Revised US Research Misconduct Rule Applies to Allegations from 1 January 2026

42 CFR Part 93 sets out how institutions that receive Public Health Service funding, most prominently from the National Institutes of Health, must respond to allegations of fabrication, falsification and plagiarism in research. The regulation had not been substantially revised since 2005. The Office of Research Integrity (ORI) published a proposed rule in 2023 and, after public comment, issued the final rule in the Federal Register on 17 September 2024. Commentators from law firms note that the final text is narrower than the 2023 proposal in several places, reflecting concerns raised by institutions during consultation.

According to the rule, its purpose is to implement policy changes and respond to technological developments affecting research misconduct over recent years. The revised text keeps the core definition of research misconduct but adds definitions and procedural detail that institutions had previously relied on guidance to interpret. For example, the earlier regulation required misconduct to be committed intentionally, knowingly or recklessly but did not define those terms; the final rule now defines them, as law firm Crowell and Moring and others have noted.

ORI has said that plagiarism, as a form of research misconduct, “does not include self-plagiarism or authorship or credit disputes.” This codifies a position that ORI had previously set out in guidance. Institutions may still address such matters under their own codes of conduct, but they fall outside the federal misconduct process.

The rule became legally effective on 1 January 2025. ORI has clarified that an institution needs to begin following the revised requirements for allegations it receives on or after 1 January 2026. Allegations received before that date continue to be handled under the 2005 version of Part 93, unless the respondent agrees in writing to proceed under the new rule. The new rule does not apply retroactively to open cases.

Institutions were not required to implement and submit revised policies and procedures until their annual report covering 2025, which was due on or before 30 April 2026. Secondary sources describe this filing as made through the Annual Report on Possible Research Misconduct (Form PHS-6349). That deadline has passed. Separately, the regulation requires institutions to keep their policies compliant and to provide them to ORI on request, so the obligation continues beyond the annual filing.

In June 2025 ORI released guidance documents to support implementation, including an implementation guide on the revised regulation and sample policies and procedures. ORI states that where guidance and the regulation conflict, the regulation prevails.

Summaries published by law firms and compliance consultancies identify several procedural changes. One secondary summary reports that the time limit for completing an investigation was extended from 120 days to 180 days. Others note that institutions must transmit a full institutional record to ORI after reaching a final determination, and that ORI findings are not required for an institution’s own decision on research misconduct to be considered final. These points are drawn from secondary sources; institutions should confirm the exact requirements and section numbers in the Federal Register text before revising procedures.

Because the procedural details differ from the 2005 process, research integrity officers who trained under the old regulation will need to review each stage of their procedures, from the initial assessment of an allegation through to the record sent to ORI.

ORI’s 2025 annual report, published in 2026, records 446 allegations received and 147 oversight cases opened in 2025, which gives a sense of the volume of matters that institutions and ORI handle each year.

For researchers and authors supported by Public Health Service funds, the rule determines how an allegation against their work will be assessed, who sees the record and how long the process takes. Because self-plagiarism and authorship disputes are excluded from the federal definition, these issues are likely to be handled through institutional policies, journal processes or publication ethics bodies instead. Authors should not assume, however, that such conduct is acceptable: institutions and journals continue to set their own standards.

Contract research organisations and medical writing teams working on NIH-funded studies should be aware that the funded institution, not the contractor, holds the assurance with ORI. Contracts and data management plans should make it possible for the institution to secure research records promptly if an allegation arises, since the record sent to ORI depends on them. This brief summarises the regulation for information only and is not legal advice.