NIH Updated Policy Guidance for Subaward/Consortium Written Agreements (NOT-OD-23-182)
In response to government audit recommendations that NIH “implement enhanced monitoring, documentation, and reporting requirements for recipients with foreign subrecipients,” NIH has issued NOT-OD-23-182, which clarifies prime recipients' responsibilities related to foreign subrecipients at the application stage and after award.
Policy Overview
Effective January 2, 2024, section 15.2 of the NIH Grants Policy Statement will be updated to include these clarifications. The requirements will affect applications and active awards with foreign subrecipients after January 1, 2024.
Within 60 days of the effective date of January 2, 2024, Sponsored Programs will amend all existing NIH-funded foreign subawards to incorporate the required terms to address the requirements outlined in NOT-OD-23-182.
As of January 2, 2023, all new NIH-funded foreign subawards will include the required provision.
NIH Expectations
NIH expects 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. (NIH GPS 15.2)
For foreign subrecipients, a provision [in a formal written agreement, signed, and agreed to by both parties] 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. (NIH GPS 15.2.1)
NIH will not support any agreement that does not meet the minimum requirements outlined in the written agreement section below (15.2.1). NIH reserves the right to request copies of the written agreement and relevant supporting documentation as needed, as part of its oversight responsibilities. Failure to provide requested documentation may lead to remedies for noncompliance and potential enforcement actions (see 8.5, Specific award conditions and remedies for noncompliance).
Facilitating Transfer and Storage of Data and Documentation
In most cases, the NIH requirement for foreign subrecipients 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 can be met by using commonly available digital file-sharing platforms.
NC State has chosen to support the Globus platform as a service to move and share research data in a single interface. Globus can move datasets of various sizes, up to petabytes in magnitude, and is well suited for sharing research data between users at various institutes. OIT supports connectivity between Research Storage and any remote Globus endpoint.
For questions related to Globus, contact oit_globus@help.ncsu.edu.
Both Globus and Research Storage are acceptable for general human subject data. If Protected Health Data (PHI) is contemplated, reach out to the IRB Office for additional guidance.
If it is anticipated that Globus and Research Storage will not meet the needs of the research team, please contact The Research Facilitation Service for consultation.
For questions related to regulatory compliance, email the Director of Research Compliance.
Pre-Award Considerations
The transfer and storage of data in compliance with this policy should be addressed within the Data Management and Sharing Plan submitted with the proposal.
There may be additional costs associated with using a transfer and storage option outside of Globus and Research Storage. It is best to identify this early in the proposal process so that any additional costs can be included in the proposal budget.
The PI and College Research Office should require subrecipients to include 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.
If an alternate template is used, the language below must be included in the subrecipient’s letter of support.
For all NIH Subrecipients:
Subrecipient agrees to abide by the requirements of NIH Grants Policy Statement, Section 15.2, (per NOT-OD-23-182) and will submit copies of signed agreements between NC State and Subrecipient as well as any supporting documentation to PI upon request.
Additional language to be inserted for foreign subrecipients:
If Subrecipient is a Foreign Entity to be supported by NIH funding, Subrecipient certifies it shall provide access to copies of all lab notebooks, all data, and all documentation that supports the research outcomes as described in progress reports (may be shared digitally). These supporting materials must be provided to the PTE with each scientific update in line with the timelines outlined in the resulting agreement. Referenced data will be retained and remain available for access by PTE for a minimum of three years after the expiration date of the prime award.
Post-Award Consideration
It is the PI’s responsibility to ensure progress reports and all other required lab notebooks and data are consistently and completely uploaded to Research Storage or otherwise collected, maintained, stored, and provided to NIH upon request.
The Authorized Organizational Representative (AOR) should obtain written confirmation from the PI that they are complying with this policy prior to each RPPR submission.
NIH requires recipients to retain the pertinent records for 3 years from the date the final Federal Financial Report is submitted to NIH.