Updated policy -Financial Conflict of Interest in Research
New changes to the research certification process within UVMClick. Researchers will now have to disclose intellectual property rights and interests (e.g., patents, copyrights), and/or technology that has been disclosed to UVM Innovations in relation to a human subject protocol under review by the IRB.
The Office of Research Integrity has convened a second Conflict of Interest Committee specifically to review conflicts related to human subject research, including industry funded clinical trials. The new committee is comprised of members from UVM Health, LCOM and UVM with specific expertise in clinical trial management, ethics, and compliance with federal regulations. When a potential conflict of interest is disclosed in the IRB protocol submission or during the COI/COC process, the IRB approval will not be released until the FCOI is either eliminated or managed through an approved management plan. Please reach out to Victoria.Jones.1@uvm.edu with questions.
Updated 2026 tax changes for reporting research participant compensation
The IRS recently revised regulations that increase the 1099 Misc reporting from $600 to $2,000, effective for payments made starting January 1st. This is good news for research participants as their social security number will only have to be collected if the amount of the research payment is $500 or if the total payments from UVM are equal to or greater than $1,000 in a calendar year. Please note that UVM has selected a slightly lower threshold than that allowed. More information on research payments can be found here and in section 8.2 of our IRB policy and procedure manual.
Reminder UVM Health System Research
UVM Health and UVM are actively preparing to expand research opportunities at affiliate hospitals. We are working to efficiently extend IRB review and oversight to all sites. Until training, education, and staffing has been put into place at the other sites, the UVM IRB will not be reviewing or approving research at sites other than UVMMC or ongoing research at CVMC. Please see the January newsletter for more details.
New Regulatory Requirements When Using UVM Health Self-Service Tools for Research
Unsure of what regulatory approvals are required when conducting secondary analysis of existing data sets from the UVM Electronic Medical Record? Learn when IRB review is or is not required when using EPIC and TriNetX self-service tools for secondary research. Additional help can be found here.
| Tool Overview | Institutional & Regulatory Requirements | |
|---|---|---|
| Epic’s Reporting Workbench | · Primarily designed for operational reporting but can also be used for research purposes. · Provides time‑sensitive, up‑to‑date information with a focused scope and concise result lists. | · Must be an existing UVM Health Epic user · Regulatory requirements depend on study‑specific criteria: o Accessing identifiable PHI for research may require IRB approval.1 o Accessing a Limited Data Set (i.e., only indirect identifiers as permitted by HIPAA) may require a Data Use Agreement2. No IRB approval is required. o Accessing identifiable PHI for study recruitment may require a partial waiver of HIPAA authorization with IRB approval or the Preparatory to Research form3. o Accessing identifiable PHI for the purpose of study/grant preparation may require the Preparatory to Research form3; no IRB approval is required. |
Epic’s Slicer Dicer | · Offers customizable data exploration capabilities. · Allows refinement of searches, trend analysis, totals, averages, and drill‑down to line‑level details. | |
Epic’s Radar Dashboards | · Provides user‑specific dashboards that consolidate information from multiple data sources available based on the user’s role. | |
| Epic's Cosmos | · Cohorting tool containing data from across the Epic community, available for clinical or research use. · Data sets that can be leveraged within Cosmos include: 1. anonymized or aggregated data sourced from a Limited Data Set 2. de-identified data via Cosmos Data Science, accessible to authorized staff | · Requires an Epic User Web account & Cosmos user account that can be requested here. · Accessing the Limited Data Set requires acceptance of the Cosmos Data Use Agreement; no IRB approval is required. |
| TriNetX | · Global health research network containing more than 250 million patient records, including data from UVM Health since 2010 · Useful for study design and feasibility (e.g., preparatory to research), clinical trial site identification and recruitment, and secondary research. · Using the Research Network, users leverage de-identified data; using the UVM Network, users leverage anonymous or aggregate data from UVM Health that can be used to obtain patient level information when appropriate for the study. | · Available to UVM Health employees (any Partner) or UVM faculty, staff, and students with an UVM NetID (refer to TriNetX Resources) · Accessing anonymized or aggregate data from TriNetX does not require IRB approval. · Requesting PHI from the DMO using TriNetX Patient IDs will require approved documentation such as IRB approval, a Data Use Agreement, or the Preparatory to Research form, depending on the study-specific criteria. |
IRB Policy & Procedure Updates
Section 1.3 Operations of the IRB 45 CFR 46.108 v.2.12.2026
Section 8.2 Participant Compensation v.1.5.2026
Section 8.9.1 Review Flow for Planned Emergency Research v. 12.3.2025
Section 8.9.2 Designing a Plan for Community Consultation and Public Disclosure in Planned Emergency Research v.12.3.2025
Section 8.9.3 Data Collection Expectations for Exception from Informed Consent for Emergency Research v.12.3.2025
Section 8.9.4 Operations of Exception from Informed Consent for Emergency Research Advisory Panel v.12.3.2025
Section 8.12 Artificial Intelligence (AI) in Research v.2.13.2026
Section 11. Certificates of Confidentiality v. 12.9.2025
Section 14.6 Fees for Committee Review v. 2.12.2026
Section 24. Participants Vulnerable to Coercion or Undue Influence v. 2.12.2026
Section 27. Research Non-Compliance Policy v. 2.12.2026
IRB Forms
Access to the IRB Forms Library
Medical Consent Template with Guidance – 1.7.2026
Behavioral & Social Science Consent Template with Guidance – 1.7.2026
Exception from Informed Consent Requirements for Emergency Research v. 1.7.2026
University of Vermont Local Context for Relying on an External IRB: Consent and HIPAA Required Language v. 1.5.2026
Consent Information Sheet v. 1.21.2026
Age of Majority Consent v. 1.29.2026
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)
March 2026 Session
Wednesday, March 11, 9:30a - 12p
Wednesday, March 18, 9:30a - 12p
Wednesday, March 25, 9:30a - 12p
Wednesday, April 1, 9:30a - 12p
Register for Fundamentals in the Conduct of Clinical Research (Staff Training)
Please plan to join us for the February RPN Workshop.
Title: Informed Consent: Being the Participant Advocate
Date/time: Thursday, February 26, 2026, 2:30-4:00pm
Workshop Description:
This workshop will equip research staff with practical skills to design and conduct informed consent that protects participant rights and supports voluntary decision-making. Participants will learn to apply ethical and regulatory principles to consent design, identify and practice communication strategies that clearly convey study details, and tailor consent approaches to accommodate participants’ functional needs and preferences. Through real-world examples and interactive exercises, attendees will leave with actionable tools to make consent processes more accessible, understandable, and ethically sound.
Joint Task Force Competency Domains:
2: Ethical and Participant Safety Considerations
4: Clinical Study Operations (Good Clinical Practice)
8: Communications and Teamwork
Level: Skilled
Register for the February workshop.