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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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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.

(US) Universities Step Up the Fight for Open-Access Research – WIRED (Gregory Barber | June 2020)0

Posted by Admin in on June 20, 2020
 

Today’s deal between the University of California and publisher Springer Nature is a big milestone on the path to dismantling paywalls around academic journals.

FIVE YEARS AGO, when Jeffrey MacKie-Mason first joined the University of California team that negotiates with academic publishers, he asked a colleague what would happen if he failed to strike a deal. What if, instead, he simply canceled their subscription? “I was told I would be fired the next day,” the UC Berkeley librarian says. Last year, he tested out the theory. The university system had been trying to negotiate a deal to make all of its research open-access—outside of a paywall—with Elsevier, the world’s largest academic publisher. But they were too far apart on what that would cost. So MacKie-Mason’s team walked away.

An update on efforts towards making the results of quality research publicly accessible to all.  We have included links to fifteen related items.

To his surprise, the army of UC researchers who depended on that subscription were willing to go along with it. They’d lose the ability to read new articles in thousands of Elsevier journals, sure, but there were ways to get by without a subscription. They could email researchers directly for copies. The university would pay for individual articles. And yes, unofficially, some would just probably download from Sci-Hub, the illicit repository where virtually every scientific article can be found. To MacKie-Mason, it was clarifying: The conventional wisdom that had weakened his negotiating hand was thoroughly dispelled.
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Since then, progress towards open access has crept along. More deals of the kind UC wants have been struck, especially in Europe. But in the United States, progress has been especially halting. Then, last week, MIT officials announced that they too had stepped away from the table with Elsevier, saying they couldn’t agree to a deal. And now, University of California officials have announced their intention to make a deal with Springer Nature, the world’s second-largest publisher, to begin publishing the university system’s research as open-access by default. The deal starts in 2021 for a large number of the company’s journals—and puts UC on the path, at least, to do so for all its journals within two years, including its most prestigious ones, like Nature.

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Friday afternoon’s funny – Catching participants with trickery0

Posted by Admin in on June 19, 2020
 

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

Tricking participants into exposing themselves to serious harm is a serious ethical breach.  Any use of overt deception should only be used with considerable justification.  In Australia this is reflected in the National Statement (2007 updated 2018)

The epic battle against coronavirus misinformation and conspiracy theories – Nature (Philip Ball & Amy Maxmen | May 2020)0

Posted by Admin in on June 18, 2020
 

Analysts are tracking false rumours about COVID-19 in hopes of curbing their spread.

In the first few months of 2020, wild conspiracy theories about Bill Gates and the new coronavirus began sprouting online. Gates, the Microsoft co-founder and billionaire philanthropist who has funded efforts to control the virus with treatments, vaccines and technology, had himself created the virus, argued one theory. He had patented it, said another. He’d use vaccines to control people, declared a third. The false claims quietly proliferated among groups predisposed to spread the message — people opposed to vaccines, globalization or the privacy infringements enabled by technology. Then one went mainstream.

There’s a second pandemic that has circled the globe. It isn’t a virus, but it imperils life, wastes precious resources and impairs efforts to deal with  COVID-19.  It is the misinformation, conspiracy theories and wild theories running rampant around the world.  Dealing with both pandemics will require science, sober reason and commitment.

On 19 March, the website Biohackinfo.com falsely claimed that Gates planned to use a coronavirus vaccine as a ploy to monitor people through an injected microchip or quantum-dot spy software. Two days later, traffic started flowing to a YouTube video on the idea. It’s been viewed nearly two million times. The idea reached Roger Stone — a former adviser to US President Donald Trump — who in April discussed the theory on a radio show, adding that he’d never trust a coronavirus vaccine that Gates had funded. The interview was covered by the newspaper the New York Post, which didn’t debunk the notion. Then that article was liked, shared or commented on by nearly one million people on Facebook. “That’s better performance than most mainstream media news stories,” says Joan Donovan, a sociologist at Harvard University in Cambridge, Massachusetts.
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Donovan charts the path of this piece of disinformation like an epidemiologist tracking the transmission of a new virus. As with epidemics, there are ‘superspreader’ moments. After the New York Post story went live, several high-profile figures with nearly one million Facebook followers each posted their own alarming comments, as if the story about Gates devising vaccines to track people were true.

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