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Playing Politics with ScienceBalancing Scientific Independence and Government Oversight$
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David B. Resnik

Print publication date: 2009

Print ISBN-13: 9780195375893

Published to Oxford Scholarship Online: January 2009

DOI: 10.1093/acprof:oso/9780195375893.001.0001

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Protecting Human Subjects in Research

Protecting Human Subjects in Research

Chapter:
(p.161) 7 Protecting Human Subjects in Research
Source:
Playing Politics with Science
Author(s):

David B. Resnik (Contributor Webpage)

Publisher:
Oxford University Press
DOI:10.1093/acprof:oso/9780195375893.003.0007

This chapter discusses some problems with the current U.S. system for protecting human research subjects. These problems indicate that in some ways the regulations provide too much oversight, in others too little. Examples of too much oversight include excessive paperwork, the review of low‐risk research, and an overly broad definition of research; examples of too little include inconsistencies and loopholes in the regulations, lack of compensation for injuries, inconsistent adverse event reporting, and lack of broad research review. Federal regulations and guidelines for research should be revised so that there is more emphasis on protection of human subjects and less emphasis on bureaucratic, administrative, and technical/legal issues. Although the current system has some problems, it has operated very well for more than three decades. In many ways, the institutional review board (IRB) system represents a judicious compromise between government oversight of human research and scientific autonomy. While there is no need to overhaul the system, changes should be made to improve the quality, scope, effectiveness, and fairness of research review and oversight.

Keywords:   human research subjects, research, federal regulations, oversight, institutional review board, risk

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