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NIH Announces New Human Biospecimen Security Policy for NIH-Funded Research

The National Institutes of Health (NIH) recently released a new policy on human biospecimen security (see NOT-OD-25-160) that will take effect on October 24, 2025. This policy establishes new requirements for sharing or distributing human biospecimens collected, obtained, stored, used, or distributed with ongoing or new 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. 

Scope 

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. See the policy notice for the definition. 

The policy does not apply to cell lines or cell 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.” 

Restrictions 

Entities holding NIH-supported biospecimens are prohibited from directly or indirectly 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; 
  • Use of 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 shared 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 documentation must be retained and provided to NIH upon request. 

You can find the full NIH Notice here. Contact exportcontrols@northwestern.edu with questions regarding this notice.

Frequently Asked Questions

Does the policy extend to all of Northwestern research or only to those studies funded by NIH?

The policy applies specifically to human biospecimens that are collected, obtained, stored, used, or distributed using ongoing or new NIH funds. It does not apply to biospecimens from research conducted at Northwestern if they were not specifically "collected, obtained, stored, used, or distributed using ongoing or new NIH funds."

What research activities are impacted?

Impacted activities include any physical transfers of covered materials to countries of concern via international shipping or travel.  

All international transfers of biospecimens or biological materials should go through a compliance review process, including:

  • Appropriate documentation through a Material Transfer Agreement (MTA), if applicable.
  • Institutional certification for shipping biological materials. Only certified hazardous materials shippers may ship biological materials from the University. Consult the  Hazardous Materials Shipping page on the Research Safety website for details.
  • A licensing determination from the Export Controls & International Compliance office for all international shipments of biological materials.  Consult ECIC International Shipping page for details. 
  • Use of eShipGlobal for all shipments.