November 2025 Newsletter
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Stay up-to-date with the latest news and resources from the Office of Research Protections (ORP)
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Human Subject Research Determination Tool
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Not all projects that involve human participants meet the definition of human subject research under the regulations of the Department of Health and Human Services (DHHS), and such activities may not require IRB oversight. To assist investigators in making this determination, the IRB has developed a decision tool to clarify whether IRB review is necessary.
For more information and/or to access the tool, click this link.
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U.S. government restricted party lists identify individuals, companies, and institutions barred or limited from trade, collaboration, or financial dealings due to national security, foreign policy, or legal concerns. They are tools implemented by the government for enforcing export controls, sanctions, and protecting U.S. interests. These lists are maintained by multiple federal entities, including the Department of the Treasury’s Office of Foreign Assets Control (OFAC), the Department of Commerce’s Bureau of Industry and Security (BIS), and the Department of Defense.
The University maintains compliance with restricted-party requirements by integrating Visual Compliance software into multiple institutional systems, which flags proposed transactions involving restricted entities. Restricted-party screenings are also conducted as part of the University’s visitor process to ensure that invited visitors—and their home institutions—are not included on any restricted-party list.
Accordingly, investigators and departments planning to host visitors are strongly encouraged to initiate the visitor process as early as possible. They may also consult with the visitor liasion (email: visitor@pitt.edu) in advance to confirm that a planned visit can be approved.
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AAALAC Site Visitors Commend Pitt's Animal Care and Use Program
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The University of Pittsburgh’s Animal Care and Use Program has maintained continuous accreditation from AAALAC International since 1983. This accreditation reflects the University’s adherence to rigorous standards governing the humane care and use of laboratory animals.
Maintaining AAALAC accreditation requires the submission of extensive documentation on our animal care and use program, as well as a site visit, every three years. The most recent site visit took place from October 27–30. We extend our sincere thanks to the investigators who met with the site visitors during their review.
The AAALAC site visit team highlighted multiple strengths of our program, including our highly knowledgeable animal care staff, well-maintained facilities, excellent veterinary care, exemplary research spaces, strong programmatic support, robust enrichment initiatives, and solid institutional commitment.
The site visitors provided only a few minor suggestions for improvement. A final accreditation decision will be forthcoming when the AAALAC Council meets in early 2026.
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Pitt's Research Data Management Policy — RI 14 — governs the ownership, handling, access, sharing, and retention of research-related data and records generated under University auspices.
Key requirements include:
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Research data must be stored in a University-approved repository to ensure proper protection.
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The University must retain the original copy of research records when an investigator departs, unless a formal agreement provides otherwise.
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Data must be retained for the period required by applicable laws, regulations, funding agencies, or the University’s retention schedule.
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While appropriate open sharing of data—per funding agency or journal mandates—is encouraged, sharing of unpublished data typically requires a formal agreement to protect intellectual property and ensure proper governance.
Additionally, investigators are encouraged to develop data management plans that comply with funder requirements prior to project initiation, thereby ensuring that all team members understand the data storage, access, and archiving practices from the outset.
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Research Security Webinar on December 5th
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Driven largely by the CHIPS and Science Act and other federal initiatives, research security requirements have expanded quickly, fundamentally changing what universities and individual investigators must do to remain compliant. Funding agencies are introducing new and evolving expectations related to disclosures of external engagements, funding sources, and foreign collaborations, as well as requirements for research security training, oversight of international travel, strengthened cybersecurity measures, and stringent adherence to export control regulations. These rapid developments have understandably created uncertainty across Pitt’s research community.
To provide clarity, the Office of Research Security and Trade Compliance will host a webinar to explain current federal expectations and outline the specific actions the University of Pittsburgh has taken to ensure compliance, reinforce research protections, and support investigators as these requirements continue to evolve.
Register here.
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The fees associated with IRB reviews of clinical research (including chart review studies) that are funded in whole or in part by industry sponsors (regardless of authorship of the protocol) will be increasing effective January 1, 2026. The updated fees are provided below; note that additional charges were added following benchmarking of other institutions.
These fees for industry sponsors differ from those for Pitt to serve as single IRB of Record (siRB). Please contact irb.reliance@pitt.edu for information regarding sIRB fees.
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Review Process |
Project Type |
New Fee Beginning 1/1/26 |
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Full Board or Expedited |
Initial Review |
$3,000 |
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Full Board |
Continuing Review |
$2,000 |
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Expedited |
Continuing Review |
$1,500 |
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Full Board or Expedited |
Study-Wide Sponsor-Initiated Amendment |
$1,000 |
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Exempt |
Initial Review |
$500 |
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All Review Types |
Study Close-Out |
$600 |
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Ceded Studies Reviewed by a Commercial IRB |
One-time Administrative Fee (in addition to the fees that the commercial IRB charges) |
$2,500 |
Studies that are subject to the IRB review fees will not be processed until the fees are paid in full. There may be circumstances when investigators can request a waiver of the fee. The most frequent basis for a waiver is when the industry collaborator is not funding the full study but is instead providing only the study drug or another form of limited support.
For studies approved prior to January 1, 2026, the previous fee structure will continue to be utilized.
If you have any questions regarding this change, please contact us at askirb@pitt.edu.
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The University will be closed for Winter Recess from December 24 through January 4. During this period, protocols and other transactions will not be processed or reviewed. To prevent any disruption to ongoing research activities, investigators are strongly encouraged to submit protocols and related materials well in advance of the recess to allow sufficient time for review and approval.
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On October 1, the federal Animal Care and Use Review Office (ACURO), which provides regulatory oversight for Department of Defense (DoD) studies involving animals, announced that DoD-funded activities can no longer be included on the same animal use protocol as research supported by other funding sources (e.g., the NIH, NSF, other federal or private grants, internal/pilot funds).
These changes* apply only to new and three-year renewal protocols submitted to the University of Pittsburgh IACUC and ACURO on or after January 1, 2026.
Guidance for Investigators with current or planned DoD projects:
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If you have an existing IACUC-approved protocol with DoD funding, no action is needed now. At your next de novo/triennial review, all DoD-funded work must be submitted as a separate protocol for IACUC approval.
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For new IACUC protocols with DoD funding submitted on or after January 1, 2026, submit them separately from protocols funded by other sources.
*This change does not affect international or DoD intramural protocols.
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Upcoming Educational & Training Opportunities
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Consider signing up for these training opportunities offered by the Office of Research Protections:
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