It is ethically appropriate to pay volunteers who are intentionally infected with the COVID virus as part of clinical research, says an international panel of experts.
In a report published in the American Journal of Bioethics, the group of ethicists, lawyers, academics, laymen and others from the UK, United States, and Canada found that paying participants in a COVID study should be decided the same way as other human infection challenge studies (HICS) and other, traditional types of clinical trials and research studies.
“Our work was spurred by concerns that payment for SARS-CoV-2 HICS might require a novel ethical framework, which we ultimately determined to be unfounded,” wrote lead author Holly Fernandez Lynch, an assistant professor of medical ethics at the University of Pennsylvania.
The report states that, “The basic framework for ethical research payment divides payment into three categories — reimbursement, compensation, and incentive — and emphasizes the importance of fairness and adequate recruitment and retention, with efforts to minimize undue influence, participant deception about their eligibility and adverse events, and negative impacts on public trust.
“The basic framework is relevant to payment for all types of clinical research, including HICS. Nonetheless, there are factors within that basic framework likely to be particularly salient to setting payment amounts for HICS, including participant isolation and confinement, anticipated discomfort, risk of lasting harm, and participant motivations.”
The panel concluded that payments for HICS and in particular for possible studies involving infection with the COVID virus, “will likely be on the high end of the payment spectrum.”
The report was sponsored by 1Day Sooner, an organization that promotes the use of human challenge trials. Unlike the trials bioscience companies like Pfizer and Modena used to test their vaccines, HCIS researchers intentionally inject volunteers with the virus they are testing against to study their reaction.
It is not uncommon to pay participants in clinical studies. Most often the payments are modest, compensating volunteers them for direct expenses and for their time. Some studies offer additional payments as incentives to recruit enough volunteers, including from diverse communities.
1Day Sooner assembled the study group – paying some of its members – to get an independent assessment of the ethics of whether and how much people should get paid to take part in COVID challenge trials. Such a study is planned in the United Kingdom.
The published report discusses multiple factors of the decision framework the group outlines, ultimately concluding that payment decision-making for HCIS – and COVID studies — should be the same as for all other clinical research involving human subjects.
Image by PIRO4D
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