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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

There’s ‘consent’ and then there’s consent: Mobilising Māori and Indigenous research ethics to problematise the western biomedical model (Papers: Kiri West-McGruer | January 2020)0

Posted by Admin in on January 23, 2020
 

Abstract

A fascinating recent paper from New Zealand reflecting on Māori research ethics, consent, First People, collective outlooks, sociology, big data and genuine respect

Challenging western research conventions has a strong documented history in Indigenous critical theory and Kaupapa Māori research discourse. This article will draw from the existing research in these fields and expand on some of the core critiques of the biomedical model in Māori research environments. Of interest are the tensions produced by an over-reliance on individual informed consent as the panacea of ethical research, particularly when the research concerns communities who prioritise collective autonomy. These tensions are further exacerbated in research environments where knowledge is commodified and issues of knowledge ownership are present. Continuing a critique of the informed consenting procedure, this article considers its role in emulating a capitalist exchange of goods and perpetuating a knowledge economy premised on the exploitation of Indigenous people, resources and knowledge. Finally, this article will consider emerging ethical concerns regarding secondary data use in an era of big data.
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Keywords
Informed consent, collective autonomy, Māori research ethics, western biomedical model, scandal and response

West-McGruer, K. (2020). There’s ‘consent’ and then there’s consent: Mobilising Māori and Indigenous research ethics to problematise the western biomedical model. Journal of Sociology. https://doi.org/10.1177/1440783319893523
Publisher: https://journals.sagepub.com/doi/abs/10.1177/1440783319893523
ResearchGate: https://www.researchgate.net/publication/338556502_There’s_’consent’_and_then…

(US) FDA and NIH let clinical trial sponsors keep results secret and break the law – Science (Charles Piller | January 2020)0

Posted by Admin in on January 21, 2020
 

For 20 years, the U.S. government has urged companies, universities, and other institutions that conduct clinical trials to record their results in a federal database, so doctors and patients can see whether new treatments are safe and effective. Few trial sponsors have consistently done so, even after a 2007 law made posting mandatory for many trials registered in the database. In 2017, the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) tried again, enacting a long-awaited “final rule” to clarify the law’s expectations and penalties for failing to disclose trial results. The rule took full effect 2 years ago, on 18 January 2018, giving trial sponsors ample time to comply. But a Science investigation shows that many still ignore the requirement, while federal officials do little or nothing to enforce the law.

Failing to report the results of clinical trials have two serious consequences: 1. It can hide from clinicians and other health professionals problems with a new agent/device/technique. 2. It is wasteful of time/resources because other reseachers might try to conduct the same trial, not realising it had already failed.  So it is very concerning these two regulatory agencies are failing to enforce the law.

Science examined more than 4700 trials whose results should have been posted on the NIH website ClinicalTrials.gov under the 2017 rule. Reporting rates by most large pharmaceutical companies and some universities have improved sharply, but performance by many other trial sponsors—including, ironically, NIH itself—was lackluster. Those sponsors, typically either the institution conducting a trial or its funder, must deposit results and other data within 1 year of completing a trial. But of 184 sponsor organizations with at least five trials due as of 25 September 2019, 30 companies, universities, or medical centers never met a single deadline. As of that date, those habitual violators had failed to report any results for 67% of their trials and averaged 268 days late for those and all trials that missed their deadlines. They included such eminent institutions as the Harvard University–affiliated Boston Children’s Hospital, the University of Minnesota, and Baylor College of Medicine—all among the top 50 recipients of NIH grants in 2019.
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The violations cover trials in virtually all fields of medicine, and the missing or late results offer potentially vital information for the most desperate patients. For example, in one long-overdue trial, researchers compared the efficacy of different chemotherapy regimens in 200 patients with advanced lymphoma; another—nearly 2 years late—tests immunotherapy against conventional chemotherapy in about 600 people with late-stage lung cancer.
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Research Ethics in an Unethical World: The Politics and Morality of Engaged Research (Claudio Morrison and Devi Sacchetto | October 2017)0

Posted by Admin in on January 14, 2020
 

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

Keywords
business and management research, ethics, materialism, post-socialism, qualitative fieldwork, workplace morality

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

Meta-analysis study indicates we publish more positive results – ARS Technica (John Timmer | December 2019)0

Posted by Admin in on January 13, 2020
 

Meta-analyses will only produce more reliable results if the studies are good.

While science as a whole has produced remarkably reliable answers to a lot of questions, it does so despite the fact that any individual study may not be reliable. Issues like small errors on the part of researchers, unidentified problems with materials or equipment, or the tendency to publish positive answers can alter the results of a single paper. But collectively, through multiple studies, science as a whole inches towards an understanding of the underlying reality.

Similar findings have been found before, but it’s important to rearticulate the value of negative results to science and practice.  This speaks to poor research culture and training. University education, and even high and primary school, do not acknowledge that failure is part of discovery. The rewards for ‘success’ are high and it is very tempting for students that can lead to research misconduct.

A meta-analysis is a way to formalize that process. It takes the results of multiple studies and combines them, increasing the statistical power of the analysis. This may cause exciting results seen in a few small studies to vanish into statistical noise, or it can tease out a weak effect that’s completely lost in more limited studies.
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But a meta-analysis only works its magic if the underlying data is solid. And a new study that looks at multiple meta-analyses (a meta-meta-analysis?) suggests that one of those factors—our tendency to publish results that support hypotheses—is making the underlying data less solid than we like.

Publication bias

It’s possible for publication bias to be a form of research misconduct. If a researcher is convinced of their hypothesis, they might actively avoid publishing any results that would undercut their own ideas. But there’s plenty of other ways for publication bias to set in. Researchers who find a weak effect might hold off on publishing in the hope that further research would be more convincing. Journals also have a tendency to favor publishing positive results—one where a hypothesis is confirmed—and avoid publishing studies that don’t see any effect at all. Researchers, being aware of this, might adjust the publications they submit accordingly.

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