FDA Site Visit
The UVM IRB underwent a routine FDA surveillance inspection from September 23-26, 2025. FDA conducts IRB inspections to determine if IRBs are operating in compliance with current FDA regulations and statutory requirements and if the IRBs are following their own written procedures when reviewing investigational drugs and devices. We are happy to report FDA observed no significant deviations from the regulations and the UVM IRB will not have another inspection for five years.
The inspector had minor suggestions for operational improvement, but no regulatory deficiencies were found. He reviewed a 200-protocol list of all open and closed FDA regulated investigational drugs and devices reviewed by our convened committee from the last 3 years. He reviewed protocol submissions in Click, minutes, regulatory committee votes and institutional policy & procedures on the following types of protocols: Significant and Non-Significant risk devices, pediatric trials with an Investigational New Drug (IND) Application, Humanitarian Use Device (HUD), expanded access (compassionate use trials), clinical trials utilizing an investigational biologic.
CITI Training News
The CITI Program announced their GCP FDA Basic and Refresher courses will be updated on October 15, 2025, to align with the new ICH E6(R3) Guideline for Good Clinical Practice. The U.S. Food and Drug Administration (FDA) announced its final guidance for industry entitled “E6(R3) Good Clinical Practice” on September 8, 2025.
The updated courses reflecting E6(R3) will also meet the minimum criteria for mutual recognition established by TransCelerate Biopharma. Please visit the CITI support center for more information on CITI Program’s TransCelerate Biopharma mutually recognized training.
If your clinical trial sponsor wants you to complete the updated GCP FDA Basic or Refresher course that reflects E6(R3), please wait until October 15, 2025 or later to take the training.
UVMClick – Exemption closures
The IRB is obligated to know which research protocols are active at UVM. It is expected researchers close exempt protocols with the IRB once the research activities are complete. This can be done by submitting a continuing review submission to close the protocol. Researchers receive annual reminders to update the IRB on the status of the exempt research. Reminders inform the researcher that the exempt protocol will be closed after 3 years if there has been no contact with the IRB.
On October 17, 2025, the IRB will be closing all open exempt protocols approved prior to 2022. If you wish to continue working on an exempt study that is greater than three years old, please submit a continuing review (PDF) indicating the research is active. Alternatively, researchers can submit a modification to their research updating key personnel (PDF)or revising the research (PDF). This will also let the IRB know the study is still active. If a protocol is closed by the IRB and the PI indicates after closure, it is still active, a new protocol will need to be submitted to allow the IRB to ensure the research is still meets the exemption criteria listed in the federal regulations.
Industry Sponsored Protocols
If your study is sponsored by an outside company for the review of a new drug or device, please ensure the Study Funding Page in Click contains the most up to date billing information. Review the company name, address and email contact. If changes are needed a modification must be submitted to update. This will help facilitate a smoother process for release of IRB approvals if the study invoice is sent to the correct sponsor address.
Research Computing Survey (10 minutes to complete)
The research computing group at UVM is seeking your help to assess how researchers are using computing resources, what is working, where there are gaps and challenges, and how we can help to grow your research in the future. Please share your opinions here.
IRB Policy & Procedure Updates
Section 1.4 Freedom of Information and Public Records (Vermont Law) v.9.15.25
Section 3.6.1 Case Studies v.9.15.25
Section 6.0 Conflict of Interest v.9.15.25
Section 7.0 Nonfaculty Researchers v.10.2.2025
Section 8.4 Biospecimen & Data Repositories v.9.17.2025
Section 15. Modification to a Previously Approved Protocol v.9.15.25
Section 18.1 Reportable New Information on External IRB Studies 9.18.2025
Section 20. Investigational New Drug Applications (INDs) v.9.15.25
Section 20.1 Use of Approved Drugs for Off-Label Indications v.9.15.25
Section 21 Investigational Devices 9.19.2025
IRB Forms
Access to the IRB Forms Library
Exemption 4 v.9.22.2025
Behavioral & Social Science Consent Template with Guidance v.9.24.2025
Medical Consent Template with Guidance v.9.24.2025
Research Information Sheet, when applying for an Exempt Determination v.9.24.2025
Repository Protocol Form 9.17.2025