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4.1.13 Human Biospecimens Security Measures

As of October 24, 2025, NIH recipients must comply with the NIH Policy on Enhancing Security Measures for Human Biospecimens ("NIH Biospecimens Security Policy").

The NIH Biospecimens Security Policy applies to ongoing or new NIH funding instruments (for the purposes of the NIH GPS grants and cooperative agreements) regardless of NIH funding level, used to obtain human clinical and research biospecimens from U.S. persons (regardless of identifiability) that are collected, obtained, stored, used, or distributed. Note that for the purposes of this policy. The NIH Biospecimens Security Policy does not apply to cell derivative products or cell lines derived from human biospecimens of U.S. persons collected, obtained, stored, used, or distributed using on-going or new NIH funds that are commercially or publicly available prior to October 24, 2025.

The entity (e.g., biorepository, institution, investigator) that holds human biospecimens of U.S. persons collected, obtained, stored, used, or distributed using ongoing or new NIH funds are prohibited from directly or indirectly distributing the human biospecimens to institutions or parties located in countries of concern. For the purposes of the NIH Biospecimens Security Policy, countries of concern are defined as those determined under 28 CFR § 202.601 (Subpart F: Determination of Countries of Concern). NIH expects the research community to recognize the risks posed by the sharing or distribution of U.S. persons biospecimens that were collected, obtained, stored, used, or distributed with previous NIH funds or support with countries of concern.

In limited circumstances, the human biospecimens may be shared or distributed to countries of concern only if use of the human biospecimens is:

  1. to meet transactions required or authorized by Federal law or international agreements, including Global health, or necessary for compliance with Federal law; or

  2. 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

  3. 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.

As a reminder, the export of human biospecimens must follow all applicable export administration regulations.

NIH requires all recipients to retain documentation related to sharing or distributing biospecimens to countries of concern under one of the allowable limited circumstances and further document the quantity and content of the biospecimen material that was shared or distributed. In accordance with 2 C.F.R. Part 200.337, Access to Records, recipients are required to provide these records to NIH upon request.