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About the IRB

What's an IRB?

An Institutional Review Board (IRB) is a federally mandated entity that oversees the protection of human subjects in research. Penn State has two IRBs: the General Review Board and the Noncompliance Board. At Penn State, an IRB must review all research involving human subjects, and the research cannot begin until the IRB has reached a determination. This is true even if a researcher perceives there are no risks for people who participate in their research–it is the role of the IRB to mitigate potential risks to participants, including their physical and psychological well-being, confidentiality and privacy, and autonomy, among others. The IRB consists of faculty, staff, and community members appointed by the Associate Vice President for Research. The IRB must have at least one member serving on the board who is not employed or affiliated with the University or has an immediate family member employed or affiliated with the University.

IRB Meeting Dates & Times

All IRB meetings are subject to change or cancellation. All IRB meetings are held virtually and could include research from any Penn State campus, including the College of Medicine.

See the 2026 IRB General Review and Non-Compliance Board Meeting Schedule.

IRB Membership

In order to conduct thorough reviews of research, IRBs include members with varied experience and expertise, including medical, science and non-scientist perspectives and community representatives serving as non-affiliated members. Each IRB member reviews materials and attends board meetings prepared to discuss proposed research within their realm of expertise or experience. Individuals interested in serving on the IRB need only an appreciation for the importance of clinical research and an interest in protecting research participants. Educational resources are provided to help all members gain the necessary information base regarding research protection.

Are you interested in becoming an IRB member? If so, please complete this application form.

Federal Wide Assurance (FWA), IRB Registration, and Institutional Official

Penn State has one approved FWA with the Department of Health & Human Services, which covers the University, including the College of Medicine and Penn State Health.

FWA

  • The Pennsylvania State University: FWA00004251

IRB Registration for all Campuses:

  • IORG#0000031
  • Registration Number for IRB #1: IRB00000046
  • Registration Number for IRB #2: IRB00000047

IRB Registration for all Campuses:

The Institutional Official for the University is Debra Thurley, Associate Vice President for Research.

Statement of IRB Compliance

The Pennsylvania State University IRBs are duly constituted, allow only those IRB members who are independent of the investigator and the sponsor of the trial to vote/provide opinion on the trial, and have written procedures for initial and continuing review of human research protocols. The IRBs each comply with requirements defined in 45 CFR 46, 21 CFR 50 and 56, and ICH-GCP to the extent required by the U.S. Food and Drug Administration. Download a Word version of Statement of IRB Compliance.

Fees for Industry-Supported Research

At the time of proposal or negotiation, industry-supported studies that do not recover full Facilities & Administrative Cost and are reviewed by the Penn State University IRB will be assessed the following fees:

Local IRB Reviewed Research

  • Initial IRB Review Fee: $3,000 (contract execution)
  • Continuing Review: $1,000 (each occurrence)
  • Study Closure Report: $600
  • Sponsor-initiated Modification: $750 (each occurrence)
    • Protocol amendments
    • New editions/versions of Investigator’s Brochures or Instructions for Use
    • Sponsor-written recruitment materials
    • Other materials from the sponsor that require IRB approval

Central IRB Reviewed Research

  • Initial IRB Review Fee: $1,950 (initial administrative review)

This process has historically only been in place for the College of Medicine, with past fee structures found below.

In compliance with Uniform 2 CFR 200.401(b), 403(c), 414(f), the Penn State University (PSU) Institutional Review Board (IRB) charges industry-supported research studies that do not recover full Facilities & Administrative Cost fees to cover the costs of reviewing research protocols, which include administrative resources, staff, and technology. These fees ensure compliance with ethical standards, federal regulations, and local laws by supporting expert reviews and ongoing oversight. When using a central IRB, the fees are used to support the necessary resources for local-context reviews, ensuring the research aligns with institutional policies. Ultimately, fees sustain IRB operations, improve efficiency, and expedite the review process, benefiting both the sponsor and research participants.

NOTE: The Initial Review fee is charged even if the study does not commence at Penn State, but the IRB review occurred.

Superseded Fee Schedules