Effective October 24, 2025, NIH-funded researchers are prohibited from directly or indirectly distributing U.S. human biospecimens to institutions or parties located in “Countries of Concern” (28 CFR § 202.601), except in very limited, documented circumstances. NOT-OD-25-160

What you Need to Know:

• Scope: This policy applies to all human biospecimens (e.g., tissue, blood, urine) from U.S. persons (regardless of identifiability) that are collected, stored, used, or distributed under any ongoing or new NIH funding mechanism.
• Key Restriction: Entities holding NIH-funded biospecimens are generally prohibited from directly or indirectly distributing them to institutions or parties located in “Countries of Concern” (as defined by 28 CFR § 202.601 (Subpart F: Determination of Countries of Concern).
• Limited Exceptions:Biospecimens may be shared with “Countries of Concern” only in very limited, documented circumstances, such as for:
  1. Transactions required by Federal law, 
  2. Rare and compelling circumstances where needed capabilities or expertise are not available elsewhere, or 
  3. At the request of the individual for their own diagnosis or treatment.
• Documentation: All entities must retain documentation detailing any sharing or distribution of biospecimens to Countries of Concern and provide it to NIH upon request.

This policy is enacted in support of the national security directives EO 14117 and 28 CFR Part 202 “Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons“ to safeguard American’s personal health-related data. Please ensure your practices comply with these new security measures.