Ethical Payment in Human Infection Challenge Studies in the American Journal of Bioethics

 There are likely more vaccine trials ahead of us, of new vaccines and modifications of old ones to defend against new variants of covid. Here's a just-published paper, written when vaccine trials were still in the future. It's still relevant, because challenge trials (in which volunteers are exposed to a particular virus) can be much more focused than ordinary vaccine trials (particularly as the prevalence of disease begins to decline...see yesterday's post).

Promoting Ethical Payment in Human Infection Challenge Studies

Holly Fernandez Lynch, Thomas C. Darton, Jae Levy, Frank McCormick, Ubaka Ogbogu, Ruth O. Payne, Alvin E. Roth, Akilah Jefferson Shah, Thomas Smiley and Emily A. Largent            

Published online: 04 Feb 2021, The American Journal of Bioethics,  https://doi.org/10.1080/15265161.2020.1854368

Abstract: To prepare for potential human infection challenge studies (HICS) involving SARS-CoV-2, we convened a multidisciplinary working group to address ethical questions regarding whether and how much SARS-CoV-2 HICS participants should be paid. Because the goals of paying HICS participants, as well as the relevant ethical concerns, are the same as those arising for other types of clinical research, the same basic framework for ethical payment can apply. This framework divides payment into reimbursement, compensation, and incentives, focusing on fairness and promoting adequate recruitment and retention as counterweights to concerns about undue inducement. Within the basic framework, several factors are especially salient for HICS, and for SARS-CoV-2 HICS in particular, including the nature of participant confinement, anticipated discomfort, risks and uncertainty, participant motivations, and trust. These factors are reflected in a payment worksheet created to help sponsors, researchers, and ethics reviewers systematically develop and assess ethically justifiable payment amounts.

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Here's a link to the original (long) working paper:

Wednesday, August 19, 2020

The ethics (and some economics) of paying participants in Human Infection Challenge Studies, for a coronavirus vaccine