Federal Government's Proposed Expansion of Regulation of Biospecimen Research Should Be Reconsidered. - PubMed - NCBI

Federal Government's Proposed Expansion of Regulation of Biospecimen Research Should Be Reconsidered. - PubMed - NCBI

Biopreserv Biobank. 2016 Mar 30. [Epub ahead of print]

Federal Government's Proposed Expansion of Regulation of Biospecimen Research Should Be Reconsidered.

Robertson CT1, Loe JD1.

Author information

Abstract

In September, the U.S. Department of Health and Human Services, together with other federal agencies, announced proposed changes to the rules governing human subjects research. This Commentary discusses how the proposals would affect research using biospecimens that is essential to the future success of precision medicine. We argue that the proposed changes unnecessarily burden such research, without meaningfully advancing the interests of donors. They should be revised before being finalized.

PMID:

 

27028135

 

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