Research Ethics and Policy Series (REPS): Scott Halpern, MD, PhD, M.Bioethics

Paying patients to participate in clinical trials: Undue, unjust, or understudied?

Abstract: For decades, providing patients with financial incentives for research participation has been controversial and variably regulated due to uncertainty regarding whether financial incentives serve as undue inducements by blunting peoples’ sensitivity to research risks, or unjust inducements by preferentially increasing enrollment among disadvantaged persons. Emerging normative analyses and a small number of empirical studies of how hypothetical offers of payments influence trial enrollment decisions have increasingly suggested that concerns with incentivizing research may be overblown. But without evidence of how real incentives influence participation in real trials, investigators, research sponsors, and regulatory bodies have rarely modified their practices or norms. This year, we published the results of two randomized trials of real incentives for participating in two real parent trials. This talk will review these trials’ designs and results, interpret these findings in the context of prior knowledge and theory, and identify the remaining unanswered questions.