Proposed Revisions to the Common Rule Perspectives of Social and Behavioral Scientists: Workshop Summary (2013) / Chapter Skim
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Introduction
Introduction
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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, col leges, and medical institutions, and each study generally took place at only a single site.
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4. Issues related to the protection of research participants in studies that involve use of existing data and data sharing, because the ANPRM proposed applying standards for protecting the privacy of healthcare data to research data.
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The workshop also did not cover the full body of evidence on the functioning of the Common Rule and IRBs, particularly questions related to the evidence for over-regulation or under-regulation of human participants in social and behavioral sciences research. However, the workshop did provide the basis for additional study of these issues and topics by the committee.
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