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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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Setting the Stage: The Past and Present of Human Subjects Research Regulations

Setting the Stage: The Past and Present of Human Subjects Research Regulations

(p.9) 1 Setting the Stage: The Past and Present of Human Subjects Research Regulations
Human Subjects Research Regulation

Amy L. Davis

Elisa A. Hurley

The MIT Press

This chapter provides a summary of the major regulatory changes to the Common Rule proposed in the June 2011 Advance Notice of Proposed Rulemaking (ANPRM), places those changes in historical context, and critically examines two proposed changes. The chapter begins with a review of the milieu in which human subjects protections regulations were developed 40 years ago and of the ANPRM’s objective to create a research oversight system better adapted to twenty-first century research. In the second, critical portion of the chapter, the authors argue that the ANPRM’s proposals regarding informed consent do not go far enough to shift focus from protecting institutions to educating potential research subjects, and propose an alternative approach to designing informed consent materials. The authors also argue that, with respect to data security, the ANPRM’s proposal to incorporate HIPAA standards to enhance privacy protections in the context of research is flawed in that it focuses on the distribution of private information, rather than its collection.

Keywords:   ANPRM, Belmont Report, Common Rule, HIPAA, Informed Consent, IRB, Privacy, Data Security

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