On September 12, 2024, the Office of Research Integrity (ORI) within the U.S. Department of Health and Human Services (HHS) issued a final rule (Final Rule) that significantly changes the standards, procedures, and requirements for research misconduct procedures. CFR Part 93 (Part 93) – A regulation that has not been amended since it was first codified in 2005.
Part 93 specifically regulates suspected research misconduct—falsification, fabrication, and plagiarism—in research funded by public health service (PHS) agencies, including the National Institutes of Health (NIH) and the Centers for Medicare and Medicaid Services (CMS). I will. , and other HHS grant-making agencies.
Key Takeaways and Practical Implications Although the final rule adopts many of the changes proposed from the proposed rule, ORI has revised certain proposed changes that may be unduly burdensome or problematic. By removing it, it appears they have listened to the concerns of institutions and other stakeholders. 30-day evaluation timeline requirements and ORI’s ability to publicly disclose information regarding final institutional actions that did not result in findings of research misconduct or settlements. The final rule clarifies a number of processes and procedures governing research misconduct proceedings. But questions such as how the new definition of “reckless” will affect principal investigators and others with oversight duties and how the narrowed “subsequent use” exception will work in practice , there are still some areas of ambiguity. Institutions and other stakeholders should look for additional ORI guidance on these topics in the future. Although the final rule also codified additional requirements, such as the extent to which investigation reports must be included, ultimately institutions retain useful discretion in discharging their responsibilities under research misconduct rules. Or earned. Overall, the final rule includes significant changes to the standards and procedures that institutions must follow when conducting research misconduct proceedings. Institutions should begin evaluating necessary revisions to their policies and procedures soon in preparation for the January 1, 2026 effective date.
For more information on the changes that ORI adopted and did not adopt, as well as an analysis of the rule’s anticipated impact on academic medical centers, research institutions, universities, and other regulated entities, see the Research Misconduct Final Rule white paper. Check it out here. organization.
