Introduction
In response to audits conducted by the HHS Office of the Inspector General (OIG) and the Government Accountability Office (GAO), the National Institutes of Health (NIH) is taking significant steps to enhance oversight of foreign subrecipients involved in research funded by NIH grants. A notice published in the Federal Register on June 5, 2023 (88 FR 36603), outlines NIH’s intention to update the NIH Grants Policy Statement, section 15.2. This update will require foreign subrecipients to provide copies of lab notebooks, data, and documentation supporting research outcomes to the primary recipient at least once every six months.
The Background
NIH acknowledges the concerns raised by the research community regarding the Federal Register Notice. Nevertheless, NIH’s decision to issue this Notice was prompted by the recommendations of the HHS Office of Inspector General and the Government Accountability Office. Both oversight bodies urged NIH to implement enhanced monitoring, documentation, and reporting requirements for recipients with foreign subrecipients.
The Notice called for public comments by July 5, 2023, and NIH received extensive feedback from the research community. The agency wants to emphasize its strong support for robust international research collaborations while recognizing the need to mitigate excessive administrative burdens.
Clarification, Not New Policy
It is important to understand that the proposed policy updates are not introducing new regulations. Instead, they serve as a reminder to NIH recipients to comply with existing policy requirements outlined in the NIH Grants Policy Statement Chapter 15, Consortium Agreements, which implements government-wide regulations.
These regulations state that subaward agreements must allow access to subrecipient records and financial statements for oversight purposes. Primary recipients must ensure subawards are used for authorized purposes, including reviewing and monitoring financial and performance reports.
The Need for Clarity
Based on public feedback, NIH is modifying the requirements. The updated policy will state that foreign subrecipients must provide access to copies of lab notebooks, data, and documentation that support research outcomes, with a frequency of no less than once per year. This change aligns with the timing requirements for Research Performance Progress Report submission and can be achieved electronically using commonly available file-sharing platforms.
Addressing Concerns
Some commenters raised concerns about the focus on foreign subrecipients. However, this emphasis is in response to recommendations from both the OIG and GAO audits, which emphasized the need for more rigorous oversight of foreign subrecipients.
The policy clarification aims to ensure compliance with existing government-wide regulations while providing specificity on how these regulatory requirements should be implemented in the case of foreign subrecipients.
Effective January 1, 2024, section 15.2 of the NIH Grants Policy Statement will be updated to reflect these changes, with clear language emphasizing the importance of access to documentation.
Conclusion
NIH is committed to fostering international research collaborations while ensuring transparency and compliance with regulations. The extensive feedback received from the research community will help refine policies to strike the right balance between oversight and administrative burden.
View the complete updated guidance below.
