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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Friday afternoon’s funny – Reclaiming medical devices0

Posted by Admin in on August 14, 2020

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

This chuckle touches on an important point for medical device clinical trials: There needs to be monitoring and support arrangements funded and in place for a period well beyond the duration of the trial.

Friday afternoon’s funny – What do they think of research participants?0

Posted by Admin in on August 7, 2020

Cartoon by Don Mayne
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.

(US) Where Should COVID-19 Vaccines Be Tested? It’s a Moving Target – WIRED (Maryn Mckenna | July 2020)0

Posted by Admin in on August 6, 2020

Developers need to test in hotspots, but those keep changing. And they must avoid ethical problems, like testing in low-income areas but only selling in rich ones.

MORE THAN 140 possibilities for making a vaccine against Covid-19 are being studied around the world. The vast majority of them are still just concepts in a lab, but more than a dozen have been injected into humans, mostly in small-scale trials to make sure each formula is safe to receive. Three are headed toward large human trials this summer, and a surprise announcement on Monday revealed that China is allowing military use of one vaccine being developed there.

That pace, faster than any vaccine has ever been produced, is intended to satisfy the US federal government’s goal of delivering a safe and potent vaccine by January. But as developers race toward broad testing, they are about to crash into a complication: the patchwork nature of the pandemic across the United States.

In order to know whether a vaccine works as intended, you have to pick your test site with care: There has to be enough virus circulating there to create a reasonable chance that vaccinated trial participants will be exposed to it. But even though the United States’ case count keeps heading upward, with 2.68 million cases as of Tuesday, the pandemic isn’t uniformly distributed across the country.

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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.

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.

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