NIH Final Updated Policy Guidance for Subaward/Consortium Written Agreements

Notice Number: NOT-OD-23-182

Purpose

In response to audits conducted by the HHS Office of the Inspector General (OIG) and by the Government Accountability Office (GAO), NIH published a Notice in the Federal Register (88 FR 36603) on June 5, 2023, outlining its plans to update the NIH Grants Policy Statement, section 15.2, to require that foreign subrecipients provide 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 no less than once every six months. NIH has received extensive feedback and is issuing this Notice to respond and to issue a final revised Notice.

Updated Policy Guidance

Effective January 1, 2024, section 15.2 will be updated to include the following clarifications (changes are bold and italicized):

15.2 ADMINISTRATIVE AND OTHER REQUIREMENTS

The following highlights several areas within the consortium relationship that the recipient needs to address with consortium organizations receiving subawards under a grant to ensure compliance with NIH requirements. The requirement for a written agreement addressing these and other areas is specified in this section.  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).

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.

Note that most of these requirements only apply to a recipient’s consortium relationships with sub-recipients. When the relationship is with a vendor that is providing routine goods and services within normal business operations that are ancillary to the operation of the research program, the public policy requirements listed below do not apply. The vendor must also be providing similar goods and services to many different purchasers and provide them in a competitive environment.

15.2.1 Written Agreement

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. At a minimum, this agreement must include the following:

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.