title: Federal Government's Proposed Expansion of Regulation of Biospecimen Research Should Be Reconsidered.
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.
authors.affiliation: James E. Rogers College of Law and Arizona Health Sciences Center Regulatory Science Program, University of Arizona , Tucson, Arizona.
authors.forename: Christopher T
authors.initials: CT
authors.lastname: Robertson
authors.affiliation: James E. Rogers College of Law and Arizona Health Sciences Center Regulatory Science Program, University of Arizona , Tucson, Arizona.
authors.forename: Jonathan D
authors.initials: JD
authors.lastname: Loe
mesh_terms: D018070:Biological Specimen Banks / Q000331:legislation & jurisprudence*; D035843:Biomedical Research / Q000331:legislation & jurisprudence*; D035082:Federal Government; D006801:Humans; D057285:Precision Medicine; D013048:Specimen Handling; D014019:Tissue Donors / Q000331:legislation & jurisprudence*; D014481:United States
keywords: biospecimens; common rule; consent; human subjects protection; privacy; regulation