New National Institutes of Health (NIH) Restrictions on Exports of Human Biospecimens to Countries of Concern
Effective October 24, 2025
Effective October 24, 2025, NIH’s new Policy on Enhancing Security Measures for Human Biospecimens, NOT-OD-25-160 largely prohibits the export of human clinical and research biospecimens obtained from U.S. persons in connection with NIH-supported work to “countries of concern”—currently Cuba, China, Iran, North Korea, Russia, and Venezuela. The Export Controls and Research Security team (ECRS) is evaluating the new policy’s potential consequences for the research community, and will provide more detailed substantive and procedural guidance in the near future.
Covered Human Biospecimens
The policy applies to any human biospecimens “collected, obtained, stored, used, or distributed and [...] supported or funded by any on-going or new NIH funding mechanisms (grants, cooperative agreements, contracts, Other Transactions, and intramural support) regardless of NIH funding level.”
A human biospecimen is defined as:
A quantity of tissue, blood, urine, or other human-derived material. A single biopsy may generate several human biospecimens, including multiple paraffin blocks or frozen sample. A human biospecimen can comprise subcellular structures, cells, tissue (e.g., bone, muscle, connective tissue, and skin), organs (e.g., liver, bladder, heart, and kidney), blood, gametes (sperm and ova), embryos, fetal tissue, and waste (urine, feces, sweat, hair and nail clippings, shed epithelial cells, and placenta). Human biospecimens include those that are isolated and propagated into new cell lines. The term also includes 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.
The policy does not apply to cell derivative products or cell lines that are commercially or publicly available prior to October 24, 2025.
Exceptions
There are narrow circumstances that allow the export of a biospecimens to countries of concern:
- to meet transactions required or authorized by Federal law or international agreements, including Global health, or necessary for compliance with Federal law; or
- needed in rare and compelling circumstances where the facility and personnel in the country of concern possess needed capabilities and/or expertise not available elsewhere, the use of the biospecimen cannot be delayed to a time when capability and/or expertise is available elsewhere, and done with the consent of the individual from whom the biospecimen was collected; or
- at the request of the individual whose biospecimen was collected, obtained, or stored using NIH-funds; for purposes of diagnosis, prevention or treatment of that individual; and in compliance with applicable Federal laws, regulations, and policies.
Exporters must retain all records related to transfers of human biospecimens to countries of concern and make them available to NIH on request.