NIH now requires small business innovation research (SBIR) and small business technology transfer (STTR) applicants to provide a Required Disclosures of Foreign Affiliations or Relationships to Foreign Countries form before receiving a grant award, as required by law. We initially discussed the policy in our July 6, 2023 article New Form to Disclose Foreign Relationships for Small Business Concerns.
In a November 14, 2023 Guide notice, NIH clarified a key aspect of the policy: NIH (and NIAID by extension) will not work with small businesses to mitigate security risks. Instead, given the presence of security risks, NIH will determine that an award cannot be issued.
Note that NIH’s recent policy guidance covers grant applications, not contract proposals. For an SBIR/STTR contract proposal, be sure to follow all instructions listed in the contract solicitation.
Reminders for SBIR/STTR Applicants
First, remember that receiving a just-in-time (JIT) request does not guarantee funding, as described at Respond to Pre-Award Requests (“Just-in-Time”). This is the stage at which you will submit a disclosure form (alongside other information), and NIAID will confirm your application meets all requirements in case the application is considered for funding.
Second, you must submit all JIT materials exclusively through the eRA Commons. This imperative extends to the new disclosure form as well. Under no circumstances should you transmit the disclosure form through email to NIAID staff. Failure to comply with this procedure may result in delays to award.
Third, foreign involvement with a country of concern does not necessarily disqualify an applicant—it’s whether that involvement falls within any of the following risk criteria:
- Interferes with the capacity for activities supported by NIH, CDC, or FDA to be carried out.
- Creates duplication with activities supported by NIH, CDC, or FDA.
- Presents concerns about conflicts of interest.
- Was not appropriately disclosed to NIH, CDC, or FDA.
- Violates federal law or terms and conditions of NIH, CDC, or FDA.
- Poses a risk to national security.
NIH SEED has useful Foreign Risk Case Studies to demonstrate instances in which foreign involvement does or does not generate security risks.
You might also find it helpful to know that NIAID staff do not conduct the security risk assessment. Your disclosure form goes directly to NIH. NIAID staff are notified of the assessment’s outcome, but the information is kept confidential from them. As such, our staff cannot discuss the due diligence process.
Remember, your organization is responsible for monitoring its relationships with foreign countries of concern.