NIH Disclosure Guidance

NIH continues to provide guidance on the disclosure of Other Support, foreign relationships and activities, and conflict of interest.

Guidance from NIH regarding what/where/when to disclose

NIH Pre-award and Post-award Disclosures Relating to the Biographical Sketch and Other Support

                                      *See NIH FCOI Policy NIH GPS 4.1.10

  • NIH continues to release information describing actions that NIH, institutions, and researchers can take to protect U.S. biomedical intellectual innovation, including disclosure requirements related to foreign relationships and activities. Please see NIH’s Protecting U.S. Biomedical Intellectual Innovation for more details, including examples of what to disclose about Senior/Key Personnel on applications and awards.
  • NIH has updated the format and instructions for the Other Support and Biographical Sketch pages to facilitate full disclosure of existing requirements. Details on the format changes can be found on NIH’s Other Support and Biosketch webpages and in the March 2021 notice NOT-OD-21-073.

NIH has also provided the following advice regarding reporting relationships:

Important Applicant/Recipient Considerations*

NIH advises that applicants/recipients should consider and identify relationships, existing and potential, that may impact research integrity, present financial conflict of interests, and/or result in overlapping commitments. In evaluating these relationships, the following questions and factors should be considered:

  • Does the relationship affect the integrity of the research by impacting established professional norms and ethical principles in the performance of all activities related to scientific research?
    • The “relationship” could be with a collaborator, an outside employer, an external appointment relationship, etc.
    • The “impact” could be real or apparent
    • The “compensation” could be of any type or level; NIH has not established a de minimis level of compensation and considers all types of support, in-kind or otherwise.
  • Is there potential overlap in any of the following areas?
    • Scientific
    • Budgetary
    • Commitment
  • Is there a potential Financial Conflict of Interest?

If the answer to any of these questions is “yes,” then the relationship is generally reportable. When in doubt, ask early and often.

 

*Click here for full details
icon-arrowicon-circlesicon-docicon-downloadicon-externalicon-lettericon-lockicon-magnifiericon-pdficon-phoneicon-resourceicon-xls