October 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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ORP Launches Centralized Research Training Hub
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The Office of Research Protections (ORP) has introduced the Research Training Hub, a comprehensive, centralized platform developed to assist University of Pittsburgh researchers in efficiently identifying both required and elective training opportunities relevant to their work.
This new resource outlines the mandatory training requirements applicable to all investigators and specifies additional specialized training needed for those engaged in human subjects research, animal subjects research, and bench-based scientific investigations.
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NIH Notice NOT-OD-25-160 prohibits the sharing, transfer, or distribution of biospecimens from U.S. persons—particularly those collected, obtained, stored, used, or distributed with NIH funding or support—to any country of concern. "Countries of Concern," as defined in this rule, include China (including Hong Kong and Macau), Iran, North Korea, Russia, Cuba and Venezuela. The Notice extends to new cell lines generated from human biospecimens after October 24, 2025.
This restriction applies not only to the transfer of samples to another institution or investigator located in a country of concern, but also to the use of companies in such countries to perform analytic services, including genomic sequencing or other analyses involving human biospecimens.
In response, Purchasing Services has updated its checklists in alignment with the requirements of NIH Notice NOT-OD-25-160. These revisions are specifically intended to prohibit the use of companies located in countries of concern for sequencing or other analytic services involving human biospecimens.
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Research in Sanctioned Countries
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Research activities involving sanctioned countries, including interviews with citizens in those countries, is subject to strict U.S. federal regulations, primarily governed by the Department of Treasury’s Office of Foreign Assets Control (OFAC).
At present, the most heavily sanctioned countries include Iran, North Korea, Cuba, and specific regions of Ukraine (Crimea, Donetsk, Luhansk). In addition, interactions with specific institutions, entities, and individuals in these and other countries—such as China, Russia, Belarus, and Venezuela—may be restricted under U.S. restricted party lists. Because U.S. sanctions programs are dynamic and frequently updated, it is essential to verify whether research activities in a country or region subject to U.S. sanctions may occur under an available authorization (general license) or require a specific OFAC license.
Investigators planning to engage in research activities involving these countries or regions are strongly encouraged to contact the Office of Research Security and Trade Compliance (researchsecurity@pitt.edu) for an assessment of whether the proposed activity is permissible under U.S. law, and to determine whether a specific license from the U.S. government would be required or feasible to obtain.
Failure to secure the necessary authorization prior to initiating research that contravenes current U.S. sanctions could result in serious penalties for both the institution and the individual investigator.
Note that individuals from sanctioned countries or regions granted a non-immigrant visa to enter the U.S. are permitted to perform activities authorized by their visa while they are in the U.S.
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Two University of Pittsburgh policies were recently revised to ensure alignment with current federal regulations and expectations. Policy RI-01 (Conflict of Interest Policy for Research) has been updated to specify that recipients of federal research awards are prohibited from participating in malign foreign talent recruitment programs, as defined under the CHIPS and Science Act.
Additionally, Policy RI-08 (Responsibilities of Sponsored Research Investigators) has been amended to clarify that all award recipients must comply with the training and disclosure requirements established by their respective funding agencies.
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Webinar Recap: Academic Visitors to Pitt and Clinical Shadowing in UPMC
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If you missed the October 10 webinar, Academic Visitors to Pitt and Clinical Shadowing in UPMC: What You Need to Know, the recording and slide deck are now available. The session provided an overview of requirements for academic visitors and individuals seeking to shadow clinical activities, helping departments navigate both processes smoothly.
🎥 Watch the Webinar Recording
📑 View the Slide Deck
As emphasized in a communication from Senior Vice Chancellors McCarthy, Pinkney, Rutenbar, and Shekhar, the University of Pittsburgh’s Academic Visitor Process serves a critical role in protecting both the University and the visitors who come to campus for academic, research, or collaborative purposes.
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ORP's Conflict of Interest (COI) Division has revised its procedures to strengthen compliance with financial conflict of interest (FCOI) requirements for outgoing subawards.
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Expanded Scope: FCOI requirements, previously limited to Public Health Service (PHS)–funded subawards, now apply to all outgoing subawards administered by the Office of Sponsored Programs Grants Management Services or Federal Contract Services teams. This includes subawards funded by federal, state, or local government agencies, nonprofits, and foundations, but excludes for-profit agreements managed by the Clinical & Corporate Contract Services team.
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Streamlined Process: Subrecipient FCOI forms have been simplified; the COI Division will send required forms directly to applicable subrecipient investigators following the University’s FCOI policy.
Additional information is available on the Outgoing Subawards page of the COI website.
For questions, contact the COI Division at coi@pitt.edu.
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The University of Pittsburgh’s Department of Environmental Health and Safety has announced the 2026 disposal dates for DEA-controlled substances. These quarterly events give Pitt researchers a free, convenient and compliant way to dispose of expired or unused controlled substances used in research.
Upcoming collection dates:
• Wednesday, January 14, 2026
• Wednesday, April 15, 2026
• Wednesday, July 15, 2026
• Wednesday, October 14, 2026
Additional details and instructions are posted on the EH&S website.
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Protocol Review Changes
Several changes are upcoming for protocol review committees supported by ORP (see sections below).
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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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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. Please review the chart carefully for budgeting purposes as there are additional charges that were added as a result of benchmarking with other institutions.
Note that this is different than budgeting for Pitt as the 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 common reason for waiver is when the industry collaborator is not funding the entire study but is supporting the study by providing only the drug or other nominal 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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Plan Ahead: Submit Protocols Early Before the Holiday Recesses
The University will observe two upcoming recesses: Thanksgiving Recess (November 26–27) and the Winter Recess (December 24–January 4).
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During these periods, protocols will not be processed or reviewed. To avoid interruptions in research activities, investigators are strongly encouraged to submit protocols well in advance of these closures to ensure timely review and approval.
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Upcoming Educational & Training Opportunities
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Consider signing up for this training opportunity offered by the Office of Research Protections:
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