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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Friday afternoon’s funny – What do they think of research participants?0

Posted by Admin in on August 7, 2020
 

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

Perhaps a small group game to open a discussion about (what’s wrong) with the governance of human research ethics.

(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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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.

Friday afternoon’s funny – Captain Placebo0

Posted by Admin in on June 25, 2020
 

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

Members of research ethics review bodies and ethics officers need to be careful they don’t slip into a superhero mindset.  You aren’t battling evil or protecting hapless participants from dangerous research.  Such thinking will turn you into the worst stereotype of someone involved in research ethics review.  Instead, we must strive to facilitate ethical research through constructive feedback and collegiate support.

Is Research Ethics Committee review of most clinical trials fundamentally broken? – BMJ Blog (Mark Yarborough | June 2020)0

Posted by Admin in on June 22, 2020
 

Imagine that you suffered from a fatal neurodegenerative disorder like Alzheimers or ALS, or that you had a serious chronic condition like hypertension or heart disease. Imagine further that you were asked to participate in a clinical trial related to your disease. Finally, imagine that the person recruiting you into the trial reassured you that the study had been vetted by a research ethics committee (REC) tasked with protecting your welfare, rights, and interests.

For more than a century combined, we have chaired, served on, supported, written about and consulted on/for research ethics committees.  And we have served on NHMRC committees.  So it will not come as a complete surprise that we don’t entirely agree with this provocative piece.  But it does raise issues worthy of sober and informed discussion.

 

Of course, countless people in these exact same circumstances routinely get recruited into REC-approved trials. While many or perhaps even most of them may have never heard of RECs and the role they play in clinical research, they nevertheless are likely to implicitly trust that the trials they are being recruited into are both important and ethical to conduct. Such trust should be warranted since that is what REC approval is meant to certify.
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But does REC approval reliably certify this? I suspect that many readers of this journal believe that they do and thus rarely if ever truly ponder the question. I know this used to be true for me, in large part due to my own personal experiences working on RECs and seeing the hard work and dedication of committee members and staff. Today, though, I am convinced that the question is one of the most central ones there is in research ethics. After all, the trustworthiness of the clinical research endeavour is in large part a direct outcome of the strength of the accountability measures in place to support it and REC review is at the heart of those accountability measures.

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