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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.
simply add a question to the “Institutional Compliance” section of the “Data Collection” part of NIH grant proposals:
“Has any grant proposal personnel been investigated or convicted of research misconduct, including Title IX-related incidents?
and leave a space for a short explanation for those applicants who feel this is not relevant
then either deny such researchers the opportunity to apply for funds, or give the reviewers a chance to decide.
NIH already asks about human stem cell, biological/infectious agent, and toxic chemical use in proposed research–why not ask about behavior that is equally potentially controversial or dangerous?
As long as NIH continues to fund misconduct offenders, institutions will not vet this behavior, and will continue to employ them, and scientific dishonesty and sexual harassment can persist.
Dr. Aldrich has a valid point. The one suggestion I would make is modifying the sentence above to “Have any grant proposal personnel been convicted of research misconduct, including Title IX-related incidents?” This would allow the legal due process mechanism to be followed.
I tried to access the video link and it appears to be private. Can that be made accessible?
ORI is working on updating their video, and a corrected link will be provided when available.
I would agree with the above 2 points but we do need to be careful as being investigated is not being found guilty (convicted is not necessarily the way this is described in other countries) and often it can be against other legal requirements to disclose an allegation that has not yet been investigated or proved. Thus I would support similar change to suggested by Robert but slightly amended to state “Have any grant proposal personnel been found guilty of research misconduct, including Title IX-related incidents?”