ACN - 101321555 Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)
Search
Generic filters
Exact text matches only
Search into
Filter by Categories
Research integrity
Filter by Categories
Human Research Ethics

Resource Library

Research Ethics MonthlyAbout Us

ResourcesHuman research ethics

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

China is tightening its grip on coronavirus research – Nature (Andrew Silver & David Cyranoski | April 2020)0

Posted by Admin in on July 5, 2020
 

Some scientists welcome government vetting because it could stop poor-quality COVID-19 papers being published – others fear it is an attempt to control information.

China’s government has started asserting tight control over COVID-19 research findings. Over the past two months, it appears to have quietly introduced policies that require scientists to get approval to publish — or publicize — their results, according to documents seen by Nature and some researchers.

This fits with media reports that at least two Chinese universities have posted notices online stating that research on the virus’s origins needs to be approved by the university’s academic committee and the Ministry of Science and Technology (MOST) or Ministry of Education (MOE) before being submitted for publication.

Scientists in China say the changes are probably a response to poor-quality studies on the virus, which have been posted online and reported widely — and several welcome them. But some academics have suggested that the policies are part of China’s attempt to control information about the start of the outbreak.

Read the rest of this discussion piece

China clamping down on coronavirus research, deleted pages suggest – The Conversation (Stephanie Kirchgaessner, et al | April 2020.)0

Posted by Admin in on July 4, 2020
 

Move is likely to be part of attempt to control the narrative surrounding the pandemic

China is cracking down on publication of academic research about the origins of the novel coronavirus, in what is likely to be part of a wider attempt to control the narrative surrounding the pandemic, documents published online by Chinese universities appear to show.

Two websites for leading Chinese universities appear to have recently published and then removed pages that reference a new policy requiring academic papers dealing with Covid-19 to undergo extra vetting before they are submitted for publication.

Research on the origins of the virus is particularly sensitive and subject to checks by government officials, the notices posted on the websites of Fudan University and the China University of Geosciences (Wuhan) said. Both the deleted pages were accessed from online caches.

Read the rest of this discussion piece

Friday afternoon’s funny – Captain Placebo II0

Posted by Admin in on July 3, 2020
 

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

The amount of paperwork a research ethics committee can generate really is scary.  An institution would be well served by a having a good electronic approach – if only to help with sorting and quick retrieval.

(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
.

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…”
.

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.

0