Just Compensation: A No-Fault Proposal for Research-Related Injuries

Journal of Law and the Biosciences, pp. 1-24, 2015, DOI: 10.1093/jlb/lsv034

U of Maryland Legal Studies Research Paper No. 2015-23

25 Pages Posted: 29 Aug 2015 Last revised: 2 Sep 2015

See all articles by Leslie Meltzer Henry

Leslie Meltzer Henry

University of Maryland Francis King Carey School of Law; Johns Hopkins Berman Institute of Bioethics

Megan Larkin

NIH Department of Bioethics

Elizabeth R. Pike

U.S. Department of Health & Human Services

Date Written: August 27, 2015

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.

Keywords: clinical trial, compensation, compensatory justice, no-fault compensation, research injury, remedy

Suggested Citation

Henry, Leslie Meltzer and Larkin, Megan and Pike, Elizabeth R., Just Compensation: A No-Fault Proposal for Research-Related Injuries (August 27, 2015). Journal of Law and the Biosciences, pp. 1-24, 2015, DOI: 10.1093/jlb/lsv034, U of Maryland Legal Studies Research Paper No. 2015-23, Available at SSRN: https://ssrn.com/abstract=2652355

Leslie Meltzer Henry (Contact Author)

University of Maryland Francis King Carey School of Law ( email )

500 West Baltimore Street
Baltimore, MD 21201-1786
United States
410-706-4480 (Phone)

HOME PAGE: http://www.law.umaryland.edu/faculty/profiles/faculty.html?facultynum=616

Johns Hopkins Berman Institute of Bioethics ( email )

1809 Ashland Ave.
Baltimore, MD 21205
United States

HOME PAGE: http://www.bioethicsinstitute.org/people/leslie-meltzer-henry

Megan Larkin

NIH Department of Bioethics ( email )

Warren G. Magnuson Clinical Center
Bethesda, MD 20895-1156
United States

Elizabeth R. Pike

U.S. Department of Health & Human Services ( email )

200 Independence Ave., SW
Washington, DC 20201
United States

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