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Pitt Research
Office of Research Protections

NIH Policy on Enhancing Security Measures for Human Biospecimens

NIH Policy on Enhancing Security Measures for Human Biospecimens

NIH recently issued a new policy aimed at enhancing security measures for human biospecimens, which include tissue, blood, urine, and other materials derived from humans. Such materials also include cell lines derived from human biospecimens that are generated after the policy’s effective date: October 24, 2025.

Under the new requirements, biospecimens collected from U.S. persons, which were obtained through NIH funding or maintained in repositories supported by NIH funds, may not be distributed to institutions or parties located in a “country of concern,” except under specific circumstances explicitly outlined in the policy.

As a reminder, no human biospecimens or related materials should be shared with any external entity without a formal agreement in place, such as a Material Transfer Agreement (MTA) or purchase agreement. These agreements are essential to ensure that export control requirements, as well as other applicable regulations, are fully addressed.

Reminder: Update Protocols When Research Spaces Change


As research laboratories are consolidated and space is reassigned, it is essential to ensure that all protocols and other authorizations submitted to the Institutional Animal Care and Use Committee (IACUC), Institutional Biosafety Committee (IBC), Environmental Health & Safety (EH&S), and other relevant offices are kept up-to-date. The research location listed in each protocol must accurately reflect the space in which the work will actually be conducted.

If your research involves animals, biohazardous materials, chemical hazards, or radiological materials, you must update all associated protocols prior to initiating work in any new location.

Additionally, some external regulatory agencies—such as the Drug Enforcement Administration (DEA)—may also require updated registrations or notifications when research activities are moved to a different location.

AAALAC International Site Visit: October 27-30

Pitt's Animal Care and Use Program has been accredited by AAALAC International since 1983, and will undergo a triennial accreditation review from October 27-30. This review will entail representatives from AAALAC International visiting animal use areas, including investigator laboratories. It is imperative that someone knowledgeable of each lab's IACUC protocol(s) is available throughout the visit to represent their group's work.

AAALAC International is a private, nonprofit organization that promotes the humane treatment of animals in science through voluntary accreditation and assessment programs. This accreditation demonstrates the University’s commitment to responsible animal care and use.

Please plan to attend an upcoming session that provides background for the site visit and expectations for your laboratory team. Presenters include representatives from the ORP Animal Research Protection and Biorisk Management Divisions, as well as the Division of Laboratory Animal Resources (DLAR).

All the sessions will be presented virtually.

Tuesday, September 30, 2025, 12 - 1 p.m.  Register for the Virtual Session

Thursday, October 2, 2025, 12 - 1 p.m.       Register for the Virtual Session

Thursday, October 16, 2025, 12 - 1 p.m.     Register for the Virtual Session

Orientation to Research Fundamentals: Register Now!


An "Orientation to Research Fundamentals" (ORF) will be held October 7–9, 8:15 a.m. to 1 p.m. This program, hosted by the Clinical and Translational Science Institute (CTSI), is an intensive and interactive workshop covering concepts necessary to successfully coordinate a clinical research study. It provides an overview of the resources and regulatory requirements for conducting clinical research at the University of Pittsburgh and UPMC.

ORF is offered at no cost to attendees and Continuing Education Units are available. Visit the CTSI Events page to register.

Webinar: Academic Visitors to Pitt and Clinical Shadowing at UPMC

Join us on Friday, October 10, from 12–1 PM, for a webinar on the University’s Academic Visitor process and UPMC’s clinical shadowing process. Presenters will outline requirements for academic visitors to Pitt, as well as steps for those seeking to shadow clinical activities at UPMC.

Speakers include:

  • Allen DiPalma, Executive Director of Research Security and Trade Compliance, and
  • Dr. Stephanie Gonzalez, Assistant Professor of Emergency Medicine.

Register for the webinar.

Congratulations to the IRB on Supporting LITES Research


We congratulate Pitt's Institutional Review Board (IRB) for its key role in the LITES Network’s groundbreaking trials. By overseeing study design, guiding consent processes, and ensuring the highest ethical standards, the IRB helped make possible research that is improving trauma care for both military and civilian patients.

2025 Basic Biomedical Researcher Symposium: Recordings Available

The Office of Research Protections (ORP) recently hosted the Basic Biomedical Researcher Symposium, a virtual event designed to connect new and established investigators with Pitt's research offices and resources. Sessions focused on key compliance and support areas, aimed at helping researchers navigate requirements and strengthen their work. 

Recordings of all presentations remain available for those who were unable to attend live: 

Executive Orders and Federal Funding


The University has launched a new webpage dedicated to tracking executive orders and their impact on federally-funded research.

Upcoming Educational & Training Opportunities

Consider signing up for this training opportunity offered by the Office of Research Protections:

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