NIH Updated Policy Guidance for Subaward/Consortium Written Agreements

NOT-OD-23-133: This notice describes the changes and additional requirements prime recipients need to address with consortium organizations receiving subawards under a grant to ensure compliance with NIH requirements. Notable changes include: 

  • The requirement for the prime institution to secure and retain all PD/PI signatures for all applications, progress reports and post-award prior approval requests. 
  • For foreign subrecipients, 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.

If the subrecipient's investigators must comply with the prime institution's Financial Conflict of Interest (FCOI) policy, the subrecipient shall certify as part of the written agreement that its policy complies with the 2011 revised FCOI regulation (42 CFR Part 50 Subpart F). If the subrecipient cannot provide such certification, the agreement shall state that subrecipient investigators are subject to the Financial Conflict of Interest policy of the prime institution for disclosing Significant Financial Interests that are directly related to the subrecipient's work for the prime institution.