New Guidance on Research Misconduct Oversight
For the first time in twenty years, US federal rules on research misconduct have been rewritten. New ORI guidance helps PHS-funded institutions get their policies ready before the January 2026 deadline.
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U.S. federal guidance on research misconduct has evolved to clarify how institutions and individuals supported by the Public Health Service (PHS) must address allegations in biomedical and behavioral research, training, and related activities. The Department of Health and Human Services Office of Research Integrity (ORI), which oversees these efforts, recognized the need for clearer and more flexible regulations and, in 2024, published the first updated Public Health Service Policies on Research Misconduct (42 CFR Part 93) in twenty years. In June 2025, ORI released accompanying guidance to help institutions prepare for the regulation’s applicability beginning January 1, 2026. Because maintaining written policies and procedures that meet PHS requirements is a condition for receiving and retaining PHS funding, this new guidance helps institutions develop compliant and effective frameworks for responding to research misconduct.
The first group of guidance documents made publicly available in June 2025 included:
Writing Policies and Procedures: Directions for developing institutional policies aligned with PHS regulations.
Sample Policies and Procedures: Customizable templates to facilitate compliance and implementation.
Small Institution Guidance: Resources for smaller institutions to align with PHS standards.
Implementation Guidance: Clarifies the effective and applicable dates of the updated regulation.
In September 2025, ORI released a second phase of guidance covering issues such as honest error, admissions, pursuing leads, sub-awardee assurances, and assessments. These materials aim to clarify procedures and promote greater consistency across all the PHS-funded institutions. The Collaborative Institutional Training Initiative, a leading provider of research ethics and compliance training, emphasized the practical value of ORI’s materials, praising their clear organization and plain language, while the law firm Ropes & Gray LLP described the release as a key compliance resource that consolidates core regulatory provisions and helps institutions update their policies to meet the revised requirements.
The Science Integrity Alliance will continue to follow ORI’s efforts and share updates as institutions prepare for full implementation of the revised regulation by January 1, 2026, supporting PHS-funded organizations in strengthening compliance and research integrity.
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Luciana Machado. New Guidance on Research Misconduct Oversight. REACH 2025;2(October-December):19.
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