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:

IRB Criteria for Approval (PDF)

The criteria for review must be used to approve research for initial review, continuing review, and review of modifications.

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.

PI Checklist for New Studies (PDF)

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.

Regulatory Binder (Setup and Maintenance) (PDF) 

Guidance will help you through some common obstacles researchers face going through the IRB Approval process.

Top 10 Obstacles to Gaining IRB Approval (PDF)

• Self-Assessment of Protocol Procedures (DOCX)
• Self-Assessment of Consent Procedures (DOCX)

Obtaining and Documenting Informed Consent Module

A plain language medical dictionary simplifies medical terms for easier understanding, helping researchers communicate effectively with diverse audiences. It ensures research findings are clear, accessible, and inclusive, fostering informed decision-making and broader engagement.

Research Conducted in Public Schools

Use of Patient Information for Research – Special Considerations and Forms

UVM IRB Quality Assurance Monitoring Program 

Quality Improvement Activities and the Common Rule

IRB & PRMC — What’s The Difference Between Committee Reviews? (PDF)

Investigator Responsibilities — Protecting The Rights, Safety, And Welfare Of Study Subjects (PDF)

Navigating IRB Ancillary Reviews (PDF)

Recruitment (PDF)

Concise Summary In The Consent (PDF)

The Keys To Successful IRB Submissions (PDF)

History And Regulations Involving Prisoners In Research (PDF)

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)

Regulations For Children In Research (PDF)

Special Protections For Children In Research Projects (PDF)

Single IRB At UVM: What We've Learned And Where We Are Now (PDF)

Using And Disclosing Protected Health Information For Research (PDF)

Creating A Data Management & Security Plan For Human Subjects Research (PDF)

Steps To Rely On An External IRB (PDF)

Are You Following Your IRB Approved Protocol? Emerging From Covid Restrictions (PDF)

Institutional Engagement In Human Subjects Research (Video)