Bass, Berry & Sims attorney Clint Hermes discussed the potential impact on research integrity following the release of the new research misconduct rule (Final Rule) issued by the Department of Health and Human Services Office of Research Integrity (ORI) in September 2024.
Part of the Final Rule changes certain procedural aspects of a research misconduct investigation by requiring that respondents be provided transcripts of witness interviews. While intended to give the subject of the investigation more transparency into the substantive evidence against them, some industry leaders worry it will prevent co-workers from speaking out, especially if a colleague is asked about their boss or senior leaders. “If you’re a person giving testimony, especially if you’re a more junior person, you can see why that might dissuade you,” said Clint.
Additionally, the Final Rule changed the stance on the production of records, only allowing an inference of research misconduct when a respondent claims to possess the records but refuses to provide them upon request. Clint took issue with that change, saying it “provides a real opportunity for someone to simply claim they don’t have the records anymore” whether they do or not.
The full article, “New Research Misconduct Rule May Expose, Chill Witnesses,” was published by Law360 Healthcare Authority on October 8 and is available online (subscription required).
For more detail about the Final Rule, Clint co-authored an article for Bloomberg Law outlining certain ambiguities within the Final Rule that research institutions will need to consider. The piece was co-authored with Zoë Hammatt, the former Director of the Division of Education and Integrity at ORI and David Wright, the former Director of ORI. The full article, “HHS Federal Rule Change Clarifies Research Misconduct Proceedings,” was published by Bloomberg Law on October 1 and is available online