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Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary

Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary

Paperback

General EducationGeneral Sociology

ISBN10: 0309288231
ISBN13: 9780309288231
Publisher: Natl Academy Pr
Published: Sep 26 2013
Pages: 110
Weight: 0.45
Height: 0.30 Width: 5.80 Depth: 8.90
Language: English

On July 26, 2011, the U.S. Department of Health and Human Services issued an advance notice of proposed rulemaking (ANPRM) with the purpose of soliciting comments on how current regulations for protecting research participants could be modernized and revised. The rationale for revising the regulations was as follows: this ANPRM seeks comment on how to better protect human subjects who are involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. The current regulations governing human subjects research were developed years ago when research was predominantly conducted at universities, colleges, and medical institutions, and each study generally took place at only a single site. Although the regulations have been amended over the years, they have not kept pace with the evolving human research enterprise, the proliferation of multisite clinical trials and observational studies, the expansion of health services research, research in the social and behavioral sciences, and research involving databases, the Internet, and biological specimen repositories, and the use of advanced technologies, such as genomics.

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General Sociology