A Framework for Ethical Payment to Research Participants
Members of the Petrie-Flom Center's collaboration with the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst | The Harvard Clinical and Translational Science Center at Harvard Medical School today published a new article addressing longstanding ethical and regulatory concerns about paying people to participate in clinical trials. The article, which reflects input from a diverse expert working group held at Harvard Law School in 2016, will help researchers and ethics boards navigate the regulatory and ethical boundaries of paying research participants.
From the article:
Payments to research participants are ubiquitous and are made for a variety of reasons, both to healthy volunteers and to volunteers who are patients. Nevertheless, such payments continue to engender controversy, and the payment-related policies and practices of institutional review boards (IRBs) often reflect some discomfort with payment. The central ethical question is whether a payment is “excessive” — whether it conflicts with the obligation, recognized in the U.S. regulations governing human-subjects research and bioethical guidelines, to minimize the possibility of coercion and undue influence during the informed consent process. There is substantial disagreement and confusion among investigators, IRBs, sponsors, bioethicists, and research participants over what constitutes an excessive payment, as well as about how to define the concepts of coercion and undue influence. As a result, no practical framework has been widely adopted to guide investigators and sponsors in developing offers of payment or to guide IRBs in evaluating their acceptability.
In this article, we set our approach to this problem in a practical framework. It reflects input from a working group that comprised ethicists, members of IRBs, investigators, regulators, research participants, and industry representatives, who together considered payments in publicly and privately funded research, at academic institutions and elsewhere, and in various phases of research. Although the views expressed here are those of the authors, they have been substantially informed and sharpened by insights from members of the working group. The Supplementary Appendix, available with the full text of this article at NEJM.org, contains more information about the composition of the working group and the scope of its involvement.
First, we identify and address foundational concerns that have been expressed about offers of payment to research participants. We then propose and defend a framework that distinguishes three rationales for payment: reimbursement for out-of-pocket expenses, compensation for time and burdens associated with research participation, and incentive to motivate participation. Payments that fall into any of these three categories can be ethically acceptable, and indeed desirable, but each rationale involves different considerations.
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bioethics clinical research health care finance holly fernandez lynch human subjects research i. glenn cohen regulation