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(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.

(EU) Make Way for the Robots! Human- and Machine-Centricity in Constituting a European Public–Private Partnership (Papers: Kjetil Rommetveit, et al | September 2019)0

Posted by Admin in on June 26, 2020
 

Abstract

Even though not directly research integrity-related, this lengthy open-access paper gives an interesting insight from Europe into the very near future of human-autonomous robot collaboration.

This article is an analytic register of recent European efforts in the making of ‘autonomous’ robots to address what is imagined as Europe’s societal challenges. The paper describes how an emerging techno-epistemic network stretches across industry, science, policy and law to legitimize and enact a robotics innovation agenda. Roadmap is the main metaphor and organizing tool in working across the disciplines and sectors, and in aligning these heterogeneous actors with a machine-centric vision along a path to make way for ‘new kinds’ of robots. We describe what happens as this industry-dominated project docks in a public–private partnership with pan-European institutions and a legislative initiative on robolaw. Emphasizing the co-production of robotics and European innovation politics, we observe how well-known uncertainties and scholarly debates about machine capabilities and human–machine configurations, are unexpectedly played out in legal scholarship and institutions as a controversy and a significant problem for human-centered legal frameworks. European robotics are indeed driving an increase in speculative ethics and a new-found weight of possible futures in legislative practice.

Rommetveit, K., van Dijk, N. & Gunnarsdóttir, K. Make Way for the Robots! Human- and Machine-Centricity in Constituting a European Public–Private Partnership. Minerva 58, 47–69 (2020). https://doi.org/10.1007/s11024-019-09386-1
Publisher (Open Access): https://link.springer.com/article/10.1007/s11024-019-09386-1

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.

The Opportunity Cost of Compulsory Research Participation: Why Psychology Departments Should Abolish Involuntary Participant Pools (Papers: Ruth Walker | June 2020)0

Posted by Admin in on June 23, 2020
 

Abstract

A widespread practice in psychology schools around the globe that needs to end.

Psychology departments often require undergraduates to participate in faculty and graduate research as part of their course or face a penalty. Involuntary participant pools (human subject pools) in which students are compulsorily enrolled are objectively coercive. Students have less autonomy than other research participants because they face a costly alternative task or the penalties that accompany failure to meet a course requirement if they choose not to participate. By contrast, other research participants are free to refuse consent without cost or penalty. Some researchers claim that the educational value of participation justifies the requirement. They treat coercion as a cost that can be outweighed by the benefits to students. This paper argues that such an approach is flawed because coercion is not like other costs and that educational value is inherently low relative to personal study or classroom time. The unethical nature of involuntary participation is best demonstrated with an opportunity cost analysis. This shows that students are forced to sacrifice higher value alternatives that they have paid to do and undertake a lower value activity that principally benefits others. Faculty have a conflict of interest as they are the beneficiaries of student coercion in their role as researchers and responsible for student achievement in their role as teachers. Voluntary participant pools can resolve this conflict but at the cost of reducing the supply of participants. A change in departmental research conduct is required to restore the autonomy of students who are competent adults and not legitimate subjects of paternalism when it comes to research participation.

Keywords
Human subject pools, Coercion, Psychology, Research, Undergraduates

Walker, R. (2020) The Opportunity Cost of Compulsory Research Participation: Why Psychology Departments Should Abolish Involuntary Participant Pools. Science and Engineering Ethics  https://doi.org/10.1007/s11948-020-00232-2

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