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What is Fair Participant Selection?

OXFORD TEXTBOOK OF CLINICAL RESEARCH ETHICS, Ezekiel J. Emanuel, et al eds., p. 377, 2008

11 Pages Posted: 1 Jul 2009  

Leslie Meltzer Henry

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

James Childress

affiliation not provided to SSRN

Date Written: July 1, 2009

Abstract

The U.S. regulations for the protection of humans in biomedical and behavioral research were "born in scandal and reared in protectionism." This paper discusses the evolution of these regulations and the gaps that still persist in the ongoing effort to strike a balance between protecting vulnerable populations from research risks and providing all individuals and groups with an equal opportunity to benefit from research. In particular, this paper focuses on racial, social, and economic inequities in the selection of research participants; the exclusion and underrepresentation of the elderly in research, and controversies about U.S. clinical trials conducted in developing countries.

Keywords: research, clinical, trial, regulations, common rule, vulnerable, justice, race, gender, international

Suggested Citation

Henry, Leslie Meltzer and Childress, James, What is Fair Participant Selection? (July 1, 2009). OXFORD TEXTBOOK OF CLINICAL RESEARCH ETHICS, Ezekiel J. Emanuel, et al eds., p. 377, 2008. Available at SSRN: https://ssrn.com/abstract=1428504

Leslie 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 )

United States

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

James Childress

affiliation not provided to SSRN ( email )

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