How Do I Address Potential Foreign Risks in My Small Business Program Application?

On August 27, 2026, the National Institutes of Health (NIH) published guidance to help small businesses navigate foreign risk requirements when applying for SBIR/STTR funding under the Small Business Innovation and Economic Security Act. The guidance, in conjunction with NIH's SBIR/STTR Foreign Disclosure and Risk Management page, directs applicants to evaluate not only their own company, owners, and key personnel but also any consultants, contractors, service companies, and partners who contribute substantively to a project's scientific development or execution. Applicants are advised to assess these individuals and entities, with particular scrutiny for foreign countries of concern, against criteria including: ownership and investment structure; professional and institutional affiliations; active business relationships; recent patent filings; participation in malign foreign talent recruitment programs; and cybersecurity practices. Since foreign risk assessment began in 2023, more than half of the Department of Health and Human Services' (HHS) denials have stemmed from foreign risks tied to consultants or contractors, underscoring the importance of vetting external collaborators before submission. Applicants who clear peer review must later submit a single Foreign Disclosure Form during the Just-in-Time process, after which NIH conducts due diligence and, if a risk is identified, requires applicants to remove it and reapply for a future receipt date.