The Human Subjects Trade: Ethical and Legal Issues Surrounding Recruitment Incentives

21 Pages Posted: 9 Feb 2004 Last revised: 6 Feb 2014

See all articles by Trudo Lemmens

Trudo Lemmens

University of Toronto - Faculty of Law

Paul B. Miller

Notre Dame Law School

Date Written: August 16, 2011

Abstract

Offers to health-care professionals of finder's fees ranging between $2,000 and $5,000 per subject referred to clinical trials are now common in the United States and Canada. Finder's fees have to be situated in the larger context of the commercialization of medical research and the growing demand for research subjects. This article first discusses the context in which these financial recruitment incentives are used and the potential impact on research subjects and on the integrity of the research process itself. The authors then argue that it is inappropriate to rely on IRBs to curb the negative consequences of this practice, because of the conflicts of interest embedded in the current IRB system and the vagueness of the guidelines they are asked to apply. The authors highlight how more stringent legal means can be used to control this practice, including statutes governing the professions, tort law, law of fiduciary duty, and criminal law. They emphasize that stricter oversight of conflicts of interest by institutional and regulatory authorities and better enforcement of existing regulatory and legal remedies are needed to safeguard the rights and well-being of research subjects and to preserve the integrity of the research process.

Keywords: Medical research, finder's fees, recruitment incentives, IRB review, research regulation, conflict of interest, legal liability, fiduciary duty

JEL Classification: K32, 118, K13, K14

Suggested Citation

Lemmens, Trudo and Miller, Paul B., The Human Subjects Trade: Ethical and Legal Issues Surrounding Recruitment Incentives (August 16, 2011). Journal of Law, Medicine & Ethics, Vol. 31, No. 3, pp. 398-418, Fall 2003. Available at SSRN: https://ssrn.com/abstract=495387

Trudo Lemmens (Contact Author)

University of Toronto - Faculty of Law ( email )

78 and 84 Queen's Park
Toronto, Ontario M5S 2C5
Canada

Paul B. Miller

Notre Dame Law School ( email )

P.O. Box 780
Notre Dame, IN 46556-0780
United States

HOME PAGE: http://law.nd.edu/directory/paul-miller/

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