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

ResourcesBeneficence

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

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WASHINGTON — The Food and Drug Administration on Monday said it had withdrawn an emergency approval for use of the malaria drug hydroxychloroquine as a Covid-19 treatment.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

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.”
.

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?
.

Read the rest of this discussion piece

Friday afternoon’s funny – Somethings should not be trialled at the same time, in the same place0

Posted by Admin in on May 22, 2020
 

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

When planning a trial it’s important to sit back and think about how the details will work in the planned setting.  If research ethics review is focussed on facilitating excellent ethical research hopefully it can also potentially spot a situation that’s going to go in an unexpected direction.  A trial might comply with the rules, but is still a bad idea.

0