment of whether the intervention is justified, and make sure the work has broad support in their own nation. “Nations might well choose different paths, but they would agree to proceed openly and with due respect to the opinions of humankind on an issue that will ultimately affect the entire species,” they write. They strongly encourage that nonscientific perspectives, including those of people with disabilities and religious groups, be included in the discussion. And they stress that they are not calling for a moratorium on genome editing of somatic cells, which would not affect future generations. .

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Adopt a moratorium on heritable genome editing – Nature (Eric Lander, et al | March 2019)

We call for a global moratorium on all clinical uses of human germline editing — that is, changing heritable DNA (in sperm, eggs or embryos) to make genetically modified children. By ‘global moratorium’, we do not mean a permanent ban. Rather, we call for the establishment of an international framework... More

We call for a global moratorium on all clinical uses of human germline editing — that is, changing heritable DNA (in sperm, eggs or embryos) to make genetically modified children. By ‘global moratorium’, we do not mean a permanent ban. Rather, we call for the establishment of an international framework in which nations, while retaining the right to make their own decisions, voluntarily commit to not approve any use of clinical germline editing unless certain conditions are met. To begin with, there should be a fixed period during which no clinical uses of germline editing whatsoever are allowed. As well as allowing for discussions about the technical, scientific, medical, societal, ethical and moral issues that must be considered before germline editing is permitted, this period would provide time to establish an international framework.

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Presenting and representing others: towards an ethics of engagement (Papers: Lucy Pickering and Helen Kara | February 2017)

Published/Released on February 16, 2017 | Posted by Admin on March 14, 2019 | Keywords: , , , , , ,

Abstract The ethics of research representation are rarely discussed. Yet representation can have a significant impact on research participants and audiences. This paper draws on some of the limited body of accounts of ethical challenges experienced in representing others in qualitative research. These accounts make clear... More

Abstract The ethics of research representation are rarely discussed. Yet representation can have a significant impact on research participants and audiences. This paper draws on some of the limited body of accounts of ethical challenges experienced in representing others in qualitative research. These accounts make clear that researchers often have to choose between ‘competing goods’ when representing others, such as participant control over what is presented and how, researchers’ ‘interpretive authority’, and whether and how to represent participants’ speech. These decisions frequently involve researchers choosing between ‘literal’ (empirical, evidence-based) and ‘real’ (authentic, experiential) truths. To resolve these dilemmas, some researchers are turning to creative methods of representation, such as poems, songs, plays and dance. Like all forms of representation, these methods require compromise: in particular, some detail, depth, or location may be sacrificed in return for accessible engagement with participants and wider audiences. Conversely, traditional methods of presentation may sacrifice some scope for engagement and accessibility in return for greater detail and depth. We argue that such sacrifices are a necessary component of all forms of qualitative representation and consequently require a reflexive approach to choices about representation. It is this reflexive approach which we argue constitutes an ethics of engagement. Keywords Ethics, presentation, representation, reflexivity, engagement

Pickering, L., and Kara, H. (2017) Presenting and representing others: towards an ethics of engagement. International Journal of Social Research Methodology, (doi:10.1080/13645579.2017.1287875) https://core.ac.uk/download/pdf/77601396.pdf

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Why were scientists silent over gene-edited babies? – Nature (Natalie Kofler | February 2019)

Published/Released on February 26, 2019 | Posted by Admin on March 12, 2019 | Keywords: , , , , , , , , ,

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The CRISPR-baby scandal: what’s next for human gene-editing – Nature (David Cyranoski | February 2019)

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Organ transplants from executed Chinese prisoners and research ethics – Radio National ABC (Norman Swan | February 2019)

Macquarie University researchers say hundreds of journal papers in the transplant field don’t follow ethical guidelines in declaring whether or not their research includes transplants from executed prisoners in China. The researchers want the papers retracted, saying it creates a moral hazard for the entire field of research. Guest: Professor Wendy Rogers More

Macquarie University researchers say hundreds of journal papers in the transplant field don’t follow ethical guidelines in declaring whether or not their research includes transplants from executed prisoners in China. The researchers want the papers retracted, saying it creates a moral hazard for the entire field of research. Guest: Professor Wendy Rogers

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Whitepaper: Practical challenges for researchers in data sharing (David Stuart, et al | September 2018)

Published/Released on March 21, 2018 | Posted by Admin on March 4, 2019 | Keywords: , , , ,

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The Ethics Ecosystem: Personal Ethics, Network Governance and Regulating Actors Governing the Use of Social Media Research Data (Papers: Gabrielle Samuel, et al | February 2019)

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Call for retraction of 400 scientific papers amid fears organs came from Chinese prisoners – The Guardian (Melissa Davey | February 2019)

Study finds failure of English language medical journals to comply with international ethical standards

A world-first study has called for the mass retraction of more than 400 scientific papers on organ transplantation, amid fears the organs were obtained unethically from... More

Study finds failure of English language medical journals to comply with international ethical standards

A world-first study has called for the mass retraction of more than 400 scientific papers on organ transplantation, amid fears the organs were obtained unethically from Chinese prisoners. The Australian-led study exposes a mass failure of English language medical journals to comply with international ethical standards in place to ensure organ donors provide consent for transplantation. The study was published on Wednesday in the medical journal BMJ Open. Its author, the professor of clinical ethics Wendy Rogers, said journals, researchers and clinicians who used the research were complicit in “barbaric” methods of organ procurement.

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He Jiankui’s Germline Editing Ethics Article Retracted by The CRISPR Journal – GEN (Julianna LeMieux – February 2019)

Published/Released on February 20, 2019 | Posted by Admin on March 2, 2019 | Keywords: , , , , , , , ,

Failure to disclose conflicts of interest was "unacceptable"

Twelve weeks after publishing a perspective on the ethics of gene editing by He Jiankui, PhD, the scientist reportedly responsible for the first gene-edited humans, the editors of The CRISPR Journal have decided to retract the... More

Failure to disclose conflicts of interest was "unacceptable"

Twelve weeks after publishing a perspective on the ethics of gene editing by He Jiankui, PhD, the scientist reportedly responsible for the first gene-edited humans, the editors of The CRISPR Journal have decided to retract the article, GEN can exclusively report. [colored_box]In late November, the shocking news of the genetically edited twin girls broke out on the eve of the second international Human Genome Editing Summit in Hong Kong. The creation of germline-edited humans was unprecedented and not something that the scientific community had prepared for. . Most of the attention focused on the actions of 34-year-old He, formerly a professor at the Southern University of Science and Technology (SUSTech) in Shenzhen. He’s decision to ignore advice from prominent members of the scientific community and serious questions over the technical and ethical procedures prompted an immediate investigation by Chinese authorities while he was held under house arrest, culminating in his dismissal by SUSTech last month.| .

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Move clinical trial data sharing from an option to an imperative – STAT (Rebecca Li | February 2019)

Data from clinical trials have long been locked away, some in this principal investigator’s computer bank, some in that pharmaceutical company’s cloud. For years we have been talking about opening up those vaults and freeing these data. The key has finally turned: Data sharing is becoming... More

Data from clinical trials have long been locked away, some in this principal investigator’s computer bank, some in that pharmaceutical company’s cloud. For years we have been talking about opening up those vaults and freeing these data. The key has finally turned: Data sharing is becoming the new reality.

From Jan. 1, 2019, onward, the world’s leading medical journals, including the New England Journal of Medicine, the Lancet, Annals of Internal Medicine, BMJ, and thousands more require authors to disclose whether and how they plan to share deidentified raw data from individual participants in their clinical trials. What’s more, researchers wishing to publish in these journals must declare their data-sharing plans in a public registry, such as ClinicalTrials.gov.

It’s a radical departure from where we’ve been. In my former life conducting trials as a scientist in industry and for the National Institutes of Health, when I’d log onto ClinicalTrials.gov to register a new trial, I didn’t have to give a second thought to if or how I’d be sharing data from the trial. Now all researchers need to think about that from the very beginning, even before the first trial participant is enrolled.

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CRISPR bombshell: Chinese researcher claims to have created gene-edited twins – Science (Dennis Normile | November 2018)

HONG KONG, CHINA—On the eve of an international summit here on genome editing, a Chinese researcher has shocked many by claiming to have altered the genomes of twin baby girls born this month in a way that will pass the modification on to future generations. The alteration is intended... More

HONG KONG, CHINA—On the eve of an international summit here on genome editing, a Chinese researcher has shocked many by claiming to have altered the genomes of twin baby girls born this month in a way that will pass the modification on to future generations. The alteration is intended to make the children’s cells resistant to infection by HIV, says the scientist, He Jiankui of the Southern University of Science and Technology in Shenzhen, China. The claim—yet to be reported in a scientific paper—initiated a firestorm of criticism today, with some scientists and bioethicists calling the work “premature,” “ethically problematic,” and even “monstrous.” The Chinese Society for Cell Biology issued a statement calling the research “a serious violation of the Chinese government’s laws and regulations and the consensus of the Chinese scientific community.” And He’s university issued a statement saying it has launched an investigation into the research, which it says may “seriously violate academic ethics and academic norms.” Other scientists, meanwhile, asked to see details of the experiment and its justification before passing judgment.

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A Star Surgeon Left a Trail of Dead Patients—and His Whistleblowers Were Punished – LeapsMag (Eve Herold | October 2018)

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(US) A new NIH rule won’t be enough to make clinical research more inclusive – STAT (Louise Aronson | January 2019)

A quiet but revolutionary new national health policy goes into effect this week, ushering in changes that could lead to important medical discoveries that benefit most Americans. There’s just one problem. Implementing the change will require that our country’s health researchers make some fundamental changes in how they... More

A quiet but revolutionary new national health policy goes into effect this week, ushering in changes that could lead to important medical discoveries that benefit most Americans. There’s just one problem. Implementing the change will require that our country’s health researchers make some fundamental changes in how they do business.

[colored_box]Under the National Institutes of Health’s new Inclusion Across the Lifespan policy, federally supported medical research must include patients of all relevant ages or explain their exclusion. Since most studies already include adults, and a mandate to include children has existed since 1998, the novelty in this policy is the stipulation that clinical research include people age 65 and older. .

That’s a big group. It currently includes both Donald Trump and Nancy Pelosi, Ruth Bader Ginsberg and Clarence Thomas, as well as the 50 million other older Americans, along with the rest of us who get lucky enough down the road to make it into elderhood. .

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(China) Researcher who edited babies’ genome retreats from view as criticism mounts – BMJ (Chang-Qing Gao, et al | February 2019)

Published/Released on February 13, 2019 | Posted by Admin on February 19, 2019

Re: Researcher who edited babies’ genome retreats from view as criticism mounts --- Making ethics committees fit for purpose in China

[colored_box]Following the recent scandal over babies born in China after gene editing, the failure of ethical oversight of biomedical research requires urgent attention.1... More

Re: Researcher who edited babies’ genome retreats from view as criticism mounts --- Making ethics committees fit for purpose in China

[colored_box]Following the recent scandal over babies born in China after gene editing, the failure of ethical oversight of biomedical research requires urgent attention.1 Ethics committees are now established in more and more hospitals in China.2-5 These ethics committees review, for example, clinical trial protocols, applications for assisted reproduction procedures, and issues related to grant applications, as well as being involved in organ transplantation and other special treatments.5 The number of these applications is increasing quickly, hence the work of the ethics committees is mounting.3 . There are, however, numerous difficulties for ethics committees in China. . First, the independence and fairness of ethics committees is questionable. This begins with the composition of the committee.3-6 Studies show that up to 96% of the chairpersons of ethics committees are administrative officials of institutions, such as the president of the hospital,6,7 and the majority of committee members are directors of related departments.4,5-7 To make matters worse, financial support for the majority of ethics committee is from their own institutions.2 These factors lead to potential of bias in favor of the institution and its researchers.3,7 .

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Children in Social Research: Do Higher Payments Encourage Participation in Riskier Studies? (Stephanie Taplin, et al | February 2019)

Published/Released on February 09, 2019 | Posted by Admin on February 18, 2019 | Keywords: , , , , , , , ,

Abstract [colored_box]The MESSI (Managing Ethical Studies on Sensitive Issues) study used hypothetical scenarios, presented via a brief online survey, to explore whether payment amounts influenced Australian children and young people to participate in social research of different sensitivity. They were more likely to participate in the... More

Abstract [colored_box]The MESSI (Managing Ethical Studies on Sensitive Issues) study used hypothetical scenarios, presented via a brief online survey, to explore whether payment amounts influenced Australian children and young people to participate in social research of different sensitivity. They were more likely to participate in the lower sensitivity study than in the higher at all payment levels (A$200 prize draw, no payment, $30, or $100). Offering payments to children and young people increased the likelihood that they would agree to participate in the studies and, in general, the higher the payments, the higher the likelihood of their participating. No evidence of undue influence was detected: payments can be used to increase the participation of children and young people in research without concerns of undue influence on their behavior in the face of relatively risky research. When considering the level of payment, however, the overriding consideration should be the level of risk to the children and young people. . Keywords children and adolescent, pediatrics, justice, participant selection, inclusion, recruitment, payment for research participation, research ethics, risks, benefits, and burdens of research, beneficence and nonmaleficence, vignette studies, decision-making capacity, surrogate decision makers, parental consent, child assent, voluntariness, coercion .

Taplin, S., Chalmers, J., Hoban, B., McArthur, M., Moore, T. and Graham, A. (2019) Research Ethics Committees’ Oversight of Biomedical Research in South Africa: A Thematic Analysis of Ethical Issues Raised During Ethics Review of Non-Expedited Protocols. Journal of Empirical Research on Human Research Ethics. Publisher:

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Cloning monkeys for research puts humans on a slippery ethical slope – The Conversation (David Hunter | February 2019)

Published/Released on February 01, 2019 | Posted by Admin on February 17, 2019 | Keywords: , , , , ,

Scientists have many tools at their disposal to study, manipulate and copy genes. [colored_box]Now it appears researchers at the Institute of Neuroscience in Shanghai, China, have combined techniques to produce a world first: gene edited, cloned macaque monkeys (Macaca fascicularis). . Qiang Sun, a senior researcher in... More

Scientists have many tools at their disposal to study, manipulate and copy genes. [colored_box]Now it appears researchers at the Institute of Neuroscience in Shanghai, China, have combined techniques to produce a world first: gene edited, cloned macaque monkeys (Macaca fascicularis). . Qiang Sun, a senior researcher in the project and Director of ION’s Nonhuman Primate Research Facility explains: .

We believe that this approach of cloning gene-edited monkeys could be used to generate a variety of monkey models for gene-based diseases, including many brain diseases, as well as immune and metabolic disorders and cancer. .

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Whose hearts, livers and lungs are transplanted in China? Origins must be clear in human organ research – The Conversation (Wendy Rogers and Matthew Robertson | February 2019)

Scientist He Jiankui’s claimed use of the genetic tool CRISPR to edit the genomes of twin girls led to international condemnation. His actions have focused a spotlight on research ethics – and what the consequences should be when scientists “go... More

Scientist He Jiankui’s claimed use of the genetic tool CRISPR to edit the genomes of twin girls led to international condemnation. His actions have focused a spotlight on research ethics – and what the consequences should be when scientists “go rogue”. The Chinese Academy of Science initially looked into He’s conduct, and a subsequent internal government investigation has allegedly identified multiple violations of state laws. He has now been fired by his university.


Read more: Tension as scientist at centre of CRISPR outrage speaks at genome editing summit
But beyond just this example, what does happen when scientists fail to comply with globally-accepted guidelines for ethical medical research? We examined this issue focusing on published research involving recipients of organ transplants performed in the People’s Republic of China.\

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Claim of CRISPR’d baby girls stuns genome editing summit – STAT (Sharon Begley | November 2018)

Published/Released on November 26, 2018 | Posted by Admin on February 12, 2019 | Keywords: , , , , , ,

HONG KONG — A Chinese scientist’s claim that he used the genome editing technology CRISPR-Cas9 to alter the DNA of human embryos, resulting in the birth a few weeks ago of twin girls, stunned organizers of the Second International Summit... More

HONG KONG — A Chinese scientist’s claim that he used the genome editing technology CRISPR-Cas9 to alter the DNA of human embryos, resulting in the birth a few weeks ago of twin girls, stunned organizers of the Second International Summit on Human Genome Editing, leaving them scrambling to evaluate the claim two days before the scientist is scheduled to speak at the meeting.

“I don’t know the details” of the claim by He Jiankui, said David Baltimore of the California Institute of Technology, chairman of the organizing committee of the summit, which begins on Tuesday in Hong Kong. “We don’t know what will be said” when He speaks at a session on human embryo editing.

The summit’s organizing committee issued a statement Monday saying they had only just learned of He’s research in Shenzhen, China. “Whether the clinical protocols that resulted in the births in China conformed with the guidance” of leading scientific bodies for conducting clinical trials of heritable genome editing “remains to be determined,” the statement said. “We hope that the dialogue at our summit further advances the world’s understanding of the issues surrounding human genome editing. Our goal is to help ensure that human genome editing research be pursued responsibly, for the benefit of all society.”

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Human genome editing: ask whether, not how – Nature (J. Benjamin Hurlbut | January 2019)

Published/Released on January 02, 2019 | Posted by Admin on February 12, 2019 | Keywords: , , , , ,

The scientific community’s response to the CRISPR twins should not pre-empt broader discussion across society, warns J. Benjamin Hurlbut

Leaders in the scientific community are urgently seeking to set international standards for producing genetically modified humans. They are reacting to November’s announcement by Chinese... More

The scientific community’s response to the CRISPR twins should not pre-empt broader discussion across society, warns J. Benjamin Hurlbut

Leaders in the scientific community are urgently seeking to set international standards for producing genetically modified humans. They are reacting to November’s announcement by Chinese scientist He Jiankui, who claims that twin girls have been born carrying gene-editing changes He made when they were embryos. In calling for standards for producing such ‘CRISPR-edited’ babies, these leaders have shunted aside a crucial and as-yet-unanswered question: whether it is (or can ever be) acceptable to genetically engineer children by introducing changes that they will pass on to their own offspring. That question belongs not to science, but to all of humanity. We do not yet understand what making heritable genetic alterations will mean for our fundamental relationships — parent to child, physician to patient, state to citizen and society to its members. In 2015, the dozen bioethicists and scientists who organized the first International Summit on Human Gene Editing agreed. They said it was irresponsible to proceed with heritable human genetic alteration until two conditions were met: one, that safety and efficacy had been demonstrated; and two, that there was “broad societal consensus” about the appropriateness of proceeding.

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Are scientists’ reactions to ‘CRISPR babies’ about ethics or self-governance? – STAT (Nina Frahm and Tess Doezema | January 2019)

It’s been two months since Chinese scientist He Jiankui shocked the world with the announcement that his lab had created the first genetically edited babies. Since then, much of the public furor surrounding the news has died down, even as He More

It’s been two months since Chinese scientist He Jiankui shocked the world with the announcement that his lab had created the first genetically edited babies. Since then, much of the public furor surrounding the news has died down, even as He has been fired by the Southern University of Science and Technology. There is one important takeaway from the controversy that seems to have gone overlooked in the CRISPR ethics discussion: defining the ethics of editing human life should not be left to scientists alone.

The research community widely agreed that He and his colleagues crossed an ethical line with the first inheritable genetic modification of human beings. Gene-editing experts as well as bioethicists described the transgression as being conducted by a “rogue” individual. But when leading voices such as NIH Director Francis Collins assert that He’s work “represents a deeply disturbing willingness by Dr. He and his team to flout international ethical norms,” what are they actually expressing concern about? Who determines what are the ethics of altering human life?

We believe that the alarm being sounded by the scientific community isn’t really about ethics. It’s about protecting a particular form of scientific self-governance, which the “ethics” discourse supports. What are currently treated as matters of research ethics are in fact political and social questions of fundamental human importance.

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American scientist played more active role in ‘CRISPR babies’ project than previously known – STAT (Jane Qiu | January 2019)

BEIJING — An American scientist at Rice University was far more involved in the widely condemned “CRISPR babies” experiment than has previously been disclosed. Most notably, STAT has learned that Rice biophysicist Michael Deem was named as the senior author on... More

BEIJING — An American scientist at Rice University was far more involved in the widely condemned “CRISPR babies” experiment than has previously been disclosed. Most notably, STAT has learned that Rice biophysicist Michael Deem was named as the senior author on a paper about the work that was submitted to Nature in late November.

Deem’s prominent authorship indicates that a respected American researcher played an instrumental role in the controversial project, which sparked a worldwide furor. His involvement could have encouraged volunteers to join the experiment and lent credibility to He Jiankui, the Chinese scientist who led the work.

Emails provided to STAT show that Deem was listed as the last author — which, in the life sciences, is typically reserved for the senior researcher who oversees a study. The paper, titled “Birth of twins after genome editing for HIV resistance,” has another nine contributors, including He as the first author, where the person who makes the most hands-on contribution is credited.

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CRISPR-baby scientist fired by university – Nature (David Cyranoski | January 2019)

Investigation by Chinese authorities finds He Jiankui broke national regulations in his controversial work on gene-edited babies

The scientist who announced last year that he had produced the world’s first gene-edited babies has been... More

Investigation by Chinese authorities finds He Jiankui broke national regulations in his controversial work on gene-edited babies

The scientist who announced last year that he had produced the world’s first gene-edited babies has been fired by his university. The decision, announced on 21 January by the Southern University of Science and Technology in Shenzhen, in China’s Guandong province, follows an investigation into He Jiankui’s work by provincial health authorities. A probe by the Guangdong health ministry found that He broke national regulations against using gene-editing for reproductive purposes, Chinese state media agency Xinhua reported on 21 January.

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Scientist Who Used Gene Editing On Human Embryos Likely To Face Criminal Charges In China – KHN (January 2019)

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(US) ‘Three Identical Strangers’: The high cost of experimentation without ethics – The Washington Post (Barron H. Lerner | January 2019)

On Sunday night, CNN will air “Three Identical Strangers,” a documentary about an experiment in which adopted twins and triplets were secretly separated. Viewers will probably be appalled as they learn about the emotional damage these individuals experienced as a result of their forced separation.... More

On Sunday night, CNN will air “Three Identical Strangers,” a documentary about an experiment in which adopted twins and triplets were secretly separated. Viewers will probably be appalled as they learn about the emotional damage these individuals experienced as a result of their forced separation. But this medical experiment was not exceptional: It was just one of many unethical studies in the 1950s and 1960s that used subjects as means to an end.

[colored_box]Injunctions against unethical research go back at least to the mid-19th century, when the French scientist Claude Bernard admonished his fellow investigators never to do an experiment that might harm a single person, even if the result would be highly advantageous to science and the health of others. Yet despite Bernard’s admonition, the next century was replete with experiments that put orphans, prisoners, minorities and other vulnerable populations at risk for the sake of scientific discovery. Medical progress often came at too high a human cost, something the CNN documentary exposes. .

Human experimentation surged during World War II as American scientists raced to find treatments for diseases encountered on the battlefield. This experimental enthusiasm continued into the Cold War years, as the United States competed with the Soviet Union for scientific knowledge. In both eras, a utilitarian mind-set trumped concerns about research subjects. .

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Research Ethics Policy Note no. 12 – Research Involving Illegal Activities

Published/Released on December 04, 2018 | Posted by Admin on February 7, 2019 | Keywords: , , , , ,

The University of Sheffield Research Ethics Policy Note no. 12 Research Involving Illegal Activities

This is a complex area. There is a long tradition of social science research into illegal activity that has enriched public debate about crime and a range... More

The University of Sheffield Research Ethics Policy Note no. 12 Research Involving Illegal Activities

This is a complex area. There is a long tradition of social science research into illegal activity that has enriched public debate about crime and a range of other public issues. Similarly, researchers in psychology or medicine, for example, might in the course of their research learn about criminal activity. But what is the legal and ethical position of the researcher in such circumstances? 1. LEGAL RESPONSIBILITIES Researchers have the same legal obligations that they would have in any other context, as citizens or legal residents. As a private member of society, there is, however, no general legal obligation in the United Kingdom to report to the relevant authorities all illegal activity that one observes or learns about. However, there may be moral obligations to report in the following circumstances:

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Political Research and Human Research Ethics Committees (Papers: Anthony J. Langlois | 2011)

Published/Released on February 16, 2011 | Posted by Admin on February 5, 2019 | Keywords: , , , , , , ,

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The picture talk project: Aboriginal community input on consent for research (Papers: Emily FM Fitzpatrick, et al | 2019)

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Ask the patients about the benefits and the risks – The Ethics Blog (Pär Segerdah | January 2019)

Published/Released on January 16, 2019 | Posted by Admin on January 31, 2019 | Keywords: , ,

Almost no medications are without risks of side effects. When new drugs are approved, decision makers must balance risks and benefits. To make the balancing, they use results from clinical trials where the drugs are tested on patients to determine (among other things) efficacy and side effects. [colored_box]But how do... More

Almost no medications are without risks of side effects. When new drugs are approved, decision makers must balance risks and benefits. To make the balancing, they use results from clinical trials where the drugs are tested on patients to determine (among other things) efficacy and side effects. [colored_box]But how do you balance risks and benefits? Is the balancing completely objective, so that all that is needed is results from clinical trials? Or can risks and benefits be valued differently? . It has been noted that decision makers can value risks and benefits differently from patients. Therefore, results merely from clinical trials do not suffice. Decision makers also need to understand how the patients themselves value the risks and the benefits associated with treatments of their disease. The patients need to be asked about their preferences. . Karin Schölin Bywall is a PhD student at CRB. She plans to carry out preference studies with patients suffering from rheumatoid arthritis. The task is complex, since risks and benefits are multidimensional. Rheumatoid arthritis is a chronic disease with several symptoms, such as pain, stiffness, fatigue, fever, weakness, deformity, malaise, weight loss and depression. Medications can be variously effective on different symptoms, while they can have a range of side effects. Which positive effect on which symptom is sufficiently important for the patients to outweigh a certain level of one of the side effects? .

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Doctor who participated in fake chocolate study fined for violating code of conduct – Retraction Watch (Hinnerk Feldwisch-Drentrup | September 2016)

Published/Released on September 22, 2016 | Posted by Admin on January 30, 2019 | Keywords: , , , , , ,

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(UK) Crackdown on unreported trials is good news for researchers – *Research (Till Bruckner | November 2018)

Published/Released on November 14, 2018 | Posted by Admin on January 27, 2019 | Keywords: , , , ,

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Ethics & Human Research (E&HR)

Published/Released on January 24, 2019 | Posted by Admin on January 25, 2019 | Keywords: , ,

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Including People with Dementia in Research: An Analysis of Australian Ethical and Legal Rules and Recommendations for Reform (Papers: Nola M. Ries, et al | 2017)

Abstract Research is crucial to advancing knowledge about dementia, yet the burden of the disease currently outpaces research activity. Research often excludes people with dementia and other cognitive impairments because researchers and ethics committees are concerned about issues related to capacity, consent, and substitute decision-making. In... More

Abstract Research is crucial to advancing knowledge about dementia, yet the burden of the disease currently outpaces research activity. Research often excludes people with dementia and other cognitive impairments because researchers and ethics committees are concerned about issues related to capacity, consent, and substitute decision-making. In Australia, participation in research by people with cognitive impairment is governed by a national ethics statement and a patchwork of state and territorial laws that have widely varying rules. We contend that this legislative variation precludes a consistent approach to research governance and participation and hinders research that seeks to include people with impaired capacity. In this paper, we present key ethical principles, provide a comprehensive review of applicable legal rules in Australian states and territories, and highlight significant differences and ambiguities. Our analysis includes recommendations for reform to improve clarity and consistency in the law and reduce barriers that may exclude persons with dementia from participating in ethically approved research. Our recommendations seek to advance the national decisionmaking principles recommended by the Australian Law Reform Commission, which emphasize the rights of all adults to make their own decisions and for those with impaired capacity to have access to appropriate supports to help them make decisions that affect their lives. Keywords Research ethics, Law. Dementia, Consent, Substitute decision-making, Advance directives

Ries, N. M., Thompson KA., & Lowe M. (2017) Including People with Dementia in Research: An Analysis of Australian Ethical and Legal Rules and Recommendations for Reform. Journal of Bioethical Inquiry 14(3): 359-374. https://link.springer.com/article/10.1007%2Fs11673-017-9794-9

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Research ethics: How to Treat People who Participate in Research – NIH (Ezekiel Emanuel, et al | nd)

[colored_box]Introduction In Alabama from the 1930s to 1970s, researchers recruited black men to participate in a study of syphilis – a terrible disease that can cause disability and death. The researchers told the men participating that they were getting medical treatment, even though they were not.... More

[colored_box]Introduction In Alabama from the 1930s to 1970s, researchers recruited black men to participate in a study of syphilis – a terrible disease that can cause disability and death. The researchers told the men participating that they were getting medical treatment, even though they were not. in fact, when the study began syphilis was untreatable. the researchers instead wanted to study what syphilis does to the body over time. after World War ii, when a treatment – penicillin – was available for syphilis, the researchers kept the men from receiving it because they wanted to study what happened as the disease got worse. What makes this study – the Tuskegee Syphilis Study – unethical? What is wrong with the way the researchers acted? . A human exercise experiment or class survey designed by a student for a science fair seems very different from the tuskegee syphilis study. however, is there anything about student studies that might raise ethical concerns? . Human subjects research is exactly what it sounds like. it is research that uses people as the subjects of experiments or studies. it can include giving people new drugs, doing tests on their blood, even having them take surveys. Researchers have a duty to treat the people they study ethically and respectfully. in particular, it is important to make sure that researchers do not exploit their subjects. Exploitation is addressed further on page 9. unfortunately, as the Tuskegee Syphilis Study shows, some people were treated. . Unfortunately, as the Tuskegee Syphilis Study shows, some people were treated horribly during research studies in the past. German and Japanese researchers, for instance, conducted terrible experiments on prisoners during World War ii. Many other incidents took place before the 1970s, when some u.s. doctors experimented on hospital patients without telling them or failed to provide medicines that would have treated potentially deadly diseases. Today, there are ethical principles for research to help ensure that people who participate are not harmed and that the scandals of the past do not occur again.these principles even apply to student research projects with humans, and they are important for you to think about as you design experiments.

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TABLE OF CONTENTS Introduction 3 Introduction to the 7 Principles 4 Other Important Concepts and Issues 8 Applying the Principles 10 Further Reading

Emanuel, E, Abodler, E. and Stunkel, L. (nd) Research ethics: How to Treat People who Participate in Research. US National Institutes of Health. https://bioethics.nih.gov/education/FNIH_BioethicsBrochure_WEB.PDF

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Research ethics now a strategic priority for doctoral schools – University World News ( Brendan O’Malley | January 2019)

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Of Parachutes and Participant Protection: Moving Beyond Quality to Advance Effective Research Ethics Oversight (Papers: Holly Fernandez Lynch, et al | December 2018)

Abstract [colored_box]There are several reasons to believe that Institutional Review Boards (IRBs) and Human Research Protection Programs (HRPPs) contribute to ethical research and the protection of research participants, but there are also important reasons to interrogate this belief. Determining whether IRBs and HRPPs “work” requires empirical... More

Abstract [colored_box]There are several reasons to believe that Institutional Review Boards (IRBs) and Human Research Protection Programs (HRPPs) contribute to ethical research and the protection of research participants, but there are also important reasons to interrogate this belief. Determining whether IRBs and HRPPs “work” requires empirical evaluation of whether and how well they actually achieve what they were designed to do. In other words, it is critical to examine their outcomes and not only their procedures and structures. In this response to Tsan, we argue that the concept of IRB and HRPP quality entails three dimensions: (1) effectiveness, (2) procedures and structures likely to promote effectiveness, and (3) features unrelated to effectiveness but nonetheless essential, such as efficiency, fairness, and proportionality. Because not all types of quality necessarily guarantee or entail effectiveness, we suggest that broad quality assessments, including such features as regulatory compliance and other procedural measures suggested by Tsan, are unhelpful as the first step in evaluating IRBs and HRPPs. Instead, we must start with outcomes relevant to effectiveness. To do this, we launched the Consortium to Advance Effective Research Ethics Oversight (AEREO), with a mission to define and specify ways to measure relevant outcomes for research ethics oversight, empirically evaluate whether those outcomes are achieved, test new approaches to achieving them, and ultimately, develop and implement empirically-based policy and practice to advance IRB and HRPP effectiveness. We describe several anticipated AEREO projects and call for collaboration between various stakeholders to more meaningfully evaluate IRB and HRPPs. Keywords Institutional Review Board, research ethics oversight, effectiveness, quality, empirical evaluation

Lynch, H. F., Nicholls, S., Meyer, M. N., & Taylor, H. A. (2018). Of Parachutes and Participant Protection: Moving Beyond Quality to Advance Effective Research Ethics Oversight. Journal of Empirical Research on Human Research Ethics. https://doi.org/10.1177/1556264618812625 Publisher: https://journals.sagepub.com/doi/abs/10.1177/1556264618812625#articleCitationDownloadContainer

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Blowback Against a Hoax – Inside Higher Ed (Colleen Flaherty | January 2019)

Published/Released on January 08, 2019 | Posted by Admin on January 11, 2019 | Keywords: , , , , , ,

Author of a recent academic scam faces disciplinary action by Portland State, for failing to alert his research review board before hoodwinking journal editors with outrageous articles. Many say he's guilty of bad form, but did he commit misconduct? [colored_box]A hoax revealing that... More

Author of a recent academic scam faces disciplinary action by Portland State, for failing to alert his research review board before hoodwinking journal editors with outrageous articles. Many say he's guilty of bad form, but did he commit misconduct? [colored_box]A hoax revealing that academic journals had accepted fake papers on topics from canine “rape culture” in dog parks to “fat bodybuilding” to an adaption of Mein Kampf met with applause and scorn in the fall. Fans of the project tended to agree with the hoaxers that critical studies scholars will validate anything aligned with their politics. Critics said that the researchers acted in bad faith, wasting editors’ and reviewers’ time and very publicly besmirching academe in the process: the story was covered by nearly every major news outlet. . Now the controversy has flared up again, with news that one of the project’s authors faces disciplinary action at his home institution. Peter Boghossian, an assistant professor of philosophy at Portland State University and the only one of three researchers on the project to hold a full-time academic position, was found by his institutional review board to have committed research misconduct. Specifically, he failed to secure its approval before proceeding with research on human subjects -- in this case, the journal editors and reviewers he was tricking with his absurd but seemingly well-researched papers. Some seven of 20 were published in gender studies and other journals. Seven were rejected. Others were pending before the spoof was uncovered. . “An IRB protocol application should have been submitted to the Office of Research Integrity,” reads a determination letter from Portland state’s IRB dated last month. “University policy requires that all research involving human subjects conducted by faculty, other employees and students [on campus] must have prior review and approval by the IRB.” .

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Amid ethics outcry, should journals publish the ‘CRISPR babies’ paper? – STAT (Adam Marcus | December 2018)

Like researchers everywhere, He Jiankui — the scientist in China who claims to have used CRISPR to edit embryos to create babies protected from HIV — is eager to publish scientific papers. It is, after all, a publish-or-perish world — although in He’s case, his fate... More

Like researchers everywhere, He Jiankui — the scientist in China who claims to have used CRISPR to edit embryos to create babies protected from HIV — is eager to publish scientific papers. It is, after all, a publish-or-perish world — although in He’s case, his fate at home may rest more with what the Chinese government thinks of his behavior than what a peer reviewer says about his work.

[colored_box]As STAT reported Monday, He shopped around a manuscript earlier this fall about using CRISPR to edit genes for a different purpose — to prevent an inherited condition that causes sky-high cholesterol levels — but it was rejected because of ethical and scientific shortcomings. And two weeks ago, in the face of withering criticism over his lack of transparency, He told the International Summit on Human Genome Editing in Hong Kong that he had submitted a paper on the “CRISPR babies” work to a journal. .

Given the maelstrom surrounding He’s claims, however, should any journals even consider papers from him? And if they do, what should they keep in mind? .

Jeremy Berg, editor of Science, told STAT that while he could not comment on whether the paper had been submitted to his journal, “given the numerous ethical issues with this situation as presented, we would be extremely unlikely to consider it." .

Howard Bauchner, the editor of the Journal of the American Medical Association, wouldn’t comment on the possibility of a submission by He either, but said, “I believe articles should be reviewed and not judged based upon what is written in the media.”.

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The Ethical Governance of German Physicians, 1890-1939: Are There Lessons from History? (Papers: Robert Dingwall & Vienna Rozelle | 2011)

The limitations of the traditional historiography of the ethical regulation of biomedical research are becoming increasingly well recognized. A simplistic history has been used to justify a simplistic policy, in the elaboration of regulatory instruments associated with a bureaucracy of administration and enforcement that has acquired its own material... More

The limitations of the traditional historiography of the ethical regulation of biomedical research are becoming increasingly well recognized. A simplistic history has been used to justify a simplistic policy, in the elaboration of regulatory instruments associated with a bureaucracy of administration and enforcement that has acquired its own material interests in self-perpetuation and jurisdictional expansion. The official history of institutionalized ethical regulation sees a clear and self-evident line of descent from the Nazi experiments of World War II to the various legal and quasi-legal instruments that now govern most scientific and, increasingly, social scientific practice. Without regulatory interventions, it is claimed, researchers will revert to barbarism. [colored_box]This version of the "rise of bioethics" tends to place considerable emphasis on the Nuremberg Doctors Trial, and the Nuremberg Code promulgated at its conclusion, and to use these as an "origin myth" that legitimizes its professional project. As a narrative, it says little, for example, about the lengthy gap between the conclusion of the Nuremberg trial in 1948 and the development of regulatory interventions for medical research in the victor countries during the 1960s. It tends not to acknowledge the evidence, from writers like Henry Beecher in the United States and Maurice Pappworth in the United Kingdom, that ethically questionable experiments continued in the victor countries well after World War II, a phenomenon explored further by Tal Bolton in a recent PhD. thesis and her article in this journal issue. However, it also tends to equate an absence of regulation with an absence of ethical concern, despite the evidence from Susan Lederer and Sydney Halpern about the effective operation of informal social controls in the United States before World War II. Most crucially, it neglects Jenny Hazelgroves exploration of the difficulty that the prosecutors faced in framing charges against the Nuremberg defendants because they were unable to point to any clear set of regulations or standards in any country other than Germany that could be said to have been violated. . The publication of further analyses of the pre-World War II German experience provides an additional resource for the critical examination of the claims being made about the importance of formal regulation in the maintenance of ethical standards in biomedical research. This body of work has documented the rise of attempts at ethical research governance in Germany from the late nineteenth century through to the 1930s. In so doing, it may seem to provide us with an opportunity to explore the limits of regulation. Why did it fail to protect the victims of the Nazi medical experiments? Why did it seemingly attract so little international interest, despite Germany's leading role in science and biomedicine over much of this period? However, as a number of influential historians of late nineteenth- and early twentieth- century Germany have observed, the study of this period has suffered from the imposition of narrative arcs, influenced by sociology or political science, that see it only as the precursor to the disaster of the Nazi regime. No actor at the time consciously sought this end for their actions: even the Nazi leadership sought power rather than defeat. Accounts that find a logic in the events from the late nineteenth century to the end of World War II may overlook the unintended consequences of actors dealing with contingent events on the basis of partial information interpreted according to what were contemporaneously considered valid knowledge or theories. It is important, then, to avoid constructing an equally simplistic counter-narrative about the general ineffectiveness of regulation.

Dingwall, R and Rozelle, V (2011) The ethical governance of German physicians, 1890–1939: Are there Lessons from History? Journal of Policy History 23(1): 29-52. http://irep.ntu.ac.uk/id/eprint/16649/1/205167_7323%20Dingwall%20Publisher.pdf

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AHRECS is calling for expressions of interest: Unpaid internship

Published/Released on December 14, 2018 | Posted by Admin on December 14, 2018 | Keywords:

Expressions of interest are sought for a two month unpaid internship with the Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS). Intern candidates must have a demonstrated interest in human research ethics and/or research integrity, have completed a HDR qualification, be an excellent communicator and have a demonstrated... More

Expressions of interest are sought for a two month unpaid internship with the Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS). Intern candidates must have a demonstrated interest in human research ethics and/or research integrity, have completed a HDR qualification, be an excellent communicator and have a demonstrated work ethic. In addition to being involved in background work, literature searches and drafting documents, the internship will provide a valuable capacity building and professional development opportunity with a growing consultancy firm under the supervision of our senior consultants. The unpaid role will require about a 35-hour commitment to be completed over two months. At the end of the two months, the intern and the AHRECS team will decide together whether to start another two month term. Work will be conducted remotely and online, with meetings at an agreed time somewhere between 8am and 10pm AEST. Expressions of interest must be submitted in writing by 15 January 2019 to internship@ahrecs.com and must be accompanied with two relevant professional/academic/research references. The expressions of interest will be considered by the AHRECS senior consultants and shortlisted candidates may be interviewed via video conference. Less

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How a simple ‘thank you’ could improve clinical trials – Nature (Editorial | November 2018)

Published/Released on November 13, 2018 | Posted by Admin on December 11, 2018 | Keywords: , , , , , ,

Everyone would benefit if researchers did more to make participants feel part of a study.

When researchers at the drug giant Pfizer wanted to improve their clinical trials, the people who had taken part had a clear suggestion: researchers should say thank you. It is... More

Everyone would benefit if researchers did more to make participants feel part of a study.

When researchers at the drug giant Pfizer wanted to improve their clinical trials, the people who had taken part had a clear suggestion: researchers should say thank you. It is a simple request, but a revealing one. When a clinical trial is completed, many participants walk away empty-handed. Most never hear from the investigators or the trial’s sponsor again. Many do not learn the results of the study in which they took part. It’s not good enough — and it indicates a deeper problem. As we discuss in a News Feature this week, clinical-trial participants and the people who care for them are increasingly seen as partners in research. They are more informed than ever about their conditions and their medical options. And they are demanding — and receiving — more of a say in how clinical trials are designed and conducted. Some of this activity has been boosted by social media, which has allowed people with medical conditions and their carers to band together, share their experiences and advocate for change.

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What These Medical Journals Don’t Reveal: Top Doctors’ Ties to Industry – New York Times (Charles Ornstein and Katie Thomas | December 2018)

Published/Released on December 08, 2018 | Posted by Admin on December 10, 2018 | Keywords: , , , , , ,

One is dean of Yale’s medical school. Another is the director of a cancer center in Texas. A third is the next president of the most prominent society of cancer doctors.

These leading medical figures are among dozens of doctors who have failed in recent years... More

One is dean of Yale’s medical school. Another is the director of a cancer center in Texas. A third is the next president of the most prominent society of cancer doctors.

These leading medical figures are among dozens of doctors who have failed in recent years to report their financial relationships with pharmaceutical and health care companies when their studies are published in medical journals, according to a review by The New York Times and ProPublica and data from other recent research.

Dr. Howard A. “Skip” Burris III, the president-elect of the American Society of Clinical Oncology, for instance, declared that he had no conflicts of interest in more than 50 journal articles in recent years, including in the prestigious New England Journal of Medicine.

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The main obstacles to better research data management and sharing are cultural. But change is in our hands – LSE Blog (Marta Teperek and Alastair Dunning | November 2018)

Published/Released on November 14, 2018 | Posted by Admin on December 7, 2018 | Keywords: , , , , , ,

This blog post is a summary of Marta Teperek’s presentation at today’s Better Science through Better Data 2018 event.

By now, it’s probably difficult to find a researcher who hasn’t heard of journal requirements for sharing research data supporting publications. Or a researcher who hasn’t... More

This blog post is a summary of Marta Teperek’s presentation at today’s Better Science through Better Data 2018 event.

By now, it’s probably difficult to find a researcher who hasn’t heard of journal requirements for sharing research data supporting publications. Or a researcher who hasn’t heard of funder requirements for data management plans. Or of institutional policies for data management and sharing. That’s a lot of requirements! Especially considering data management is just one set of guidelines researchers need to comply with (on top of doing their own competitive research, of course).

All of these requirements are in place for good reasons. Those who are familiar with the research reproducibility crisis and understand that missing data and code is one of the main reasons for it need no convincing of this. Still, complying with the various data policies is not easy; it requires time and effort from researchers. And not all researchers have the knowledge and skills to professionally manage and share their research data. Some might even wonder what exactly their research data is (or how to find it).

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The Ethical Quandary of Human Infection Studies – Undark (Linda Nordling | November 2018)

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Vulnerability in research subjects: a bioethical taxonomy (Kenneth Kipnis | 2001)

The concept of vulnerability appears to have been grandfathered into the lexicon, lore, and literature of research ethics without undergoing stringent certification. And yet the need for some such notion has long been appreciated. More than 50 years ago, reflecting on the ethical implications of the Nazi medical experiments,... More

The concept of vulnerability appears to have been grandfathered into the lexicon, lore, and literature of research ethics without undergoing stringent certification. And yet the need for some such notion has long been appreciated. More than 50 years ago, reflecting on the ethical implications of the Nazi medical experiments, the authors of the Nuremberg Code emphasized the necessity of the subject’s informed consent, too hastily ruling out, as it quickly became apparent, medical research on children and those with cognitive impairments. In the United States, widely studied episodes such as Willowbrook,1 the Brooklyn Jewish Chronic Disease Hospital Case,2 and the Tuskegee Syphilis Study3 provoked debates that eventually gave birth to our current methods for ensuring the ethical conduct of research. But despite the remarkable circumstances of the subjects involved in those studies—institutionalized children, hospitalized elderly, and impoverished and poorly educated black Alabama males—it is not much of an exaggeration to say that in the minds of many investigators the paradigmatic research subject remains more or less a mature, respectable, moderately well-educated, clearthinking, literate, self-supporting U.S. citizen in good standing—that is, a man who could understand a 12- page consent form and act intelligently on the basis of its contents. While I shall assume in what follows both that the existing guidelines are sufficient to deal ethically with the paradigmatic research subject, and, further, that all those standard protections are reliably in place, the vulnerable research subject nonetheless requires ethical consideration going beyond that baseline. More recently, in the wake of the Nuremberg Code’s shortcomings, systematic attention has been accorded to a motley collection of vulnerable subpopulations. In 1979, for example, the seminal Belmont Report4 briefly considered children, the institutionalized mentally ill, and prisoners, mentioning dependency and compromised capacity for consent as representative hallmarks of vulnerability. There was no effort to be comprehensive. The more recent Federal Regulations on the Protection of Human Subjects (45 CFR 46) implement the requirement that Institutional Review Boards (IRBs) take into account the “special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons” (46–111). Criteria for vulnerability are not discussed although subparts are included with supplementary regulations for some of these groups. Finally, the Final Report of the Advisory Committee on Human Radiation Experiments,5 after reviewing patterns of unethical misconduct in military research, recommended special protections for enlistees.

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Kipnis K. (2001) Vulnerability in research subjects: a bioethical taxonomy. In: National Bioethics Advisory Commission, editor. Ethical and policy issues in research involving human participants. Bethesda: National Bioethics Advisory Commission. pp. G1–G13. http://www.aapcho.org/wp/wp-content/uploads/2012/02/Kipnis-VulnerabilityinResearchSubjects.pdf

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Respect for Human Vulnerability: The Emergence of a New Principle in Bioethics (Papers: Henk ten Have | 2015)

Published/Released on July 10, 2015 | Posted by Admin on November 30, 2018 | Keywords: , , , , , , , ,

Abstract Vulnerability has become a popular though controversial topic in bioethics, notably since 2000. As a result, a common body of knowledge has emerged (1) distinguishing between different types of vulnerability, (2) criticizing the categorization of populations as vulnerable, and (3) questioning the practical implications. It... More

Abstract Vulnerability has become a popular though controversial topic in bioethics, notably since 2000. As a result, a common body of knowledge has emerged (1) distinguishing between different types of vulnerability, (2) criticizing the categorization of populations as vulnerable, and (3) questioning the practical implications. It is argued that two perspectives on vulnerability, i.e., the philosophical and political, pose challenges to contemporary bioethics discourse: they re-examine the significance of human agency, the primacy of the individual person, and the negativity of vulnerability. As a phenomenon of globalization, vulnerability can only be properly addressed in a global bioethics that takes the social dimension of human existence seriously. Keywords Global bioethics, Globalization, Vulnerability, Research ethics, Philosophy of medicine

ten Have, H. Respect for Human Vulnerability: The Emergence of a New Principle in Bioethics. Bioethical Inquiry (2015) 12: 395. https://doi.org/10.1007/s11673-015-9641-9 Publisher: https://link.springer.com/article/10.1007/s11673-015-9641-9

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Vulnerability: new essays in ethics and feminist philosophy (Books: Catriona Mackenzie (Editor), et al | 2014)

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Rethinking the Vulnerability of Minority Populations in Research (Papers: Wendy Rogers and Margaret Meek Lange | 2013)

Abstract The Belmont Report, produced in 1979 by a United States government commission, includes minority populations among its list of vulnerable research participants. In this article, we consider some previous attempts to understand the vulnerability of minorities in research, and then provide our own account. First we... More

Abstract The Belmont Report, produced in 1979 by a United States government commission, includes minority populations among its list of vulnerable research participants. In this article, we consider some previous attempts to understand the vulnerability of minorities in research, and then provide our own account. First we examine the question of the representation of minorities in research. Then we argue that the best understanding of minorities, vulnerability, and research will begin with a broad understanding of the risk of individual members of minority groups to poor health outcomes. We offer a typology of vulnerability to help with this task. Finally, we show how researchers should be guided by this broad analysis in the design and execution of their research. Vv

Rogers, W., & Lange, M. M. (2013). Rethinking the vulnerability of minority populations in research. American Journal  of Public Health, 103(12), 2141-6.. 2013;103(12). NCBI (Full text available): https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3828952/

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Vulnerability in Research Ethics: a Way Forward (Papers: Margaret Meek Lange, et al | 2013)

Published/Released on July 27, 2013 | Posted by Admin on November 30, 2018 | Keywords: , , , , , ,

Abstract Several foundational documents of bioethics mention the special obligation researchers have to vulnerable research participants. However, the treatment of vulnerability offered by these documents often relies on enumeration of vulnerable groups rather than an analysis of the features that make such groups vulnerable. Recent attempts... More

Abstract Several foundational documents of bioethics mention the special obligation researchers have to vulnerable research participants. However, the treatment of vulnerability offered by these documents often relies on enumeration of vulnerable groups rather than an analysis of the features that make such groups vulnerable. Recent attempts in the scholarly literature to lend philosophical weight to the concept of vulnerability are offered by Luna and Hurst. Luna suggests that vulnerability is irreducibly contextual and that Institutional Review Boards (Research Ethics Committees) can only identify vulnerable participants by carefully examining the details of the proposed research. Hurst, in contrast, defines the vulnerable as those especially at risk of incurring the wrongs to which all research ethics participants are exposed. We offer a more substantive conception of vulnerability than Luna but one that gives rise to a different rubric of responsibilities from Hurst's. While we understand vulnerability to be an ontological condition of human existence, in the context of research ethics, we take the vulnerable to be research subjects who are especially prone to harm or exploitation. Our analysis rests on developing a typology of sources of vulnerability and showing how distinct sources generate distinct obligations on the part of the researcher. Our account emphasizes that the researcher's first obligation is not to make the research participant even more vulnerable than they already are. To illustrate our framework, we consider two cases: that of a vulnerable population involved in international research and that of a domestic population of people with diminished capacity. Keywords Vulnerability, Research ethics, Alzheimer's Disease, Tenofovir case

Lange, M. M., Rogers, W. and Dodds, S. (2013), Vulnerability in Research Ethics: A Way Forward. Bioethics, 27: 333-340. doi:10.1111/bioe.12032 Publiher (PDF available): https://onlinelibrary.wiley.com/doi/abs/10.1111/bioe.12032

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Why bioethics needs a concept of vulnerability (Papers: Wendy Rogers, et al | 2012)

Published/Released on October 08, 2012 | Posted by Admin on November 30, 2018 | Keywords: , , , , , ,

Abstract Concern for human vulnerability seems to be at the heart of bioethical inquiry, but the concept of vulnerability is under-theorized in the bioethical literature. The aim of this article is to show why bioethics needs an adequately theorized and nuanced conception of vulnerability. We first... More

Abstract Concern for human vulnerability seems to be at the heart of bioethical inquiry, but the concept of vulnerability is under-theorized in the bioethical literature. The aim of this article is to show why bioethics needs an adequately theorized and nuanced conception of vulnerability. We first review approaches to vulnerability in research ethics and public health ethics, and show that the bioethical literature associates vulnerability with risk of harm and exploitation, and limited capacity for autonomy. We identify some of the challenges emerging from this literature: in particular, how to reconcile universal human vulnerability with a context-sensitive analysis of specific kinds and sources of vulnerability; and how to reconcile obligations to protect vulnerable persons with obligations to respect autonomy. We then briefly survey some of the theoretical resources available within the philosophical literature to address these challenges, and to assist in understanding the conceptual connections between vulnerability and related concepts such as harm, exploitation, needs, and autonomy. We also sketch out a taxonomy of sources and kinds of vulnerability. Finally, we consider the implications for policy evaluation of making vulnerability an explicit and central focus of bioethics. Our investigation is in the form of a broad survey motivating a research agenda rather than a detailed analysis. Keywords Bioethics, Disabilities, Child molestation, Feminism, Public health, Territories, Productivity, Research ethics. Morality, Informed consent

Rogers, W., Mackenzie, C., & Dodds, S. (2012). Why bioethics needs a concept of vulnerability. International Journal of Feminist Approaches to Bioethics, 5(2), 11-38. doi:10.2979/intjfemappbio.5.2.11 Publisher (PDF available with frre login): https://www.jstor.org/stable/10.2979/intjfemappbio.5.2.11?seq=1#metadata_info_tab_contents

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Patients find misleading information on the internet – The Ethics Blog (Pär Segerdahl | October 2018)

Published/Released on October 30, 2018 | Posted by Admin on November 25, 2018 | Keywords: , , , , , , ,

In phase 1 clinical studies of substances that might possibly be used to treat cancer in the future, cancer patients are recruited as research participants. These patients almost always have advanced cancer that no longer responds to the standard treatment. That research participation would affect the cancer is unlikely. The... More

In phase 1 clinical studies of substances that might possibly be used to treat cancer in the future, cancer patients are recruited as research participants. These patients almost always have advanced cancer that no longer responds to the standard treatment. That research participation would affect the cancer is unlikely. The purpose of a phase 1 study is to determine safe dosage range and to investigate side effects and other safety issues. This will then enable proceeding to investigating the effectiveness of the substance on specific forms of cancer, but with other research participants. Given that patients often seek online information on clinical trials, Tove Godskesen, Josepine Fernow and Stefan Eriksson wanted to investigate the quality of the information that currently is available on the internet about phase 1 clinical cancer trials in Sweden, Denmark and Norway.

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Constructive Voices: Panel discussion about institutional implementation of the National Statement (2007 updated 2018)

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(US) ER patients given ketamine, other powerful drugs in clinical trials without their consent, FDA finds – STAT (Sharon Begley | October 2018)

Minneapolis hospital tested powerful antipsychotics and the potent anesthetic ketamine on emergency room patients without their knowledge or consent, violating regulations on human research, federal inspectors have determined.

Based on those findings, a health watchdog group on Monday urged federal regulators to suspend... More

Minneapolis hospital tested powerful antipsychotics and the potent anesthetic ketamine on emergency room patients without their knowledge or consent, violating regulations on human research, federal inspectors have determined.

Based on those findings, a health watchdog group on Monday urged federal regulators to suspend all clinical trials at the hospital. In a letter to the Food and Drug Administration and the Department of Health and Human Services office that protects human research subjects, Public Citizen also called for regulators to immediately launch an investigation into the conduct and oversight of the studies and “impose severe sanctions for the serious ethical and regulatory lapses that have occurred in the ketamine clinical trials and other studies” at Minneapolis’s Hennepin County Medical Center.

The hospital committee that green-lighted the studies, called an institutional review board (IRB), “appears incapable of doing its job,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group, who organized the letter. It acted unethically and placed patients in danger, he said, “including by waiving the requirement for informed consent in situations where that is not allowed.”

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Research ethics, informed consent and the disempowerment of First Nation peoples (Papers: Juan M Tauri | 2017)

Abstract Recently, Indigenous commentators have begun to analyse the way in which institutional Research Ethics Boards (REBs) engage with Indigenous researchers and participants, respond to Indigenous peoples’ concerns with academic research activities, and scrutinise the ethics proposals of Indigenous scholars. Of particular concern for Indigenous commentators... More

Abstract Recently, Indigenous commentators have begun to analyse the way in which institutional Research Ethics Boards (REBs) engage with Indigenous researchers and participants, respond to Indigenous peoples’ concerns with academic research activities, and scrutinise the ethics proposals of Indigenous scholars. Of particular concern for Indigenous commentators is that the work of REBs often results in the marginalisation of Indigenous approaches to knowledge construction and dissemination, especially in relation to the vexed issue of informed consent. Based on analysis of the results of research with Indigenous researchers and research participants, this paper argues that institutionalised REBs’ preference for ‘universal’ and ‘individualised’ approaches for determining ethical research conduct marginalises Indigenous approaches to ethical research conduct. The paper concludes by calling for a decolonisation of REB processes through recognition of the validity of communal processes for attaining the informed consent of Indigenous research participants. Keywords First Nations, research ethics boards, informed consent, decolonisation

Tauri, J. M. (2018). Research ethics, informed consent and the disempowerment of First Nation peoples. Research Ethics, 14(3), 1–14. https://doi.org/10.1177/1747016117739935 Publisher (Open Access): https://journals.sagepub.com/doi/full/10.1177/1747016117739935

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Qualitative Research Ethics in the Big Data Era (Papers: Arielle Hesse, et al | 2018)

Published/Released on November 05, 2018 | Posted by Admin on November 11, 2018 | Keywords: , , , , , , ,

Abstract This article examines the developments that have motivated this special issue on Qualitative Research Ethics in the Big Data Era. The article offers a broad overview of many pressing challenges and opportunities that the Big Data era raises particularly for qualitative research. Big Data has... More

Abstract This article examines the developments that have motivated this special issue on Qualitative Research Ethics in the Big Data Era. The article offers a broad overview of many pressing challenges and opportunities that the Big Data era raises particularly for qualitative research. Big Data has introduced to the social sciences new data sources, new research methods, new researchers, and new forms of data storage that have immediate and potential effects on the ethics and practice of qualitative research. Drawing from a literature review and insights gathered at a National Science Foundation-funded workshop in 2016, we present five principles for qualitative researchers and their institutions to consider in navigating these emerging research landscapes. These principles include (a) valuing methodological diversity; (b) encouraging research that accounts for and retains context, specificity, and marginalized and overlooked populations; (c) pushing beyond legal concerns to address often messy ethical dilemmas; (d) attending to regional and disciplinary differences; and (e) considering the entire lifecycle of research, including the data afterlife in archives or in open-data facilities. Keywords Big Data, qualitative research, research ethics

Hesse, A., Glenna, L., Hinrichs, C., Chiles, R., & Sachs, C. (2018). Qualitative Research Ethics in the Big Data Era. American Behavioral Scientist. https://doi.org/10.1177/0002764218805806

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(Egypt) Debate over misconduct stalls Egyptian clinical trials law – Sci Dev Net (Hazem Badr | October 2018)

[Cairo] Egypt’s president Abdel Fattah El-Sisi has declined to sign the country’s clinical trials law into action, after objecting to parts that, he said, might violate the human body. [colored_box]According to researchers following the law’s creation, Sisi returned seven amendments to the law, which... More

[Cairo] Egypt’s president Abdel Fattah El-Sisi has declined to sign the country’s clinical trials law into action, after objecting to parts that, he said, might violate the human body. [colored_box]According to researchers following the law’s creation, Sisi returned seven amendments to the law, which could delay its creation. For example, articles 28, 29 and 32 of the law have been amended to reduce the severity of proposed prison terms for misconduct, such as using human samples without informed consent. . But the scientists following the law’s creation are positive about the president’s response, saying that his amendments show he is engaging with the matter and keen to see the law signed into life. “The president’s comments address the complex equation of respecting the sacredness of the human body and, at the same time, endorsing scientific research,” said Mahmoud Sakr, the director of Egypt’s Academy of Scientific Research and Technology. . “The text [as it stands] contradicts our goal of motivating universities to pursue joint research and hinders the exploration of samples using advanced equipment that might not be available locally,” ......Abdel Fattah El-Sisi, Egypt’s president .

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Code Of Research Ethics in the University of Malaya

Published/Released on August 01, 2013 | Posted by Admin on November 3, 2018 | Keywords: , , ,

[colored_box]"1. All research conducted by staff and students of the university involving human participants and the use of vertebrate animal subjects must be referred to the appropriate ethics committee. . 2. These include all research, qualitative or quantitative, regardless of whether the research is funded by internal/external grants or... More

[colored_box]"1. All research conducted by staff and students of the university involving human participants and the use of vertebrate animal subjects must be referred to the appropriate ethics committee. . 2. These include all research, qualitative or quantitative, regardless of whether the research is funded by internal/external grants or even unfunded. . 3. All research conducted by staff and students must follow codes of ethical guidelines for research involving human participants which include:" .

a) Sources of Data – The participant is subject to ethical clearance, meaning the researcher must define whether the data involves new data collection or existing data and how the data will be collected.

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Vulnerability in Research: Defining, Applying, and Teaching the Concept (Books: Sana Loue & Bebe Loff | 2019)

Published/Released on October 15, 2018 | Posted by Admin on November 1, 2018 | Keywords: , , , , , , , , , ,

Abstract The concept of vulnerability and the attendant responsibility of researchers to provide special protections for research participants deemed to be vulnerable are considered to be foundational concepts in bioethics. However, not only do international and national guidelines differ in their definition of vulnerability, but they... More

Abstract The concept of vulnerability and the attendant responsibility of researchers to provide special protections for research participants deemed to be vulnerable are considered to be foundational concepts in bioethics. However, not only do international and national guidelines differ in their definition of vulnerability, but they also vary with respect to who is to be considered vulnerable in research. This chapter describes the ways in which vulnerability has been defined by international and national guidelines, discusses the considerations deemed relevant by international and national guidance and writers on the topic, and concludes with thoughts on how the meaning of vulnerability might be communicated in teaching.

Sana Loue & Bebe Loff (2019) Vulnerability in research: defining, applying, and teaching the conceptEthics in Research Practice and Innovation https://www.igi-global.com/chapter/vulnerability-in-research/216663

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The ‘problem’ of undesigned relationality: Ethnographic fieldwork, dual roles and research ethics (Papers: Kirsten Bell | 2018)

Abstract [colored_box]Perhaps the most unique feature of ethnographic fieldwork is the distinctive form of relationality it entails, where the ethnographer’s identity as a researcher is not fixed in the way typical of most other forms of research. In this paper, I explore how this ‘undesigned relationality’... More

Abstract [colored_box]Perhaps the most unique feature of ethnographic fieldwork is the distinctive form of relationality it entails, where the ethnographer’s identity as a researcher is not fixed in the way typical of most other forms of research. In this paper, I explore how this ‘undesigned relationality’ is understood, both in procedural ethics frameworks and by the different disciplines that have come to claim a stake in the ‘method’ itself. Demonstrating that the ethical issues it entails are primarily conceptualized via the lens of the ‘dual role’, I use this as a means of exploring the ideal relationship between researcher and subject that procedural ethics frameworks are premised upon. I go on to explore the epistemological differences in ways that ethnographers themselves understand and respond to the multiple forms of relationality that characterize fieldwork and the challenge this poses to the possibility of a pan-disciplinary consensus on ethnographic research ethics. . Keywords ethnography, research ethics, dual roles, disciplinarity, relationality .

Bell, K. (2018). The ‘problem’ of undesigned relationality: Ethnographic fieldwork, dual roles and research ethics. Ethnography. https://doi.org/10.1177/1466138118807236

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(US) Participants In Rogue Herpes Vaccine Research Take Legal Action – KHN (Marisa Taylor | March 2018)

Published/Released on September 13, 2018 | Posted by Admin on October 20, 2018 | Keywords: , , , , , ,

Three people injected with an unauthorized herpes vaccine by a Southern Illinois University researcher have filed suit against his company, demanding compensation for alleged adverse side effects from the experiments. SIU professor William Halford, who died in June, had injected Americans with his experimental herpes vaccine in... More

Three people injected with an unauthorized herpes vaccine by a Southern Illinois University researcher have filed suit against his company, demanding compensation for alleged adverse side effects from the experiments. SIU professor William Halford, who died in June, had injected Americans with his experimental herpes vaccine in St. Kitts and Nevis in 2016 and in Illinois hotel rooms in 2013 without safety oversight that is routinely performed by the Food and Drug Administration or an institutional review board. Two of the participants who filed the lawsuit, Elizabeth Erkelens and Ed Biel, received the vaccine in the Caribbean trial, according to the lawsuit. The third participant, Terry Graham, was injected in two Illinois hotel rooms, it states.

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The Next Phase of Human Gene-Therapy Oversight – The New England Journal of Medicine (Francis S. Collins and Scott Gottlieb | August 2018)

The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) have played key roles in the emergence of safe and effective human gene therapies. Now, we are proposing new efforts to encourage further advances in this rapidly evolving field.

The potential to alter human... More

The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) have played key roles in the emergence of safe and effective human gene therapies. Now, we are proposing new efforts to encourage further advances in this rapidly evolving field.

The potential to alter human genes directly was first recognized nearly 50 years ago, around the same time as initial groundbreaking advances were being made in recombinant DNA technology. After intense discussions regarding the ethical, legal, and social implications of this technology, conversations were initiated at the NIH that led to the establishment of the Recombinant DNA Advisory Committee (RAC) in 1974. The RAC’s mission was to advise the NIH director on research that used emerging technologies involving manipulation of nucleic acids — a mission that was eventually expanded to encompass the review and discussion of protocols for gene therapy in humans. In 1990, the FDA oversaw the first U.S. human gene-therapy trial, which involved pediatric patients with adenosine deaminase deficiency and was conducted at the NIH Clinical Center in Bethesda, Maryland.

Although no major safety concerns were initially reported, over the course of the 1990s it became evident that many questions regarding the safety and efficacy of gene therapy remained unanswered. These unknowns were brought into sharp focus in 1999 when Jesse Gelsinger died of a massive immune response during a safety trial of gene therapy for ornithine transcarbamylase deficiency.1 This tragic death led to closer scrutiny of the field, including a greater focus on open dialogue and increased regulatory oversight.

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Who Says You Need Permission to Study Yourself? – NEO.LIFE (Emily Mullin | September 2018)

Published/Released on September 27, 2018 | Posted by Admin on October 16, 2018 | Keywords: , , , , , ,

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Sara Riggare can’t finish her PhD because an ethics committee says she needed their approval first. For the past six years, Sara Riggare, who has Parkinson’s disease, has been conducting research on herself as part of her PhD at the prestigious Karolinska Institute in Sweden. Using mobile apps, she tracks her symptoms, sleep, and activity. She’s not unique in doing so: Many people self-monitor with apps and wearable devices like Fitbit and the Apple Watch, a trend spurred by the broader Quantified Self movement, where “lifeloggers” track everything from their blood sugar to their microbiome, and even carry out experiments on themselves.

For the past six years, Sara Riggare, who has Parkinson’s disease, has been conducting research on herself as part of her PhD at the prestigious Karolinska Institute in Sweden. Using mobile apps, she tracks her symptoms, sleep, and activity.

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Research with former refugees: Moving towards an ethics in practice (Nisha Thapliyal and Sally Baker | September 2018)

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Clinical Trials – More Blinding, Less Worry! – Statistically Funny (Hilda Bastian | August 2018)

Published/Released on August 12, 2018 | Posted by Admin on October 11, 2018 | Keywords: , , , , , , ,

She's right to be worried! There are so many possible cracks that bias can seep through, nudging clinical trial results off course. Some of the biggest come from people knowing which comparison group a participant will be, or has been, in. Allocation concealment and blinding are strategies to reduce this... More

She's right to be worried! There are so many possible cracks that bias can seep through, nudging clinical trial results off course. Some of the biggest come from people knowing which comparison group a participant will be, or has been, in. Allocation concealment and blinding are strategies to reduce this risk. [colored_box]Before we get to that, let's look at the source of the problems we're aiming at here: people! They bring subjectivity to the mix, even if they are committed to the trial - and not everyone who plays a role will be supportive, anyway. On top of that, randomizing people - leaving their fate to pure chance - can be the rational and absolutely vital thing to do. But it's also "anathema to the human spirit", so it can be awfully hard to play totally by the rules. . And we're counting on a lot of people here, aren't we? There are the ones who enter an individual into one of the comparison groups in the trial. There are those individual participants themselves, and the ones dealing with them during the trial - healthcare practitioners who treat them, for example. And then there are the people measuring outcomes - like looking at an x-ray and deciding if it's showing improvement or not. .

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Ethical Guidelines for Observational Studies

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Practical, Epistemological, and Ethical Challenges of Participatory Action Research: A Cross-Disciplinary Review of the Literature (Papers: Danielle Lake and Joel Wendland | 2018)

Published/Released on September 15, 2018 | Posted by Admin on October 9, 2018 | Keywords: , , , , , , , , , , ,

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What information and the extent of information research participants need in informed consent forms: a multi-country survey (Juntra Karbwang, et al | 2018)

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A Major Industry-Funded Alcohol Study Was Compromised. How Many Others Are Out There? – UnDark (Jeremy Samuel Faust | July 2018)

Published/Released on July 13, 2018 | Posted by Admin on October 2, 2018 | Keywords: , , , , ,

The most salient takeaway from the collapse of the MACH15 trial is that the conflicts of interest at its core are probably not as rare as we think.

LAST YEAR, the National Institute on Alcohol Abuse and Alcoholism, part of the federal National Institutes... More

The most salient takeaway from the collapse of the MACH15 trial is that the conflicts of interest at its core are probably not as rare as we think.

LAST YEAR, the National Institute on Alcohol Abuse and Alcoholism, part of the federal National Institutes of Health, laid out plans for what is a rarity in the realm of public health: a high quality clinical trial. The “Moderate Alcohol and Cardiovascular Health Trial,” known as MACH15, was to be randomized so that some subjects would be selected to drink and some would not. It would follow participants “prospectively,” over time, not retrospectively. And in the end, the results were to be adjudicated by evaluators blinded to which subjects had been instructed to drink and which to abstain. The goal was an assessment of the effect of alcohol consumption on cardiovascular health. [colored_box]But last month, the National Institutes of Health took the unusual step of shutting down one of its own clinical trials — a $100 million dollar experiment gone wrong. The announcement followed an internal investigation, prompted by a dogged New York Times report, that uncovered inappropriate interactions between the alcohol industry (Anheuser-Busch InBev, Heineken, and others) and the NIAAA in the execution of MACH15. . By law, federal health agencies can receive funding from for-profit industry. But direct courting of funding, coordination, and collaboration on research design, and excessive communications are not permitted, and according to The Times and the findings of the NIH’s subsequent internal investigation, these violations occurred early and often during the development of the MACH15 trial. The NIH report concluded that the actions uncovered “calls into question the impartiality of the process and thus casts doubt that the scientific knowledge gained from the study would be actionable or believable.” .

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Contextualising Merit and Integrity within Human Research (Papers: Ian Pieper and Colin Thomson | 2014)

Abstract The first consideration of any Australian Human Research Ethics Committee should be to satisfy itself that the project before them is worth undertaking. If the project does not add to the body of knowledge, if it does not improve social welfare or individual wellbeing then... More

Abstract The first consideration of any Australian Human Research Ethics Committee should be to satisfy itself that the project before them is worth undertaking. If the project does not add to the body of knowledge, if it does not improve social welfare or individual wellbeing then the use of human participants, their tissue or their data must be questioned. Sometimes, however, committees are criticised for appearing to adopt the role of scientific review committees. The intent of this paper is to provide researchers with an understanding of the ethical importance of demonstrating the merit of their research project and to help them develop protocols that show ethics committees that adequate attention has been paid to this central tenet in dealing ethically with human research participants. Any person proposing human research must be prepared to show that it is worthwhile. This paper will clarify the relationship between research merit and integrity, research ethics and the responsibilities of human research ethics committees. Keywords Human Research, National Statement, Australian Code, Integrity, Article

Pieper, I. & Thomson, C.J.H. (2011) Contextualising Merit and Integrity within Human Research, Monash Bioethics Review  29: 39. https://doi.org/10.1007/BF03351329 Publisher: https://link.springer.com/article/10.1007/BF03351329

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Justice in Human Research Ethics (Papers: Ian Pieper and Colin Thomson | 2014)

Abstract One of the core values to be applied by a body reviewing the ethics of human research is justice. The inclusion of justice as a requirement in the ethical review of human research is relatively recent and its utility had been largely unexamined until debates... More

Abstract One of the core values to be applied by a body reviewing the ethics of human research is justice. The inclusion of justice as a requirement in the ethical review of human research is relatively recent and its utility had been largely unexamined until debates arose about the conduct of international biomedical research in the late 1990s. The subsequent amendment of authoritative documents in ways that appeared to shift the meaning of conceptions of justice generated a great deal of controversy. Another difficulty has been that both the theory and the substance of justice that are applied by researchers or reviewers can be frequently seen to be subjective. Both the concept of justice — whether distributive or commutative — and what counts as a just distribution or exchange — are given different weight and meanings by different people. In this paper, the origins and more recent debates about the requirement to consider justice as a criterion in the ethical review of human research are traced, relevant conceptions of justice are distinguished, and the manner in which they can be applied meaningfully in the ethical review of all human research is identified. We also explain the way that these concepts are articulated in, and the intent and function of, specific paragraphs of the National Statement on Ethical Conduct in Human Research (2007). The National Statement identifies a number of issues that should be considered when a human research ethics committee is reviewing the justice aspects of an application. We provide guidance to researchers as to how they can show that there is a fair distribution of burdens and benefits in the participant experience and the research outcomes. We also provide practical guidance to researchers on how to think through issues of justice so that they can demonstrate that the design of their research projects meets this ethical requirement. Keywords Human Research, National Statement, Human Research Ethics, Distributive Justice

Pieper, I. & Thomson, C.J.H. (2013) Justice in Human Research Ethics. Monash Bioethics Review (2013) 31: 99. Publisher: https://link.springer.com/article/10.1007/BF03351345#citeas

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(US) NIH delays controversial clinical trials policy for some studies – Science (Jocelyn Kaiser | July 2018)

Published/Released on July 24, 2018 | Posted by Admin on September 30, 2018 | Keywords: , , , , , , ,

Basic brain and behavioral researchers will get more than a year to comply with a new U.S. policy that will treat many of their studies as clinical trials. The announcement from the National Institutes of Health (NIH) appears to defuse, for now, a yearlong controversy over whether basic research... More

Basic brain and behavioral researchers will get more than a year to comply with a new U.S. policy that will treat many of their studies as clinical trials. The announcement from the National Institutes of Health (NIH) appears to defuse, for now, a yearlong controversy over whether basic research on humans should follow the same rules as studies testing drugs. [colored_box]Although research groups had hoped NIH would drop its plans to tag basic studies with humans as trials, they say they’re relieved they get more time to prepare and give the agency input. “It’s a positive step forward,” says Paula Skedsvold, executive director of the Federation of Associations in Behavioral & Brain Sciences in Washington, D.C. . At issue is a recently revised definition of a clinical trial along with a set of rules in effect since January that are meant to increase the rigor and transparency of NIH-funded clinical trials. About a year ago, basic scientists who study human cognition—for example, using brain imaging with healthy volunteers—were alarmed to realize many of these studies fit the new clinical trial definition. .

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Research ethics versus ethical approval: A response to Tomaselli (Papers: Katie Fitzpatrick | 2017)

Keyan Tomaselli’s opinion piece provides a great deal of food for thought about a wide range of issues in research. I want to pick up here on one point he makes, which I think is worth further consideration: the issue of research ethics and approvals in ethnography. He notes... More

Keyan Tomaselli’s opinion piece provides a great deal of food for thought about a wide range of issues in research. I want to pick up here on one point he makes, which I think is worth further consideration: the issue of research ethics and approvals in ethnography. He notes that “bio-medical ethical models are imposed on anthropologists” and he raises concerns about how universities engage in the gate keeping of research approvals. This is an important point and one that might usefully be explored further in future issues of this journal. It seems to me that ethical approval has, indeed, been divorced from the academic field of research ethics, especially in qualitative research. As Tomaselli notes, we might question the right of “organisations [to] claim jurisdiction over the right of adult individuals or researchers to make their own respective choices”. I think we might also seek to uphold the rights of young people—not only adults—to make decisions about the kinds of research they engage in and how their voices are represented therein. Ethical issues in ethnographic research are, indeed, complex, locally and culturally specific, and are difficult to regulate. Part of this difficulty lies in the fact that ethnographic research is, by definition, relational. Romero and Walker (2010, 209) observe that “some of the most prevalent methodological and ethical questions in contemporary ethnographic research concern whose voice is heard and how it is represented”. They note that “in theory and in practice, Institutional Review Boards require that the identity of individuals be protected and remain anonymous or at very least confidential” [sic] (223). Many ethnographers adhere to this approach because they are committed to protecting the identities of their participants, especially when the research concerns personal, legal, sexual or other sensitive materials. However, an assumption that people’s identities should and will be obscured in research representations is also problematic, especially when this decision is made prior to even entering the field.

Fitzpartrick, Katie. 2017. “ Research ethics versus ethical approval: A response to Tomaselli.” The Ethnograhic Edge  1, (1): 21– 33. http://dx.doi.org/10.14663/tee.v1i1.20 Publisher: http://dx.doi.org/10.14663/tee.v1i1.20

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Let the Sun Shine into the Medical Ivory Tower – The Hastings Center (Adriane Fugh-Berman | September 2018)

In 2012, I coauthored a case report about the successful use of dietary supplements in treating a case of male infertility in the American Family Physician. Before it was published, I was surprised to receive a communication asking me to disclose the fact that I had... More

In 2012, I coauthored a case report about the successful use of dietary supplements in treating a case of male infertility in the American Family Physician. Before it was published, I was surprised to receive a communication asking me to disclose the fact that I had written a textbook on dietary supplements. It had not occurred to me to disclose the publication of my then decade-old book, but I certainly should have, and I was impressed that the publication had actually checked up on me. Would that more journals would follow AFP’s example. A joint New York Times and ProPublica investigation found that Jose Baselga, the chief medical officer at Memorial Sloan Kettering Cancer Center in New York, failed to disclose payments from pharmaceutical and health care companies in more than 100 articles he authored in medical journals. Between August 2013 (when Federal Open Payments disclosures began) and 2017, nine pharmaceutical and medical device companies paid Dr. Baselga almost $3.5 million. Dr. Baselga has been on the board of directors of Bristol Myers Squibb and Varian medical systems, which sells radiation equipment to Memorial Sloan Kettering, among other clients. Dr. Baselga has been a consultant to Astra Zeneca, Eli Lilly, Novartis, and Roche/Genentech and an advisor to many pharmaceutical companies, diagnostics companies, and start-ups. He has presented favorable opinions about drugs made by companies that paid him– including drugs that other researchers found ineffective or unsafe. According to the Times article, Dr. Baselga called the results of a Roche trial of taselisib, a P13K inhibitor “incredibly exciting” at a meeting of the American Society of Clinical Oncology; Roche, the manufacturer, considered the drug so disappointing they scrapped further development.

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Privacy in User Research: Can You? – Scholarly Kitchen (Lisa Janicke Hinchliffe | September 2018)

We may live in the age of privacy nihilism but recognizing one’s reality does not have to mean agreeing to do your own work by its terms. This post is for those publishers, academic and research librarians, and others who conduct research on user behavior in... More

We may live in the age of privacy nihilism but recognizing one’s reality does not have to mean agreeing to do your own work by its terms. This post is for those publishers, academic and research librarians, and others who conduct research on user behavior in library information systems, who — whether for personal and/or professional ethical reasons or policies — want to do so in ways that prioritize privacy. Situating Myself and Academic Librarianship [colored_box]A bit of my own background is probably useful to contextualize this discussion. My own attention to this topic of privacy and user data came into focus when I led the launch of the Value of Academic Libraries Initiative as President of the Association of College and Research Libraries (ACRL) in 2010-2011. Grounded in The Value of Academic Libraries: A Comprehensive Research Review and Report, my work that year and since then has been heavily focused on advocating for the profession to move to evidence-based claims for library value and for the collection and analysis of individual user data in order to do so. This work has been heavily criticized for its focus on collecting user data and, at times, for facilitating the neoliberal transformation of higher education. . Given that, I have also had to confront hard questions about how gathering and analyzing user data aligns with the values of my profession. Specifically, the value of privacy as expressed in the ALA Code of Ethics statement that: “We protect each library user’s right to privacy and confidentiality with respect to information sought or received and resources consulted, borrowed, acquired or transmitted.” These questions have not had easy or straightforward answers, particularly as the value of privacy can be in tension with another principle in the ALA Code of Ethics: “We provide the highest level of service to all library users.” I’m grateful to Andrew Asher who joined me in a series of public presentations exploring these issues (e.g., CNI Fall 2014). .

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‘Telling our story… Creating our own history’: caregivers’ reasons for participating in an Australian longitudinal study of Indigenous children (Papers: Katherine Ann Thurber, et al | 2018)

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Was it Ethical for Dropbox to Share Customer Data with Scientists? – Wired (Emily Dreyfuss | July 2018)

Published/Released on July 24, 2018 | Posted by Admin on September 18, 2018 | Keywords: , , , , , , , ,

FOR THE PAST two years, researchers at Northwestern University have been analyzing the habits of tens of thousands of scientists—using Dropbox. Looking at data about academics' folder-sharing habits, they found the most successful scientists share some collaboration behaviors in common. And on Friday, they published their results in... More

FOR THE PAST two years, researchers at Northwestern University have been analyzing the habits of tens of thousands of scientists—using Dropbox. Looking at data about academics' folder-sharing habits, they found the most successful scientists share some collaboration behaviors in common. And on Friday, they published their results in an article for the Harvard Business Review. [colored_box]The study quickly attracted the notice of academics—but not for the reason Dropbox and the researchers had hoped. One sentence in particular caught readers' attention: “Dropbox gave us access to project-folder-related data, which we aggregated and anonymized, for all the scientists using its platform over the period from May 2015 to May 2017—a group that represented 1,000 universities." Written by Northwestern University Institute on Complex Systems professors Adam Pah and Brian Uzzi and Dropbox Manager of Enterprise Insights Rebecca Hinds, that wording suggested Dropbox had handed over personally identifiable information on hundreds of thousands of customers. . By Tuesday, Harvard Business Review had corrected that part of the article to say the data was anonymized and aggregated prior to being given to the researchers. “Before providing any Dropbox users’ data to the researchers, Dropbox permanently anonymized the data by rendering any identifying user information unreadable, including individual emails and shared folder IDs," a Dropbox spokesperson told WIRED. But while Dropbox's more than half a billion users can rest easy that their de-anonymized data isn't readily shared with researchers, the only consent Dropbox obtained from customers involved in the study was their agreement to its privacy policy and terms of service, according to representatives for Dropbox. .

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Indigenous Data Sovereignty: University Institutional Review Board Policies and Guidelines and Research with American Indian and Alaska Native Communities (Papers: Tennille L. Marley | 2018)

Abstract American Indians, Alaska Native, and other Indigenous people throughout the world have undergone and continue to experience research abuses. Qualitative data such as intellectual property, Indigenous knowledge, interviews, cultural expressions including songs, oral histories/stories, ceremonies, dances, and other texts, images, and recordings are at risk... More

Abstract American Indians, Alaska Native, and other Indigenous people throughout the world have undergone and continue to experience research abuses. Qualitative data such as intellectual property, Indigenous knowledge, interviews, cultural expressions including songs, oral histories/stories, ceremonies, dances, and other texts, images, and recordings are at risk of exploitation, appropriation, theft, and misrepresentation and threaten the cultural sovereignty of American Indians, Alaska Native, and other Indigenous people. These issues are potentially magnified with the increasing use of big data. Partly as a result of past and current research abuse, the Indigenous data sovereignty, the control, ownership, and governance of research and data, is growing. In this article, I discuss American Indian political sovereignty, cultural sovereignty, and Indigenous data sovereignty, with an emphasis on qualitative data sovereignty. In addition, I explore whether Arizona’s public universities—Northern Arizona University, Arizona State University, and University of Arizona—policies and guidelines support Indigenous data sovereignty and the extent to which they align with the Arizona Board of Regent’s tribal consultation policy that governs relations between the three Arizona universities and Arizona American Indian nations. Overall expectations, requirements, and processes do not go far enough in supporting Indigenous data sovereignty. Although each university has specific research policies that follow the Arizona Board of Regent’s tribal consultation policy, the university guidelines differ in scope in term of supporting Indigenous data sovereignty. In addition, none of the policies address qualitative data sharing, including those in big data sets. Based on the findings I make several recommendations for researchers, including supporting the Indigenous sovereignty movement and to reconsider big data use and past positions about qualitative data ownership and sharing with regard to American Indians, Alaska Native, and other Indigenous people. Keywords Indigenous data sovereignty, American Indian and Alaska Native, Indigenous people, qualitative data

Marley, T. L. "Indigenous Data Sovereignty: University Institutional Review Board Policies and Guidelines and Research with American Indian and Alaska Native Communities." American Behavioral Scientist 0(0): 0002764218799130. Publisher: http://journals.sagepub.com/doi/abs/10.1177/0002764218799130#articleCitationDownloadContainer

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Compensation for research-related harm: The implications of Venter v Roche Products (Pty) Limited and Others for research ethics committees (Papers: Ann Strode & Priya P. Singh | 2014)

Published/Released on August 01, 2014 | Posted by Admin on September 13, 2018 | Keywords: , , , , , , , ,

Background. The issue of what type of compensation a research participant would be entitled to in a clinical trial when they have signed an informed consent document excluding certain forms of compensation recently came before our courts in the matter of Venter v Roche Products (Pty)... More

Background. The issue of what type of compensation a research participant would be entitled to in a clinical trial when they have signed an informed consent document excluding certain forms of compensation recently came before our courts in the matter of Venter v Roche Products (Pty) Limited and Others (Case No. 12285/08). In this case, the court had to consider whether the plaintiff, Mr Venter, was entitled to claim for non-medical costs such as pain and suffering, loss of income and general damages, even though the informed-consent document expressly excluded such claims. Objectives. To set out the facts, issues and judgment in the case, concluding with a discussion of the implications of the judgment for research ethics committees (RECs). Methods. Critical review of a judgment of the Western Cape High Court. Results. The court concluded that Mr Venter’s application for damages should be dismissed because he had voluntarily agreed to the limited compensation as set out in the informed consent form that had been approved by both the local RECs and the Medicines Control Council. Conclusions. The Venter case has shown that delictual claims for research-related injuries will not be successful if plaintiffs have agreed to limit their own rights through signing an informed-consent form that limits compensation. This places an important obligation on RECs to ensure that they carefully review compensation clauses in informed-consent documents and that these are made clear to potential research participants.

Strode, A., & Singh, P. (2014). Compensation for research-related harm: The implications of Venter v Roche Products (Pty) Limited and Others for research ethics committees. South African Medical Journal, 104(11), 759-761. doi:10.7196/SAMJ.8596 http://www.samj.org.za/index.php/samj/article/view/8596/6379

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The perils of fieldwork in authoritarian states – University World News (Yojana Sharma | September 2018)

Doctoral students and researchers in the social and political sciences need more training to deal with the perils of fieldwork in authoritarian states in Southeast Asia, according to two experts on the region. [colored_box]They note that existing “one size fits all” recommendations on field research “presume the setting to be... More

Doctoral students and researchers in the social and political sciences need more training to deal with the perils of fieldwork in authoritarian states in Southeast Asia, according to two experts on the region. [colored_box]They note that existing “one size fits all” recommendations on field research “presume the setting to be liberal democratic regimes” rather than the less accessible or less secure and transparent authoritarian regimes prevalent in the region. . “The discipline of political science is poorly positioned to guide its own scholars on the best way to perform field research in countries lacking guarantees for norms of speech, movement and scholarship,” say Meredith Weiss, associate professor of political science at the State University of New York at Albany in the United States, and Lee Morgenbesser, a lecturer in comparative politics at Griffith University in Australia, in a just-published paper that draws on their own and other academics’ experiences of working in such countries. . “The implications of this lacuna are acute in Southeast Asia,” where nine out of 11 countries are classified as having authoritarian regimes, they say in their paper published in the Asian Studies Review entitled “Survive and Thrive: Field research in authoritarian Southeast Asia”. .

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Research ethics in the Kalahari: issues, contradictions and concerns (Papers: Keyan Tomaselli | 2017)

Abstract The effects of ethical clearance or institutional review board practices are discussed in relation to the experiences of academic field researchers on the one hand and indigenous research participants and/or co-generators of knowledge on the other. Ethical procedures such as protection (do no harm), control... More

Abstract The effects of ethical clearance or institutional review board practices are discussed in relation to the experiences of academic field researchers on the one hand and indigenous research participants and/or co-generators of knowledge on the other. Ethical procedures such as protection (do no harm), control (micromanaging methods) and exploitation (taking ownership) are discussed in relation to researcher experiences in southern Africa. Researcher–researched relations, researcher and subject alienation, ethics creep and the clash of ontologies are examined. Some tentative solutions are proposed. Keywords: ethics, gatekeepers, indigenous rights, institutional review board, Kalahari, ≠Khomani Bushmen

Tomaselli, K.G. (2017): Ethical Procedures? A Critical Intervention: The sacred, the profane, and the planet. The Ethnographic Edge, [S.l.], v. 1, n. 1, p. 3-16. Publisher: https://www.tandfonline.com/doi/abs/10.1080/02560046.2016.1267253

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Financial Ties That Bind: Studies Often Fall Short On Conflict-Of-Interest Disclosures – KHN (Rachel Bluth | August 2018)

Papers in medical journals go through rigorous peer review and meticulous data analysis. Yet many of these articles are missing a key piece of information: the financial ties of the authors. Nearly two-thirds of the 100 physicians who rake in the most money from 10 device manufacturers failed to disclose a... More

Papers in medical journals go through rigorous peer review and meticulous data analysis. Yet many of these articles are missing a key piece of information: the financial ties of the authors. Nearly two-thirds of the 100 physicians who rake in the most money from 10 device manufacturers failed to disclose a conflict of interest in their academic writing in 2016, according to a study published Wednesday in JAMA Surgery.

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Too dangerous for fieldwork? The challenge of institutional risk-management in primary research on conflict, violence and ‘Terrorism’ (Papers: Jeffrey Sluka | July 2018)

Published/Released on July 16, 2018 | Posted by Admin on September 3, 2018 | Keywords: , ,

Research on conflict and ‘terrorism’ is confronted by an expanding range of daunting ethical, methodological, and institutional challenges. One of these is the increasing involvement of university ethics and fieldwork safety committees in ‘managing’ researcher safety and security as an issue which requires institutional oversight, control, and approval. This... More

Research on conflict and ‘terrorism’ is confronted by an expanding range of daunting ethical, methodological, and institutional challenges. One of these is the increasing involvement of university ethics and fieldwork safety committees in ‘managing’ researcher safety and security as an issue which requires institutional oversight, control, and approval. This paper contributes to contemporary reflection on and conversations about social sciences fieldwork in what is deemed to be an increasingly dangerous world. It focuses specifically on the increasing application of institutional ethics and safety review processes to ‘dangerous’ fieldwork on socio-political violence. While these new restrictions are clothed in the language or idiom of ethics and worker safety and security, a political analysis suggests that these committees represent powerful institutions of censorship and control, a serious challenge to academic freedom, and even movement towards the recolonisation of social science research. This paper describes and addresses this threat, and offers a constructive proposal for potentially responding by the development of risk assessment and management protocols which may contribute both to researcher survival in perilous field sites and help researchers to negotiate the necessary approval by university ethics and safety committees.

luka, J. A. (2018). Too dangerous for fieldwork? The challenge of institutional risk-management in primary research on conflict, violence and ‘Terrorism’. Contemporary Social Science, 1-17. doi:10.1080/21582041.2018.1498534 Publisher: https://www.tandfonline.com/doi/abs/10.1080/21582041.2018.1498534 ResearchGate: https://www.researchgate.net/publication/326437314

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Research with, not about, communities – Ethical guidance towards empowerment in collaborative research, a report for the TRUST project – TRUST (Kate Chatfield, et al | July 2018)

Executive Summary and Introduction Community engagement is an ethical imperative (a ‘must’) for researchers operating globally. Research participants, their local communities and research partners in international locations should be equal stakeholders1 in the pursuit of research-related gains.2,3 [colored_box]In the 1990s, community engagement became prominent as the new... More

Executive Summary and Introduction Community engagement is an ethical imperative (a ‘must’) for researchers operating globally. Research participants, their local communities and research partners in international locations should be equal stakeholders1 in the pursuit of research-related gains.2,3 [colored_box]In the 1990s, community engagement became prominent as the new guiding light of public health efforts. Involving communities in research and health-improvement programs led to better results than government-led programs alone.4 At the same time, the emerging need to protect indigenous communities in genetic research led Canadian Charles Weijer to demand a fifth principle in bioethics5,6: protection for communities.7 The individualistic nature of existing research ethics principles, stemming from US origins with its traditional emphasis upon individual autonomy was thus questioned. Asian and African ethicists added their voices to highlight the importance of respect for communities, as well as individuals.8,9 . This report provides guidance on community engagement in research from the perspective of the four TRUST values: fairness, respect, care and honesty. . These values were identified by a global group of experts as the cornerstones of equitable research partnerships between high-income country (HIC) and low- and middle-income country (LMIC) research partners in any discipline10. The group included representatives from two vulnerable populations that carry a high burden of research: Kenyan sex workers and San indigenous peoples of Southern Africa. The guidance is suitable for all who support vulnerable populations involved in research projects, including civil society organisations, whether or not they are carrying out the research projects themselves. .

Chatfield, K. et al. (2018) Research with, not about, communities - Ethical guidance towards empowerment in collaborative research, a report for the TRUST project.  http://trust-project.eu/wp-content/uploads/2018/07/TRUST-Community-Participation-in-Research-Final.pdf

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Ethical Considerations When Using Social Media for Evidence Generation (Papers: Gabrielle Berman, et al | 2018)

ABSTRACT There are significant ethical implications in the adoption of technologies and the production and use of the resulting data for evidence generation. The potential benefits and opportunities need to be understood in conjunction with the potential risks and challenges. When using social media to directly... More

ABSTRACT There are significant ethical implications in the adoption of technologies and the production and use of the resulting data for evidence generation. The potential benefits and opportunities need to be understood in conjunction with the potential risks and challenges. When using social media to directly engage children and their communities, or when establishing partnerships with these organizations for data collection and analysis, adoption of these technologies and their resultant data should not be exclusively driven by short-term necessity but also by the long-term needs of our younger partners. When engaging with social media and indeed most technology, thoughtfulness, reflection and ongoing interrogation is required. This paper examines the benefits, risks and ethical considerations when undertaking evidence generation: (a) using social media platforms and (b) using third-party data collected and analysed by social media services. It is supplemented by practical tools to support reflection on the ethical use of social media platforms and social media data.

Berman, Gabrielle; Powell, James; Garcia Herranz, Manuel (2018). Ethical Considerations When Using Social Media for Evidence Generation, Innocenti Discussion Papers no. 2018-01, UNICEF Office of Research - Innocenti, Florence https://www.unicef-irc.org/publications/967-ethical-considerations-when-using-social-media-for-evidence-generation-discussion.html

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Ethical Considerations When Using Geospatial Technologies for Evidence Generation (Papers: Gabrielle Berman, et al | 2018)

ABSTRACT Geospatial technologies have transformed the way we visualize and understand social phenomena and physical environments. There are significant advantages in using these technologies and data however, their use also presents ethical dilemmas such as privacy and security concerns as well as the potential for stigma... More

ABSTRACT Geospatial technologies have transformed the way we visualize and understand social phenomena and physical environments. There are significant advantages in using these technologies and data however, their use also presents ethical dilemmas such as privacy and security concerns as well as the potential for stigma and discrimination resulting from being associated with particular locations. Therefore, the use of geospatial technologies and resulting data needs to be critically assessed through an ethical lens prior to implementation of programmes, analyses or partnerships. This paper examines the benefits, risks and ethical considerations when undertaking evidence generation using geospatial technologies. It is supplemented by a checklist that may be used as a practical tool to support reflection on the ethical use of geospatial technologies.

Berman, Gabrielle; de la Rosa, Sara; Accone, Tanya (2018). Ethical Considerations When Using Geospatial Technologies for Evidence Generation, Innocenti Discussion Papers no. 2018-02, UNICEF Office of Research - Innocenti, Florence https://www.unicef-irc.org/publications/971-ethical-considerations-when-using-geospatial-technologies-for-evidence-generation.html

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Are you liable for misconduct by scientific collaborators? What a recent court decision could mean for scientists – Retraction Watch (Richard Goldstein | August 2018)

Published/Released on August 13, 2018 | Posted by Admin on August 19, 2018 | Keywords: , , , , , , ,

Retraction Watch readers may have followed our coverage of the case of Christian Kreipke, a former Wayne State researcher who was recently barred from U.S. Federal funding for five years. That punishment followed years of allegations and court cases, along with half a... More

Retraction Watch readers may have followed our coverage of the case of Christian Kreipke, a former Wayne State researcher who was recently barred from U.S. Federal funding for five years. That punishment followed years of allegations and court cases, along with half a dozen retractions. The case has been complicated, to say the least, and led to a 126-page decision by a judge last month. Here, Boston-based attorney Richard Goldstein, who represented the scientist in Bois v. HHS, the first case to overturn a funding ban by the U.S. Office of Research Integrity (ORI), tries to explain what it could all mean. [colored_box]Can you commit research misconduct if you fail to detect false data from another scientist? . The answer is yes and here’s how it can happen. . You work in a well-regarded laboratory that receives government funding. You are frequently a principal investigator (PI) and a lead author. The lab suffered from some disorganization so when you took over, you demanded quality work and hired a new lab administrator. . Things are generally good but life in the laboratory is demanding.  The size of the lab makes it impossible for you to validate every piece of data.  So, you often have to trust that a colleague’s work is reliable and truthful, including from collaborators at other facilities.  Funding, as always, is a problem, which means you can’t buy enough equipment and data security software; tracking who did what is difficult.  Some lab employees (inherited from your predecessor) have professional or ‘personnel’ issues and you suspect some will leave the laboratory. And of course, there is growing pressure to publish, attend conferences, make new findings, and to keep the funding stream going.  There is never enough time. .

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Did a study of Indonesian people who spend most of their days under water violate ethical rules? – Science (Dyna Rochmyaningsih | July 2018)

Published/Released on July 26, 2018 | Posted by Admin on August 14, 2018 | Keywords: , , , , , , ,

In April, a paper showing why Indonesia's Bajau people are such great divers drew worldwide attention as a striking example of recent human evolution. But the study, published in Cell, has created a different kind of stir in Indonesia, where some say it... More

In April, a paper showing why Indonesia's Bajau people are such great divers drew worldwide attention as a striking example of recent human evolution. But the study, published in Cell, has created a different kind of stir in Indonesia, where some say it is an example of "helicopter research" carried out by scientists from rich countries with little consideration for local regulations and needs. [colored_box]"Too many mistakes were made here," says geneticist Herawati Sudoyo, who heads the Eijkman Institute for Molecular Biology in Jakarta. Indonesian officials say the research team failed to obtain ethical approval from a local review board and took DNA samples out of the country without the proper paperwork. And some Indonesian scientists complain that the only local researcher involved in the study had no expertise in evolution or genetics. But Eske Willerslev, director of the University of Copenhagen's (KU's) Centre for GeoGenetics, says the team he headed had a permit from the Indonesian government and worked hard to follow the rules. "I would never participate in research that I felt was unethical," Willerslev says. The government hasn't informed him about problems, he says, but, "If we have made an error that violates national or international guidelines, we would like to apologize for that." . The issue escalated in late May, when Pradiptajati Kusuma, a geneticist at the Eijkman Institute who has also studied the Bajau, suggested in a tweet that the team could have faced prosecution under strict new rules on foreign research, proposed by the Indonesian government and now under debate. "Jail? Possible," Kusuma wrote. He later deleted the tweet, but Melissa Ilardo, the Cellstudy's first author, says she was so rattled that she canceled a July trip to Indonesia during which she planned to inform the Bajau about her study. "I did everything I could to conduct this research ethically and properly, and this is breaking my heart," says Ilardo, a Ph.D. student at KU at the time of the fieldwork and now at the University of Utah in Salt Lake City. .

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(US) Controversial alcohol study cancelled by US health agency – Nature (Sara Reardon | June 2018)

The US National Institutes of Health (NIH) has terminated a controversial US$100-million study examining whether drinking small amounts of alcohol every day can improve health. [colored_box]The agency's decision, announced on 15 June, came shortly after an NIH advisory council voted unanimously to end the trial. An More

The US National Institutes of Health (NIH) has terminated a controversial US$100-million study examining whether drinking small amounts of alcohol every day can improve health. [colored_box]The agency's decision, announced on 15 June, came shortly after an NIH advisory council voted unanimously to end the trial. An agency investigation had found that NIH staff and outside researchers acted inappropriately by soliciting industry funding and biasing the grant-review process to favour specific scientists. . Those findings would have undermined the study’s credibility if it had been allowed to proceed, said NIH director Francis Collins at the advisory-council meeting. “Is it even possible at this point that the results of this trial would have the credibility to influence anyone’s decision-making?” he asked. “That does in fact seem quite doubtful.” . The study, which began enrolling participants in February 2018 under the auspices of the National Institute on Alcohol Abuse and Alcoholism (NIAAA), included $67 million from 5 alcohol companies over 10 years. It came under fire in March after the New York Times reported that the study’s lead investigator — cardiovascular researcher Kenneth Mukamal of Beth Israel Deaconess Medical Center in Boston, Massachusetts — and his collaborators had directly courted funding from the liquor industry in 2013 and 2014, before the study’s launch. .

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Message from Professor Colin Thomson AM

Published/Released on August 10, 2018 | Posted by Admin on August 10, 2018 | Keywords: , , , , , , ,

Dear Colleague, I hope this finds you well and my apologies for this unsolicited email. Hopefully you already know about Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS - https://www.ahrecs.com) and that I am one of its three senior consultants (along... More

Dear Colleague, I hope this finds you well and my apologies for this unsolicited email. Hopefully you already know about Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS - https://www.ahrecs.com) and that I am one of its three senior consultants (along with Prof. Mark Israel and Dr Gary Allen). If you don’t already know, the AHRECS site includes a freely available Resource Library of over 1200 papers, books, news and other resources relating to both human research ethics and to research integrity (https://www.ahrecs.com/resources) and is also home to the free Research Ethics Monthly (https://www.ahrecs.com/blog). We are currently finalising plans for two web-based 30-minute panel discussions to be held in November covering:

  1. implementing the 2018 edition of the Australian Code for the Responsible Conduct of Research, and
  2. the updated National Statement.
The panels will both be moderated by one of AHRECS’ senior consultants and will include a nominee of the NHMRC.  We plan to also include a researcher, a research office staff member and a HREC Chair.  These live activities will be accessible free of charge and information on dates, times and how to join either or both of them will be available on the AHRECS website before the end of October. We are using these live panel discussions to introduce and promote a subscription service designed to raise revenue to cover our costs for more of these activities. Modelled on the idea of patronage, where patrons choose the level of support with which they are comfortable, our new service will allow Australian subscriber/patrons to download vignettes and other material for use in their in-house professional development activities. We expect to be adding at least one item to this area every month together with commentary on major breaking news and publications, as well as other exclusive information. We will put video copies of the panel discussions into the subscribers' area. We invite you to join this service.  Subscriptions start at USD1/month and USD15/month* grants access to all the material. This can be paid for using a credit card or PayPal account. After each payment we can provide an invoice showing it as paid (for accounting purposes) Please consider visiting https://www.patreon.com/ahrecs to subscribe. Kind regards, Prof. Colin Thomson AM * The amount is in US dollars because we are using a US service provider to host our subscribers’ area. On current exchange rates this equate to just over $20 per month. Less

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Sensitive Data can be Shared (Michael Martin | 2014)

A discussion of the legal and ethical context of publishing and sharing sensitive data with two experts who contributed to the ANDS Guide to Publishing & Sharing Sensitive Data.

Provides practical advice about sharing human data as part of ethical research practice (YouTube,... More

A discussion of the legal and ethical context of publishing and sharing sensitive data with two experts who contributed to the ANDS Guide to Publishing & Sharing Sensitive Data.

Provides practical advice about sharing human data as part of ethical research practice (YouTube, 40 min) Baden Appleyard, Barrister, also offers insight into legal requirements.

Martin, M (2014) Sensitive Data can be Shared. https://www.youtube.com/watch?v=FopQez8P-lU&feature=youtu.be

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Vulnerable patients – easy targets for companies willing to sacrifice ethics for profits – The Hill (Jody Lyneé Madeira | May 2018)

A small medical device has just become embroiled in a large controversy, suggesting violations of fundamental ethical norms and settled principles of scientific research. [colored_box] At first glance, the Bridge — a neuro-modulation device that attaches behind the ear — resembles a hearing aid with wires. The Bridge received Food... More

A small medical device has just become embroiled in a large controversy, suggesting violations of fundamental ethical norms and settled principles of scientific research. [colored_box] At first glance, the Bridge — a neuro-modulation device that attaches behind the ear — resembles a hearing aid with wires. The Bridge received Food and Drug Administration (FDA) clearance in November 2017 for easing opioid withdrawal symptoms during detoxification; before, it was approved only for acupuncture. . This device is supposed to help patients get through the difficult opioid withdrawal process. It’s used in pilot programs in several states, available in at least one major Indiana hospital chain, and is starting to be covered by insurance. .

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Kindness Ethics: A Possible Approach to Virtue Ethics (Papers: Kuangfei Xie | 2015)

Published/Released on September 07, 2015 | Posted by Admin on August 3, 2018

Abstract: As a possible alternative approach to the modern virtue ethics, kindness ethics focuses on the specific virtue of kindness, which, essentially speaking means a person's moral capacity to be kind to life itself, not only one's own individual life. Kindness ethics, largely speaking, constitutes the... More

Abstract: As a possible alternative approach to the modern virtue ethics, kindness ethics focuses on the specific virtue of kindness, which, essentially speaking means a person's moral capacity to be kind to life itself, not only one's own individual life. Kindness ethics, largely speaking, constitutes the core value or fundamental essence of the traditional Chinese moral doctrine of Confucianism. The general decline of the morality as well as the continuous worsening of the modern characters education have prompted us to work out a corresponding solution. Kindness ethics can possibly provide the modern people a way out. Keywords: Kindness Ethics, Virtues, Virtue Ethics

uangfei, Xie (2015) Kindness Ethics: A Possible Approach to Virtue Ethics. Education Journal. Vol. 4, No. 5, pp. 189-193. doi:10.11648/j.edu.20150405.11 Publisher (Open Access): http://article.sciencepublishinggroup.com/html/10.11648.j.edu.20150405.11.html

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Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities

In general, ethics guidelines provide a set of principles to ensure research is safe, respectful, responsible, high quality, of benefit to Aboriginal and Torres Strait Islander people and communities and of benefit to research. More

In general, ethics guidelines provide a set of principles to ensure research is safe, respectful, responsible, high quality, of benefit to Aboriginal and Torres Strait Islander people and communities and of benefit to research. Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders 2018 (the Guidelines) defines six core values — spirit and integrity, cultural continuity, equity, reciprocity, respect, and responsibility. Applying these values and other ethical principles will ensure that research conducted with or for Aboriginal and Torres Strait Islander people and communities, or their data or biological samples, is ethically conducted.  The Guidelines are intended for use by researchers and ethics review bodies, such as Human Research Ethics Committees (HRECs). Aboriginal and Torres Strait Islander Peoples, individual research participants, participant groups, the wider community and other stakeholders may also find the Guidelines useful.  Advice about how to use the Guidelines is provided on page 13. This includes information about Keeping research on track II 2018, which describes how the values and principles in the Guidelines can be put into practice. Additional principles and concepts relevant to research with Aboriginal and Torres Strait Islander Peoples and communities are set out on pages 15 to 19. Key terms, a glossary and a list of further resources are also provided. More information about the Guidelines is available on NHMRC’s website.

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Keeping research on track II

This guideline aims to support research participants, Aboriginal and Torres Strait Islander Peoples and communities to:

  • Make decisions that ensure the research journey respects Aboriginal and Torres Strait Islander Peoples’... More

    This guideline aims to support research participants, Aboriginal and Torres Strait Islander Peoples and communities to:

    • Make decisions that ensure the research journey respects Aboriginal and Torres Strait Islander Peoples’ and communities’ shared values, diversity, priorities, needs and aspirations.
    • Make decisions that ensure the research journey benefits Aboriginal and Torres Strait Islander people and communities as well as researchers and other Australians.
    • Recognise and understand their rights and responsibilities in being involved in all aspects of research.
    • Better understand the steps involved in making research ethical.
    The information in this guideline comes from two key national publications which set out the requirements for the ethical conduct of research:
    • National Statement on Ethical Conduct in Human Research (the National Statement) The National Statement is the principal guideline setting out the requirements for the ethical design, review and conduct of all human research in Australia. The National Statement is about four main principles: respect; research merit and integrity; justice; and beneficence. The National Statement provides guidance on the ethical considerations that are relevant to the way that research is designed, reviewed and conducted.

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Indigenous Data Sovereignty (Books: Edited by Tahu Kukutai and John Taylor | November 2016)

As the global ‘data revolution’ accelerates, how can the data rights and interests of indigenous peoples be secured? Premised on the United Nations Declaration on the... More

As the global ‘data revolution’ accelerates, how can the data rights and interests of indigenous peoples be secured? Premised on the United Nations Declaration on the Rights of Indigenous Peoples, this book argues that indigenous peoples have inherent and inalienable rights relating to the collection, ownership and application of data about them, and about their lifeways and territories. As the first book to focus on indigenous data sovereignty, it asks: what does data sovereignty mean for indigenous peoples, and how is it being used in their pursuit of self-determination? The varied group of mostly indigenous contributors theorise and conceptualise this fast-emerging field and present case studies that illustrate the challenges and opportunities involved. These range from indigenous communities grappling with issues of identity, governance and development, to national governments and NGOs seeking to formulate a response to indigenous demands for data ownership. While the book is focused on the CANZUS states of Canada, Australia, Aotearoa/New Zealand and the United States, much of the content and discussion will be of interest and practical value to a broader global audience. ‘A debate-shaping book … it speaks to a fast-emerging field; it has a lot of important things to say; and the timing is right.’  — Stephen Cornell, Professor of Sociology and Faculty Chair of the Native Nations Institute, University of Arizona ‘The effort … in this book to theorise and conceptualise data sovereignty and its links to the realisation of the rights of indigenous peoples is pioneering and laudable.’  — Victoria Tauli-Corpuz, UN Special Rapporteur on the Rights of Indigenous Peoples, Baguio City, Philippines

Kukutai, T and Taylor, J (2016) Indigenous Data Sovereignty: Toward an agenda. ANU Press. https://press.anu.edu.au/publications/series/centre-aboriginal-economic-policy-research-caepr/indigenous-data-sovereignty

Publisher (Free to download): https://press.anu.edu.au/publications/series/centre-aboriginal-economic-policy-research-caepr/indigenous-data-sovereignty
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Why Internet Scholars Are Calling Out Facebook for Restricting Access to Its Data – The Chronicle of Higher Education (Nell Gluckman | May 2018)

Published/Released on May 09, 2018 | Posted by Admin on July 31, 2018 | Keywords: , , , , , ,

After news broke in March that a scholar had harvested data about millions of Facebook users and shared it with Cambridge Analytica, a political-consulting firm that advised the Trump campaign, the social-media company made some changes. [colored_box]Facebook announced plans to restrict outsiders’ access to user information. It also... More

After news broke in March that a scholar had harvested data about millions of Facebook users and shared it with Cambridge Analytica, a political-consulting firm that advised the Trump campaign, the social-media company made some changes. [colored_box]Facebook announced plans to restrict outsiders’ access to user information. It also said that a select group of scholars would be granted unprecedented access to its data in a project that will be partly overseen by the Social Science Research Council. . The scholars will not be able to publish that information, but they will learn what the company will and won’t share with outside researchers and, presumably, why. They will then serve as a filter, meting out the data to researchers whose projects will seek to answer one question: How have social media influenced democracy? . Those announcements may sound like welcome changes to social-media users worried about their privacy. User data will be less accessible to outside companies and researchers who may have nefarious intentions, but trustworthy scholars will still be able to tap into the endless trove of information. . That’s the theory, at least. But some scholars of the internet say the new restrictions are actually a problem. A group of those scholars last month published an open letter sounding the alarm. They also created a document listing research papers that would not exist, they say, under the new restrictions Facebook has imposed on the use of its data.  

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Te Mana Raraunga Statement on 2018 New Zealand Census of Population and Dwellings: A Call for Action on Māori Census Data

Published/Released on July 24, 2018 | Posted by Admin on July 24, 2018 | Keywords: , , , ,

The five-yearly Census of Population and Dwellings is the flagship of the Official Statistics System (OSS) and is essential for many of the functions that underpin democracy. Te Mana Raraunga, the Māori Data Sovereignty Network, is concerned that Census 2018 may fail to deliver high quality Māori and iwi... More

The five-yearly Census of Population and Dwellings is the flagship of the Official Statistics System (OSS) and is essential for many of the functions that underpin democracy. Te Mana Raraunga, the Māori Data Sovereignty Network, is concerned that Census 2018 may fail to deliver high quality Māori and iwi data. Te Mana Raraunga supports a comprehensive independent review of Census 2018 and calls for Māori governance of Māori data across the entire Official Statistics System. [colored_box]Problems with the 2018 Census and Stats NZ response . Interim figures for the 2018 Census released by Stats NZ indicate that full or partial information has only been received for about 90 percent of individuals, compared with 94.5 percent for the 2013 Census1. Given that a key goal of the census is to count all usual residents in the country on census night2, commentators are rightly concerned that up to ten percent of the population may be missing3. For Māori, the extent of the problem will inevitably be worse. Census 2018 may yet turn out to be the poorest quality enumeration of Māori in recent history. . But how poor? Stats NZ will not have a definitive answer for some months yet but the early signs are not positive. Let’s begin with the ‘full or partial’ information received by 90 percent of individuals. One might have the impression that ‘partial’ information means incomplete information on an individual’s census form. However, as used by Stats NZ, ‘partial’ information appears to mean a partial-response dwelling where there is no individual form but the dwelling form or household summary page has a list of people at the dwelling on census night4. We do not yet know what share of the 90 percent comprises partial-response dwellings, however we can gain some insight by considering the 2013 results. While recent Stats NZ releases report full or partial informaton was received for 94.5 percent5 of individuals for the 2013 Census, the total (or achieved) response rate was 92.9 percent6. The lower, and more informative, figure excludes all individuals in partly and completely missing households in 2013, as well as the 2.4 percent estimated national net undercount (coverage level) determined by the Post Enumeration Survey7 undertaken after the 2013 Census. Stats NZ has also noted that for Census 2018 ‘there are more households where no one has responded to the census than previous censuses’. . What does all of this mean for Census 2018? It means that the total response rate will inevitably be below 90 per cent. For Māori, the 2018 total response rate will be be significantly below 90 per cent. The crucial question is, how much lower? And at what point does this seriously compromise the quality and usefulness of the census data? To date Stats NZ has not provided any guidance on these important questions but needs to. . Constitutional and other implications for Māori . Recently Stats NZ announced that: ‘New Zealanders can be confident the 2018 Census will produce accurate and high-quality data which can be relied on by communities and decision-makers’9. We question whether this will be the case for Māori communities, iwi and Māori decision-makers. .

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The Ethics of Research on Leaked Data: Ashley Madison – Discover (Neuroskeptic | July 2018)

Published/Released on July 14, 2018 | Posted by Admin on July 22, 2018 | Keywords: , , , , , , ,

A paper just published reports that Republicans are more likely to have used the adultery website Ashley Madison than Democrats, while Libertarians were even more likely to do so. [colored_box]That’s a claim that could ruffle some feathers, but the way in which the researchers conducted this study might be... More

A paper just published reports that Republicans are more likely to have used the adultery website Ashley Madison than Democrats, while Libertarians were even more likely to do so. [colored_box]That’s a claim that could ruffle some feathers, but the way in which the researchers conducted this study might be even more controversial. That’s because this paper is based on the 2015 Ashley Madison data leak, which exposed the personal data, including names and credit-card details, of millions of registered users. . For this study, the authors, Kodi B. Arfer and Jason J. Jones, took the leaked data and matched it up against voter registration records for five U.S. states. They considered a voter to be an active Ashley Madison user if they had ever paid money to the website. About 1 in 500 voters met these criteria. . Those voters registered as Libertarians were most likely to be active users, even controlling for age, gender and state. Registered Republicans came next and Democrats were least likely. .

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Science needs clarity on Europe’s data-protection law – Nature (May 2018 | Editorial)

As a commendable European law on personal data comes into force, the research community must not let excessive caution about data sharing, however understandable, become the default position.

European policymakers have been discussing new rules on data protection for years, and scientists and... More

As a commendable European law on personal data comes into force, the research community must not let excessive caution about data sharing, however understandable, become the default position.

European policymakers have been discussing new rules on data protection for years, and scientists and universities — like everyone else across the continent — are about to see the results. Entering into force on 25 May, a new law known as the General Data Protection Regulation (GDPR), is designed to protect the personal privacy of citizens and will overhaul how personal data are collected, handled, processed and stored. It’s a welcome move to safeguard individuals and is the biggest shake-up of data protection in more than 20 years. [colored_box]However, as this journal has noted before, earlier drafts of the law posed a problem for science and the research community. Of particular concern was the issue of consent — the draft language suggested researchers would be required to seek renewed consent to reuse data collected for a different purpose, which could have introduced delays and made some research impractical. But many in the research community worked relentlessly to warn policymakers of the potential harm. In response, officials put in place rules that exempt research from some of the requirements, provided the proper safeguards are in place. Universities and organizations have introduced plans to make sure they are. The bulk of the work should be done. . The passing of the final GDPR rules is, therefore, a good example of political engagement by researchers and their advocates, and a sensible and informed reaction from policymakers. Those involved, on both sides, deserve great credit. Harmonization of how data can be sourced, stored and used would, in theory, be good for research. It could smooth the difficulties that scientists face when they try to pool analysis of genomic data and tissue samples across national borders. Such sharing could help scientists to organize powerful trials with large numbers of participants. .

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Genome editing and human reproduction (Nuffield Council on Bioethics | July 2018)

Published/Released on July 02, 2018 | Posted by Admin on July 19, 2018 | Keywords: , , , , , , , ,

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Self-Determination in Health Research: An Alaska Native Example of Tribal Ownership and Research Regulation (Vanessa Y. Hiratsuka, et al | 2017)

Abstract

[colored_box]Alaska Native (AN) and American Indian (AI) people are underrepresented in health research, yet many decline to participate in studies due to past researcher misconduct. Southcentral Foundation (SCF), an Alaska Native-owned and operated health care organization, is transforming... More

Abstract

[colored_box]Alaska Native (AN) and American Indian (AI) people are underrepresented in health research, yet many decline to participate in studies due to past researcher misconduct. Southcentral Foundation (SCF), an Alaska Native-owned and operated health care organization, is transforming the relationship between researchers and the tribal community by making trust and accountability required features of health research in AN/AI communities. In 1998, SCF assumed ownership from the federal government of health services for AN/AI people in south central Alaska and transformed the health system into a relationship-based model of care. This change reimagines how researchers interact with tribal communities and established community oversight of all health research conducted with AN/AI people in the region. We describe the SCF research review process, which requires tribal approval of the research concept, full proposal, and dissemination products, as well as local institutional review board approval, and a researcher-signed contract. This review evaluates research through the lens of tribal principles, practices, and priorities. The SCF example provides a framework for other tribes and organizations seeking to reshape the future of health research in AN/AI communities. .

Keywords: community review, Alaska Native, tribal, ethics, Native American, research, research conduct, trust, accountability .

Hiratsuka, V. Y., Beans, J. A., Robinson, R. F., Shaw, J. L., Sylvester, I., & Dillard, D. A. (2017). Self-determination in health research: An Alaska Native example of Tribal ownership and research regulation. International Journal of Environmental Research and Public Health, 14(11), 1324. http://dx.doi.org/10.3390/ijerph14111324 Publisher (Open Access): https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5707963/

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Conducting Research with Tribal Communities: Sovereignty, Ethics, and Data-Sharing Issues (Papers: Anna Harding, et al | 2011)

Abstract

Background: When conducting research with American Indian tribes, informed consent beyond conventional institutional review board (IRB) review is needed because of the potential for adverse consequences at a community or governmental level that are unrecognized by academic researchers.

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Abstract

Background: When conducting research with American Indian tribes, informed consent beyond conventional institutional review board (IRB) review is needed because of the potential for adverse consequences at a community or governmental level that are unrecognized by academic researchers.

Objectives: In this article, we review sovereignty, research ethics, and data-sharing considerations when doing community-based participatory health–related or natural-resource–related research with American Indian nations and present a model material and data-sharing agreement that meets tribal and university requirements.

Discussion: Only tribal nations themselves can identify potential adverse outcomes, and they can do this only if they understand the assumptions and methods of the proposed research. Tribes must be truly equal partners in study design, data collection, interpretation, and publication. Advances in protection of intellectual property rights (IPR) are also applicable to IRB reviews, as are principles of sovereignty and indigenous rights, all of which affect data ownership and control.

Conclusions: Academic researchers engaged in tribal projects should become familiar with all three areas: sovereignty, ethics and informed consent, and IPR. We recommend developing an agreement with tribal partners that reflects both health-related IRB and natural-resource–related IPR considerations.

Keywords: American Indian, data sharing, informed consent, intellectual property, IRB, research ethics, sovereignty, tribal

Harding A, Harper B, Stone D, O’Neill C, Berger P, et al. (2011) Conducting Research with Tribal Communities: Sovereignty, Ethics, and Data-Sharing Issues. Environmental Health Perspectives.  120: 6–10. pmid:21890450 Publisher (Open Access): https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3261947/

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Moving Forward on Consent Practices in Australia (Papers: Rebekah E. McWhirter & Lisa Eckstein | 2018))

Abstract Allowing persons to make an informed choice about their participation in research is a pre-eminent ethical and legal requirement. Almost universally, this requirement has been addressed through the provision of written patient information sheets and consent forms. Researchers and others have raised concerns about the... More

Abstract Allowing persons to make an informed choice about their participation in research is a pre-eminent ethical and legal requirement. Almost universally, this requirement has been addressed through the provision of written patient information sheets and consent forms. Researchers and others have raised concerns about the extent to which such forms—particularly given their frequent lengthiness and complexity—provide participants with the tools and knowledge necessary for autonomous decision-making. Concerns are especially pronounced for certain participant groups, such as persons with low literacy and Indigenous persons. Multimedia strategies have the potential to usefully supplement current consent practices in Australia; however, information is needed about the need for supplementary consent practices, along with drivers for and barriers against adoption. This study initiates the required evidence base through an audit of informed consent practices for medical research in the Australian state of Tasmania to assess the need for, and current uptake of, supplementary consent strategies. Drivers for and barriers against adoption of multimedia consent practices were explored in detail through interviews with key stakeholders, including researchers, HREC chairs and members, and research participants, including Indigenous participants. Keywords Informed consent, Research ethics, Multimedia consent, Consent apps

McWhirter, RE and Eckstein, L (2018) Moving Forward on Consent Practices in Australia. Journal of Bioethical Inquiry. Published online: 12 March 2018 https://doi.org/10.1007/s11673-018-9843-z

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National Statement on Ethical Conduct in Human Research (2007) – Updated with new link to July 2018 update

Nationa... <a href=More

National Statement 2018 coverThe National Statement is the Australian national reference for human research. It was issued by the NHMRC and has been endorsed by the ARC and UA. The document articulates the four core principles of merit and integrity, beneficence, justice and respect for persons. Specific advice is provided with regard to benefits and risk, informed consent, privacy, methodologies and potential participant populations. Guidance is also provided with regard to the appointment and operation of human research ethics committees, the conduct of ethical reviews, and the responsibilities of institutions. Even though the document has not been enacted compliance with the National Statement is a strict condition of NHMRC and ARC funding. Since 2014 a joint working group (including appointees from AHEC, the ARC and UA) have been conducting a rolling review of the National Statement. Dr Allen is involved in this rolling review. In 2015-17 a joint drafting committee (including appointees from AHEC, the ARC and UA) drafted changes and addition to the chapters in Section 3 of the National Statement, as well as corresponding changes to Section 5 and the glossary Dr Allen, Prof Israel and Prof Thomson, are involved in this rolling review.

Access - the PDF copy | the NS page

National Health and Medical Research Council, Australia (2007, updated 2018) National Statement on Ethical Conduct in Human Research. Available at: https://nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018

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Research, Ethics and Indigenous Peoples: An Australian Indigenous perspective on three threshold considerations for respectful engagement (Ambelin Kwaymullina | 2016)

Abstract [colored_box]Indigenous peoples have long critiqued the harmful effects of Eurocentric research processes upon Indigenous cultures and communities. This paper—which is grounded in the author's knowledge and experience as an Aboriginal Australian academic—examines three threshold considerations relevant to non-Indigenous scholars who seek to enter... More

Abstract [colored_box]Indigenous peoples have long critiqued the harmful effects of Eurocentric research processes upon Indigenous cultures and communities. This paper—which is grounded in the author's knowledge and experience as an Aboriginal Australian academic—examines three threshold considerations relevant to non-Indigenous scholars who seek to enter into respectful research relationships with Indigenous peoples or knowledges. The first is the question of whether the research should be conducted at all. The second is positionality and how this affects research. The third is the need for scholars to comprehensively inform themselves about ethical research principles, including in relation to free, prior and informed consent, and Indigenous cultural and intellectual property. .

Keywords research, colonialism, sovereignty, free, prior and informed consent, ethics, Indigenous peoples .

Kwaymullina, A. (2016). "Research, Ethics and Indigenous Peoples: An Australian Indigenous perspective on three threshold considerations for respectful engagement." AlterNative: An International Journal of Indigenous Peoples 12(4): 437-449. Publisher: http://journals.sagepub.com/doi/abs/10.20507/AlterNative.2016.12.4.8#articleCitationDownloadContainer

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Research ethics committees in the Pacific Islands: gaps and opportunities for health sector strengthening (Papers: Justin T Denholm, et al | 2017)

Abstract There has been a range of developments in recent years to stimulate increasing public health research activity throughout the Pacific. Development of local capacity for ethics committee review and oversight is, however, frequently underdeveloped. This is reflected in the number of Pacific Island nations where... More

Abstract There has been a range of developments in recent years to stimulate increasing public health research activity throughout the Pacific. Development of local capacity for ethics committee review and oversight is, however, frequently underdeveloped. This is reflected in the number of Pacific Island nations where ethics committees have not been established or where only informal processes exist for ethics review and oversight. This is problematic for the optimal development of relevant and culturally appropriate research, and building up local ethics committees should be part of continued research development in the Pacific. Three areas in which local ethics committees may add value are 1) offering better capacity to reflect local priorities, 2) providing broader benefits for research capacity building, and 3) assisting to strengthen systems beyond research ethics. This article considers benefits and challenges for ethics committees in the Pacific, and suggests directions for regional development to further strengthen public health research activity. Keywords: research ethics, Pacific Islands, operational research, public health, ethics

J. T. Denholm, K. Bissell, K. Viney, A. M. Durand, H. L. Cash, C. Roseveare, O. E. Merilles, Jr., A. D. Harries and S. Biribo (2017) Research ethics committees in the Pacific Islands: gaps and opportunities for health sector strengthening. Public Health Action. 2017 Mar 21; 7(1): 6–9. Published online 2017 Mar 21. doi: 10.5588/pha.16.0076 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5526493/

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Europe’s biggest research fund cracks down on ‘ethics dumping’ – Nature (Linda Nordling | July 2018)

The practice of conducting ethically dubious research in foreign countries is under fresh scrutiny.

Ethics dumping — doing research deemed unethical in a scientist’s home country in a foreign setting with laxer ethical rules — will be rooted out in research funded by the... More

The practice of conducting ethically dubious research in foreign countries is under fresh scrutiny.

Ethics dumping — doing research deemed unethical in a scientist’s home country in a foreign setting with laxer ethical rules — will be rooted out in research funded by the European Union, officials announced last week. [colored_box]Applications to the EU’s €80-billion (US$93-billion) Horizon 2020 research fund will face fresh levels of scrutiny to make sure that research practices deemed unethical in Europe are not exported to other parts of the world. Wolfgang Burtscher, the European Commission’s deputy director-general for research, made the announcement at the European Parliament in Brussels on 29 June. . Burtscher said that a new code of conduct developed to curb ethics dumping will soon be applied to all EU-funded research projects. That means applicants will be referred to the code when they submit their proposals, and ethics committees will use the document when considering grant applications. .

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(Philippines) National Ethical Guidelines for Health and Health-Related Research (PHREB | 2017)

Prepared by the Philippine Health Research Ethics Board Ad Hoc Committee for Updating the National Ethical Guidelines

R E S O L U T I O N “RECOGNIZING DR.... More

Prepared by the Philippine Health Research Ethics Board Ad Hoc Committee for Updating the National Ethical Guidelines

R E S O L U T I O N “RECOGNIZING DR. MARITA V.T. REYES AND THE MEMBERS OF THE AD HOC COMMITTEE FOR THEIR EFFORTS ON THE REVISION OF THE NATIONAL ETHICAL GUIDELINES”

WHEREAS, the Ad Hoc Committee for the Updating of the National Ethical Guidelines was created to update the existing ethical guidelines to ensure adherence to local, national, and international principles and values and respect for Filipino morals and culture; WHEREAS, the Ad Hoc Committee for the Updating of the National Ethical Guidelines was created on 13 January 2015, with Dr. Marita V.T. Reyes as Chair and the following as members: Dr. Rosario Angeles T. Alora, Dr. Leonardo D. de Castro, Prof. Edlyn B. Jimenez, Dr. Ricardo M. Manalastas, Jr., Dr. Evangeline O. Santos, and Dr. Cecilia V. Tomas; WHEREAS the Ad Hoc Committee has completed its draft and the Philippine Health Research Ethics Board (PHREB) has approved the National Ethical Guidelines for Health and Health-Related Research 2017 (NEGHHR 2017);

Access the Filippino health research guidelines

Philippine Health Research Ethics Board (2017) National Ethical Guidelines for Health and Health Related Research. Manila: Department of Science and Technology - Philippine Council for Health Research and Development. http://www.ethics.healthresearch.ph/index.php/phoca-downloads/category/4-neg

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Indigenous Knowledge Systems and Practices (IKSPs) and Customary Laws (CLs) Research and Documentation Guidelines, Philippines (NCIP | 2012)

National Commission for Indigenous Peoples (NCIP) Administrative Order No. 1 Series of 2012

I. PRELIMINARY PROVISIONS Section 1. Title. This guideline shall be known as “The Indigenous Knowledge Systems and Practices (IKSPs) and Customary Laws... More

National Commission for Indigenous Peoples (NCIP) Administrative Order No. 1 Series of 2012

I. PRELIMINARY PROVISIONS Section 1. Title. This guideline shall be known as “The Indigenous Knowledge Systems and Practices (IKSPs) and Customary Laws (CLs) Research and Documentation Guidelines of 2012.

Section 2. Legal Bases. This Guidelines is hereby promulgated pursuant to the Constitution, Republic Act No. 8371 and other pertinent and applicable laws, international covenants, treaties and declarations.

Section 3. Policy Statement.

It is the policy of the Commission to:

a. Promote, protect and recognize the rights of Indigenous Cultural Communities/Indigenous Peoples (ICCs/IPs) to cultural integrity and to prescribe protection mechanisms at the international and national government levels and within the context of relevant customary laws;

b. Ensure and guarantee the due exercise by the concerned ICCs/IPs of their right to allow or reject, through free and prior informed consent (FPIC), research and documentation of their IKSPs and customary laws and their derivatives; and

c. Regulate the use of IKSPs and customary laws, and ensure that the ICCs/IPs benefit from the use of research output/outcome.

Read the rest of the Filipino guidelines

 

National Commission for Indigenous Peoples, Philippines (2012) The Indigenous Knowledge Systems and Practices (IKSPs) and Customary Laws (CLs) Research and Documentation Guidelines of 2012. NCIP Administrative Order No. 1 Series of 2012. http://www.wipo.int/edocs/lexdocs/laws/en/ph/ph190en.pdf

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The Lifespan of a Lie – Medium (Ben Blum | June 2018)

The most famous psychology study of all time was a sham. Why can’t we escape the Stanford Prison Experiment?

It was late in the evening of August 16th, 1971, and twenty-two-year-old Douglas Korpi, a slim, short-statured Berkeley graduate with a mop of pale, shaggy... More

The most famous psychology study of all time was a sham. Why can’t we escape the Stanford Prison Experiment?

It was late in the evening of August 16th, 1971, and twenty-two-year-old Douglas Korpi, a slim, short-statured Berkeley graduate with a mop of pale, shaggy hair, was locked in a dark closet in the basement of the Stanford psychology department, naked beneath a thin white smock bearing the number 8612, screaming his head off. [colored_box]“I mean, Jesus Christ, I’m burning up inside!” he yelled, kicking furiously at the door. “Don’t you know? I want to get out! This is all fucked up inside! I can’t stand another night! I just can’t take it anymore!” . It was a defining moment in what has become perhaps the best-known psychology study of all time. Whether you learned about Philip Zimbardo’s famous “Stanford Prison Experiment” in an introductory psych class or just absorbed it from the cultural ether, you’ve probably heard the basic story. .

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About the AHRECS patrons’ page

Published/Released on July 01, 2018 | Posted by Admin on July 1, 2018 | Keywords: , ,

[embed]https://youtu.be/RUX6aBJdgws[/embed] Exclusive human research ethics and research integrity resources (e.g. vignettes with facilitator notes) and events (e.g. online Q&A session with a panel of AHRECS consultants) from as little as USD 1 per month) - with a recommended approach for institutions that can't make payments via Paypal. Emails patrons@ahrecs.com to discuss.

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[embed]https://youtu.be/RUX6aBJdgws[/embed] Exclusive human research ethics and research integrity resources (e.g. vignettes with facilitator notes) and events (e.g. online Q&A session with a panel of AHRECS consultants) from as little as USD 1 per month) - with a recommended approach for institutions that can't make payments via Paypal. Emails patrons@ahrecs.com to discuss.

You can access the AHRECS patrons' page at - https://www.patreon.com/ahrecs

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AHRECS team news

Published/Released on June 30, 2018 | Posted by Admin on June 30, 2018 | Keywords: , ,

This is just a quick update on some changes to the AHRECS team. Assoc. Prof. Karen MartinMs Susanna Gorman and Dr Ian Pieper have joined the team. Our first intern is just about to start a 90 day internship with us, which is pretty exciting. Our old friend Assoc. Prof.... More

This is just a quick update on some changes to the AHRECS team. Assoc. Prof. Karen MartinMs Susanna Gorman and Dr Ian Pieper have joined the team. Our first intern is just about to start a 90 day internship with us, which is pretty exciting. Our old friend Assoc. Prof. Martin Tolich is moving onto his next exciting project. Martin played an important role in the conception and maturation of AHRECS so we wish him well and every success for his future endeavours. AHRECS will continue to work in New Zealand led by Dr Barry Smith. Less

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The Academy partners in €2.8 million project

The PRO-RES (PROmoting integrity in the use of RESearch results) project, coordinated by the European Science Foundation (ESF), France, aims at building a research ethics and integrity framework devised cooperatively with the full range of stakeholders. The Academy of Social Sciences (AcSS) is a partner in this €2.8 million... More

The PRO-RES (PROmoting integrity in the use of RESearch results) project, coordinated by the European Science Foundation (ESF), France, aims at building a research ethics and integrity framework devised cooperatively with the full range of stakeholders. The Academy of Social Sciences (AcSS) is a partner in this €2.8 million project along with 13 other European scientific institutions aiming to build an ethics/integrity framework for all non-medical research. [colored_box]This consortium of 14 scientific institutions from 10 countries will draw upon previous foundational work funded by the European Commission, and other national and international agencies: “…PRO-RES is to be as inclusive as possible when targeting the ‘non-medical’ sciences. The consortium partner composition is very diverse by design, ensuring that all relevant communities, to the extent possible, are represented.” says Dr. Jean-Claude Worms, Chief Executive of ESF, coordinator of PRO-RES. The project has received funding from the European Union’s Horizon 2020 research and innovation programme. . Fraud or corrupt practices by researchers can lead to serious damage to society and the physical environment. Reliable and transparent research, divorced from political ideology and undeclared vested interests, produces robust evidence that benefits social wellbeing and societal progress. .

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Time to Dismiss the Stanford Prison Experiment? – Inside Higher Ed (Greg Toppo | June 2018)

The 1971 Stanford Prison Experiment has long been considered a window into the horrors ordinary people can inflict on one another, but new interviews with participants and reconsideration of archival records shed more light on the findings

[colored_box]Since its inception nearly 47 years ago,... More

The 1971 Stanford Prison Experiment has long been considered a window into the horrors ordinary people can inflict on one another, but new interviews with participants and reconsideration of archival records shed more light on the findings

[colored_box]Since its inception nearly 47 years ago, the Stanford Prison Experiment has become a kind of grim psychological touchstone, an object lesson in humans' hidden ability to act sadistically -- or submissively -- as social conditions permit. . Along with Yale University researcher Stanley Milgram’s 1960s experiments on human cruelty, the August 1971 experiment has captured Americans’ imaginations for nearly half a century. It is a long-standing staple of psychology and social science textbooks and has been invoked to explain horrors as wide-ranging as the Holocaust, the My Lai massacre and the Abu Ghraib prisoner-torture scandal. . But new interviews with participants and reconsideration of archival records are shedding new light on the experiment, questioning a few of its bedrock assumptions about human behavior.

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NDA (Ireland) Ethical Guidance for Research with People with Disabilities (Guidance | 2009)

"As the field of disability research in Ireland expands, it is vital that quality in such research be ensured. In accordance with its statutory role in relation to disability research, the National Disability Authority offers new ethical guidelines for disability research as a resource to assist the expansion of quality... More

"As the field of disability research in Ireland expands, it is vital that quality in such research be ensured. In accordance with its statutory role in relation to disability research, the National Disability Authority offers new ethical guidelines for disability research as a resource to assist the expansion of quality disability research in Ireland. The guidelines have been drawn up through consideration of best practice internationally alongside a wide process of consultation, in particular consultation with people with disabilities. These guidelines are designed to be used by those involved in funding, conducting, or managing disability research, most especially that which involves people with disabilities as participants. They do not replace existing general ethical guidelines in social and policy research but supplement them by providing an outline of key issues from a disability perspective."

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TABLE OF CONTENTS 1. INTRODUCTION TO DISABILITY RESEARCH AND ETHICS 5 2. ETHICAL GUIDANCE ON RESEARCH WITH PEOPLE WITH DISABILITIES 11 3. CORE VALUES FOR RESEARCH WITH PEOPLE WITH DISABILITIES 17 4. GUIDANCE FOR GOOD PRACTICE IN RESEARCH WITH PEOPLE WITH DISABILITIES 23 5. CASE STUDIES 45 6 REFERENCES 55 APPENDIX 1 69 ENDNOTES 75   Less

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The Dying Scientist and his Rogue Vaccine Trial – Wired (Amanda Schaffer | May 2018)

Bill Halford was convinced he'd found a miracle cure, but he was running out of time to prove it. So he teamed up with a Hollywood executive and recruited a band of desperate patients. IN A PHOTO from 2009, Bill Halford, who was then 40 years old, looks like... More

Bill Halford was convinced he'd found a miracle cure, but he was running out of time to prove it. So he teamed up with a Hollywood executive and recruited a band of desperate patients. IN A PHOTO from 2009, Bill Halford, who was then 40 years old, looks like a schoolboy who hasn’t quite grown into his big ears. He wears an ill-fitting red shirt tucked into belted khakis; his jawline is square and his eyes are full of wonder. The picture was taken at Southern Illinois University, where he was a respected professor. A few years before, he had made a significant discovery—one that would determine the course of his life. Halford, a microbiologist, had taken an interest in the peculiar nature of herpes—how it lies dormant in the nervous system and reactivates to cause disease. Herpes is one of the most pervasive viral infections in the world, sometimes causing painful genital blisters, and it has frustrated scientists attempting to find a cure. But in 2007, Halford realized that a weakened form of the virus he’d been studying might serve as a vaccine. He designed an experiment in which he inoculated mice with this variant, then exposed them to the wild-type form of the virus. In 2011 he published the results: Virtually all the mice survived. By contrast, animals that were not injected with his vaccine died in large numbers. It was promising science. That same year, however, Halford became seriously ill. At first he thought he had a sinus infection, but it turned out to be a rare and aggressive form of cancer, sinonasal undifferentiated carcinoma. Halford was 42 years old at the time, with two teenage children. He underwent chemotherapy and radiation followed by surgery, but he was told that the form of cancer he had did not usually stay at bay for long. Halford had always been determined—“a 90-hours-a-week sort of researcher,” as his wife, Melanie Halford, puts it. The cancer diagnosis only seemed to harden his focus. Others had tried, and failed, to develop a herpes vaccine, but Halford was convinced that his method—using a live, attenuated form of the virus—would succeed. He would use whatever time he had left to show he was right.

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Building an Effective Research Safety Protocol and Emergency Exit Strategies – SSRC (Angelica Duran-Martinez | June 2014)

Social Science Research Council Papers DRUGS SECURITY AND DEMOCRACY PROGRAM DSD WORKING PAPERS ON RESEARCH SECURITY NO.4

This examination of strategies to minimize risks and identify dangerous situations for researchers in conflict and crime-ridden areas focuses on the design of... More

Social Science Research Council Papers DRUGS SECURITY AND DEMOCRACY PROGRAM DSD WORKING PAPERS ON RESEARCH SECURITY NO.4

This examination of strategies to minimize risks and identify dangerous situations for researchers in conflict and crime-ridden areas focuses on the design of a flexible safety and exit protocol that can help researchers return home safely. Safety depends on how scholars gain access to research locations, introduce their work to potential subjects, and pose questions to them. Naturally, defining what security is and determining levels of danger is a subjective and fluid process contingent on factors intrinsic to the project. The aim here is to help researchers think through security issues systematically and build a working written protocol to deal with emergency situations they may encounter. The discussion first addresses risk assessment and its role in building effective safety protocols. Risk assessment depends on variables such as research location, type and duration of research, and personal characteristics of the researcher. The second section examines the role of pre-fieldwork preparation in researcher safety, and the third analyzes the role of routine field safety procedures in maintaining awareness of evolving security threats and exit strategies. Ultimately, this examination seeks to go beyond how to conduct research safely, emphasizing instead how to increase the chances of the researcher’s safe return home. Thus, the fourth section builds on sound safety procedures to outline the basic elements of exit protocols that can help researchers and their supporters obtain or render aid under emergency circumstances. The conclusion presents a rubric for creating and thinking through safety before, during, and after field research. This guide is intended to help researchers think through crucial questions regarding risks and safety. They do not need to consider every issue mentioned here but should focus on those that appear more relevant to their projects. Scholars can define safety according to their own professional needs and develop exit protocols that can assist them in navigating both the ordinary fear and danger and the more extreme threats that affect their research locations...

Duran-Martinez, Angelica (2014) Building an Effective Research Safety Protocol and Emergency Exit Strategies. SSRC Paper. Publishers (Creative Commons): http://webarchive.ssrc.org/working-papers/DSD_ResearchSecurity_04_Duran-Martinez.pdf

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Security Considerations for Conducting Fieldwork In Highly Dangerous Places or on Highly Dangerous Subjects – SSRC (Vanda Felbab-Brown | June 2014)

Published/Released on June 07, 2014 | Posted by Admin on June 14, 2018 | Keywords: , , , , , , ,

DRUGS, SECURITY AND DEMOCRACY PROGRAM DSD WORKING PAPERS ON RESEARCH SECURITY: NO. 3

Over the last generation, activists, journalists, and researchers working in Latin America have increasingly faced the challenge of operating in areas affected by chronic police and non-state violence. Further, rising crime... More

DRUGS, SECURITY AND DEMOCRACY PROGRAM DSD WORKING PAPERS ON RESEARCH SECURITY: NO. 3

Over the last generation, activists, journalists, and researchers working in Latin America have increasingly faced the challenge of operating in areas affected by chronic police and non-state violence. Further, rising crime rates are leading a growing number of scholars to conduct research on high-risk topics, which involves gathering data on communities that experience conflict, writing and publishing on these difficult and sensitive issues, and developing and implementing programs to deal with the needs of communities affected by violence as well as the wider conflicts in which those communities are embedded. Despite these trends, the literature on safe practices for those working in high-risk environments remains thin. The DSD Working Papers on Research Security series seeks to address this deficit by examining a range of research security concerns, providing a framework to help those working in the region consider how they can enhance their own safety as well as the safety of their associates and research participants. The DSD Program is funded by the Open Society Foundations. The program is a partnership between OSF, the SSRC, Universidad de los Andes in Bogotá, Colombia, and Centro de Investigación y Docencia Económicas in Mexico.

Felab-Brown, V. (2014) Security considerations for conducting fieldwork in highly dangerous places or on highly dangerous subjects. DSD Working Papers on Research Security. SSRC Drugs, Security and Democracy Program. Creative Commons: http://webarchive.ssrc.org/working-papers/DSD_ResearchSecurity_03_Felbab-Brown.pdf

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‘How was Your Trip?’ Self-care for Researchers Working and Writing on Violence (Kimberly Theidon | 2014)

Published/Released on April 02, 2014 | Posted by Admin on June 12, 2018 | Keywords: , , , , , , ,

Social Science Research Council DRUGS, SECURITY AND DEMOCRACY PROGRAM | DSD WORKING PAPERS ON RESEARCH SECURITY: NO. 2

ABOUT THE PROGRAM The Drugs, Security and Democracy (DSD) Program strives to create a stronger, more systematized knowledge base on... More

Social Science Research Council DRUGS, SECURITY AND DEMOCRACY PROGRAM | DSD WORKING PAPERS ON RESEARCH SECURITY: NO. 2

ABOUT THE PROGRAM The Drugs, Security and Democracy (DSD) Program strives to create a stronger, more systematized knowledge base on drugs, security, and democracy in Latin America and the Caribbean; to build capacity—both institutional and individual—by supporting relevant research; and to encourage policy-relevant, evidence-based research that could lead to the development of alternatives to present-day drug policies. Support is provided for research across a variety of disciplines—anthropology, criminology, economics, history, international relations, journalism, legal studies, political science, public health, public policy, sociology, and other related fields—to create a network of scholars interested in developing alternative approaches to drug policy. ABOUT THE SERIES Over the last generation, activists, journalists, and researchers working in Latin America have increasingly faced the challenge of operating in areas affected by chronic police and non-state violence. Further, rising crime rates are leading a growing number of scholars to conduct research on high-risk topics, which involves gathering data on communities that experience conflict, writing and publishing on these difficult and sensitive issues, and developing and implementing programs to deal with the needs of communities affected by violence as well as the wider conflicts in which those communities are embedded. Despite these trends, the literature on safe practices for those working in high-risk environments remains thin. The DSD Working Papers on Research Security series seeks to address this deficit by examining a range of research security concerns, providing a framework to help those working in the region consider how they can enhance their own safety as well

Theidon, K. (2014) ‘How was Your Trip?’ Self-care for Researchers Working and Writing on Violence. Drugs Security and Democracy Program DSD Working Papers in Research Security. New York: Social Science Research Council

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Colin Thomson recognised in this week’s Queen’s Birthday Honours List

Published/Released on June 11, 2018 | Posted by Admin on June 11, 2018 | Keywords: , , , , ,

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Qualitative Research in Dangerous Places: Becoming an ”Ethnographer” of Violence and Personal Safety (Guidance: Social Science Research Council | 2016)

Social Science Research Council | Working Papers

"Over the last generation, activists, journalists, and researchers working in Latin America have increasingly faced the challenge of operating in areas affected by chronic police and non-state violence. Further, rising crime rates are leading a growing number... More

Social Science Research Council | Working Papers

"Over the last generation, activists, journalists, and researchers working in Latin America have increasingly faced the challenge of operating in areas affected by chronic police and non-state violence. Further, rising crime rates are leading a growing number of scholars to conduct research on high-risk topics, which involves gathering data on communities that experience conflict, writing and publishing on these difficult and sensitive issues, and developing and implementing programs to deal with the needs of communities affected by violence as well as the wider conflicts in which those communities are embedded. Despite these trends, the literature on safe practices for those working in high-risk environments remains thin. The DSD Working Papers on Research Security series seeks to address this deficit by examining a range of research security concerns, providing a framework to help those working in the region consider how they can enhance their own safety as well as the safety of their associates and research participants."

Goldstein, D. (2016) Qualitative Research in Dangerous Places: Becoming an ‘Ethnographer’ of Violence and Personal Safety. Brooklyn, NY: Social Science Research Council. Publisher (Open Access): http://webarchive.ssrc.org/working-papers/DSD_ResearchSecurity_01_Goldstein.pdf

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‘Silicon Valley is ethically lost’: Google grapples with reaction to its new ‘horrifying’ and uncanny AI tech – Financial Post (Mark Bergen | May 2018)

Published/Released on May 10, 2018 | Posted by Admin on June 8, 2018 | Keywords: , , , , , , , ,

The most talked-about, futuristic product from Google’s developer show isn’t even finished yet — and Google hasn’t agreed how to do it. [colored_box]At its I/O conference on Tuesday, Alphabet Inc.’s Google previewed Duplex, an experimental service that lets its voice-based digital assistant book appointments on its own. It was part... More

The most talked-about, futuristic product from Google’s developer show isn’t even finished yet — and Google hasn’t agreed how to do it. [colored_box]At its I/O conference on Tuesday, Alphabet Inc.’s Google previewed Duplex, an experimental service that lets its voice-based digital assistant book appointments on its own. It was part of a slate of features, such as automated writing in emails, where Google touted how its artificial intelligence technology saves people time and effort. In a demonstration on stage, the Google Assistant spoke with a hair salon receptionist, mimicking the “ums” and “hmms” pauses of human speech. In another demo, it chatted with a restaurant employee to book a table. The audience of software coders cheered. . Outside the Google technology bubble, critics pounced. The company is placing robots in conversations with humans, without those people realizing. The obvious question soon followed: Should AI software that’s smart enough to trick humans be forced to disclose itself. Google executives don’t have a clear answer yet. Duplex emerged at a sensitive time for technology companies, and the feature hasn’t helped alleviate questions about their growing power over data, automation software and the consequences for privacy and work. . .

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Why all randomised controlled trials produce biased results (Papers: Alexander Krauss | March 2018)

Abstract Background: Randomised controlled trials (RCTs) are commonly viewed as the best research method to inform public health and social policy. Usually they are thought of as providing the most rigorous evidence of a treatment’s effectiveness without strong assumptions, biases and limitations. Objective:... More

Abstract Background: Randomised controlled trials (RCTs) are commonly viewed as the best research method to inform public health and social policy. Usually they are thought of as providing the most rigorous evidence of a treatment’s effectiveness without strong assumptions, biases and limitations. Objective: This is the first study to examine that hypothesis by assessing the 10 most cited RCT studies worldwide. Data sources: These 10 RCT studies with the highest number of citations in any journal (up to June 2016) were identified by searching Scopus (the largest database of peer-reviewed journals). Results: This study shows that these world-leading RCTs that have influenced policy produce biased results by illustrating that participants’ background traits that affect outcomes are often poorly distributed between trial groups, that the trials often neglect alternative factors contributing to their main reported outcome and, among many other issues, that the trials are often only partially blinded or unblinded. The study here also identifies a number of novel and important assumptions, biases and limitations not yet thoroughly discussed in existing studies that arise when designing, implementing and analysing trials. Conclusions: Researchers and policymakers need to become better aware of the broader set of assumptions, biases and limitations in trials. Journals need to also begin requiring researchers to outline them in their studies. We need to furthermore better use RCTs together with other research methods. Key messages

  • RCTs face a range of strong assumptions, biases and limitations that have not yet all been thoroughly discussed in the literature.
  • This study assesses the 10 most cited RCTs worldwide and shows that trials inevitably produce bias.
  • Trials involve complex processes – from randomising, blinding and controlling, to implementing treatments, monitoring participants etc. – that require many decisions and steps at different levels that bring their own assumptions and degree of bias to results.
Keywords: Randomised controlled trial, RCT, reproducibility crisis, replication crisis, bias, statistical bias, evidence-based medicine, evidence-based practice, reproducibility of results, clinical medicine, research design

Krauss, A. (2018) Why all randomised controlled trials produce biased results. Annals of Medicine. 50:4, 312-322, DOI: 10.1080/07853890.2018.1453233 Publisher (Open Access): https://www.tandfonline.com/doi/full/10.1080/07853890.2018.1453233

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The Case of the Girl from La Noria: Implications for Ethics in Research with Human Remains – Etilmercurio (Por Invitado Especial | April 2018)

Published/Released on April 03, 2018 | Posted by Admin on June 5, 2018 | Keywords: , , , , , , , , ,

A recent article describing the whole-genome sequencing of a body of alleged «extraterrestrial» origin according to UFO organisations (1), journalists (2), and other media outlets (3), has initiated an important controversy regarding adherence to scientific, legal and ethical standards for studies involving human skeletal remains. This controversy began with... More

A recent article describing the whole-genome sequencing of a body of alleged «extraterrestrial» origin according to UFO organisations (1), journalists (2), and other media outlets (3), has initiated an important controversy regarding adherence to scientific, legal and ethical standards for studies involving human skeletal remains. This controversy began with the commentary published by Etilmercurio (4), which was followed by press reports (5,6,7), public statements released by local and international scientific organisations (8,9,10), the authors of the original article (11), and the journal where it was published (12). [colored_box]The basic issues raised by researchers questioning the article are clearly summarised in a tweet by Professor Tom Higham (School of Archaeology, University of Oxford, UK): «Accepting a human sample sent via TV film crew from a private owner in Spain; not seen or viewed by them - without any checks for provenance or permission, let alone ethical considerations... what were they thinking?». This is exactly what the authors (Nolan and Butte) claimed in their statement, as part of their argument disavowing responsibility, without acknowledging their lack of involvement as the root of the problem. . In their statement (11), the authors attempted to rebut these claims, identifying an earlier lack of criticism or legal action from the Chilean press and authorities when these remains originally became subject to public attention in 2013. Moreover, they declare to have followed U.S. regulations in this regard, completely ignoring Chilean law. .

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