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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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Subjects, Participants, and Partners: What Are the Implications for Research as the Role of Informed Consent Evolves?

Subjects, Participants, and Partners: What Are the Implications for Research as the Role of Informed Consent Evolves?

Chapter:
(p.143) 9 Subjects, Participants, and Partners: What Are the Implications for Research as the Role of Informed Consent Evolves?
Source:
Human Subjects Research Regulation
Author(s):

Alexander Morgan Capron

Publisher:
The MIT Press
DOI:10.7551/mitpress/9780262027465.003.0013

Informed consent is usually thought of as the ethical cornerstone of research with human beings yet over the past thirty years a largegap has opened between informed consent as an object of veneration and its actual role as a governing concept in research with human subjects. This chapter argues that our failure to recognize that gap—and to make necessary policy adjustments—should be on the minds of the drafters of any proposal to reframe the federal regulations for research with human beings.Such attention would be particularly fitting because the federal rules themselves bear much of the responsibility for the diminishing importance of informed consent in research.

Keywords:   Common Rule, Declaration of Helsinki, informed consent, Institutional Review Board (IRB), Nuremberg Code, research subject/participant, research review

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