title: Just compensation: a no-fault proposal for research-related injuries.
abstract: Biomedical research, no matter how well designed and ethically conducted, carries uncertainties and exposes participants to risk of injury. Research injuries can range from the relatively minor to those that result in hospitalization, permanent disability, or even death. Participants might also suffer a range of economic harms related to their injuries. Unlike the vast majority of developed countries, which have implemented no-fault compensation systems, the United States continues to rely on the tort system to compensate injured research participants-an approach that is no longer morally defensible. Despite decades of US advisory panels advocating for no-fault compensation, little progress has been made. Accordingly, this article proposes a novel and necessary no-fault compensation system, grounded in the ethical notion of compensatory justice. This first-of-its-kind concrete proposal aims to treat like cases alike, offer fair compensation, and disburse compensation with maximum efficiency and minimum administrative cost. It also harmonizes national and international approaches-an increasingly important goal as research becomes more globalized, multi-site trials grow in number, and institutions and sponsors in the United States move to single-IRB review.
authors: University of Maryland Carey School of Law, Baltimore, MD 21201, USA and Johns Hopkins Berman Institute of Bioethics, Baltimore, MD 21205, USA.
authors: Leslie Meltzer
authors: LM
authors: Henry
authors: Food and Drug Administration, Office of the Chief Counsel; Department of Health and Human Services, Office of General Counsel, Food and Drug Division, Silver Spring, MD USA.
authors: Megan E
authors: ME
authors: Larkin
authors: Presidential Commission for the Study of Bioethical Issues, Washington, D.C. 20005, USA.
authors: Elizabeth R
authors: ER
authors: Pike
keywords: clinical trial; compensation; compensatory justice; no-fault compensation; remedy; research injury