Background
September 24, 2025, the National Institutes of Health published a Policy titled “Enhancing Security Measures for Human Biospecimens,” (Policy) based on Executive Order 14117 “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern.” The Policy placed new restrictions on the sharing of human biospecimens of U.S. persons that were collected, obtained, stored, used, or distributed using NIH funds. Effective October 24, 2025, the Policy prohibits the sharing of human biospecimens with individuals or entities located in the federally designated “Countries of Concern” which include China (including Hong Kong and Macau), Russia, Iran, North Korea, Cuba and Venezuela.
Scope and Applicability
Unlike other recent NIH policies around U.S. bulk sensitive data, there is no bulk threshold for biospecimens, and therefore the sharing of even a single biospecimen covered by the Policy with a Country of Concern is prohibited. 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.
Human biospecimens are defined in the Policy as any quantity of tissue, blood, urine, or other human-derived material. A single biopsy may generate several human biospecimens, including multiple paraffin blocks or frozen samples. Examples of human biospecimens include the following:
| Covered Human Biospecimens | Examples |
|---|---|
| Subcellular structures, cells, tissue | e.g. bone, muscle, connective tissue, and skin |
| Organs | e.g. liver, bladder, heart, and kideny |
| Gametes | e.g. sperm and ova |
| Embryos, fetal tissue, and waste | e.g. urine, feces, sweat, hair and nail clippings, shed epithelial cells, and placenta |
| Biospecimens that are isolated and propagated into new cell lines | e.g. cell lines collected, obtained, stored, used, or distributed using NIH funds on or after 10/24/2025 |
| Blood | e.g. Bone marrow cells |
| Fecal Samples | e.g. human derived microbiota |
The Policy provides for a very few, limited exceptions for biospecimens that were commercially or publicly available prior to the effective date of the Policy, as well as for certain transactions that are specifically authorized by Federal law. MSU faculty, students or staff who have questions about previous transactions, prior to the effective date of October 24, 2025, or who would like to obtain federal authorization to proceed should contact MSU’s Research Security Program at researchsecurity@msu.edu.
Guidance for MSU Faculty
The NIH Biospecimens Security Policy introduces significant changes. MSU faculty, students and staff working with human biospecimens should take proactive measures to evaluate their research activities and ensure compliance, including the following:
- Assess whether you have any human biospecimens of U.S. persons that were collected, obtained, stored, used, or distributed with ongoing or new NIH funds.
- Assess whether you have a need to share human biospecimens with individuals or entities located in a federally designated “Country of Concern:” China (including Hong Kong and Macau), Russia, Iran, North Korea, Cuba and Venezuela. If so, please reach out to MSU’s Research Security Program researchsecurity@msu.edu
- Pursuant to Doug Gage’s recent communication on Increased Monitoring of Imports and Exports, please utilize a Material Transfer Agreement (MTA) to share biospecimens with individuals and entities, whether domestically or internationally. Contact MSU Technologies at cdamta@msu.edu to put an agreement in place prior to shipping or receiving.
- Remember that international research shipments, including human biospecimens, must comply with the U.S. Export Control Regulations. Utilizing a Material Transfer Agreement for these shipments allows MSU’s Office of Export Control & Trade Sanctions to be notified of the transfer and conduct export classifications, as needed, prior to shipment.
This guidance is intended to provide an overview of the regulations with additional details provided in the NIH Biospecimens Security Policy: Enhancing Security Measures for Human Biospecimens. For questions, please reach out to MSU’s Research Security Program at researchsecurity@msu.edu.