*Updated 9/29/23*
A message from the Office of the Vice Chancellor for Research about complying with the National Institutes of Health’s (NIH) new requirements for Foreign Subrecipients.
This communication is the first step in a larger process to comply with new NIH requirements.
Effective January 1, 2024, in order to make an award, NIH will require foreign subrecipients to provide access to all records (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 at an agreed upon frequency (e.g., once a quarter, once a month). For UNC-Chapel Hill, this requirement is once per year, in line with Research Performance Progress Reports requirements. This is a change form the previous requirement of every three months. While these are welcome changes, it appears the changes will have to apply to current as well as future awards to foreign subrecipients.
In addition:
- 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).
- NIH encourages 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 issue.
Obviously, this represents several challenges and will be time and resource intensive. The Office of the Vice Chancellor for Research (OVCR) is currently working to develop an SOP and guidance documents for the research community. For now, we want to make you aware of what we are doing, and what you as a research PI or team member should be doing to be in compliance with the new requirements.
*Reminder: HIPAA/PHI cannot be stored in LabArchives at this time. More information will follow for regulated data and foreign subrecipients working in areas without regular internet access.
OVCR Responsibilities:
- Office of Sponsored Programs (OSP) and Research Science and Security (RSS) will work to finalize guidance documentation and SOPs.
- OSP and RSS will serve as the primary point of contact with NIH for general compliance inquiries.
- OSP will coordinate and be responsible for agreement language and any requests concerning agreements from NIH.
PI and Research Team Responsibilities:
- Ensure progress reports and all other required lab notebooks and data are consistently and completely uploaded in LabArchives or otherwise collected, maintained, stored, and provided to NIH upon request.
- Sharing, when appropriate, draft language with foreign subrecipients to include in their letter of support.
- Working collaboratively with OSP and RSS to maintain subrecipient relationships including assisting in explaining the purpose and source of these new requirements.
How did we get here?
NIH is implementing this new policy in response to an unfavorable audit finding by the OIG. This language is from the policy update; “2 CFR 200.332(a)(5) states that subaward agreements must include, ‘a requirement that the subrecipient permit the pass-through entity and auditors to have access to the subrecipient’s records and financial statements as necessary for the pass-through entity to meet the requirements of this part.’”
The Office of the Vice Chancellor for Research is currently working to develop updated guidance for the research community that will include best practices and additional information from the Office of Sponsored Programs.
If you have any questions or concerns, please reach out to Quinton Johnson at quinton@unc.edu who will direct you to the appropriate subject matter expert.
More detailed guidance and processes will be communicated in the coming weeks.