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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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Outsourcing Ethical Obligations: Should the Revised Common Rule Address the Responsibilities of Investigators and Sponsors?

Outsourcing Ethical Obligations: Should the Revised Common Rule Address the Responsibilities of Investigators and Sponsors?

Chapter:
(p.127) 8 Outsourcing Ethical Obligations: Should the Revised Common Rule Address the Responsibilities of Investigators and Sponsors?
Source:
Human Subjects Research Regulation
Author(s):

Seema K. Shah

Publisher:
The MIT Press
DOI:10.7551/mitpress/9780262027465.003.0012

The Common Rule sets up a division of moral labor in research. It implies that investigators and sponsors can outsource their ethical obligations to IRBs and participants. This ethical outsourcing fosters a culture of compliance amongst researchers and sponsors, rather than one of responsibility. The proposed revisions to the Common Rule are likely to exacerbate this problem by granting increased discretion to investigators without a corresponding increase in accountability. This chapter argues that the Common Rule should be revised to harness the expressive power of the law and should directly address the ethical responsibilities of investigators and sponsors.

Keywords:   Role morality, Research ethics, Regulatory compliance, Post-trial obligations

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