08/07/2023
By Holly Norton
The National Institutes of Health (NIH) issued Notice NOT-OD-23-133 on May 19, 2023, regarding their updated requirements for consortium/subaward agreements. The primary concern is to ensure that the pass-through entity and auditors have access to a foreign subrecipient’s data and records at an agreed upon frequency, but no less than once every three months. Written agreements with foreign subrecipients must include the following:
- A provision requiring the foreign subrecipient to provide copies of all lab notebooks, all data, and all documentation that supports the research outcomes as described in the progress report. These supporting materials must be provided to the prime recipient with each scientific update (no less than once every three months) in line with the timelines outlined in the agreement.
- This new requirement is effective on Oct. 1, 2023, for all new and continuation awards, thus it will be implemented on a go-forward basis.
In terms of other administrative requirements, the NIH has also highlighted the following issues:
- The NIH will not support any agreement that does not meet the minimum requirements outlined in the Written Agreement section of this notice.
- NIH reserves the right to request copies of the written agreement and relevant supporting documentation as needed, as part of its oversight responsibilities.
- The recipient must enter into a formal written agreement, signed, and agreed to by both parties, with each consortium participant/subrecipient that addresses the negotiated arrangements for meeting the scientific, administrative, financial, and reporting requirements of the grant, including those necessary to ensure compliance with all applicable Federal regulations and policies and facilitate an efficient collaborative venture.
- If a subrecipient is unwilling to accept the requirements outlined in this section, by signing a written agreement, then an agreement cannot be issued.
The Association of American Medical Colleges (AAMC), the Council for Government Relations (COGR) and other associations have provided NIH with comments and feedback on the new requirement for foreign subrecipients. NIH is expected to provide additional and more detailed guidance in the coming months.