UVM’s Research Education Program was designed and developed through collaboration with IRB members of the research community. It is our goal to make sure this program is tailored to meet the ongoing educational needs of the research community.
The Research Protections Office offers a variety of educational opportunities, both in-person and online. The goal is to improve understanding of federal and local regulatory requirements, UVMClick application completion, and special topics related to human subjects research protection.
Criteria for Approval
To approve research under 45 CFR 46.111 or 21 CFR 56.111, the UVM convened IRB or designated reviewer using the expedited procedure must determine that the research satisfies all the requirements set forth in:
The criteria for review must be used to approve research for initial review, continuing review, and review of modifications.
PI Checklist for New Studies
In working with investigators, the IRB staff have noticed common areas that tend to delay progress when moving protocols throughout the IRB process.
We have outlined a list of questions for you to consider while working your way through the IRB submission process.
Regulatory Binder (Setup and Maintenance)
Federal and state regulations, institutional policy, and good clinical and research practices require investigators to maintain documents related to human subjects research.
Guidance was developed to assist researchers in organizing research-related documents.
Top 10 Obstacles to Gaining IRB Approval
Guidance will help you through some common obstacles researchers face going through the IRB Approval process.
Self-Audit Tools for Researchers
Additional UVM Consent Process and Documentation Training
Plain Language Medical Dictionary
- QA Reviews UVM: What It Is and What To Expect
- Navigating IRB Ancillary Reviews
- Recruitment
- Concise Summary in the Consent
- The Keys to Successful IRB Submissions
- History and Regulations involving Prisoners in Research
- Institutional Engagement in Human Subjects Research
- Informed Consent of Subjects Who Do Not Speak English
- Which projects do and do not require IRB review
- Guidance on RNI submissions: UAP's and Deviations
- Regulations for Children in Research
- Special Protections for Children in Research Projects
- Single IRB at UVM: What We've Learned and Where We Are Now
- Using and Disclosing Protected Health Information for Research
- Creating a Data Management & Security Plan for Human Subjects Research
- Steps to Rely on an External IRB
- Are you Following your IRB Approved Protocol? Emerging from COVID Restrictions