NIH Foreign Subawards

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.

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.

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.

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.