NIH Foreign Subawards

Updated NIH Grants Policy for Foreign Subawards

Posted 1/3/2024

Effective January 2, 2024, NIH Grants Policy Statement, section 15.2, is being updated to require that foreign subrecipients receiving subawards under a grant provide access to copies of all lab notebooks, all data, and all documentation that supports the research outcomes as described in the RPPR (Research Performance Progress Report), to the primary recipient no less than once a year. Access may be entirely electronic.

This updated requirement applies to existing awards, as well.  NIH expects recipients to update existing foreign subaward agreements within 60 days of the effective date (by March 2, 2024). NIH recognizes that recipients may need additional time depending on the number of agreements an institution has in place for each project. Extensions may be requested.

The agreement to the new requirement must be in writing and must be signed by both parties; NIH will not support grant awards lacking agreement to the new requirement. NIH reserves the right to request copies of the written agreement and relevant supporting documentation as needed, as part of its oversight responsibilities. 

NIH expects prime recipients to ask potential subrecipients, at the application stage, to submit language in their letters of support indicating their awareness of these requirements and the subrecipient’s willingness to abide by all requirements should an award be issued.

Compliance with NIH Foreign Subaward Requirements at Emory

RCRA is partnering with OSP and OIT to support PIs with compliance with the new requirement.

Beginning January 2, 2024, OSP’s Subaward Team will incorporate the new requirements in all new foreign subawards issued from NIH grants. OSP is taking the lead to coordinate with PIs to make modifications to existing foreign subawards between now and March 2, 2024.

There is no prescribed method to archive and access copies of all lab notebooks, all data, and all documentation that supports the research outcomes as described in the RPPR (Research Performance Progress Report). PIs will need to have discussions with their foreign collaborators to mutually agree upon a solution that fits the unique nature of their project and associated data files. Emory’s SharePoint Sites may be a suitable solution in some cases. Technical support for the decision-making process can be obtained from local IT support and Emory’s Office of Information Technology. Emory's Office of Information Technology (OIT) supports a variety of platforms and services for researchers – infrastructure to store and manage data, collaboration tools to work across teams and organize projects, applications to collect and track information about research studies, environments to visualize and compute data analyses, and more. In some cases, OIT also provides onboarding, training, and consultation resources to help researchers benefit from these platforms successfully. OIT often partners with school, unit IT organizations to coordinate the delivery of these services. Contact local IT support or Research Security for additional information.

Sharing Documents with External Collaborators Using SharePoint
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Frequently Asked Questions

Recipients must revise current foreign subaward agreements within 60 days from the effective date to align with the stipulations specified in NOT-OD-23-182.

Certainly. The NIH acknowledges that recipients may require extra time based on the quantity of agreements an institution manages for each project. As such, Emory OSP may request extensions by contacting the Office of Policy for Extramural Research Administration.

Prime recipients must continue to examine all subaward documentation to ensure that the performance outcomes reported in the Research Performance Progress Report (RPPR) are precise, comprehensive, and aligned with programmatic goals as outlined in the RPPR.

The NIH requires all institutions will adhere to the existing record retention policies detailed in the NIHGPS 8.4.2 Record Retention and Access, which incorporates 2 CFR Part 200.334. Essentially, recipients are required to preserve records relevant to the entire competitive segment for three years from the submission date of the final FFR to NIH. As stated in GPS 8.4.2, aligning with 2 CFR Part 200.337, recipients must grant NIH access upon request.

This policy mandate extends to all subaward arrangements. The NIH's Policy Guidance for Subaward/Consortium Written Agreements (NOT-OD-23-182) explicitly addresses domestic prime recipients tasked with supervising foreign subrecipients, which was highlighted in an Office of Inspector General's audit findings.

Both the Office of Inspector General (OIG) and the General Accounting Office (GAO) audits of NIH explicitly highlighted foreign subrecipients, with one audit specifically addressing the unique challenges that domestic prime recipients encounter when dealing with foreign subrecipients.

OIG and GAO recognize the diversity among foreign subrecipients, acknowledging that some may have fewer resources than others. The aim is to clarify that employing commonly used digital platforms can facilitate compliance with this longstanding regulatory requirement for everyone. The overarching principle of adhering to the terms and conditions of an award, along with access to materials supporting a progress report, applies universally.

Three key points should be noted. First, both prime recipients and subrecipients must adhere to the terms and conditions of the award. Prime recipients bear responsibility to NIH, and these obligations extend to subrecipients. Second, NIH anticipates that all recipients, including subrecipients, will comply with relevant state and local laws. Third, if there are concerns regarding how local laws or regulations might impact compliance with award terms and conditions, recipients and/or subrecipients should seek guidance from their legal counsel, considering the specific circumstances at hand.

The two policies differ. Data sharing pertains to the expectations for grant recipients to share information with the public. Meanwhile, the NIH's mandate for foreign subawardees to grant the prime awardee access to notebooks and other supporting documentation, as reported in the RPPR, concerns the information that collaborators must share to facilitate award oversight and compliance.

Restrictions on data access, aimed at safeguarding personally identifiable information, extend to the revised foreign subrecipient/consortium written agreement prerequisites, which mandate foreign subrecipients to furnish the prime recipient with access to notebooks and other documentation substantiating research outcomes disclosed in the research performance progress report (RPPR). Consequently, personally identifiable information may be redacted to ensure participant privacy. Refer to NIH Grants Policy Statement (GPS) Section 4.1.4 and Section 15.2.1 for further details on the criteria for safeguarding identifiable, sensitive information gathered by the prime recipient or subrecipients.

NIH encourages recipients to request potential subrecipients, during the application phase, to include language in their letters of support affirming their understanding of these requirements and their commitment to adhering to all stipulations should an award be granted.

NIH will not endorse any agreement that fails to meet the minimum requirements outlined in the written agreement section (NIH Grants Policy Statement Section 15.2.1). NIH retains the right to solicit copies of the written agreement and pertinent supporting documentation as necessary, as part of its oversight responsibilities. Failure to furnish requested documentation may result in remedies for noncompliance and potential enforcement actions (refer to Section 8.5, Specific award conditions and remedies for noncompliance).

The recipient institution is required to establish a formal written agreement, duly signed and consented to by both parties, with each consortium participant/subrecipient. This agreement should delineate negotiated arrangements to fulfill the scientific, administrative, financial, and reporting requirements of the grant, ensuring compliance with all pertinent Federal regulations and policies to facilitate an effective collaborative venture. If a subrecipient declines to accept the stipulations outlined in this section through a signed written agreement, an agreement cannot be issued. Note: All current requirements remain in place, with the addition of:

  • For foreign subrecipients, a provision requiring the foreign subrecipient to 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. Such access may be entirely electronic.

Yes, all data and supporting documentation provided to the prime recipient must be translated into English, so that it is available to NIH, upon request.

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