title: In need of remedy: US policy for compensating injured research participants.
abstract: There is an emerging ethical consensus that injured research participants should receive medical care and compensation for their research-related injuries. This consensus is premised on notions of beneficence, distributive justice, compensatory justice and reciprocity. In response, countries around the world have implemented no-fault compensation systems to ensure that research participants are adequately protected in the event of injury. The United States, the world's leading sponsor of research, has chosen instead to rely on its legal system to provide injured research participants with medical care and compensation. This article argues that US reliance on its legal system leaves injured research participants unprotected in the event of injury. Nearly every injured research participant will have difficulty receiving compensation in court, and certain classes of research participants will be barred from receiving compensation altogether. The United States' outlier status also threatens to impede US-sponsored multinational research, potentially delaying important biomedical advances. To rectify this injustice, researchers, Institutional Review Boards, sponsors and research institutions should advocate systematic no-fault compensation in the United States to bring US law into accord with global ethical norms and ensure that injured research participants are adequately protected.
authors.affiliation: CC-Department of Bioethics, National Institutes of Health, , Bethesda, Maryland, USA.
authors.forename: Elizabeth R
authors.initials: ER
authors.lastname: Pike
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics*; D035881:Compensation and Redress / Q000941:ethics* / Q000331:legislation & jurisprudence*; D032984:Ethics, Research; D006291:Health Policy / Q000331:legislation & jurisprudence / Q000639:trends; D006801:Humans; D007194:India; D007391:International Cooperation; D028681:Moral Obligations; D009316:National Institutes of Health (U.S.); D035842:Research Subjects; D012109:Research Support as Topic; D014481:United States; D014947:Wounds and Injuries
keywords: Law; Public Policy; Research Ethics; Tort Law