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

Christopher T. Robertson, Jonathan D. Loe

Research output: Contribution to journalArticlepeer-review

2 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)447-449
Number of pages3
JournalBiopreservation and Biobanking
Volume14
Issue number5
DOIs
StatePublished - Oct 1 2016

Keywords

  • biospecimens
  • common rule
  • consent
  • human subjects protection
  • privacy
  • regulation

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • General Biochemistry, Genetics and Molecular Biology
  • Cell Biology

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