February 2026 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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Funding Agency Requirements for Foreign Components
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International collaboration remains an important element of scientific research; however, federal funding agencies require prior approval whenever a significant portion of a funded project will be conducted outside the United States. Oversight of such “foreign components” has intensified in recent years, and the risks associated with non-compliance have increased accordingly.
A foreign component is defined as any significant element of a project performed outside the United States by the recipient or by collaborators affiliated with a foreign organization, regardless of whether grant funds are used abroad. Examples include collaborations expected to result in co-authorship, use of foreign facilities or specialized equipment, research involving human participants or animals at a foreign site, or the engagement of a foreign contract research organization to perform key aspects of the work.
Investigators must obtain sponsor approval before initiating a foreign component, either by describing it in the original proposal or by submitting a prior-approval request if it is added after an award is made. Failure to disclose a foreign component constitutes a serious compliance violation and may result in grant suspension or termination, recovery of funds, investigator debarment, or other enforcement actions.
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The Annual Conflict of Interest Disclosure period begins on March 16, 2026. Disclosures must be submitted by April 15, 2026. Supervisors must complete reviews of disclosures by June 15, 2026.
If you are required to complete and certify an Annual Disclosure, you will receive an email notification from MyDisclosures between March 16 and March 20. Do not complete your Annual Disclosure until you receive the email notification from MyDisclosures! Disclosures submitted before March 16, 2026 do not satisfy the 2026 annual disclosure requirement.
To review the disclosure requirements, MyDisclosures training videos and step-by-step instructions or guidance for supervisors, visit the COI site.
If you have questions, contact the Office of Research Protections’ Conflict of Interest Division at mydisclosures_support@pitt.edu.
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As we prepare for the 2026 Annual Conflict of Interest Disclosure period, now is an excellent time to deepen your understanding of the process — including why it is required, what supervisors are responsible for when reviewing disclosures, and how the information is used to identify and manage conflicts of interest and commitment.
These topics will be the focus of our next Office of Research Protections (ORP) Seminar Series presentation:
Managing Financial Conflicts of Interest in Research:
Why "I Didn't Know" Isn't an Excuse
📅 March 6, 2026 | 12:00 – 1:00 p.m.
🎤 Speaker: Christina Gasdia, JD
Director, ORP's Conflict of Interest Division
Click Here to Register
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The University's conflict of interest process is codified in Pitt Policy RI-01, Conflict of Interest Policy for Research. Several related policies also help define the process, including RI-11, Institutional Conflict of Interest, ER-02, Conflict of Interest for Designated Administrators and Staff, and ER-03, Conflict of Interest for University of Pittsburgh Employees.
Together, these policies recognize that faculty and staff are encouraged to engage in outside professional activities and may hold financial interests in external entities, but require that those interests be disclosed and managed so they do not interfere with University duties or compromise the objectivity of research. When a financial relationship may be perceived as affecting the objectivity of research, these policies require the formulation of a Conflict Management Plan (CMP).
An additional provision addresses the use of University resources. Pitt facilities, lab space, offices, equipment, and other University employees or students generally may not be used for outside professional activities. However, incidental use of University resources is permitted, defined as limited personal use of Pitt equipment or services that the University is already providing, subject to three conditions: the use must result in no additional expense to the University, it may cause only normal wear and tear, and it must comply with existing contractual obligations.
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Upcoming Changes to Industry-Sponsored Human Participant Protocol Review Fees
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The Office of Research Protections (ORP) will implement an updated fee structure for industry-sponsored human participant protocol reviews involving Human Gene Transfer and Innovative Uses of Radiation, effective July 1, 2026.
What’s Changing?
Beginning July 1, two new ancillary fees will apply to any new protocols initiated on or after this date in the following areas:
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Gene Transfer studies
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Innovative Uses of Radiation — specifically studies involving radiopharmaceuticals (not routine research-related radiation, such as standard X-rays)
These updates reflect the increasing complexity, regulatory oversight, and specialized expertise required to review high-risk and emerging research. The revised fees will support enhanced scientific and regulatory review, including additional biosafety and radiation safety evaluation and expanded compliance resources.
Updated fee schedules will be posted on the ORP website. Please ensure teams and external partners are aware of these changes prior to budget development and submission.
Note that these fees do not apply to industry-sponsored animal or bench studies, but only to studies involving humans.
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Congratulations, Kelly Dornin-Koss!
Congratulations to Kelly Dornin-Koss on her upcoming retirement after more than 30 years of dedicated service to the University. Kelly began her career as a clinical nurse, primarily working in intensive care, before transitioning into research coordination. In 1996, she founded Pitt's Education and Compliance Office for Human Subject Research — the first of its kind in the country — and has led its education and compliance mission ever since.
Her contributions will have a lasting impact on ORP, Pitt Research, and the broader UPMC research community.
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The Office that Kelly Dornin-Koss founded, now known as the Education and Compliance Support for Human Subjects Research Division of ORP (ECS-HSR), plays several major roles in supporting human participant research. ECS-HSR aims to protect the rights and safety of research participants and support investigators in the conduct of quality research at the University of Pittsburgh by providing regulatory education and assistance to the research community.
ECS-HSR assists Sponsor-Investigators with the development and submission of Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications to the FDA, and supports researchers with ClinicalTrials.gov registration, record maintenance, and results submission in compliance with federal requirements.
ECS-HSR also provides local monitoring services for clinical studies and conducts Research Investigator Start-up Education (RISE) Reviews — a collaborative initiative designed to assist principal investigators and study teams with regulatory and ethical issues specific to their IRB-approved protocols at the time of study initiation.
ECS-HSR additionally offers educational outreach through presentations and a Good Clinical Practice (GCP) Toolbox containing general guidance and study documentation tools, as well as guidance for multicenter clinical trials conducted under a University-based IND or IDE at external sites.
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If you feel that the federal regulatory burden on institutions and investigators receiving federal funding has grown significantly in recent years, the data backs you up.
The Council on Governmental Relations (COGR), a national organization that tracks federal requirements affecting research institutions, has documented that 62% of all new or revised federal regulations and policies affecting research since 1991 were issued in just the past ten years.
Among the most notable recent additions are the Department of Justice Data Security Program, Security and Operational Standards for NIH Controlled-Access Data Repositories, and new restrictions on sharing human biospecimens with countries of concern.
To explore the full scope of these changes, visit this page on COGR's website.
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The Research Ethics Consultation Service (RECS) offers Pitt researchers a place to talk through ethical questions that can arise during research projects. The service helps investigators think through complex situations and identify potential concerns early, but it does not replace formal oversight committees or reporting channels. RECS is available to students, faculty, staff, and research administrators across the University who want guidance on responsible research practices.
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ORP Seminar Series Highlights
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ORP recently hosted two seminars focused on research compliance and best practices. As part of the ORP Seminar Series, both webinars are now available to watch on demand, with accompanying presentation slides and resources.
Links to all the ORP Webinars are posted on this page.
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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:
⭐️ - part of the ORP Seminar Series
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