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Human Subjects Research RegulationPerspectives on the Future$
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I. Glenn Cohen and Holly Fernandez Lynch

Print publication date: 2014

Print ISBN-13: 9780262027465

Published to MIT Press Scholarship Online: January 2015

DOI: 10.7551/mitpress/9780262027465.001.0001

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Back to the Future? Examining the Institute of Medicine's Recommendations to Loosen Restrictions on Using Prisoners as Human Subjects1

Back to the Future? Examining the Institute of Medicine's Recommendations to Loosen Restrictions on Using Prisoners as Human Subjects1

Chapter:
(p.93) 6 Back to the Future? Examining the Institute of Medicine's Recommendations to Loosen Restrictions on Using Prisoners as Human Subjects1
Source:
Human Subjects Research Regulation
Author(s):

Osagie K. Obasogie

Publisher:
The MIT Press
DOI:10.7551/mitpress/9780262027465.003.0009

There have been notable discussions within scientific literature, bioethics scholarship, and the popular press regarding the Institute of Medicine’s 2006 recommendations to the Department of Health and Human Services to loosen federal restrictions on using prisoners in biomedical and behavioral research. Yet there has been little dialogue among legal scholars about the recommendations’ potential impact on administrative policy. A common underlying theme in this debate is a focus on the possible outcomes produced by these recommendations rather than examining the argument made by the IOM Committee in proposing changes to 45 C.F.R. § 46, Subpart C. While valuable, this focus on possible outcomes might obscure a critical question that has thus far remained relatively unexamined: did the IOM come to this recommendation for a substantial shift in regulatory policy in a rigorous manner? As part of a broader effort to think about ethics’ evolving relationship with administrative policy, this chapter takes a closer look at the ethical framework used to justify these recommendations. Before considering any changes to Subpart C, the chapter argues that greater attention must be paid to how empirical methods can inform research ethics in prison, the different contexts that heighten prisoners’ vulnerability as human subjects, and the relevance of human rights to research ethics.

Keywords:   Research ethics, Prisoners, Human rights, Institute of Medicine, Administrative Policy

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