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Human Subjects Research Regulation
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Human Subjects Research Regulation: Perspectives on the Future

I. Glenn Cohen and Holly Fernandez Lynch

Abstract

The current framework for the regulation of human subjects research emerged largely in reaction to the horrors of Nazi human experimentation, revealed at the Nuremburg trials, and the Tuskegee syphilis study, conducted by U.S. government researchers from 1932 to 1972. This framework, combining elements of paternalism with efforts to preserve individual autonomy, has remained fundamentally unchanged for decades. Yet, as this book documents, it has significant flaws—including its potential to burden important research, overprotect some subjects and inadequately protect others, generate inconsist ... More

Keywords: Human subjects research, Regulation, Law, Common Rule, Genetics, Paternalism, Consent, Institutional Review Board, Risk

Bibliographic Information

Print publication date: 2014 Print ISBN-13: 9780262027465
Published to MIT Press Scholarship Online: January 2015 DOI:10.7551/mitpress/9780262027465.001.0001

Authors

Affiliations are at time of print publication.

I. Glenn Cohen, editor
Harvard Law School

Holly Fernandez Lynch, editor

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Contents

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Introduction

I. Glenn Cohen and Holly Fernandez Lynch

I Regulation of Risk

II Protection of Vulnerable Populations

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