April IRB Education Session
Using and Disclosing Protected Health Information for Research
Tomorrow - Tuesday April 14, 2026 3:00 – 4:00PM HSRF 300
Presented by: Lynn A. Combs, JD, Program and Research Integrity
Office of Compliance, UVM Health
This session 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.
This session is specific for researchers who wish to access, collect, and disclose PHI for research purposes.
No registration is needed. Bring your questions!
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.
Faculty Input Requested: Brief Survey on Research Support and Training
Through a partnership between the Department of Neurological Sciences, the LCOM Office of Research and Engagement, and the Northern New England CTR Professional Development Core, we are planning to offer a future clinical research training course/workshop for LCOM Faculty and trainees.
To assess your needs for this course, we are seeking your input through a brief survey aimed at better understanding faculty members’ research experience, training needs, and preferences. Your feedback is essential in helping us shape the content of this course, as well as any future training and educational programs and resources to support the professional development of our faculty community. The survey takes only a few minutes to complete, and your responses will remain confidential and reported only in aggregate. Please take a moment to complete the survey here.
Reminder - Closure of Protocol by Committee
This policy outlines criteria used by the IRB to discard submissions that have not yet been approved. All protocol submission types may be removed from committee consideration under the following circumstances:
• PI fails to respond to the IRB’s initial request for revisions and/or clarifications within 60 days while in UVMClick clarification requested (pre-review) state, prior to Committee or Designated review.
• PI fails to respond to the IRB’s request for revisions and/or clarifications within 60 days while in the modifications required state, after Committee or Designated review.
• Ancillary reviewer(s) fail to respond to the IRB’s request for review within 10 months while in post review.
The Cancer Center is Hiring
Research Supervisor - Clinical Trials Office, Apply here
Updates from the UVMMC 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).
ClinicalTrials.gov Compliance and Enforcement Activities
Reminder to researchers conducting clinical trials to register and update their studies on clinicaltials.gov. The FDA’s compliance activities related to these requirements provide the opportunity for responsible parties to take voluntary corrective actions before the agency proceeds with enforcement action. The agency uses a risk-based approach to compliance and enforcement to prioritize the greatest risks to public health.
The final guidance on Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank outlines FDA’s approach to its compliance and enforcement activities related to ClinicalTrials.gov, including potential civil money penalties for violations.
See pre-notices of noncompliance and notices of noncompliance for more information.
Submit Studies to ClinicalTrials.gov PRS for information about registering clinical trials on ClinicalTrials.gov. Contact register@clinicaltrials.gov with questions related to:
- Regulations at 42 CFR Part 11
- How to register studies and how to submit clinical trial results information
- Technical issues related to submission of information to the ClinicalTrials.gov databank
IRB Policy & Procedure Updates
Section 1.2 Committee Membership v. 4.7.2026
Section 5.3 Retention of Research Records v. 2.23.2026
Section 13.2 Reliance Agreements in Place at UVM for Multiple Studies v. 2.23.2026
Section 14.4 Research Contract and Collaborative Research Agreements v. 2.23.2026
Section 14.6 Fees for Committee Review
Section 16.0 Continuing Review Requirements v. 2.26.26
Section 20.0 Investigational New Drug Applications (INDs) v.2.19.2026
IRB Forms
Access to the IRB Forms Library
Request to Rely on an External IRB v. 2.25.2026
University of Vermont Single IRB (sIRB) Request and Consultation Form v. 2.25.2026