The document critically examines the expanding regulatory and administrative burdens faced by U.S. academic research institutions engaged in federally funded research, particularly under the Department of Health and Human Services (HHS) and the National Institutes of Health (NIH). Despite a series of expert and congressional reports since the late 1990s recommending streamlining and harmonization of federal research regulations, few substantive reforms have materialized, and compliance requirements continue to increase. The document argues that efforts to reduce the regulatory burden should not be linked to short-term financial adjustments, such as reductions in facilities and administrative costs, as tangible benefits from reforms require significant time to be realized and because administrative burdens on faculty do not correlate straightforwardly with institutional costs. Persistent issues include duplicative and inconsistent requirements for conflict of interest reporting, subrecipient monitoring, personnel expense documentation, financial reporting (including redundant reporting for minimal credits and real-time cash balance), and proposal and award management.
In response to these challenges, the document outlines a series of targeted recommendations intended to align with recent legislative initiatives like the 21st Century Cures Act. Key recommendations include harmonizing conflict of interest definitions and disclosure thresholds across agencies, reducing unnecessary and duplicative reporting and documentation—particularly for subrecipients subject to federal audits—, adopting the 120-day grant closeout period universally within HHS, eliminating redundant reporting such as the Federal Cash Transaction Report, and providing flexibility in documenting personnel costs. The document also advises limiting the single IRB mandate for multisite studies to large biomedical trials, clarifying definitions relevant to clinical trials to avoid overburdening social and behavioral research, piloting streamlined proposal and budgeting procedures, and re-evaluating longstanding NIH policy positions on genomic data and inventions. The overarching thrust is to ensure that regulatory processes both maintain the integrity and credibility of research and the protection of participants, while refocusing limited investigator and institutional resources on scientific discovery rather than administrative compliance.
