ACN - 101321555 Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

In the news

Sort list by:


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.

Access the rest of this piece (Includes audio and transcript)

Less

View full details | Go to resource


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’).

Read the rest of this discussion piece

Less

View full details | Go to resource


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.

Read the rest of this discussion piece

Less

View full details | Go to resource


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.

Read the rest of this blog post

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

View full details | Go to resource #1, resource #2


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...

Read the rest of this discussion piece Subscription required

Less

View full details | Go to resource


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?

Read the rest of this discussion piece

  Less

View full details | Go to resource


(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.

Read the rest of this discussion piece

Less

View full details | Go to resource


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.

Read the rest of this discussion piece

Less

View full details | Go to resource


(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.

Read the rest of this discussion piece

Less

View full details | Go to resource


(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. .

Read the rest of this new story

Less

View full details | Go to resource


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.”

Read the rest of this discussion piece

Less

View full details | Go to resource


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.

Read the rest of this discussion piece

Less

View full details | Go to resource


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.

Read the rest of this discussion piece

Less

View full details | Go to resource


(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.

Read the rest of this news story

Less

View full details | Go to resource


(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.

Read the rest of this discussion piece

Less

View full details | Go to resource


Friday afternoon’s funny – Data Food Chain

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

View full details


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. .

Read the rest of this news story

Less

View full details | Go to resource


(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.

Read the rest of this discussion piece

Less

View full details | Go to resource


Friday afternoon’s funny – Participant betrayal

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

View full details


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.

Read the rest of this discussion piece

Less

View full details | Go to resource


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.

Read the rest of this news story

Less

View full details | Go to resource


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.

Read the rest of this interview

Less

View full details | Go to resource


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.

Read the rest of this news story

Less

View full details | Go to resource


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

View full details | Go to resource


Friday afternoon’s funny – Faster recruitment

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

View full details


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: , , , , , ,

View full details | Go to resource


‘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.”

Read the rest of this discussion piece

Less

View full details | Go to resource


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.

Read the rest of this discussion piece

Less

View full details | Go to resource


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.

Read the rest of this discussion piece

[colored_box] Less

View full details | Go to resource


(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. .

Read the rest of this discussion piece

Less

View full details | Go to resource


(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%).

Read the rest of this discussion piece

Less

View full details | Go to resource


(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.

Read the rest of this discussion piece

  Less

View full details | Go to resource


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.

Read the rest of this discussion piece

Less

View full details | Go to resource


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

View full details | Go to resource


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.

Read the rest of this discussion piece

Less

View full details | Go to resource


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. .

Read the rest of this discussion piece

Less

View full details | Go to resource


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. .

Read the rest of this discussion piece

Less

View full details | Go to resource


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.

Read the rest of this discussion piece

Less

View full details | Go to resource


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: , , , , , , , , ,

View full details | Go to resource


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

View full details | Go to resource


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

Access the page | Download/stream the audio | Access the transcript

Less

View full details | Go to resource


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.

Read the rest of this discussion piece

Less

View full details | Go to resource


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.| .

Read the rest of this discussion piece

  Less

View full details | Go to resource


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.

Read the rest of this discussion piece

Less

View full details | Go to resource


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.

Read the rest of this discussion piece

Less

View full details | Go to resource


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

View full details | Go to resource


(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. .

Read the rest of this discussion piece

Less

View full details | Go to resource


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. .

Read the rest of this discussion piece

Less

View full details | Go to resource


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.\

Read the rest of this discussion piece

Less

View full details | Go to resource


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.”

Read the rest of this discussion piece

Less

View full details | Go to resource



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.

Read the rest of this discussion piece

Less

View full details | Go to resource


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.

Read the rest of this discussion piece

Less

View full details | Go to resource


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.

Read the rest of this discussion piece

Less

View full details | Go to resource


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.

Read the rest of this discussion piece

Less

View full details | Go to resource


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

View full details | Go to resource


(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. .

Read the rest of this discussion piece

Less

View full details | Go to resource


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? .

Read the rest of this discussion piece

Less

View full details | Go to resource


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: , , , , , ,

View full details | Go to resource


(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: , , , ,

View full details


Ethics & Human Research (E&HR)

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

View full details | Go to resource #1, resource #2


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

View full details | Go to resource


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.” .

Read the rest of this news item

Less

View full details | Go to resource


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.”.

Read the rest of this discussion piece

Less

View full details | Go to resource


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

View full details


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.

Read the rest of this discussion piece

  Less

View full details | Go to resource


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.

Read the rest of this discussion piece

Less

View full details | Go to resource


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).

Read the rest of this discussion piece

Less

View full details | Go to resource


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

View full details | Go to resource


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.

Read the rest of this discussion piece

Less

View full details | Go to resource


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

View full details


(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.”

Read the rest of this discussion piece

Less

View full details | Go to resource


(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 .

Read the rest of this discussion piece

Less

View full details | Go to resource


(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.

Read the rest of this discussion piece About the lawyer Alan C. Milstein

Less

View full details | Go to resource #1, resource #2


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.

Read the rest of this discussion piece

Less

View full details | Go to resource


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: , , , , , ,

More

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.

Read the rest of this discussion piece

Less

View full details | Go to resource


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. .

Read the rest of this discussion piece

Less

View full details | Go to resource


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.” .

Read the rest of this discussion piece

Less

View full details | Go to resource


(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. .

Read the rest of this discussion piece

Less

View full details | Go to resource


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.

Read the rest of this discussion piece

Less

View full details | Go to resource


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). .

Read the rest of this discussion piece

Less

View full details | Go to resource


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. .

Read the rest of this discussion piece

Less

View full details | Go to resource


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”. .

Read the rest of this discussion piece

Less

View full details | Go to resource


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.

Read the rest of this discussion piece

Less

View full details | Go to resource


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. .

Read the rest of this discussion piece

Less

View full details | Go to resource


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. .

Read the rest of this discussion piece

Less

View full details | Go to resource


(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. .

Read the rest of this discussion piece

Less

View full details | Go to resource


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

View full details | Go to resource


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. .

Read the rest of this discussion piece

Less

View full details | Go to resource


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.  

Read the rest of this discussion piece

Less

View full details | Go to resource


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. .

Read the rest of this statement

Less

View full details | Download file


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. .

Read the rest of this discussion piece

Less

View full details | Go to resource


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. .

Read the rest of this discussion piece

Less

View full details | Go to resource


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. .

Read the rest of this discussion piece

Less

View full details | Go to resource


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. .

Read the rest of this discussion piece  

Less

View full details | Go to resource


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.

More

[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

Less

View full details | Go to resource


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

View full details


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. .

Read the rest of this announcement

Less

View full details | Go to resource


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.

Read the rest of this discussion piece

Less

View full details | Go to resource


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.

Read the rest of this discussion piece

Less

View full details | Go to resource


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: , , , , ,

View full details


‘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. . .

Read the rest of this discussion piece

Less

View full details


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. .

Read the rest of this discussion piece

Less

View full details | Go to resource


(US) ‘Right-to-try’ bill passes Congress – CNN (Michael Nedelman and Jacqueline Howard | May 2018)

Published/Released on May 29, 2018 | Posted by Admin on June 3, 2018 | Keywords: , , , , , , ,

With a House of Representatives vote Tuesday, Congress passed legislation that could give terminally ill patients a way to independently seek drugs that are still experimental and not fully approved by the US Food and Drug Administration. [colored_box]The House voted 250-169 in favor of the bill, More

With a House of Representatives vote Tuesday, Congress passed legislation that could give terminally ill patients a way to independently seek drugs that are still experimental and not fully approved by the US Food and Drug Administration. [colored_box]The House voted 250-169 in favor of the bill, which the Senate passed in August. The bill will now be sent to President Trump, who is expected to sign it. . "This is an extraordinarily great day," Democratic Sen. Joe Donnelly of Indiana, one of the original cosponsors of the bill, said in a press conference after the event. Donnelly said he met with Vice President Mike Pence a few weeks ago and urged him to push for a House vote on the bill. .

Read the rest of this news  story

Less

View full details | Go to resource


The Lose-Lose Ethics of Testing Self-Driving Cars in Public – Wired (Aarian Marshall | May 2018)

Published/Released on May 23, 2018 | Posted by Admin on May 30, 2018 | Keywords: , , ,

View full details | Go to resource


Facebook’s New Data Restrictions Will Handcuff Even Honest Researchers – Wired (Robbie Gonzalez | March 2018)

Published/Released on March 22, 2018 | Posted by Admin on May 24, 2018 | Keywords: , , , , , ,

LAST WEEK, WHEN news broke (again) that Cambridge Analytica had allegedly misused 50 million Facebook users' data, it immediately raised a difficult question: When a company possesses information about some 2 billion people, is its chief obligation to More

LAST WEEK, WHEN news broke (again) that Cambridge Analytica had allegedly misused 50 million Facebook users' data, it immediately raised a difficult question: When a company possesses information about some 2 billion people, is its chief obligation to share that information, or protect it? [colored_box]The answer's not as obvious as you might think. To social and computer scientists, Facebook is arguably the most valuable data repository on earth. Insight into many of the most pressing issues of our time, from social media's role in political processes to technology's impact on individual wellbeing, could well reside on the social network's servers—a fact that has led many scientists and policymakers to call for more permeable borders between public researchers and Facebook's private data hoard. . But then Cambridge Analytica happened, and gave a lot of researchers a scare: Tapping into Facebook's data is already more onerous than many of them would like. How would the company's reaction to one of its most devastating public disasters to date affect their access going forward? .

Read the rest of this discussion piece

Less

View full details | Go to resource


PRO-RES PROJECT

Published/Released on May 24, 2018 | Posted by Admin on May 23, 2018 | Keywords: , , , ,

AHRECS is delighted to have three of its senior consultants, Mark Israel, Gary Allen and Colin Thomson form part of the UK Academy of the Social Sciences team in an ambitious €2.8 million project involving 13 European scientific institutions. The PRO-RES project, coordinated by the European Science Foundation,... More

AHRECS is delighted to have three of its senior consultants, Mark Israel, Gary Allen and Colin Thomson form part of the UK Academy of the Social Sciences team in an ambitious €2.8 million project involving 13 European scientific institutions. The PRO-RES project, coordinated by the European Science Foundation, is aiming to build a research ethics and integrity framework, covering all non-medical research fields. It seeks the same reach that the Oviedo and Helsinki frameworks have in the medical field. Less

View full details


(UK) ‘Unethical not to’ submit Brexit interviews to MPs, says academic – THE (John Morgan | April 2018)

Emma Briant defends actions over exchanges with key figures from Leave.EU and Cambridge Analytica parent

An academic who submitted to a UK parliamentary inquiry interviews with key figures from Leave.EU and Cambridge Analytica’s parent company – raising questions about how voters were targeted in the... More

Emma Briant defends actions over exchanges with key figures from Leave.EU and Cambridge Analytica parent

An academic who submitted to a UK parliamentary inquiry interviews with key figures from Leave.EU and Cambridge Analytica’s parent company – raising questions about how voters were targeted in the European Union referendum – says that it would have been “unethical” not to do so. [colored_box]Emma Briant, senior lecturer in journalism at the University of Essex, submitted essays and audio files of interviews to the UK’s Electoral Commission, Information Commissioner’s Office and Parliament’s Digital, Culture, Media and Sport committee. The DCMS committee published Dr Briant’s material on 16 April as part of its inquiry into “fake news”. . Dr Briant has since faced suggestions that her decision to hand over the material raises questions about research ethics, particularly in the context of the Economic and Social Research Council's principles of ethical research, given that those interviewed agreed to contribute to an academic research project. .

Read the rest of this discussion piece

Less

View full details | Go to resource


What factors do scientists perceive as promoting or hindering scientific data reuse? – LSE Impact Blog (Renata Gonçalves Curty, et al | March 2018)

Published/Released on March 20, 2018 | Posted by Admin on May 17, 2018 | Keywords: , , , , , , , , , ,

Increased calls for data sharing have formed part of many governments’ agendas to boost innovation and scientific development. Data openness for reuse also resonates with the recognised need for more transparent, reproducible science. But what are scientists’ perceptions about data reuse? Renata Gonçalves Curty, Kevin Crowston, Alison Specht, Bruce... More

Increased calls for data sharing have formed part of many governments’ agendas to boost innovation and scientific development. Data openness for reuse also resonates with the recognised need for more transparent, reproducible science. But what are scientists’ perceptions about data reuse? Renata Gonçalves Curty, Kevin Crowston, Alison Specht, Bruce W. Grant and Elizabeth D. Dalton make use of existing survey data to analyse the attitudes and norms affecting scientists’ data reuse. Perceived efficiency, efficacy, and trustworthiness are key; as is whether scientists believe data reuse is beneficial for scientific development, or perceive certain pressures contrary to the reuse of data. Looking ahead, synthesis centres can be important for supporting data-driven interdisciplinary collaborations, and leveraging new scientific discoveries based on pre-existing data. [colored_box]“If I have seen further, it was by standing upon the shoulders of giants.” This quote, attributed to Sir Isaac Newton, expresses the cumulative and synergistic nature of the growth of science. Intellectual progress and major scientific achievements are built upon the contributions of previous thinkers and discoveries. Thus the scientific enterprise thrives upon openness and collaboration. . The unrestricted sharing of research outputs is increasingly seen as critical for scientific progress. The calls for data sharing in particular, aligned with investment in infrastructures for housing research data, have been part of many governments’ agendas to boost innovation and scientific development, while optimising resources. The ability of researchers to access and build upon previous knowledge has thus evolved from elementary access to final published manuscripts and research reports, to the capability of accessing different outputs produced throughout the research lifecycle, including digital data files. . There have been a number of promising developments in funding bodies’ policies promoting and requesting compliance with data sharing requirements to ensure preservation and access to scientific data for further reuse. In the US, the Data Observation Network for Earth (DataONE), supported by the National Science Foundation (NSF), is committed to broadening education on data-related issues (e.g. data documentation, data citation), as well as to provide standards/guidelines and sustainable cyberinfrastructure to secure openness, persistence, robustness, findability, and accessibility to environmental science data

Read the rest of this discussion piece

Less

View full details


(US) FDA Launches Criminal Investigation Into Unauthorized Herpes Vaccine Research – KHN (Marisa Taylor | April 2018)

The Food and Drug Administration has launched a criminal investigation into research by a Southern Illinois University professor who injected people with his unauthorized herpes vaccine, Kaiser Health News has learned. SIU professor William Halford, who died in June, injected participants with his experimental herpes vaccine in... More

The Food and Drug Administration has launched a criminal investigation into research by a Southern Illinois University professor who injected people with his unauthorized herpes vaccine, Kaiser Health News has learned. SIU professor William Halford, who died in June, injected participants 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 FDA or an institutional review board. According to four people with knowledge about the inquiry, the FDA’s Office of Criminal Investigations is looking into whether anyone from SIU or Halford’s former company, Rational Vaccines, violated FDA regulations by helping Halford conduct unauthorized research. The probe is also looking at anyone else outside the company or university who might have been complicit, according to the sources who asked not to be identified because of the sensitivity of the matter.

Less

View full details | Go to resource


Canada sued over years of alleged experimentation on indigenous people – The Guardian (Ashifa Kassam | May 2018)

Class-action suit filed on behalf of thousands of people allegedly subjected to medical tests without consent in the mid-20th century

A class action lawsuit has been filed in a Canadian court on behalf of the thousands of indigenous people alleged to have... More

Class-action suit filed on behalf of thousands of people allegedly subjected to medical tests without consent in the mid-20th century

A class action lawsuit has been filed in a Canadian court on behalf of the thousands of indigenous people alleged to have been unwittingly subjected to medical experiments without their consent. [colored_box]Filed this month in a courtroom in the province of Saskatchewan, the lawsuit holds the federal government responsible for experiments allegedly carried out on reserves and in residential schools between the 1930s and 1950s. . The suit also accuses the Canadian government of a long history of “discriminatory and inadequate medical care” at Indian hospitals and sanatoriums – key components of a segregated healthcare system that operated across the country from 1945 into the early 1980s. . “This strikes me as so atrocious that there ought to be punitive and exemplary damages awarded, in addition to compensation,” said Tony Merchant, whose Merchant Law Group filed the class action. .

Read the rest of this discussion piece

Less

View full details | Go to resource


(Queensland, Australian case) Fishy research opens a can of worms – THE (John Ross | March 2018)

Published/Released on March 20, 2018 | Posted by Admin on May 12, 2018 | Keywords: , , , , , , , , ,

An expanding research misconduct investigation has stretched its net from the chilly Baltic to an idyllic Queensland island and the grasslands of Saskatchewan

It is the hedgehog of the reef: a tropical fish whose quill-like fin spines inflict a painful sting. Now the zebra lionfish... More

An expanding research misconduct investigation has stretched its net from the chilly Baltic to an idyllic Queensland island and the grasslands of Saskatchewan

It is the hedgehog of the reef: a tropical fish whose quill-like fin spines inflict a painful sting. Now the zebra lionfish has become embroiled in an expanding research misconduct investigation that stretches from a Queensland island to the chilly Baltic and the grasslands of Saskatchewan. The journal Biology Letters has issued an expression of concern about a 2014 research paper that claimed that the colourful creatures hunted cooperatively with each other and with other lionfish species – behaviour previously documented among marine mammals such as killer whales and bottlenose dolphins but never demonstrated in fish. “It has been brought to the attention of the editorial team that there are concerns regarding the validity of data used in the study,” the journal notice says.

Read the rest of this discussion piece

  Less

View full details | Go to resource


How We Found Sources for Our Research Misconduct Story — And How You Can Help Us Find More – ProPublica Illinois (Jodi S. Cohen | April 2018)

View full details | Go to resource


Scientific misconduct at an elite medical institute: The role of competing institutional logics and fragmented control (Papers: Christian Berggren and Solmaz Filiz Karabag | April 2018)

Abstract The incidence of revealed fraud and dishonesty in academia is on the rise, and so is the number of studies seeking to explain scientific misconduct. This paper builds on the concepts of competing logics and institutional fields to analyze a serious case of medical and... More

Abstract The incidence of revealed fraud and dishonesty in academia is on the rise, and so is the number of studies seeking to explain scientific misconduct. This paper builds on the concepts of competing logics and institutional fields to analyze a serious case of medical and scientific misconduct at a leading research institute, Karolinska in Sweden, home to the Nobel Prize in Medicine. [colored_box]By distinguishing between a market-oriented, a medical and an academic logic, the study analyzes how various actors − executives, research leaders, co-authors, journal editors, medical doctors, science bloggers, investigative journalists and documentary filmmakers − sustained or tried to expose the misconduct. Despite repeated warnings from patient-responsible doctors and external academic reviewers, Karolinska protected the surgeon, Paolo Macchiarini, until a documentary film at the Swedish national public TV exposed the fraud which led to public inquiries and proposals for a new national ethics legislation. . The analysis illustrates the power of a market-oriented logic focused on brand and image at the research institute and at a leading journal, but also the perseverance of the logics of scientific scrutiny and medical care among practicing doctors and independent academics although the carriers of these logics were less well organized than the carriers of the market-oriented logic. Furthermore, the analysis shows the problem of fragmented control in the academic institutional field. The discussion of remedies compares the Karolinska case, where media actors were instrumental in sanctioning the perpetrators, with a similar instance of medical misconduct at Duke in the US where the government agency (ORI) intervened and shows the limitations of both types of actors. The conclusion highlights the importance of studying misconduct management and institution-building in different fields to develop effective remedies. . Keywords Institutional logics, Institutional actors, Scientific misconduct, Retraction, Academic dishonesty, Fragmented control. .

Berggren, C. and S. F. Karabag (2018). "Scientific misconduct at an elite medical institute: The role of competing institutional logics and fragmented control." Research Policy. Publisher: https://www.sciencedirect.com/science/article/pii/S0048733318300817

Less

View full details | Go to resource


(US) Boston University rejects geologist David Marchant’s appeal of termination – Science (Meredith Wadman | February 2018)

Boston University (BU) has denied geologist David Marchant’s appeal of its decision to terminate him, the Massachusetts-based institution announced yesterday. Late last year, the university moved to fire Marchant after an investigation concluded that he sexually harassed a graduate student during fieldwork in Antarctica nearly 2 decades ago. [colored_box]Marchant has not... More

Boston University (BU) has denied geologist David Marchant’s appeal of its decision to terminate him, the Massachusetts-based institution announced yesterday. Late last year, the university moved to fire Marchant after an investigation concluded that he sexually harassed a graduate student during fieldwork in Antarctica nearly 2 decades ago. [colored_box]Marchant has not yet exhausted all options in attempting to save his job. Marchant “has the right to have a faculty committee determine whether termination is the appropriate sanction, and the timing of the initiation of that committee’s work is being determined,” BU spokesperson Colin Riley wrote in a 27 February email. Riley said that Marchant remains on paid administrative leave. He declined to identify who at the university denied the appeal, or when and on what grounds the decision was made.

Read the rest of this news story

Less

View full details | Go to resource


Chileans Criticize US Scientists Over Treatment of Ata the “Alien” Mummy – Futurism (Kristin Houser | March 2018)

Published/Released on March 29, 2018 | Posted by Admin on April 26, 2018 | Keywords: , , , , , , ,

It looks like an alien, but its story is much stranger. And now it’s causing an international incident. [colored_box]Chilean scientists and government officials are protesting a study published in the journal Genome Research on March 22. It’s not the study’s conclusions or science they take issue with,... More

It looks like an alien, but its story is much stranger. And now it’s causing an international incident. [colored_box]Chilean scientists and government officials are protesting a study published in the journal Genome Research on March 22. It’s not the study’s conclusions or science they take issue with, though. It’s the study’s subject: the body of a mummified Chilean girl. . Alien enthusiasts are pretty obsessed with Ata, a 6-inch-long skeleton that was discovered in 2003. Oscar Munoz found the tiny mummy in a leather pouch in a Chilean ghost town near the Atacama Desert (hence its name), and soon after, rumors began swirling as to Ata’s origin. . Ata had a conical head shape and large eye sockets that looked straight out of a sci-fi film. The mummy was barely the length of a 19-week-old human fetus, but had bones as mature as those of a six-year-old. It also had hard teeth and only 10 pairs of ribs while humans have 12.  

Read the rest of this discussion piece

Less

View full details | Go to resource


Cambridge University rejected Facebook study over ‘deceptive’ privacy standards – The Guardian (Matthew Weaver | April 2018)

Exclusive: panel told researcher Aleksandr Kogan that Facebook’s approach fell ‘far below ethical expectations’ A Cambridge University ethics panel rejected research by the academic at the centre of the Facebook data harvesting scandal over the social network’s “deceptive” approach to its users privacy, newly released documents... More

Exclusive: panel told researcher Aleksandr Kogan that Facebook’s approach fell ‘far below ethical expectations’ A Cambridge University ethics panel rejected research by the academic at the centre of the Facebook data harvesting scandal over the social network’s “deceptive” approach to its users privacy, newly released documents reveal. [colored_box]A 2015 proposal by Aleksandr Kogan, a member of the university’s psychology department, involved the personal data from 250,000 Facebook users and their 54 million friends that he had already gleaned via a personality quiz app in a commercial project funded by SCL, the parent company of Cambridge Analytica. Separately, Kogan proposed an academic investigation on how Facebook likes are linked to “personality traits, socioeconomic status and physical environments”, according to an ethics application about the project released to the Guardian in response to a freedom of information request. . The documents shed new light on suggestions from the Facebook CEO, Mark Zuckerberg, that the university’s controls on research did not meet Facebook’s own standards. In testimony to the US Congress earlier this month, Zuckerberg said he was concerned over Cambridge’s approach, telling a hearing: “What we do need to understand is whether there is something bad going on at Cambridge University overall, that will require a stronger action from us.” .

Read the rest of this news story

Less

View full details | Go to resource


Tool ‘names and shames’ hidden drug trials – BBC (Chris Foxx | February 2018)

Institutions that fail to report the results of their drug and medical trials will be named on a new website.

[colored_box]Trials Tracker logs which clinical trials have missed deadlines for reporting their results in the US. . Some pharmaceutical organisations have been accused of... More

Institutions that fail to report the results of their drug and medical trials will be named on a new website.

[colored_box]Trials Tracker logs which clinical trials have missed deadlines for reporting their results in the US. . Some pharmaceutical organisations have been accused of burying unfavourable drug and medical test results. . Dr Ben Goldacre, who devised the website, told the BBC he hoped it would "nudge" institutions into properly disclosing data. . Dr Ben Goldacre, who devised the website, told the BBC he hoped it would "nudge" institutions into properly disclosing data. . "For many years, trials transparency has been neglected," he said. . "I'm not interested in naming and shaming people in order to criticise them. This project is being done to nudge institutions to prioritise trial reporting.

Read the rest of this discussion piece

Less

View full details | Go to resource


Facebook Says It Will Help Academics Use Its Data. Here’s How That’s Supposed to Work – The Chronicle of Higher Education (Nell Gluckman | April 2018)

Published/Released on April 13, 2018 | Posted by Admin on April 19, 2018 | Keywords: , , , ,

There has never been a time when so much data existed about human behavior. What many of us buy, sell, like, dislike, read, and tell our friends is recorded on the internet thanks to sites like Facebook. To social scientists, the company is sitting on a gold mine. Some of... More

There has never been a time when so much data existed about human behavior. What many of us buy, sell, like, dislike, read, and tell our friends is recorded on the internet thanks to sites like Facebook. To social scientists, the company is sitting on a gold mine. Some of that information is public, but much is not, and the company’s reach is so vast most people don’t know how far it extends. Several research projects that use Facebook data have ended as high-profile privacy-breach scandals in part because subjects didn’t know they were being studied. In the most recent and possibly the largest data breach at the company, an academic harvested information about millions of Facebook users and shared it with Cambridge Analytica, a firm that advised the Trump campaign. One might think that in the wake of that scandal, Facebook would lock academics out. That’s what Gary King, a political scientist at Harvard University who has pitched Facebook about opening up its data for research, expected. He met with Facebook officials right before the Cambridge Analytica news broke and, to his surprise, he got a call a few days later. They wanted him to study the company’s impact on elections.

Read the rest of this discussion piece

Less

View full details | Go to resource


A real-life Lord of the Flies: the troubling legacy of the Robbers Cave experiment – The Guardian (David Shariatmadari | April 2017)

In the early 1950s, the psychologist Muzafer Sherif brought together a group of boys at a US summer camp – and tried to make them fight each other. Does his work teach us anything about our age of resurgent tribalism? More

In the early 1950s, the psychologist Muzafer Sherif brought together a group of boys at a US summer camp – and tried to make them fight each other. Does his work teach us anything about our age of resurgent tribalism? ......Read an extract from The Lost Boys

July 1953: late one evening in the woods outside Middle Grove, New York state, three men are having a furious argument. One of them, drunk, draws back his fist, ready to smash it into his opponent’s face. Seeing what is about to happen, the third grabs a block of wood from a nearby pile. “Dr Sherif! If you do it, I’m gonna hit you,” he shouts. [colored_box]The man with the raised fist isn’t just anybody. He is one of the world’s foremost social psychologists, Muzafer Sherif. The two others are his research assistants. Sherif is angry because the experiment he has spent months preparing for has just fallen apart. . Born in the summer of 1905 and raised in İzmir province, Turkey, during the dying days of the Ottoman empire, Sherif won a place at Harvard to study psychology. But he found himself frustrated by the narrowness of the discipline, which mainly involved tedious observation of lab rats. He was drawn instead to the emerging field of social psychology, which looks at the way human behaviour is influenced by others. In particular, he became obsessed by group dynamics: how individuals band together to form cohesive units and how these units can find themselves at each other’s throats. .

Read the rest of this discussion piece

Less

View full details | Go to resource


‘Cult’ Universal medicine practices promoted by researchers, UQ launches investigation – ABC News (Josh Robertson | Apr 2017)

Researchers who promoted an alleged cult and showcased its bizarre healing claims in published studies have embroiled one of Australia's top universities in an academic misconduct probe. The University of Queensland (UQ) and two international medical journals are investigating alleged ethical violations in research around Universal Medicine (UM), an organisation... More

Researchers who promoted an alleged cult and showcased its bizarre healing claims in published studies have embroiled one of Australia's top universities in an academic misconduct probe. The University of Queensland (UQ) and two international medical journals are investigating alleged ethical violations in research around Universal Medicine (UM), an organisation based in Lismore in New South Wales, which touts the healing power of "esoteric breast massage" and other unproven treatments. Founded by Serge Benhayon — a former bankrupt tennis coach with no medical qualifications who claims to be the reincarnation of Leonardo Da Vinci — UM is a multi-million-dollar enterprise with 700 mostly female followers in 15 countries.

Read the rest of this news story

Less

View full details | Go to resource


3 Strategies for Accountable, Ethical Online Behavior Research – Medium (J. Nathan Matias | November 2017)

Published/Released on November 03, 2017 | Posted by Admin on April 13, 2018 | Keywords: , , , , , ,

Help CivilServant develop ways to inform people about their participation in online research and hold us accountable

In 2014, after researchers worked with Facebook to test the effect of newsfeed adjustments on the emotional tone of people’s future posts, academics took a closer look... More

Help CivilServant develop ways to inform people about their participation in online research and hold us accountable

In 2014, after researchers worked with Facebook to test the effect of newsfeed adjustments on the emotional tone of people’s future posts, academics took a closer look at the ethics of online behavioral research, in the midst of a wider public debate over the power of online platforms in society. [colored_box]Two ideas were central to these conversations: consent and debriefing. In consent-based models of research, people are asked in advance if they are willing to participate in the study. Individual consent often works best under controlled, lab-style studies or surveys and interviews, where it’s easy to decide which people are part of a study and which people aren’t. Debriefing is a process where people are told after the study. Debriefing is also a way to identify any unexpected, harmful effects that the researchers weren’t looking out for, so the harms can be addressed. . In field research, which tests ideas out in the world, individual consent and debriefing can be hard to acquire. For example, consider this study that tested the effect of lawn signs on voter participation rates. It wouldn’t be possible to obtain the advance consent of every single driver who passed by the signs; it would be impossible to predict exactly who would drive by. Even if you could obtain consent, you wouldn’t be able to show or hide the sign for people who hadn’t consented to the study. Likewise with debriefing: a researcher might be able to place a camera next to every sign in order to figure out the license plate, identity, and address of everyone who passed by, but in the effort to contact everyone in the study about ethics, the ethics procedure might become more risky and intrusive than the original study.

Read the rest of this guidance piece

Less

View full details | Go to resource


Dark past of deep-brain stimulation – Nature (Christian Lüscher | March 2018)

Christian Lüscher considers an alarming career from the early days of psychiatry.

Many people consider deep-brain stimulation (DBS) to have begun in 1987 in Grenoble, France, when Pierre Pollak and Alim Benabid stopped a person’s tremor by delivering high-frequency pulses of electricity to her... More

Christian Lüscher considers an alarming career from the early days of psychiatry.

Many people consider deep-brain stimulation (DBS) to have begun in 1987 in Grenoble, France, when Pierre Pollak and Alim Benabid stopped a person’s tremor by delivering high-frequency pulses of electricity to her thalamus. In fact, more than three decades earlier, a psychiatrist called Robert G. Heath at Tulane University in New Orleans, Louisiana, had experimented with this approach. Now, science writer Lone Frank pulls Heath (1915–99) from obscurity for her exploration of DBS, The Pleasure Shock. [colored_box]Frank has traced and interviewed surviving patients, former collaborators, family members and current DBS scientists. The result is a rarity: a thrilling, well-researched read. Above all, it is a chilling reminder of how early neurosurgical experimentation knew few ethical boundaries — even firmly within the medical and academic establishment. Heath was chair of Tulane’s psychiatry and neurology department for 31 years, from 1949 to 1980. . Today, DBS is an approved treatment for Parkinson’s disease, dystonia (uncontrollable muscle contractions) and essential tremor. Other indications, such as therapy for obsessive–compulsive disorder, depression and addiction, are the focus of intensive research. Just a few patients are treated ‘off label’, with mixed results. .

Read the rest of this discussion piece

Less

View full details | Go to resource


Call for Papers: Complex ethical issues and consent to research in LMICs

Published/Released on March 31, 2018 | Posted by Admin on March 31, 2018 | Keywords: , , , , ,

View full details


Cambridge Analytica controversy must spur researchers to update data ethics – Nature (Editorial | March 2018)

Published/Released on March 27, 2018 | Posted by Admin on March 30, 2018 | Keywords: , , , , , , , , ,

A scandal over an academic’s use of Facebook data highlights the need for research scrutiny.

Revelations keep emerging in the Cambridge Analytica personal-data scandal, which has captured global public attention for more than a week. But when the dust settles, researchers harvesting data online... More

A scandal over an academic’s use of Facebook data highlights the need for research scrutiny.

Revelations keep emerging in the Cambridge Analytica personal-data scandal, which has captured global public attention for more than a week. But when the dust settles, researchers harvesting data online will face greater scrutiny. And so they should. At the centre of the controversy is Aleksandr Kogan, a psychologist and neuroscientist at the University of Cambridge, UK. In 2014, he recruited people to complete a number of surveys and sign up to an app that handed over Facebook information on themselves — and tens of millions of Facebook friends. Kogan passed the data to SCL, a UK firm that later founded controversial political-consultancy firm Cambridge Analytica in London. (All those involved deny any wrongdoing.) Last week, Facebook announced restrictions on data harvesting by third parties, including drastically reducing the kinds of information that app developers can access. (It had already changed its rules in 2014 to stop developers gleaning data from users’ friends through their apps.) But damage has been done: the public has good reason to be angry about the way in which researchers and companies have seemingly used personal data without consumers’ full understanding or consent.

Read the rest of this discussion piece

  Less

View full details | Go to resource


What is ‘Necessary Training’ In Health-Related Research Ethics? – EthoxBlog (Kristine Bærøe | June 2017)

A couple of months ago a new Research Ethics Act was implemented in Norway. The rationale for replacing the preceding regulation was to strengthen legal responsibilities of researchers and institutions for promoting acceptable research [1]. According to the new regulation, researchers are held legally responsible for ensuring that they... More

A couple of months ago a new Research Ethics Act was implemented in Norway. The rationale for replacing the preceding regulation was to strengthen legal responsibilities of researchers and institutions for promoting acceptable research [1]. According to the new regulation, researchers are held legally responsible for ensuring that they ‘act with caution to ensure that all research is conducted according to recognised research ethical norms’ [2]. At the same time ‘institutions are responsible for: a) necessary training of candidates and employees in recognised research ethical norms and b) that everyone who conducts or participates in the research is familiar with recognised research ethical norms’ [2]. The lawmakers have explicitly left it to the researcher community to define what is covered by ‘recognised norms’ [1], but implicitly the community will also have to define what should go into ‘necessary training’. [colored_box]Today this interpretation is dependent on the opinions of local study program committees, course coordinators and the available teachers. There is no common standard, either for the education, or for the expected competence required by the researchers. This could threaten the legal security of the researchers; they may end up being held responsible according to a standard that their particular, institutional training has not properly prepared for. Therefore, clarification of ‘necessary training’ is not only crucial for safe practice of human research; it secures the legal protection of researchers as well. . This new regulation prompts an issue of crucial importance within all research disciplines in general, and within health-related research in particular: What is required for a ‘necessary training’ in health-related research ethics? A justified approach would need to address a variety of challenges. Let me mention some of them here. .

Read the rest of this discussion piece

Less

View full details | Go to resource


New curriculum prioritizes tribal sovereignty, cultural respect in scientific research of American Indian, Alaska Native communities – UW News (Kim Eckart | February 2018)

When scientists have conducted research in Native American communities, the process and the results have sometimes been controversial. There have been a few well-known cases, such as the 1979 Barrow Alcohol Study, in which researchers examined substance use in the tiny Arctic Circle town and issued findings to the... More

When scientists have conducted research in Native American communities, the process and the results have sometimes been controversial. There have been a few well-known cases, such as the 1979 Barrow Alcohol Study, in which researchers examined substance use in the tiny Arctic Circle town and issued findings to the press, before briefing the local community. Media coverage interpreting the findings described an “alcoholic” society of Iñupiats “facing extinction,” while the people of Barrow (now known as Utqiaġvik) felt betrayed, and researchers faced questions and criticism. Then in 1990, members of the Havasupai Tribe gave DNA to an Arizona State University researcher for the study of diabetes; when they learned their blood samples had been used for other studies as well, they filed a lawsuit, ultimately winning a financial settlement and the return of their DNA.

Read the rest of this discussion piece

Less

View full details | Go to resource


Facebook scandal: I am being used as scapegoat – academic who mined data – The Guardian (Matthew Weaver | March 2018)

Published/Released on March 21, 2018 | Posted by Admin on March 22, 2018 | Keywords: , , , , , ,

The academic at the centre of Facebook’s data breach claims he has been unfairly scapegoated by the social network and Cambridge Analytica, the firm that acquired the information.