NIH Director, Dr. Francis Collins, issued a statement in August of 2018 identifying three areas of concern related to inappropriate foreign efforts to influence NIH-supported research activities. The concerns include:
- Diversion of intellectual property (IP) in grant applications or produced by NIH-supported biomedical research to other entities, including other countries;
- Sharing of confidential information on grant applications by NIH peer reviewers with others, including foreign entities, or otherwise attempting to influence funding decisions; and
- Failure by some researchers working at NIH-funded institutions in the U.S. to disclose substantial resources from other organizations, including foreign governments, which threatens to distort decisions about the appropriate use of NIH funds.
NIH has issued policies to address each of these concerns and it is the responsibility of both the investigator and the institution to ensure compliance with these policies.
- NIH NOT-OD-21-073 details changes to the Biosketch and Other Support formats effective for all application submissions Research Performance Progress Report due on or after January 25, 2022. For all foreign support reported, PIs and institutions must provide related contracts and agreements governing those relationships. Institutions must also disclose any unreported foreign affiliations not reported by PIs. Watch video. View a table of required activities that must be disclosed on Other Support documents.
- NIH NOT-OD-18-233 requires that “Recipients of NIH-funded research awards must report all inventions that result from NIH-funded projects.” This requirement arises from the Bayh-Dole Act and its implementing regulations. This reporting requirement can be satisfied by submitting an intellectual property disclosure to the Clemson University Research Foundation through the inventor portal.
- NIH NOT-OD-14-069 and NIH NOT-OD-13-010 describe NIH policies and peer-reviewer requirements for managing actual and perceived conflicts of interest in the peer-review process. According to the NIH Conflict of Interest Rules, “The NIH peer review system relies on the professionalism of each reviewer to identify any conflict of interest (COI) or apparent COI that may affect or appear to affect the integrity of the NIH peer review process.” This disclosure does not flow through the University and must be managed independently by the reviewer.
- NIH NOT-OD-19-114 and NIH NOT-OD-18-160 remind the research community of their other support, foreign components, and financial conflict of interest (fCOI) reporting requirements. NIH has also provided a Frequently Asked Questions Document and additional guidance related to these topics. Disclosures must be entered through InfoEd at the time your proposal is submitted. Your college pre-award office can assist. For any changes that need to be disclosed after the award as been made, please contact Grants and Contracts Administration or the Office of Conflict of Interest for assistance. Financial conflicts of interest (fCOI) must be disclosed through InfoEd annually or within 60 days of any subsequently identified fCOI.