July IRB Education Session
“Managing Financial Conflicts of Interest in Human Subject Research”
Presented by: Victoria Jones, Research Compliance Officer and Melanie Locher, IRB Director
Wednesday July 22, 2026
12:00 – 1:00pm
This session will assist researchers navigate the federal regulations and local UVM policy when disclosing a significant financial conflict of interest specific to an IRB protocol. We will review the UVM policy, define types of potential conflicts and discuss possible management plans. No registration is needed.
Did you miss the April IRB Education Session?
Access the slides here - Using and Disclosing Protected Health Information for Research
These slides will assist researchers navigate the federal regulations on the most common “HIPAA pathways” permitting UVM Health to disclose PHI for research and the related IRB requirements and limitations for each exception. Slides are specific for researchers who wish to access, collect, and disclose PHI for research purposes.
Research Data Management and Risk Classifications
In December 2025, the IRB introduced the new data matrix to determine Risk Classifications for Human Subject Data. All federally regulated research data types such as HIPAA, must be stored in a secure location within the College of Medicine or UVM. The Larner College of Medicine Technology Services (COMTS) has added the use of the L:/Centers folders for secure storage of research PHI and all data classified as low, moderate, or high risk under the updated framework. Recommendations for managing L:/Centers folders, can be found here. Researchers should ensure their clinical trial data or any research data obtained under an IRB protocol is stored within an approved location. The COMTS team is available to assist with relocation of files to align with the new guidance and update protocol Data Management & Security Plans. Please contact Caitlyn Dayman, Research Intelligence Lead, with questions on LCOM storage options for research data.
New - The UVM Health System has updated where research data can be stored within the hospital network. Refer to the UVM Health Information Security User Policy in PolicyStat on the UVM Health Intranet or contact, DataGovernance@UVMHealth.org
with questions.
Reminder - Any time protocol derived research data is moved, stored, transferred, or shared the Data Management & Security Plan must be updated through a protocol modification submitted through UVMClick.
Updates from the Research Billing Compliance (RBC) Team
Consultant support for coverage analyses/billing plans: Following recent staffing changes, the RBC Team has engaged Huron to assist with drafting coverage analyses and billing plans. The RBC Team remains your primary point of contact and will coordinate directly with Huron to help maintain an efficient review process.
Updated coverage analysis/billing plan format: The RBC team has revised the coverage analysis template to improve clarity and completeness, and to align the document the OnCore formatting. Updates include definitions for billing designations, tracking of key decisions and changes to billing plan, a new “bundle” sheet tracking ancillary charges associated with certain procedures, and inclusion of protocol footnotes that affect timelines and billing.
Coverage analysis preparation fee for industry-sponsored studies: UVM Health now charges a $2,800 coverage analysis preparation fee for industry-sponsored studies. Investigator-initiated, grant-funded, and collaborative studies are not affected. OCTR will negotiate this fee during contracting, and the RBC team will work directly with teams to coordinate fund transfers. Study-specific fee exemption requests may be directed to Lynn Combs, System Director of Program and Research Integrity (lynn.combs@uvmhealth.org).
Questions or feedback can be sent to ResearchBillingCompliance@uvmhealth.org
IRB Policy & Procedure Updates
Section 8.5 Blood Collection Protocols, version 5.5.2026
Section 8.14 Investigator Self-Experimentation, version 4.27.2026
Section 8.13 Procedure/Equipment Development & Practice/Proficiency Training in Non-Participants, version 5.13.2026
Section 9.10 Telemedicine and Remote Research Visits, version 5.21.2026
IRB Forms
Access to the IRB Forms Library
Blood Collection Protocol for Non-Clinical Laboratory Research, version 5.5.2026
UVM Local Context for Relying on an External IRB: Consent and HIPAA Required Language, version 1.7.2026
Expanded Access Consent, version 6.23.2026
Fundamentals in the Conduct of Clinical Research Training Program – Upcoming Sessions
The Larner College of Medicine, in conjunction with The Office of Clinical Trials Research, requires that all research staff engaged in human subjects research at LCOM and the UVM Health Network complete LCOM Research Professionals Training, “Fundamentals in the Conduct of Clinical Research”, including, but not limited to; Research Coordinators, Research Nurses, Research Health Care Professionals, and Regulatory Staff, or individuals fulfilling these roles regardless of job title.
This requirement applies to all research staff who are involved in the conduct of research involving human subjects, irrespective of funding source supporting the research activity. Next training sessions (via Zoom). Register for Fundamentals in the Conduct of Clinical Research (Staff Training)
August 2026 Session
Wednesday, August 05, 9:30am-12:00pm
Wednesday, August 12, 9:30am-12:00pm
Wednesday, August 19, 9:30am-12:00pm
Wednesday, August 26, 9:30am-12:00pm
UVM Annual Researcher Credentialing Reminder
This reminder applies to UVM research faculty, staff, and students who are engaging in clinical research activities at UVM Health or with UVM Health research data. UVM Researcher Credentialing (Research5 Policy) is a regulatory requirement that ensures that UVM research faculty, staff, and students are appropriately oriented before engaging in clinical research activities at UVM Health or with UVM Health research data.
This includes working on research projects that involve direct patient interaction, collecting blood or tissue, or health record data review (i.e., Epic data). The credentialing process must be completed annually through the Office of Clinical Trials Research (OCTR).
- Faculty, staff, and students who have credentialed in the past will receive an email shortly with a unique link to their credentialing renewal form.
- New faculty, staff, and students engaged in research that need to credential for the first time, please complete the following survey: New UVM Researcher Credentialing Request. Once processed, they will receive an email with a unique link to their new credentialing form.
UVM research faculty, staff, and students must renew their UVM Research Credentialing by June 30, 2026.
Failure to complete the credentialing process by June 30, 2026, will result in denied access to UVM Health resources, associated with research activities, including IT access, until the credentialing requirements are met.
Please note:
- UVM Health employees do not need to complete this credentialing.
- UVM Faculty with dual appointments (LCOM and UVM Health) do not need to complete this credentialing.
For more details and answers to common questions, please visit the OCTR SharePoint UVM Researcher Credentialing page.
If you have questions regarding UVM Research Credentialing, please contact us at (802) 656-8990 or clinicaltrials@med.uvm.edu.