Reflections on the 2024 Final Rule on Public Health Service Policies on Research Misconduct

The Office of Research Integrity (ORI) of the U.S. Department of Health and Human Services (HHS) recently issued the 2024 Final Rule on Public Health Service Policies on Research Misconduct (42 CFR 93), the first major revision of the regulation in nearly twenty years. Much of the commentary published about the 2024 Final Rule has focused on its impacts on research misconduct proceedings at institutions receiving Public Health Service funding. But formally addressing research misconduct is just one part of a larger effort needed to promote research integrity and the responsible conduct of research, and the new rule has the potential to affect this larger effort.

This article examines the evolution of the 2024 Final Rule and analyzes five changes with the potential to have broader impacts on cultures of research integrity at U.S. institutions. We consider changes that did and not happen in development from the 2005 Final Rule to the 2023 Notice of Proposed Rulemaking (NPRM) and the 2024 Final Rule.

We identify three changes that the research community should welcome (partnership between ORI and the regulated community, identifying potential respondents, and defining research integrity), one change of concern (redefining plagiarism), and one change that might or might not be welcome (promoting research integrity and the responsible conduct of research).

Although there is cause for concern about some of the 2024 Final Rule's potential implications for cultures of research integrity at US institutions, the positive changes support an optimistic outlook. In the coming years, it will be critical for HHS, ORI, the research community, and other stakeholders to work hand-in-hand to build on the progress made in the 2024 Final Rule to prevent and address research misconduct as part of a comprehensive effort to promote research integrity and the responsible conduct of research.