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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.

Controversial ‘human challenge’ trials for COVID-19 vaccines gain support – Science (Jon Cohen | July 2020)0

Posted by Admin in on August 2, 2020
 

Since the early days of the pandemic, some researchers have advocated a fast way to determine whether a COVID-19 vaccine works: Intentionally attempt to infect vaccinated volunteers with the virus, SARS-CoV-2. Ethicists and vaccine scientists alike raised red flags, and the discussion has remained mostly theoretical. But now two key elements are taking shape: a large corps of volunteers willing to take part in a “human challenge” trial, and the well-understood lab-grown virus strains needed for the studies.

Challenge studies are always ethically challenging, but the circumstances here a little unusual.  Generally, challenge studies follow thorough lab testing and then monitoring across the earlier Phases, but we’ve arrived at this point very quickly.  Also usually, there will be an established treatment that can be used if the experimental agent doesn’t work.  We don’t have such a treatment.  We know infection can be fatal and there are indications there can be long term lung and brain damage. Yet the stakes can’t be more compelling.  The death toll every day is truly awful and billions crying out for vaccine and treatment.

The volunteers come from an advocacy group, 1Day Sooner, that has signed up more than 30,000 people from 140 countries. The group, co-founded by a 22-year-old, organized an open letter that was signed by 15 Nobel laureates and 100 other prominent researchers, ethicists, and philosophers, which it sent to U.S. National Institutes of Health Director Francis Collins on 15 July. The letter urged the U.S. government “to undertake immediate preparations for human challenge trials” in young, healthy people, who are less likely to suffer severe disease from COVID-19. Among the signatories was Adrian Hill of the University of Oxford, whose lab developed one of the leading COVID-19 vaccine candidates and plans to produce virus strains that could be used in the trials.
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Researchers use human challenges to test vaccines for other diseases, including cholera and malaria, but in those experiments, proven drugs can help “rescue” study participants if the vaccine doesn’t work and they become seriously ill. In a June report on COVID-19 vaccine challenges, an advisory group to the World Health Organization (WHO) was split over whether they should take place in the absence of a rescue treatment. The group was also evenly divided on whether human challenges would truly speed the vaccine effort, given that efficacy trials using participants at risk of natural infection have already begun. Still, the report offered guidelines for these trials, suggesting they should recruit volunteers between ages 18 and 25 and require them to remain in “high-level isolation units” during the study so they don’t infect others.

Read the rest of this discussion piece

Covid-19 studies based on flawed Surgisphere data force medical journals to review processes – The Guardian (Melissa Davey | June 2020)0

Posted by Admin in on July 13, 2020
 

New England Journal of Medicine and Lancet peer reviewers did not see raw data behind findings before publication

Some of the world’s leading medical journals are reviewing their processes after they were forced to retract studies based on flawed data.

None of the peer reviewers who examined a questionable study on the impact of blood pressure medications on Covid-19 saw the raw data behind the findings before it was approved for publication in world-renowned medical journal, the New England Journal of Medicine.

The study was based on a massive dataset supposedly gathered from hospitals worldwide by a US company called Surgisphere, but a Guardian investigation has since revealed the database to be seriously flawed. The revelation, combined with concerns highlighted by scientists worldwide about the data, prompted the journal to retract the study. The Lancet, another leading medical journal, also published a study based on the Surgisphere database.

Read the rest of this discussion piece

(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

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