NIH Policy on Enhancing Security Measures for Human Biospecimens (NOT-OD-25-160)

General Prohibition

The entity holding NIH-supported U.S.-person biospecimens (e.g., biorepository, institution, investigator) is prohibited from directly or indirectly distributing those biospecimens to institutions or parties located in countries of concern. “Indirectly” includes transfers via intermediaries where the ultimate destination is a country of concern.

Limited Allowable Circumstances

Distribution to countries of concern may occur only if the use of biospecimens is:

• Required/authorized by Federal law or international agreements (including global health) or necessary for Federal compliance; or
• Needed in rare and compelling circumstances where unique capabilities/expertise exist only in the country of concern, delay is not feasible, and the individual’s consent covers such use; or
• At the request of the individual whose specimen was collected with NIH funds, for that individual’s diagnosis, prevention, or treatment, and in compliance with applicable Federal laws, regulations, and policies.

Documentation & Recordkeeping

Entities must retain documentation supporting any distribution to a country of concern under an allowable circumstance, including quantity and content of material shared, and provide to NIH upon request.

Contractual Safeguards

Existing Material Transfer Agreement (MTA) and Data Use Agreement (DUA) requirements remain in force. All outgoing or incoming transfers must be governed by an executed MTA/DUA that (i) prohibits onward transfer to countries of concern, (ii) requires recipients to screen any subcontractors/affiliates and obtain prior written approval for any rerouting, and (iii) makes UCSF Export Control & Research Security clearance a condition precedent to shipment. Coordinate with OSR/Industry Contracts to ensure NIH policy language is included.

Export Control Requirements

All international shipments must be reviewed and cleared by UCSF Export Control & Research Security prior to shipment and must comply with UC policy and applicable federal regulations.

This policy applies to all NIH-supported activities (grants, cooperative agreements, contracts, Other Transactions, and intramural) involving U.S.-person biospecimens, regardless of amount of NIH support or whether the biospecimens are identifiable. Notably, the policy “…applies to all human clinical and research biospecimens obtained from U.S. persons (regardless of identifiability) that are collected, obtained, stored, used, or distributed and that are 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.”

It does not apply to cell-derivative products or cell lines from U.S.-person biospecimens that were already commercially or publicly available before the policy’s effective date.

Why it Matters

UCSF is applying this requirement broadly. If NIH funds in any way touch a biospecimen (at any stage of collection, processing, storage, use, or distribution [including subawards, supplements, or collaborative projects]) it will be considered covered.

UCSF investigators regularly work with biospecimens (e.g., blood, tissues, cell lines) and may collaborate internationally. Under NOT-OD-25-160, direct or indirect distribution of NIH-supported U.S.-person biospecimens to countries of concern is broadly restricted, with only narrow allowable circumstances. 

This policy is part of the evolving federal research-security posture and complements DOJ’s data-security rule under 28 C.F.R. Part 202, which addresses the handling of bulk sensitive personal data. Together, these rules aim to secure biological materials and associated data from misuse or unauthorized access.

UCSF investigators, biorepositories, and departmental administrators must ensure biospecimen transfers, MTAs/DUAs, subawards, and collaborations reflect these restrictions.

• Countries of concern: Those countries as determined under 28 CFR § 202.601 (Subpart F: Determination of Countries of Concern). This list is subject to change by the DOJ with input from the State and Commerce Departments.
  • The People’s Republic of China (including Hong Kong and Macau)
  • The Republic of Cuba
  • The Islamic Republic of Iran
  • The Democratic People’s Republic of North Korea
  • The Russian Federation
  • The Bolivarian Republic of Venezuela
• Human biospecimens: 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.
• U.S. person: As defined under 28 CFR § 202.256, any United States citizen, national, or lawful permanent resident; any individual admitted to the United States as a refugee under 8 U.S.C. 1157 or granted asylum under 8 U.S.C. 1158; any entity organized solely under the laws of the United States or any jurisdiction within the United States (including foreign branches); or any person in the United States.

October 24, 2025: Policy effective; restrictions and documentation duties apply to covered activities and transfers on/after this date. 

For PIs / Labs / Biorepositories

• Obtain Export Control & Research Security review and written clearance before any export or international shipment. Do not ship until clearance is confirmed.
• Halt new or pending distributions of NIH-supported U.S.-person biospecimens to entities in countries of concern unless an allowable circumstance applies and is fully documented.
• Update agreements (MTAs/DUAs/subawards/CTAs) to prohibit onward transfer to countries of concern and to require notification/approval for any transfer implicating allowable circumstances.
• Capture documentation when allowable circumstances apply (legal basis, consent, rationale for unique capability, materials inventory). Retain records and be prepared to produce to NIH.
• Include the NIH grant number or other funding identifier when requesting Export Control clearance.

For Departments / Administrators

• Implement a pre-shipment attestation and routing review for any biospecimen transfer; require Export Control & Research Security review and clearance when the recipient is outside the U.S., when routing is uncertain, or when any export may occur.
• Ensure award files and biospecimen logs reflect NIH-funding ties and that staff can determine when the policy applies (including mixed-funding scenarios).
• Ensure outbound MTAs include a clause requiring recipients to flow down NIH NOT-OD-25-160 obligations to any sub-recipients.

Operational tracking: Ensure LIMS/REDCap or local logs can flag NIH-supported U.S.-person biospecimens, capture destination country, and record Export Control clearance status prior to release.

• UCSF Export Control & Research Security
• Office of Sponsored Research (OSR)
• IT Research Cybersecurity
• UC Legal

• UCSF International Shipment Requirements
• UCSF Material/Data Transfer Agreement Requirements
• NIH Notice NOT-OD-25-160
• DOJ Final Rule / Program Materials (EO 14117; 28 C.F.R. Part 202)