HHS Federal Rule Change Clarifies Research Misconduct Proceedings

Changes are coming for institutions, from universities to hospitals, that apply for or receive research funding from the US Public Health Service. Earlier this month, the Department of Health and Human Services’ Office of Research Integrity issued a final rule, making major revisions to its research misconduct regulations for the first time in nearly 20 years.

The regulated community will likely view the final rule as a significant improvement to both current 42 CFR part 93 and the notice of proposed rulemaking issued last year. As with any significant rulemaking, ambiguities and unresolved issues remain.

Part 93 applies to all research funded by the National Institutes of Health and other components of the Public Health Service. Institutions that apply for or receive such funding must apply the final rule to research misconduct proceedings based on allegations received on or after Jan. 1, 2026, and implement and submit revised policies and procedures that comply with the final rule to the ORI on or before April 30, 2026.

Pending the ORI’s issuance of sample policies and procedures to comply with the final rule, as they currently have for part 93, PHS-funded institutions should consider how to address the following points.

Definition of “recklessness.” Part 93 states that a finding of research misconduct requires that the misconduct be committed intentionally, knowingly, or recklessly. The final rule introduces definitions of these scienter terms.

“Recklessly,” in the context of research misconduct, is defined as “to propose, perform, or review research, or report research results, with indifference to a known risk of fabrication, falsification, or plagiarism.”

A common scenario in research misconduct proceedings is alleged misconduct by an early career researcher that went unnoticed by a supervisor or more senior co-author, often due to lack of effective supervision and proper training.

Institutions should consider whether senior researchers can be found to have been indifferent to a known risk of misconduct, if in their supervisory role, they fail to provide necessary training and oversight for the research in question.

What should be the obligations of co-authors—especially senior ones—to review and ensure the integrity of manuscripts and grant proposals before submission? Obligations should be addressed in institutional policy.

Interview transcripts. Research misconduct proceedings take place in three stages (assessment, inquiry, and investigation) with distinct procedural requirements for each stage based on its purpose.

Part 93 requires that witness interviews be transcribed in the investigation stage, and the final rule includes a new requirement that the respondent is provided a copy of those transcripts. While this is helpful for respondents, this could dissuade more junior scientists from giving testimony against senior colleagues.

The ORI suggested in the preamble to the final rule that institutional policies could provide for redactions of transcripts to protect the identities of witnesses, but in some cases, only summaries or dramatic redactions could plausibly shield the identity of witnesses.

This could create an inevitable area of future disputes between institutions and counsel for respondents. Institutions should be as clear as possible about this to ensure protection of complainants and witnesses in their policies.

Subsequent use exception. Part 93 applies only to research misconduct occurring within six years of the date an institution receives an allegation of research misconduct, subject to two exceptions. One, the “subsequent use exception,” renews the limitation period each time the respondent cites, republishes, or makes certain uses of the research material subject to the misconduct allegation.

The final rule narrows this exception so that it will apply only to the respondent’s use or citation of “the portion(s) of the research record that is alleged to have been fabricated, falsified, or plagiarized.” This is likely to create fact-finding quandaries for institutions because citations in scientific literature, grant applications, and progress reports are rarely made to a specific portion of the research record. Institutions are free to provide policy guidance in the absence of any further clarification from the ORI.

Respondent production of records. A respondent’s failure to provide research records in a misconduct proceeding can be considered evidence of research misconduct where the institution establishes that the respondent intentionally, knowingly, or recklessly destroyed the records, failed to maintain the records, or doesn’t produce them in a timely manner.

The final rule changes this significantly, stating that “a respondent’s failure to provide records documenting the questioned research is evidence of research misconduct where the respondent claims to possess the records but refuses to provide them upon request.”

This seems to create an escape clause for those not cooperating in good faith with proceedings, while also allowing respondents to circumvent their data management responsibilities as researchers.

Institutions are presumably free to impose research record retention requirements and apply sanctions for failure to adhere to those requirements, but institutions don’t appear free to consider that failure to be evidence of ORI-regulated research misconduct outside of the circumstances described in the final rule.

Research institutions face a spectrum of challenges when handling allegations of research misconduct. On the one hand, there is evidence that research misconduct is a growing problem, exacerbated by allegations involving university presidents and hospital executives emerging in the national spotlight. A 2023 Pew Research Center survey demonstrates declining public trust in scientists.

Most respondents in research misconduct allegations aren’t found responsible for research misconduct, and the volume of claims that must be investigated has increased dramatically with the rise of platforms such as PubPeer.

These issues can improve with good institutional policies, practices, and tools—not just those that pertain specifically to part 93—e.g., defining and sanctioning bad faith allegations and deliberate breaches of confidentiality.

Detecting potential misconduct before a research record is published or used, providing training and supervision, and shifting institutional incentives, such as giving doctoral candidates academic credit for replicating experiments, could reduce the likelihood of misconduct while also contributing to the trustworthiness of the research system and its results.

This article does not necessarily reflect the opinion of Bloomberg Industry Group, Inc., the publisher of Bloomberg Law and Bloomberg Tax, or its owners.

Author Information

Clint Hermes is head of the clinical research practice at Bass, Berry & Sims and spent 13 years as the chief legal officer of two major research institutions.

Zoë Hammatt is adjunct associate professor at University of Hawaii School of Medicine and was director of the Division of Education and Integrity at ORI.

David Wright is president of Research Integrity Consultants and former director of ORI.

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