October IRB Education Session

Institutional Review Board (IRB) and the Protocol Review and Monitoring Committee (PRMC) – What’s the Difference?

Presented by: Melanie Locher, IRB Director, Ben Briggs & Liz Abrecht, MS, Administrative Director, UVM Cancer Center Clinical Trials Office

Thursday October 29, 2026 | 3:00-4:00pm | HSRF 400

For researchers who intend to recruit cancer patients from cancer-focused clinics, or the primary aim of the study is related to cancer (diagnosis, screening, treatment, or prevention of cancer; risk factors associated with the development or survivorship of cancer; data and/or biological specimens from cancer patients) this session will review the fundamental differences and regulatory mandates required for each committee’s review.  No registration is needed, stop in anytime with questions.

December IRB Education Session

Updated UVM Single IRB Policies & Procedures

Presented by: Jen Dulin, MS, DVM, CIP, IRB Reliance Administrator and Health Network Liaison

Monday December 7, 2026 | 12:00 - 1:00pm | HSRF300

This session will guide researchers through the single IRB process at UVM, including, revised policies and procedures, steps needed to establish a reliance agreement, roles & responsibilities of the UVM PI and Study Team and requirements for submitting through UVMClick. No registration is needed, stop in anytime with questions.

Attention - Researchers using the U.S. Bank digital rewards program

Fraudulent survey responses and increasingly realistic follow-up emails continue to present financial, data integrity, and research compliance risks, particularly when survey links are distributed indirectly through websites, newsletters, or listservs. Follow this guidance (pdf) to reduce the risk to you and UVM, and to protect the integrity of your research.

New - Eligibility Checklists are Required at Time of Initial Submission for PI initiated protocols

One of the most common noncompliance findings during a Quality Assurance review is finding discrepant eligibility criteria between the protocol, internal documents, and RedCap. Often the REDCap and eligibility checklists do not match the IRB approved protocol. The IRB regulatory analysts and/or the Committee Chairs may request submission of a separate eligibility checklist at time of initial review in an effort to reduce future protocol deviations and enrolling of ineligible participants. Researchers can create their own eligibility checklists or can use a template from OCTR. The eligibility checklist must have corresponding source documentation (lab results, medical records, questionnaires, data collection tools, etc.) to support that the participant meets eligibility criteria. When researchers are amending their inclusion/exclusion criteria with the IRB, it is important to remember this change may affect the protocol, checklists, consents forms and electronic data capture systems. 

Reminder - Subpart D - Additional Protections for Children Involved as Subjects in Research

For any protocol involving children, the IRB must determine which of the three categories of research apply to that study, if any. The US Department of Health and Human Services lists four categories of research permissible with children under 18. When designing your study researchers must understand the risk level of the research and apply the corresponding regulations.  Some protocols may require adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians or parental consent from more than more parent and plans to reconsent when a child becomes an adult. Determine which risk level (PDF) your research may fall into here and review further protocol guidance on children in research in our policy and procedure manual. 

New - IRB Medical and Behavioral & Social Sciences 2027 Meeting Dates 

CHRMS and CHRBSS meeting dates and agenda deadlines can be found here. 

IRB Policy & Procedure Updates

Access to the complete P&P

Section 13.3 Procedures for Reliance on External IRB for Federally Funded Research, version 9.10.2026

IRB Forms

Access to the IRB Forms Library

Expedited Category 5 and Exempt 4 Determinations, Secondary Research, version 9.17.2026

Exempt 2, version 9.29.2026

Exempt 3, version 9.29.2026

Guidance Materials Required for UVMClick Submissions, version 9.8.2026

Research Data Management & Security Plan, version 9.1.2026