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.
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.
Cooperative Research (Single IRB)
The definition of cooperative research is any research project that involves more than one institution. At this time, UVM IRB will not act as a lead single IRB nor will it rely on external IRBs for any non-NIH funded projects as there are insufficient resources. Read the information below for details.
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
- U 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
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.
Regulatory Changes (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 to the rule. UVM applies the Common Rule to all human subject research conducted at the two institutions. The FDA has not signed onto the Common Rule changes and therefore FDA regulated studies are not currently subject to these Common Rule changes. However, as mandated by the Cures Act, HHS and the FDA must work together to harmonize long-standing differences within the next three years. We have created the Regulatory Changes web page to provide a snapshot of all the regulatory changes. As these deadlines approach, we encourage you to check the web page periodically for updates.
- Office for Human Research Protections (OHRP) (DHHS 45 CFR 46)
- Food and Drug Administration (FDA)
- FDA Investigational Device Exemptions - IDE Application
- FDA Drug Development - IND Forms and Instructions
- Public Responsibility in Medicine and Research (PRIM&R) is a national organization for advancement of strong research programs and for the consistent application of ethical precepts in both medicine and research.
- National Institutes of Health (NIH) mission is to improve overall human health through biomedical and behavioral research.
UVM Medical Center Information
UVM Medical Center Research Subject Registrations
As of January 1, 2014 researchers and research staff will need to complete a registration form for any UVM Medical Center patients executing a new consent form to participate in a research study. For more information please see annoucement from UVM Medical Center (PDF).
Completed forms must be submitted to “Registration – Research Studies” Outlook Mailbox (firstname.lastname@example.org) or FAX to 847-4179.
- Research Subject Registration Form (PDF)
- Credentialing for Clinical Research Personnel
- Jeffords Institute for Quality - Research
Guidelines for Registering a Clinical Trial