Further Clarifying NIH’s Foreign Subaward Agreement Policy: Addressing Community Feedback

Today, in response to feedback received from the research community, we are releasing our final guide notice clarifying NIH’s long-standing policy on foreign subaward and consortium written agreements. In the video below, we talk about the origins of this notice, the consideration of and changes made in response to public comment, the final oversight and compliance requirements, and how these efforts will ensure NIH remains a proper steward of taxpayer support. Dr. Lawrence Tabak, Acting Director of NIH, and Ms. Michelle Bulls, Director of the OER Office of Policy for Extramural Research Administration join me in this video.

Last June, we published a Notice in the Federal Register. The notice sought public comments on our plans to update the NIH Grants Policy Statement, section 15.2, to require that foreign subrecipients provide copies of all lab notebooks, all data, and all documentation that supports the research outcomes as described in the progress report, to the primary recipient no less than once every six months. This step was taken in response to separate audit recommendations from the HHS Office of Inspector General and Government Accountability Office.

We appreciate the many thoughtful comments received (available in the NIH FOIA Reading Room). Based on the feedback, today’s notice modifies the requirements to state that “subaward agreements must stipulate that foreign subrecipients will provide access to copies of all lab notebooks, all data, and all documentation that supports the research outcomes as described in the progress report, to the primary recipient with a frequency of no less than once per year, in alignment with the timing requirements for Research Performance Progress Report submission.” And we clarify that by “access to,” it is understood that such access may be entirely electronic.  Effective January 2, 2024, section 15.2 of the NIH Grants Policy Statement will be updated to include these clarifications. Grant recipients will need to be in compliance with this updated policy guidance by March 2, 2024.

We have also developed a new subaward webpage and FAQs, will provide language that can be included in subaward agreements, and will offer other resources to help the community comply with this policy guidance.

I appreciate your continued efforts to ensure NIH functions as an effective steward of limited taxpayer funds. We take our stewardship over the Nation’s investment in biomedical research very seriously and will continue to routinely evaluate processes and measures for strengthening our oversight efforts.