In his nearly 25 years of studying research ethics, Western University Professor Dr. Charles Weijer says this is the most difficult ethical question he’s ever encountered. As part of The Working Group for Guidance on Human Challenge Studies, Dr. Weijer along with 13 other international experts were tasked with developing guidance for the World Health Organization (WHO) on the ethical permissibility of purposefully infecting informed and willing healthy volunteers with COVID-19 in order to test a vaccine.
Called human challenge studies, trials of this kind have been carried out for decades in highly controlled laboratory environments for diseases like malaria, influenza and cholera to test potential treatments or vaccines.
“Even with all of the important public health interventions that have been implemented, there is a strong sense that we as a society are not going to get past the COVID-19 threat until there is a widely available and effective vaccine for the virus,” said Dr. Weijer, Professor at Western’s Schulich School of Medicine & Dentistry and Faculty of Arts & Humanities. “This led the WHO to start considering how we could speed vaccine development, and might human challenge studies be an important part of that?”
The Working Group for Guidance on Human Challenge Studies developed a set of eight requirements for COVID-19 human challenge studies to be considered ethically permissible. They include a requirement that they can only be done in communities where COVID-19 is already circulating and research participants have a high probability of contracting the virus outside of the research study. They also require an exceptionally high standard for informed consent, and a requirement that these studies only be conducted among individuals who have the lowest risk of developing complications of COVID-19 – healthy individuals between the ages 18 and 29
“From my perspective there are a highly limited set of circumstances in which COVID-19 challenge studies may be done ethically. These studies may only be conducted with healthy young volunteers who are exceptionally well informed about the risks and also where they had a substantial chance of contracting COVID-19 outside of the study,” Dr. Weijer said. “Those are the only circumstances in which I would endorse COVID-19 challenge studies.”
Commentary reflects the perspective and scholarly interest of Western faculty members and is not an articulation of official university policy on issues being addressed.
MEDIA CONTACT: Crystal Mackay, Media Relations Officer, Schulich School of Medicine & Dentistry, Western University, 519.933.5944, crystal.mackay@schulich.uwo.ca @CrystalMackay
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