NCCIH Research Blog

Are you a researcher who collaborates on a National Institutes of Health (NIH)-funded grant with foreign colleagues or is planning to do so? If the answer is yes, you need to review several recent NIH policy documents that give important guidance on collaborating with foreign researchers.

NIH’s longstanding policy on foreign subaward/consortium written agreements was clarified in a notice released on September 15, 2023: NOT-OD-23-182, NIH Final Updated Policy Guidance for Subaward/Consortium Written Agreements. The notice underscores NIH’s interest in strong international research collaborations and explains some policy requirements. 

In a nutshell, recipients of NIH grants, including foreign collaborators receiving subawards, must comply with Federal requirements on oversight. The primary recipient must ensure monitoring processes are in place so there is compliance with the terms and conditions of the award. 

Most importantly: This policy requires subaward agreements to stipulate that foreign subrecipients will provide the primary recipient with access to copies of all lab notebooks, data, and documentation supporting the research outcomes as described in the Research Performance Progress Report. Access to the records will be at a frequency of no less than once per year, which aligns with the timing of progress report submission. The requirement is effective January 1, 2024, and applies to all new and existing subaward agreements. Current subawards may need to be renegotiated or revised. To find out more, I recommend a blog post on NIH’s foreign subagreement policy by Dr. Michael Lauer, NIH’s deputy director for extramural research, and the NIH Subawards webpage.

NIH awards, and applications for awards, via the Small Business Innovation Research (SBIR) and the Small Business Technology Transfer (STTR) Programs are the topic of NOT-OD-23-139, Implementation of the NIH SBIR and STTR Foreign Disclosure Pre-award and Post-Award Requirements (released June 12, 2023). This notice implements more disclosure and post-award reporting requirements for small businesses regarding covered relationships.

The Department of Health and Human Services has implemented a due diligence program designed to assess security risks. In the SBIR and STTR Extension Act of 2022, signed into law by President Biden, Congress requires Federal agencies to establish a due diligence program to evaluate security risks. Aspects to be examined include foreign ownership and control, foreign financial obligations, foreign affiliations, and cybersecurity concerns from applicants in countries of concern. The risk review is separate from the merit review process. 

More information about NOT-OD-23-139 is in NOT-OD-24-029, Clarification of Implementation of the NIH SBIR and STTR Foreign Disclosure Pre-award and Post-Award Requirements (released November 14, 2023). A major message is that NIH will not mitigate identified security risks prior to award. For competing SBIR and STTR applications with due dates on or after September 5, 2023, applicants will have to submit a completed disclosure form via the Just-In-Time (JIT) process. The Foreign Disclosure and Risk Management webpage of the NIH Small Business Education and Entrepreneurial Development (SEED) Office provides more details. 

We at the National Center for Complementary and Integrative Health do appreciate the many ways the extramural community collaborates with NIH on effective stewardship of the Nation’s taxpayer funds for biomedical research. Should you have any questions, please consult the end section of each notice for items such as FAQs and contact information for the applicable NIH offices or divisions. 

For More Information

• NIH Final Updated Policy Guidance for Subaward/Consortium Written Agreements (NOT-OD-23-182)
• Implementation of the NIH SBIR and STTR Foreign Disclosure Pre-award and Post-Award Requirements (NOT-OD-23-139)
• Clarification of Implementation of the NIH SBIR and STTR Foreign Disclosure Pre-award and Post-Award Requirements (NOT-OD-24-029)
• View video: NIH Update Regarding Oversight of Foreign Subawards