title: Disruptive Influences on Research in Academic Pathology Departments: Proposed Changes to the Common Rule Governing Informed Consent for Research Use of Biospecimens and to Rules Governing Return of Research Results.
abstract: Academic pathology departments will be dramatically affected by proposed United States federal government regulatory initiatives. Pathology research will be substantially altered if proposed changes to the Common Rule (Code of Federal Regulations: Protection of Human Subjects title 45 CFR 46) and regulations governing the return of individual research results are approved and finalized, even more so now that the Precision Medicine initiative has been launched. Together, these changes are disruptive influences on academic pathology research as we know it, straining limited resources and compromising advances in diagnostic and academic pathology. Academic research pathologists will be challenged over the coming years and must demonstrate leadership to ensure the continued availability of and the ethical use of research pathology specimens.
authors.affiliation: American Society for Investigative Pathology, Bethesda, Maryland. Electronic address: mesobel@asip.org.
authors.forename: Mark E
authors.initials: ME
authors.lastname: Sobel
authors.affiliation: Dreyfus Consulting, LLC, Takoma Park, Maryland.
authors.forename: Jennifer C
authors.initials: JC
authors.lastname: Dreyfus
mesh_terms: D035843:Biomedical Research / Q000331:legislation & jurisprudence*; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D010336:Pathology / Q000331:legislation & jurisprudence*