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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

COVID-19 research: pandemic versus “paperdemic”, integrity, values and risks of the “speed science” (Papers: Ricardo Jorge Dinis-Oliveira | April 2020)0

Posted by Admin in on July 11, 2020
 

Abstract

This open access paper from April 2020 makes familiar arguments about the problem of junk science and COVID-19, but they are points worth repeating and we loved the first sentence of the abstract.  We have included links to 16 related items.

Scientific integrity is a learned skill. When researchers and students learn integrity in laboratories or in the classroom, they are empowered to use similar principles in other aspects of their lives. This commentary reviews the concepts related to scientific integrity at a time when science faces important challenges related to the increase(d) number of articles produced regarding research on coronavirus disease 2019 (COVID-19). Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has ignited another parallel viral pandemic, with science ranging from robust studies to dishonest studies being conducted, posted, and shared at an unprecedented rate. A balance is needed between the benefits of the rapid access to new scientific data and the threat of causing panic or erroneous clinical decisions based on mistakes or misconduct. The truth is that the “scientific research has changed the world” but now, and more than ever, “it needs to change itself”. A pandemic with a “paperdemic” will be even more complicated to manage if it progresses in an uncontrolled manner and is not properly scrutinized.

Keywords:
SARS-CoV-2, COVID-19, research and academic integrity, peer review, pandemic, paperdemic

Ricardo Jorge Dinis-Oliveira (2020) COVID-19 research: pandemic versus “paperdemic”, integrity, values and risks of the “speed science”, Forensic Sciences Research, DOI: 10.1080/20961790.2020.1767754
Publisher (Open Access): https://www.tandfonline.com/doi/full/10.1080/20961790.2020.1767754

Friday afternoon’s funny – Captain Placebo III0

Posted by Admin in on July 10, 2020
 

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

Every decent superhero needs an origin story and a development arc so does second rate heroes.  Oh okay… I guess Captain Placebo doses too.

(China, Australia) Against the use and publication of contemporary unethical research: the case of Chinese transplant research (Papers: Wendy C Higgins, et al | July 2020)0

Posted by Admin in on July 9, 2020
 

Abstract

This July 2020 paper examines the argument for and against the publication of new, or retraction of old research outputs, where the work utilised organs from executed prisoners.  This isn’t just about an intensely captive relationship.

Recent calls for retraction of a large body of Chinese transplant research and of Dr Jiankui He’s gene editing research has led to renewed interest in the question of publication, retraction and use of unethical biomedical research. In Part 1 of this paper, we briefly review the now well-established consequentialist and deontological arguments for and against the use of unethical research. We argue that, while there are potentially compelling justifications for use under some circumstances, these justifications fail when unethical practices are ongoing—as in the case of research involving transplantations in which organs have been procured unethically from executed prisoners. Use of such research displays a lack of respect and concern for the victims and undermines efforts to deter unethical practices. Such use also creates moral taint and renders those who use the research complicit in continuing harm. In Part 2, we distinguish three dimensions of ‘non-use’ of unethical research: non-use of published unethical research, non-publication, and retraction and argue that all three types of non-use should be upheld in the case of Chinese transplant research. Publishers have responsibilities to not publish contemporary unethical biomedical research, and where this has occurred, to retract publications. Failure to retract the papers implicitly condones the research, while uptake of the research through citations rewards researchers and ongoing circulation of the data in the literature facilitates subsequent use by researchers, policymakers and clinicians.
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Higgins, WC., Rogers, W.A., Ballantyne, A., Lipworth, W. (2020)  Against the use and publication of contemporary unethical research: the case of Chinese transplant research. Journal of Medical Ethics. doi: 10.1136/medethics-2019-106044

(US) Senators ask government watchdog to investigate for-profit study review boards (June 2020)0

Posted by Admin in on July 2, 2020
 

“We write to request a Government Accountability Office (GAO) investigation of the operation of commercial Institutional Review Boards (IRBs), the private, for-profit entities that approve drug research and other studies involving human subjects. As clinical trials related to the coronavirus disease 2019 (COVID-19) pandemic accelerate, ensuring that IRBs are providing adequate patient protection is more important than ever. Our preliminary investigation, opened in November 2019, raises questions about whether the commercial IRBs’ reviews of these studies have significant vulnerabilities that may leave patients exposed to unnecessary risks during their participation in clinical trials.

Our thanks to STAT that originally posted a link to this letter. And to US Senators Elizabeth Warren, Bernie Sanders and Sherrod Brown for raising this important issue.

In 2009, GAO released a study that exposed alarming vulnerabilities in human subject research reviews.1 In an undercover investigation, GAO was able to obtain IRB approval for a fictitious test of a medical device that met the Food and Drug Administration’s (FDA) guidelines for “significant risk.” The for-profit IRB that approved the fictitious device, Coast IRB, closed after the GAO investigation was made public.2 The report concluded that “the IRB system is vulnerable to unethical manipulation, particularly by companies or individuals who intend to abuse the system or to commit fraud, or who lack the aptitude or qualifications to conduct and oversee clinical trials. This vulnerability elevates the risk that experimental products are approved for human subjects testing with little or no substantive due diligence.”3
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In the decade since this GAO investigation, the IRB landscape has shifted in several significant ways. First, while the 2009 GAO study noted “IRBs were historically located at academic institutions,” it found that commercial IRBs “are playing an increasingly prominent role in the protection of human research subjects.”4 That trend has continued in the intervening decade, and commercial, for-profit IRBs now oversee approximately 70% of all drug and medical device 2 trials in the United States.5 This is a particular concern because this private, for-profit model creates an inherent conflict of interest for IRBs, which may incentivize them to approve as many studies as they can as rapidly as possible.6 The urgency of the COVID-19 pandemic may further increase pressure for IRBs to provide rapid approvals that may be inadequate or incomplete. Though conflicts of interest are common among individual IRB reviewers, including at academic IRBs,7 the profit motive and lack of transparency at commercial IRBs make potential conflicts especially worrisome…”
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Read the rest of this discussion piece

1 Government Accountability Office, “Human Subjects Research: Undercover Tests Show the Institutional Review Board System is Vulnerable to Unethical Manipulation,” March 26, 2009, https://www.gao.gov/assets/130/122142.pdf.

2 Wall Street Journal, “Coast IRB, Caught in Sting, to Close,” Alicia Mundy, April 22, 2009, https://www.wsj.com/articles/SB124042341694744375.

3 Government Accountability Office, “Human Subjects Research: Undercover Tests Show the Institutional Review Board System is Vulnerable to Unethical Manipulation,” March 26, 2009, https://www.gao.gov/assets/130/122142.pdf.

4 Id.

5 Stat News, “In clinical trials, for-profit review boards are taking over for hospitals. Should they?” Sheila Kaplan, July 6, 2016, https://www.statnews.com/2016/07/06/institutional-review-boards-commercial-irbs/.

6 Letter from Senators Elizabeth Warren, Bernard Sanders, and Sherrod Brown to WCG Clinical and Advarra, November 19, 2019, https://www.warren.senate.gov/oversight/letters/senators-warren-brown-and-sanders-investigate-inherent-conflicts-of-interest-of-private-equity-owned-institutional-review-boards.

7 JAMA Internal Medicine, “Industry Relationships Among Academic Institutional Review Board Members: Changes from 2005 Through 2014,” September 2015, E.G. Campbell, C. Vogeli, S.R. Rao, M. Abraham, R. Pierson, and S. Applebaum, https://www.ncbi.nlm.nih.gov/pubmed/26168043.

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