The U.S. Department of Health and Human Services (HHS) Office of Research Integrity (ORI) released a notice of proposed rulemaking to update the 2005 Public Health Service (PHS) Policies on Research Misconduct. HHS seeks public comments on the proposal through Dec. 5, 2023.
ORI expects the proposed changes to be effective Jan. 1, 2025. If adopted, the proposed amendments would impact PHS-supported biomedical or behavioral research, including research conducted by subrecipients. The proposed rule would update investigation and reporting of research misconduct procedures based on ORI learnings and feedback on processes over the past two decades.
Proposed updates include addressing confidentiality concerns during an investigation, such as defining for the first time who has a “need to know” certain details of the investigation. ORI suggested that this clarification should help institutions balance the need to disclose certain information while respecting the rights of parties involved. ORI also suggested formally defining “institutional record” and “administrative record,” and would require institutions to maintain a formal institutional record as part of the investigative process. The institutional record would include detailed findings from the inquiry and the investigation, which would in turn become part of the administrative record that forms the basis for ORI review and appeal.
ORI further proposed improving the process for an informal, although not required, practice often permitted by institutions under the conflict-of-interest policy. Under the current policy, institutions may provide a person accused of misconduct the opportunity to object to another’s participation on the inquiry committee, based on a personal, professional or financial conflict of interest. ORI clarified that while this practice is not strictly required, if an institution opts to provide the accused with an opportunity to object, then it must allow the accuser and any witnesses the opportunity to object as well.
Additionally, an institution’s research misconduct findings could now be published by ORI, even where ORI does not find formal research misconduct, to the extent permissible by privacy laws and after redacting identifiable information of the parties involved. ORI indicated that it believes publication would “protect the health and safety of the public, [ ] promote the integrity of the PHS supported research and research process, or [ ] conserve public funds.”
Changes to the inquiry, investigation and appeals processes were proposed as well, to help reduce administrative burden. Inquiry-stage interviews would not need to be repeated at the investigation stage, saving institutions critical time and resources. Currently, any appeal of ORI findings of research misconduct and administrative actions requires a complete review — and hearing — by an administrative law judge (ALJ). The proposal would require only that an ALJ review the (newly defined) administrative record to determine whether ORI’s findings are “reasonable and not based on a material error of law or fact,” and if not, conduct a limited hearing to resolve only genuinely disputed facts. Thereafter, any decision other than suspension or debarment would be deemed a final administrative action. If the determination does involve a suspension or debarment, however, ORI would continue to follow the current appeal practice.
While the changes would not go into effect until 2025, the updates have the potential to affect all recipients and subrecipients of federal research funding. For more information on how this proposed guidance may apply to you, or for assistance drafting a comment, please contact the authors of this article.
The authors thank McGuireWoods first-year associates Jonathan Wrobel and Renee Kumon for assistance preparing this legal alert. They are not licensed to practice law.
