Comment Letter

COGR Submits Comments to ORI on Public Health Service Policies on Research Misconduct Notice of Proposed Rulemaking

The Council on Governmental Relations (COGR), representing over 200 major U.S. research universities and affiliates, submits extensive comments regarding the Office of Research Integrity's (ORI) proposed revisions to the Public Health Service (PHS) Policies on Research Misconduct. COGR expresses significant concerns that the proposed regulations, intended to clarify and streamline the research misconduct review process, would in fact impose additional administrative burdens, complicate procedures, and undermine institutional autonomy. Key criticisms include the introduction of a formalized assessment phase that restricts institutions' authority and flexibility during the initial review of allegations, the transition from a peer-driven process to a prosecution-focused, timeline-driven framework, and requirements that could inadvertently stigmatize honest error, discourage reporting, and prolong investigations unnecessarily.

COGR argues that the proposed changes disregard the intent of the NIH Revitalization Act, which vested primary responsibility for initial misconduct assessments with institutions. The association recommends maintaining institutional discretion at early process stages, ensuring due process for respondents, and modifying or deleting requirements that add undue complexity—such as rigid timelines, expanded reporting and documentation obligations, and certain confidentiality clauses that risk reputational harm before findings are substantiated. Additionally, COGR raises doubts about the estimates of institutional burden and implementation timelines put forth by ORI, advocating for a longer adjustment period and more realistic impact assessments. In conclusion, COGR cautions that the proposed regulations, as drafted, are likely to hinder rather than advance the goals of research integrity, urging ORI to consider more targeted amendments developed with substantive stakeholder engagement.

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