Citation

Chapman CR, Sukumaran S, Tsegaye GT, Shevchenko Y, Caplan AL. J. Law Med. Ethics 2019; 47(4): 732-747.

Affiliation

Carolyn Riley Chapman, Ph.D., M.S., is a Faculty Affiliate of the Division of Medical Ethics at NYU School of Medicine. Dr. Chapman received her B.A. from Dartmouth College (Hanover, NH), her Ph.D. from Harvard University (Cambridge, MA) and her M.S. in Bioethics at Columbia University (New York, NY). Sangita Sukumaran, M.D., is Professor and Head of Department of Pharmacology at Terna Medical College, Navi Mumbai, India. She received her MD (Pharmacology) degree from Lokmanya Tilak Municipal Medical College, Mumbai, India and her MBBS (Bachelors in Medicine & Bachelors in Surgery) from Grant Medical College, Mumbai, India. She received her Post Graduate Diploma in Bioethics from Indira Gandhi National Open University (IGNOU), India and received her International Fellowship in Bioethics & Ethics Committee administration from Western IRB, Puyallup, Washington, USA. Geremew Tarekegne Tsegaye, M.D., M.P.H., M.Sc., Pg. Dip., is a Program manager for Grand Challenges Ethiopia and IRB chair at Armauer Hansen Research Institute, Addis Ababa, Ethiopia. He received his MD (Medicine) degree from Jimma University, Ethiopia, and his MPH from Universite Libre De Bruxulles (Belgium) and Advanced Master of Bioethics of Erasmus Mundus program, organized by a consortium of three European Universities: Katholieke Universiteit Leuven (Belgium), Radboud Universiteit Nijmegen (The Netherlands) and Università di Padova (Italy). He has received an Advanced Post Graduate Diploma in African Bioethics from Stellenbosch University, South Africa, and an International Fellowship in Bioethics & Ethics Committee administration from Western IRB, Puyallup, USA. Yelena Shevchenko, Ph.D., is a Head of Strategic Planning and Analytics Department in the Science Fund of the Republic of Kazakhstan and a member of the Central State Ethics Commission under the Ministry of Health of the Republic of Kazakhstan. She has been conferred her Ph.D. in Economics by the decision of the Control Committee in Education and Science under the Ministry of Education and Science of the Republic of Kazakhstan. She has received her International Fellowship in Bioethics & Ethics Committee administration from Western IRB, Puyallup, USA. Arthur L. Caplan, Ph.D., is the Drs. William F and Virginia Connolly Mitty Professor and founding head of the Division of Medical Ethics at NYU School of Medicine. He received his B.A. from Brandeis University (Waltham, MA) and an M.A., M.Phil, and Ph.D. from Columbia University (New York, NY).

Copyright

(Copyright © 2019, American Society of Law, Medicine and Ethics, Publisher John Wiley and Sons)

DOI

10.1177/1073110519897737

PMID

31957586

Abstract

In the U.S., there is no requirement for research sponsors to compensate human research subjects who experience injuries as a result of their participation. In this article, we review the moral justifications that compel the establishment of a better research-related injury compensation system. We explore how other countries and certain institutions within the U.S. have adopted various systems of compensation. The existence of these systems demonstrates both that the U.S. lags behind other nations in its protection of human research subjects and that the establishment of a compensation system is both practical and feasible. We then examine factors which have prevented the U.S. from establishing its own compensation system. We consider possible alternatives for the U.S. by examining the advantages and disadvantages of both established and proposed systems. We offer a new proposal that addresses the justice concerns which compel the establishment of a national compensation system, distributes the burdens of such a system on multiple stakeholders that benefit from research, and has the additional advantage of minimizing the administrative and logistical challenges associated with initiating such a system.

Language: en