July 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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New NIH Training Requirement – Compliance Required by October 1, 2025
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On July 17, 2025, the National Institutes of Health (NIH) announced a new training requirement for Senior/Key Personnel on grant applications and active awards. Effective October 1, 2025, NIH-funded institutions must implement and enforce a policy ensuring that key personnel receive training on disclosure requirements.
The University has confirmed with NIH that its existing Research Security training module meets this requirement and aligns with broader federal mandates.
As noted below, the National Science Foundation (NSF) requires research security training for Senior/Key Personnel by October 10, 2025, and the U.S. Department of Agriculture (USDA) has similar requirements. To comply with NIH policy, all named key personnel on NIH grants must also complete this training by October 1, 2025.
Using the University’s research security module for this purpose allows investigators to efficiently meet multiple federal training requirements. Instructions on completing the training are provided below.
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To complete the Research Security training that fulfills the requirements of the NIH, NSF, and USDA:
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Visit https://www.citi.pitt.edu.
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Log in using your University credentials.
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Scroll to the bottom of the menu and select “Add a Course.”
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Under the “Other Courses” section, choose Research Security Training (currently the final option on the list).
Once completed, your training record will be automatically recorded and made available to the appropriate University offices for compliance and reporting.
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The National Science Foundation (NSF) recently announced that, effective October 10, all covered (key) personnel listed on NSF-funded grant applications must complete research security training on an annual basis. Beginning October 10, the Office of Sponsored Programs must certify that all covered (key) personnel have successfully taken research security training before it can submit an application. To ensure compliance, covered individuals listed on NSF grants are strongly encouraged to complete the required training within the next two months.
Similarly, the U.S. Department of Agriculture (USDA) has issued a parallel mandate, requiring annual research security training for all key individuals supported by USDA-funded grants.
Please refer to the information above for instructions on how to complete the training module.
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New to Research at Pitt? Don't Miss the Basic Biomedical Researcher Symposium
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Are you a new biomedical researcher at Pitt—or just looking to better understand the landscape of research support across campus? Don’t miss the Basic Biomedical Researcher Symposium, a virtual event taking place on Thursday, August 21, 2025, from 8:30 a.m. to 1:30 p.m. This annual workshop is designed to introduce researchers to the many departments and offices that support compliant, safe, and successful research.
For more information about the Symposium, see this link.
Presenters will cover essential topics including animal research protocols, biosafety, radiation safety, research security, conflict of interest, data sharing, and more. Whether you’re faculty, staff, or a trainee, this is a valuable opportunity to connect with experts and learn how to navigate research processes at Pitt. Please help spread the word to new members of your department!
Register for the Symposium.
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The Scientists Center for Animal Welfare (SCAW), in collaboration with the University of Pittsburgh, will host an in-person IACUC Training Workshop on Thursday, September 25, 2025, at The Assembly, 5051 Center Avenue, Pittsburgh, PA.
This workshop offers training on the ethics and regulatory oversight for the use of laboratory animals in research.
Learn more and register.
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As recently communicated by Senior Vice Chancellors McCarthy, Pinkney, Rutenbar, and Shekhar, the University has issued updated guidance concerning individuals classified as visitors. A visitor is defined as any person who is not formally appointed, enrolled, or employed by the University of Pittsburgh. While certain informal titles may include the term visitor, the visitor guidance applies exclusively to individuals who do not hold a formal affiliation with the institution.
Adherence to this guidance is essential to comply with federal laws and safeguard both the visitor and the University.
Details regarding the visitor process can be found at visitor.pitt.edu. For additional assistance, please contact the University Visitor Liaison at visitor@pitt.edu.
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Principal investigators are responsible for formally closing an IRB application once all human subject involvement has ended, including the completion of all interventions, interactions, data collection, and analysis of identifiable private information or specimens. Studies must also be closed if ended early due to funding, feasibility, or recruitment issues. For additional information and instructions, see: Study Closure.
Allowing a study to lapse in IRB approval or not submitting a final report even if a continuing review is not required may be perceived as non-compliance by the IRB. Formally closing a study indicates to the IRB that regulatory oversight is no longer needed. In addition, formally closing the protocol allows the audit and records retention timelines to begin, including the requirements for reporting in clinicaltrials.gov.
Faculty listed as mentors on a student research project are responsible for study closure when a research project is completed or upon the graduation of the student.
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Later this month, Advarra eReg will be made available to research teams conducting studies that meet the NIH’s definition of a clinical trial or that are conducted under a faculty held Investigational New Drug (IND) or Investigational Device Exemption (IDE) Application. The Advarra eReg system is a Secure Document Exchange allowing all regulatory documents, originating with a sponsor or at a site, to be managed, signed, and securely exchanged seamlessly within the investigator site file. The system offers:
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Centralized Regulatory Document Management
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Electronic Signatures & Compliance
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Investigator & Staff Credential Tracking
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Automated Workflows & Notifications
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Integration with Advarra OnCore
An introduction to the system is planned for early August. Registration for the session will be available soon on the ORP events page.
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Is your start-up company thinking of applying for a Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) award? Participating in an SBIR or STTR program through a small business could create potential individual and institutional conflicts of interest.
Check out the new FAQ page on the COI Division website related to SBIR and STTR awards.
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Thank You to Our Committee Members!
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The Office of Research Protections extends heartfelt thanks to the faculty and staff who generously serve on our committees. Your time and expertise are vital to ensuring the integrity, safety, and ethical conduct of research at Pitt.
Committees supported by ORP include:
• Institutional Review Board (IRB)
• Institutional Animal Care and Use Committee (IACUC)
• Institutional Biosafety Committee
• Human Stem Cell Research Oversight Committee
• Radiation Safety Committee
• Radioactive Drug Research Committee
• Human Use Subcommittee
• Conflict of Interest Committee
• Institutional Conflict of Interest Committee
Interested in joining a committee? We welcome new members! To learn more about available opportunities or to express interest, please contact vcorp@pitt.edu.
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Did you know that Clinical Trials that involve recombinant DNA materials such as gene therapy studies also must be reviewed by the Institutional Biosafety Committee (IBC)? Fortunately, we have a video for that!
The Institutional Biosafety Review Division maintains a library of quick reference videos that walk you through the Institutional Biosafety Committee (IBC) review process for research that uses recombinant technology.
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The Office of Research Protections (ORP) is proud to share highlights from its 2025 Annual Report, showcasing our ongoing commitment to supporting safe, ethical, and compliant research at Pitt. This year’s accomplishments include:
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Biosafety & Biosecurity Enhancements: ORP assumed oversight of biosafety functions and led institutional improvements in response to new federal guidance.
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Cost-Saving Upgrades: Replaced legacy radiological devices, saving over $1 million, and introduced AI tools to streamline IACUC protocol review.
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Boosting Compliance: Launched an eReg system for clinical trials and new resources for e-Consent and visitor authorization.
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Policy and Training Development: Partnered with campus offices to update the Research Integrity Policy and formalize research security training.
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Investigator Support: ORP expanded support for investigators.
📘 Read the full report and explore the data
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Whether you are new to Pitt or preparing to retire or relocate, we are here to assist you.
For new University members, our Onboarding Service offers customized help with protocol writing and other regulatory matters.
If you are leaving, please refer to our Departing Investigator Checklist and complete the accompanying form to receive guidance from relevant offices.
Simply reach out, and we'll provide the support you need.
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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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