Disruptive Influences on Research in Academic Pathology Departments

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.

A Proposed Process for Reliably Updating the Common Rule

“…Some argued that, despite this sustained negative feedback from research institutions, the subsequent NPRM proposal on biospecimens still did not address concerns raised during the first comment period (Grizzle 2015). Stakeholders expressed similar worries during the NPRM comment period; one study estimated that 70% of comments on the NPRM referenced the biospecimen proposals and “more than half of the general public and 80% of the top 30-ranked universities opposed the proposed changes” (Sobel and Dreyfus 2017, 6).…”