On September 12, 2024, the federal Office of Research Integrity (ORI) announced the release of the Department of Health & Human Services’ Final Rule on Public Health Service Policies on Research Misconduct. This marks the first changes to the federal research misconduct regulations in nearly two decades, as the current regulations were implemented in 2005. While the new rule is scheduled to be formally published on September 17, 2024, an unpublished version is already available for public inspection on the Federal Register’s website. The new rule retains an effective date of January 1, 2025, from the Notice of Proposed Rulemaking published in October 2023. However, the regulatory requirements are now applicable as of January 1, 2026—in recognition of the need to provide adequate time for necessary updates to institutional policies and procedures. ORI has announced it will also release additional guidance regarding the new rule.
This adoption of modified regulations by ORI will profoundly affect on the management of all research misconduct matters going forward, including impacts on respondents and the institutional policies that tend to mirror the federal regulations. In the days and weeks to come, our team will thoroughly analyze the new rule to share our thoughts and guidance on what respondents and institutions should be aware of in light of this historic update to the federal research misconduct regulations.
