September 24, 2025 - Research Security Office

The National Institutes of Health (NIH) recently released a new policy on biospecimen security (see NOT-OD-25-160) that will take effect on October 24, 2025. This policy establishes new requirements for the handling of human biospecimens collected, stored, used, or distributed with NIH support, in alignment with Executive Order 14117 and 28 CFR Part 202.

The policy is designed to protect sensitive personal health data from misuse by foreign adversaries and applies to all NIH-funded mechanisms, including grants, cooperative agreements, contracts, Other Transactions, and intramural support.

The policy applies to all human biospecimens from U.S. persons, regardless of identifiability, that are supported by NIH funds. This includes, but is not limited to, tissue, blood, urine, gametes, embryos, fetal tissue, and derived cell lines not yet publicly available.

The policy does not apply to cell lines or derivative products that were commercially or publicly available prior to the effective date. However, it does apply to “cell lines for which an agreement is in place to commercially or publicly make them available, but for which the cell lines have not yet been made commercially or publicly available on or after the effective date of this policy.”

Entities holding NIH-supported biospecimens are prohibited from sharing or distributing them to institutions or individuals in countries of concern (China, Cuba, Iran, North Korea, Russia, Venezuela) unless one of the following limited exceptions applies:

• The transaction is required or authorized by Federal law or international agreement;
• The biospecimen is needed in rare and compelling circumstances where unique expertise exists in the country of concern and the donor has provided consent; or
• The donor requests the biospecimen be used for their own diagnosis, prevention, or treatment, in compliance with applicable laws.

All exceptions must be documented, including the quantity and content of biospecimens shared, and made available to NIH upon request.