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

Christopher T Robertson, Jonathan D. Loe

Research output: Contribution to journalArticle

2 Scopus citations


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
Issue number5
Publication statusPublished - Oct 1 2016



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

ASJC Scopus subject areas

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

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