The document from the Council on Governmental Relations (COGR) provides a comprehensive analysis of regulatory challenges faced by research institutions under the U.S. Department of Health and Human Services (HHS) and the National Institutes of Health (NIH). It details longstanding concerns about the escalating administrative burden and costs associated with federal research regulations, highlighting minimal implementation of prior reform recommendations despite repeated studies over several decades. The core argument is that while increased regulatory requirements have yielded marginal improvements in research integrity or transparency, they have simultaneously imposed significant costs—both financial and in lost research productivity—on universities and investigators. Efforts to alleviate this burden, the document argues, should not be conflated with short-term reductions in overhead costs, as the actual impact of reforms on expenditures will be neither immediate nor directly proportional.
The document systematically reviews key areas of regulatory burden, including financial conflict of interest disclosure, subrecipient monitoring, animal research oversight, personnel expense documentation, financial reporting, and the use of single Institutional Review Boards (IRBs) for multi-site studies. It provides specific practical recommendations, such as harmonizing and streamlining conflict of interest policies across agencies, simplifying subrecipient monitoring for entities already subject to federal single audits, adopting more flexible methods for documenting personnel expenses, standardizing financial closeout and reporting timelines, and reevaluating mandates like the single IRB review and expanded definitions of clinical trials. The overarching theme is the call for consistency, reduction of redundancy, and engagement with stakeholders to ensure new policies genuinely support scientific productivity without compromising research integrity or compliance. Finally, the document urges reconsideration or withdrawal of policies that uniquely burden research without clear benefit, such as certain NIH genomic data and licensing policies, advocating for evidence-based reforms that balance accountability with operational efficiency.
