Required Training through CITI
All faculty, students and staff involved in the conduct of research with human subjects, regardless of funding source, must complete the Human Subjects Training through CITI. In addition, principal investigators or key personnel working on a clinical trial involving human subjects and all personnel affiliated with the UVM Larner College of Medicine will need to complete the Good Clinical Practice Training. Every three years, all personnel still listed on an active protocol are required to retake the training. Follow the link below for instructions on how to access CITI and add the appropriate course to complete.
A certificate of completion can be obtained from your CITI main menu at any time. Additionally, you may follow the link below to view the list of people who have completed the required training.
Determine if the Project Requires IRB Review
Electronic Submission Guidance (UVMClick)
Investigators should visit our Forms Library and the "User Guides" to prepare a submission.
Single/External IRB (Cooperative Research)
In January 2018 the NIH mandated the use of Single IRB for all NIH-sponsored multi-site protocols. Over the last year UVM has entered into multiple agreements to rely on other IRBs. On January 20, 2020, the last requirement under the 2018 Final Common Rule, Single IRB for all federally funded multi-site protocols, will be in effect. Below are links to instructions, forms, and educational materials in this regard.
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
News & Special Notices
A program of continuing education and training in the protection of human subjects is a federal requirement. We use our IRB listserve and specifically the Newsletters to partially fulfill this mandate. Key personnel listed on each protocol are required to receive and review information provided in this listserve. If at any time key personnel lose their ability to receive these notices (based upon return email notice), the principal investigator will be notified of the problem. Those key personnel will be inactivated in our system until the problem has been resolved. Of note, key personnel who have been inactivated in the IRB system should not be participating in any research until they have been reactivated.
Self-Audit Tools for Researchers
- History and Regulations involving Prisoners in Research (PDF)
- Criteria for Approval (PDF)
- PI Checklist for New Studies (PDF)
- Institutional Engagement in Human Subjects Research
- Informed Consent of Subjects Who Do Not Speak English (PDF)
- Which projects do and do not require IRB review (PDF)
- Guidance on RNI submissions: UAP's and Deviations (PDF)
- Common Rule 2018 Exemption Changes (PDF)
- Regulatory Binder: Set-up and Maintenance (PDF)
- Regulations for Children in Research (PDF)
- Top 10 Obstacles to Gaining IRB Approval (PDF)
- Waivers and Alterations (PDF)
- Single IRB Monthly Educational Session (PDF)
- Special Protections for Children in Research Projects (PDF)
Additional UVM Consent Process and Documentation Training
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.
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.
Guidelines for Registering a Clinical Trial on Clinicaltrials.gov