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ORI Issues Final Changes to Research Misconduct Regulations: Key Reforms and Lingering Complexities
Webinar
September 19, 2024 @ 1:00 pm – 2:30 pm
Description: On Thursday, September 19, 2024, the MRCT Center and Ropes & Gray will be co-presenting a webinar to review significant changes to the federal research misconduct regulations outlined in the highly anticipated Final Rule, issued on September 12, 2024, by the U.S. Department of Health and Human Services’ (“HHS”) Office of Research Integrity (“ORI”). Ropes & Gray has prepared a redline of the changes against the current regulations (available here) and a redline of the changes against the proposed rule (available here).
The Final Rule outlines changes to the federal research misconduct regulations set forth at 42 C.F.R. Part 93 (“Part 93”). Part 93 sets forth the federal regulatory framework that must be followed for investigating allegations of research misconduct (falsification, fabrication, or plagiarism) pertaining to research in which U.S. Public Health Service funds—including NIH funds—have been provided. The changes outlined under the Final Rule are extensive and highly impactful and include significant changes from the proposed rule that was published by ORI in October 2023. By way of example, the Final Rule omits a provision in the proposed rule that would have prohibited institutions from reaching an “honest error” finding at an early stage of a research misconduct proceeding. These changes will require institutions to implement significant changes to their existing policies and practices for reviewing allegations of misconduct. The Final Rule provides that institutions must implement these changes by January 1, 2026.
For a detailed discussion of the key changes in the Final Rule, we invite you to attend our webinar on Thursday, September 19, 2024. MRCT Center Faculty Director Barbara Bierer and Ropes & Gray presenters, including Mark Barnes, co-founder and Faculty co-Director of the MRCT Center, will be joined by The University of Texas MD Anderson Cancer Center’s Madhu Purewal, Senior Legal Officer & Executive Director, Research Compliance, who will offer perspective during the question and answer portion of the webinar on the significance of the rule changes from the perspective of a large academic research institution.