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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.
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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

(Australia) Why did a journal suddenly retract a 45-year-old paper over lack of informed consent? – Retraction Watch (Adam Marcus | July 2020)0

Posted by Admin in on July 26, 2020
 

A journal has retracted a 45-year-old case study over concerns that the authors had failed to obtain proper informed consent from the family they’d described.

Part of good governance is recognising when a tough position is just silly. Not too long ago, AHEC took a stance that cell lines, for instance, could still be used even though consent was not a routine part of the process 30+ years ago. There has to be a balance between respect and common sense. In this instance, no one would have noticed if it hadn’t been retracted. Perhaps it should highlight the need to have routine mechanisms in place for consent for case series.

The article, “Stickler syndrome report of a second Australian family,” appeared in Pediatric Radiology, a Springer Nature title, in 1975. The first author was Kazimierz Kozlowski, a prominent radiologist who was born in Poland and worked in the United States and Australia, where he studied skeletal diseases in children.
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Stickler syndrome is an inherited disorder marked by defects in the skeleton, eyes and other organ systems. The condition affects roughly one in 7,500 babies in the United States, although the true incidence may be somewhat higher because some cases are mild enough to go undiagnosed.
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According to the retraction notice:

The Editors have retracted this article [1] as is it is not clear whether parental consent was provided for publication of the images and case. Given the age of the article we have been unable to verify this, therefore the article is no longer available online in order to protect the privacy of the individual. Both authors agree to this retraction.

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Read the rest of this discussion piece

Characteristics of registered clinical trials assessing treatments for COVID-19: a cross-sectional analysis (Papers: Hemalkumar B Mehta, et al | June 2020)0

Posted by Admin in on July 25, 2020
 

Abstract
Objectives The coronavirus disease 2019 (COVID-19) pandemic has prompted many initiatives to identify safe and efficacious treatments, yet little is known regarding where early efforts have focused. We aimed to characterise registered clinical trials assessing drugs or plasma treatments for COVID-19.

Design, setting and participants
Cross-sectional analysis of clinical trials for the treatment of COVID-19 that were registered in the USA or in countries contributing to the WHO’s International Clinical Trials Registry Platform. Relevant trial entries of drugs or plasma were downloaded on 26 March 2020, deduplicated, verified with reviews of major medical journals and WHO websites and independently analysed by two reviewers.

Main outcome(s)
Trial intervention, sponsorship, critical design elements and specified outcomes

Results Overall
201 clinical trials were registered for testing the therapeutic benefits of 92 drugs or plasma, including 64 in monotherapy and 28 different combinations. Only eight (8.7%) products or combinations involved new molecular entities. The other test therapies had a wide range of prior medical uses, including as antivirals, antimalarials, immunosuppressants and oncology treatments. In 152 trials (75.7%), patients were randomised to treatment or comparator, including 55 trials with some form of blinding and 97 open-label studies. The 49 (24.4%) of trials without a randomised design included 29 single armed studies and 20 trials with some comparison group. Most trial designs featured multiple endpoints. Clinical endpoints were identified in 134 (66.7%) of trials and included COVID-19 symptoms, death, recovery, required intensive care and hospital discharge. Clinical scales were being used in 33 (16.4%) trials, most often measures of oxygenation and critical illness. Surrogate endpoints or biomarkers were studied in 88 (42.3%) of trials, primarily assays of viral load. Although the trials were initiated in more than 17 countries or regions, 100 (49.8%) were registered in China and 78 (37.8%) in the USA. Registered trials increased rapidly, with the number of registered trials doubling from 1 March to 26 March 2020.

Conclusions
While accelerating morbidity and mortality from the COVID-19 pandemic has been paralleled by early and rapid clinical investigation, many trials lack features to optimise their scientific value. Global coordination and increased funding of high-quality research may help to maximise scientific progress in rapidly discovering safe and effective treatments.

Ehrhardt, S., Moore, T.J., Segal, J.B. & G Alexander, G.C. (2020) Characteristics of registered clinical trials assessing treatments for COVID-19: a cross-sectional analysis. BMJ Open doi: 10.1136/bmjopen-2020-039978

Friday afternoon’s funny – What do they really mean?0

Posted by Admin in on July 24, 2020
 

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

If you’re sniggering while remembering a real project you aren’t alone.

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