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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

(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

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)

(US) FDA revokes emergency use ruling for hydroxychloroquine, the drug touted by Trump as a Covid-19 therapy – STAT (Lev Facher | June 2020)0

Posted by Admin in on June 17, 2020
 

WASHINGTON — The Food and Drug Administration on Monday said it had withdrawn an emergency approval for use of the malaria drug hydroxychloroquine as a Covid-19 treatment.

The latest development in the hydroxychloroquine saga.  We have included links to seven related items.

Almost since the beginning of the novel coronavirus pandemic, President Trump and other world leaders have touted hydroxychloroquine as an effective treatment based on scattered anecdotes, not reliable scientific studies. But the FDA said Monday that the drug, along with chloroquine, is “unlikely to be effective in treating Covid-19,” and highlighted “serious side effects.”
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The FDA’s withdrawal of the emergency use order, which Politico first reported, appears to formally close the door on U.S. officials’ willingness to use the drug to prevent or treat Covid-19, the disease caused by the novel coronavirus.

Read the rest of this discussion piece

Should We Purposely Infect Healthy Volunteers With Covid-19? – WIRED (Victoria Turk | May 2020)0

Posted by Admin in on June 4, 2020
 

Such studies could speed up the development of a vaccine—but would mean deliberately giving people a disease that could kill them.

IN LATE MARCH, Josh Morrison was sitting in his apartment in Brooklyn, New York, feeling miserable. Work had slowed down at the nonprofit he runs, which advocates for living organ donors, and he was worried about his parents and whether they were following the guidelines to stay safe during the coronavirus pandemic. He’d been planning to visit them in early April for their 40th anniversary in Florida, but had to cancel. “That was hard, and that was really sad,” he says. “I really want to be able to see my parents as soon as I can, and be back to a situation where you can do that.”

Ethical reflections when they are theoretical can be entertaining and engaging, but the stakes and consequences here are frightening and real.  In a world desperate for a cure, a vaccine or just an efficacious treatment, how far should we go?  Should we allow people to expose themselves to a risk of death or potentially longterm disability?

Morrison, who is 34, felt powerless. He wanted to be able to do something constructive. It was in this context that he came across a paper in The Journal of Infectious Diseases which put forward the case for human challenge studies of Covid-19 vaccine candidates. Challenge studies purposely infect healthy volunteers with a pathogen in order to study a disease or test a treatment or vaccine. This paper suggested that using human challenge studies could speed up the development of a Covid-19 vaccine by months, potentially saving thousands of lives. “The idea of speeding that all up and getting this stuff done with is pretty appealing,” Morrison says. “And also, I thought that I personally could participate in one of these.”
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After contacting some friends, Morrison set up 1 Day Sooner, a group that advocates on behalf of volunteers for Covid-19 human challenge studies. No such studies are yet being conducted, but at the time of writing, more than 24,000 people from 102 countries have signed up on the 1 Day Sooner website to express an interest in taking part in one. Globally, there have now been more than five million reported cases of Covid-19, and 300,000 deaths. Should we let people volunteer to be purposely exposed to a virus we know can sometimes be fatal?
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Read the rest of this discussion piece

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