Federal Government’s Proposed Expansion of Regulation of Biospecimen Research Should Be Reconsidered image

Biopreservation and Biobanking, September 2016
Christopher T. Robertson and Jonathan D. Loe


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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.

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bioethics biotechnology genetics health law policy human subjects research human tissue innovation regulation research