The Council on Governmental Relations (COGR), representing leading research institutions, provided a comprehensive critique of the proposed revisions to the Federal Policy for the Protection of Human Subjects (Common Rule), as published in September 2015. While supporting efforts to streamline administrative requirements—such as eliminating continuing reviews for minimal risk studies and broadening exempt/expedited review categories—COGR expressed strong concerns over several major proposed changes. Chief among these were expanding the definition of “human subject” to include all biospecimens, imposing mandatory and universal consent requirements, restricting the use of IRB consent waivers, requiring new HIPAA-like data security measures, and mandating single IRB oversight for all multisite studies.
COGR argued that these proposals would introduce significant operational burdens, render compliance more costly and ambiguous, and risk impeding valuable research, particularly for smaller or less-resourced institutions. They cautioned that such requirements would curtail research opportunities and could lead to the destruction of valuable biospecimen resources, without tangible improvements to participant protections. The organization highlighted an ethical imbalance in the rule’s focus, cautioning that an emphasis on autonomy appeared to overshadow the equally critical Belmont principles of beneficence and justice.
The response emphasized the adequacy of existing oversight—such as institutional review boards and HIPAA—for safeguarding human subjects, pointing out a lack of evidence to justify more restrictive consent and biospecimen provisions. COGR favored maintaining current definitions concerning identifiability, recommending only cautious, targeted updates in response to advances such as whole genome sequencing rather than across-the-board expansions. Throughout, they championed clarity, practical investigator tools, regular but measured regulatory updates, and risk-based harmonization across agencies.
COGR also challenged proposals to extend Common Rule requirements to all clinical trials regardless of funding source, arguing this would unduly strain institutions without benefiting participants, especially in behavioral and social sciences research. They advocated for flexibility in the application of IRB waivers, careful definition of “clinical trial” and “vulnerable populations,” and a collaborative, evidence-driven process for developing any new regulatory guidance. Ultimately, COGR called for only consensus, well-developed changes to be advanced, underpinned by robust cost-benefit analysis and developed in partnership with the research community, to ensure that regulatory efforts enhance, rather than undermine, both the protection of human subjects and the research enterprise itself.
COGR Detailed and Summary Comments on Common Rule
