The Council on Governmental Relations (COGR) expresses significant concerns regarding the proposed revisions to the Common Rule governing human subjects research. COGR argues that the proposed changes offer minimal advantages in terms of strengthening protections or reducing administrative burdens for researchers, contrary to assertions by the Department of Health and Human Services. Analyses of public comments and expert feedback reveal widespread opposition to the rule, citing its complexity, lack of clarity, insufficient data support, and exclusion of critical provisions. Leading advisory bodies, including SACHRP and the National Academies, have recommended either a comprehensive rewrite or withdrawal of the rule, warning that rapid implementation could lead to increased costs, inefficiencies, and lost opportunities for meaningful modernization.
Substantively, COGR opposes the reclassification of de-identified data and biospecimens as inherently identifiable, as these changes could impede important research without necessarily enhancing participant protections. Additionally, COGR challenges the mandate for single institutional review boards (IRBs) in multi-site studies, questioning the cost-efficiency claims and noting a lack of evidence for improved efficiency outside of large-scale clinical trials. Concerns are also raised about extending the Common Rule to non-federally funded research and imposing standardized data security requirements, which could constrain flexibility and add disproportionate burdens, especially for low-risk studies. In conclusion, COGR urges withdrawal of the proposed rule, advocating for greater stakeholder engagement and transparency to ensure any revisions address both the practical and ethical imperatives of human research protection.
