The document, produced by the Council on Governmental Relations (COGR), provides a comprehensive critique of the current landscape of federal research regulations, with particular attention to the policies promulgated by the Department of Health and Human Services (HHS) and the National Institutes of Health (NIH). It draws attention to the growing administrative and financial burden placed on researchers and institutions due to increasingly complex and often overlapping regulatory requirements, despite numerous past recommendations for reform from prominent reports and advisory entities. Key issues highlighted include inconsistent definitions and thresholds for financial conflicts of interest across agencies, overly prescriptive subrecipient monitoring obligations, non-uniform grant closeout and reporting requirements, and duplicative or redundant financial and compliance processes. The document also critiques policies specific to human subjects research, such as the NIH single IRB mandate for multisite studies and the expanded NIH definition of “clinical trial,” arguing that such measures, while intended to improve research integrity, often introduce new inefficiencies or administrative difficulties without clear benefit.
COGR offers practical, well-supported recommendations to address these concerns, advocating for harmonization and simplification of key regulatory areas. Specific proposals include aligning conflict of interest policies and disclosure thresholds across agencies to reduce unnecessary reporting, exempting certain subrecipients from duplicative monitoring when single federal audits are already in place, and standardizing the 120-day closeout model for grants to minimize administrative complexity. The document further suggests eliminating redundant financial reporting (such as the Federal Cash Transaction Report where real-time systems exist), reevaluating NIH rules on modular budgets, biosketch requirements, and proposal submissions, and calling for broader stakeholder engagement in the implementation of new reporting and compliance systems. COGR also recommends that definitions and regulatory scopes, such as those defining clinical trials and human subjects for genomic data sharing, be realigned or narrowed for greater clarity and efficiency. Overall, the document stresses that careful regulatory reform and harmonization across federal agencies is necessary to ensure that compliance activities support rather than impede the effective conduct of federally funded research.
