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Institutional Review Board: Human Subjects Research
University of Vermont (UVM) and UVM Medical Center are involved in important behavioral and biomedical research and are committed to assuring that all research activities are conducted in a manner that promotes the rights and welfare of the participants.
Investigator Resources
Electronic Submission Guidance (UVM Click)
UVMClick is a paperless, electronic method to submit new protocols, modifications, continuing reviews and reportable new information.
Investigators should visit our Forms Library and the "User Guides" to prepare a submission.
Federalwide Assurance (FWA) & IRB Registration
An Assurance is the documentation of institutional commitment to comply with Federal regulations and maintain adequate programs and procedures for the protection of human participants. This is the principal mechanism for compliance oversight by the Office for Human Research Protections. The University of Vermont Institutional Review Boards (IRBs) which serve the University of Vermont and UVM Medical Center are organized and operate in compliance with the US Department of Health and Human Services and the Food and Drug Administration regulations.
Federalwide Assurance Information
- University of Vermont & State Agricultural College FWA Number FWA00000723
- The University of Vermont Medical Center Inc. FWA Number FWA00000727
- The expiration date for these assurances changes frequently. If you need the expiration date, enter the applicable FWA Number, and click "Search".
- The Terms that apply for both FWAs are available under "A. Terms of the Federalwide Assurance for Institutions Within the United States"
The IRBs that serve the two institutions are registered to the University of Vermont and State Agricultural College (IORG 0000289) with the Department of Health & Human Services. Registration numbers for the IRBs are:
- IRB00000485 (IRB #1 - Biomedical I IRB - OHRP/FDA)
- IRB00000486 (IRB #2 - Behavioral IRB - OHRP)
- IRB00000487 (IRB #3 - Biomedical II IRB - OHRP/FDA)
- Expiration dates for the IRB registrations are available
Human Gene Transfer
“Human Gene Transfer” or “HGT” is used to describe research involving the transfer of recombinant DNA, or DNA or RNA derived from recombinant DNA, into human subjects. It is also sometimes referred to as “Gene Therapy.”
Effective April 27, 2016, UVM Institutional Biosafety Committee will determine whether investigator-initiated research requires RAC review based on specific criteria. If the project is sponsored, the sponsor is responsible for determining if RAC review is required.
Review and approval of a gene transfer protocol can be complex, therefore we have developed a step-by-step guide for submission of a human gene transfer protocol at UVM/UVMMC.
Other Resources
UVM Medical Center Information
UVM Medical Center Research Subject Registrations
Researchers and research staff are required to associate any UVM Health Network patients executing a new consent form to participate in a research study to the research study in Epic. For more information please see Research Subject Registration Requirements and UVM Health Network Research4 policy.
Credentialing Process for University of Vermont Clinical Research Personnel
It is mandatory for University of Vermont (UVM) employees involved in clinical research activities at The University of Vermont Medical Center (UVMMC) to complete and submit the credentialing documents to the Office of Clinical Trials Research (OCTR). This includes working on projects involving direct patient interaction, retrieving blood, tissue, or health record data review.
Credentialing for Clinical Research Personnel
Guidelines for Registering a Clinical Trial on Clinicaltrials.gov
What Is the Definition of a Clinical Trial for Registration Purposes? (opens in a new window)
Clinical Trials Registration Information - Last updated June 16, 2020 (PDF)
Revised Common Rule
The Common Rule is the set of regulations governing the conduct of human subjects research conducted or sponsored by the federal departments and agencies that subscribe.
Projects Not Requiring IRB Review
When projects are quality improvement or assessment and do not meet the criteria as research.
Projects Not Requiring IRB Review Tool
Research Not Involving Human Subjects
When studies involve the review of data or specimens when there are no identifiers.
Self-Determination of Research Not Involving Human Subjects Tool
Have a Question?
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To find out which IRB Research Analyst is assigned to your department, select your department in the dropdown menu below and click the "Who's My Research Analyst" button.
Your Research Analyst is: Aubrie Clas
Your Research Analyst is: Donna Silver
Your Research Analyst is: Melanie Locher
Your Research Analyst is: Sarah Wright
Your Research Analyst is: Karen Crain
Your Research Analyst is: Ryann Guayasamin
Your Research Analyst is: Jen Dulin
Your Research Analyst is: Coralee Tye
Your Research Analyst is: Diana Naser
Updated 03/13/2023
