A Therapeutic Jurisprudence Perspective on Participation in Research by Subjects with Reduced Capacity to Consent: A Comment on Kim and Appelbaum

Behavioral Sciences & the Law, Vol. 24, pp. 486-494, 2006

University of Miami Legal Studies Reseach Paper No. 2007-11

11 Pages Posted: 7 May 2007 Last revised: 8 Feb 2014

See all articles by Bruce J. Winick

Bruce J. Winick

University of Miami School of Law

Kenneth W. Goodman

University of Miami

Abstract

The law on the protection of human subjects in biomedical and behavioral research remains unclear for research subjects of reduced capacity. Regulations of the U.S. Department of Health and Human Services fail to address many of the key issues. Federal regulations prohibit participation in research unless the investigator has obtained a legally effective informed consent of the subject or the subject's legally authorized representative. When the individual is not competent to provide informed consent, the key question is when his representative can consent on his behalf. Few people execute advance directive instruments, and even those who do rarely deal with future participation in research.

Research is much needed to increase understanding of conditions such as Alzheimer's disease and chronic mental illness. Yet, many individuals in these categories will not possess sufficient competence to decide on research participation for themselves. This article argues for a relaxation of traditional competency rules in this area so as to facilitate increased research. While strong utilitarian considerations argue for expansion of the opportunities for research with these populations, the traditional value we place on the protection of human rights and dignity justifies imposing restrictions on such participation. When an individual is unable to comprehend the risks and rationally decide, society is generally reluctant and even unwilling to permit participation.

This article contends that the debate has insufficiently taken into account an important consideration - the therapeutic dimension. By focusing attention on the therapeutic jurisprudence considerations that participation in research raises, this article seeks to clarify the debate.

Suggested Citation

Winick, Bruce J. and Goodman, Kenneth W., A Therapeutic Jurisprudence Perspective on Participation in Research by Subjects with Reduced Capacity to Consent: A Comment on Kim and Appelbaum. Behavioral Sciences & the Law, Vol. 24, pp. 486-494, 2006, University of Miami Legal Studies Reseach Paper No. 2007-11 , Available at SSRN: https://ssrn.com/abstract=984463

Bruce J. Winick (Contact Author)

University of Miami School of Law ( email )

P.O. Box 248087
Coral Gables, FL 33146
United States
304-284-3031 (Phone)
304-284-3210 (Fax)

HOME PAGE: http://www.brucewinick.com

Kenneth W. Goodman

University of Miami ( email )

Miami, FL 33136
United States

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