Bass, Berry & Sims attorney Clint Hermes co-authored an article for Bloomberg Law examining the Final Rule that was issued by the Department of Health and Human Services Office of Research Integrity (ORI) related to research misconduct regulations. Clint authored the article with Zoë Hammatt, the former Director of the Division of Education and Integrity at ORI and David Wright, the former Director of ORI.
This is the first time in nearly 20 years that changes have been made (the Final Rule) to 42 CFR part 93. To view a redlined comparison of the Final Rule to the existing Part 93, click here. Institutions that apply for or receive funding from the National Institutes of Health and other Public Health Service agencies “must (1) apply the Final Rule to research misconduct proceedings based on allegations received on or after January 1, 2026, and (2) implement and submit revised policies and procedures that comply with the Final Rule to ORI on or before April 30, 2026.”
The authors outline certain ambiguities and unresolved issues within the Final Rule that institutions should consider ahead of these deadlines, including issues related to:
- Definition of “recklessness.”
- Interview transcripts.
- Subsequent use exception.
- Respondent production of records.
The authors conclude by noting that many of these quandaries posed by the Final Rule can be ameliorated to some extent by 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), but also those that affect the maintenance of the research record, detection of potential misconduct before a research record is published or used (e.g., software that detects image manipulation in a manuscript), training and supervision, and shifting institutional incentives (e.g., giving doctoral candidates academic credit for replicating experiments) —all of which could reduce the likelihood of misconduct while contributing to the trustworthiness of the research system and its results.
The full article, “HHS Federal Rule Change Clarifies Research Misconduct Proceedings,” was published by Bloomberg Law on October 1 and is available online.