For the first time in nearly two decades, the regulations and policies governing how we address research misconduct associated with NIH (and other Public Health Service) funding are being updated. We are sharing this announcement on behalf of our colleagues with the HHS Office of Research Integrity (ORI) to ensure we continue maintaining and promoting research integrity of NIH-supported research.
The notable changes center around clarifying definitions, explaining procedures for handling allegations, imposing administrative compliance actions, and the appeals process. These steps build upon the existing regulations while also suggesting important improvements. As outlined in an accompanying press release and video from the ORI Director, ORI’s Notice of Proposed Rulemaking calls for feedback on specific areas such as:
- Expanding definitions of key terms to help institutions make decisive research misconduct findings.
- Clarifying responsibilities of HHS, ORI, and PHS-funded agencies in addressing research misconduct allegations, including assessment, reporting, inquiry, investigation, documentation, and record-keeping.
- Developing a streamlined appeals process for respondents who wish to dispute ORI’s findings and administrative actions.
- Supporting streamlined assurance and compliance processes for institutions to meet mandatory PHS funding requirements.
- Requiring subrecipients comply with the regulation.
- Establishing ORI’s responsibilities in issuing timely guidance to support institutional implementation and compliance with the Final Rule.
Your thoughts will help us continue making research integrity an utmost priority wherever NIH funded research is conducted. Comments may be submitted until January 4, 2023. Please be sure to reference Regulatory Information Number 0937–AA12.
Want to know more about how NIH handles research misconduct and works with ORI? We welcome you to watch this recent conversation with their new Director(Sheila Garrity) and also listen to this NIH All About Grants podcast.
Editorial note, 11/30/2023: updated ORI video was added to reflect the extended deadline for responses of January 4, 2024.