NIH-funded researchers working with human biospecimens are prohibited from "directly or indirectly distributing" human biospecimens obtained from U.S. persons with institutions or persons located in "countries of concern" per a recent NIH policy.
As a reminder, transfer of materials to or from another institution, regardless of location, may require a Materials Transfer Agreement:
NIH's policy became effective October 24, 2025.
What are the countries of concern?
Per the federal government, the current list of countries of concern are China, Cuba, Iran, North Korea, Russia, and Venezuela.
What is considered a human biospecimen?
NIH defines a human biospecimen as any "quantity of tissue, blood, urine, or other human-derived material." They note that one biopsy may result in multiple specimens and that this includes cell lines. The notice "applies to all human clinical and research biospecimens obtained from U.S. persons (regardless of identifiability)." See the Notice for full details.
What about publicly available or commercial cell lines?
This 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.”
Questions about Materials Transfer Agreements?
Questions about Materials Transfer Agreements should be directed to the Office of Technology Transfer (University Park and Commonwealth Campuses) or the Center for Medical Innovation (College of Medicine).