Research Protections Office News
The IRB Meetings dates and agenda deadlines for 2026 can be found here.
Holiday Schedule
UVM offices are closed December 24 through Thursday January 1, 2026 for the Christmas and New Year holidays. We are back on Friday, January 2, 2026.
New Risk Classifications for Human Subject Data
The IRB has published guidance here to assist researchers on classifying their research data into three categories of low, moderate and high/restricted risk data. Researchers can now classify their data and then reference our table to determine how best to collect, store, transfer and analyze their human subject research data. Specific federally regulated data types such as, HIPAA, GDPR and FERPA are highlighted to assist with best practices and correspond with UVM Enterprise Technology Services (ETS) policies for security, storage and user responsibility.
- Definitions of research data can be found here, but may include - clinical or research derived test data, surveys/questionnaires, consent forms, any data derived from drug or device trials.
- All new IRB protocols or protocols currently under review will need to adhere to this guidance when completing the Data Security & Monitoring Plan (DSMP). This will guide researchers on where to store human subject data and how best to adhere to federal regulations addressing data security.
- Previously approved studies should reference the table to ensure their data is properly stored based on their classification.
- It is reasonable that data may need to be moved and DSMP’s updated. This can be done during an upcoming study modification.
- The IRB does not expect researchers to halt research procedures to move data but wants to promote data security and compliance. If applicable, researchers should on updating their DSMP’s over the next 12 months.
The COMTS Research Data Team is dedicated to supporting LCOM researchers by helping them organize, store, and safeguard sensitive information in full alignment with UVM policies and medical research best practices. COMTS provides tailored guidance in selecting secure storage solutions based on data risk levels unique to medical research. If you need to move your research data to a new location, please contact COMTS for assistance submitting a footprint here.
- If you need help moving your research data at UVM please submit a footprint here.
- If you have Research data stored on the UVMMC drives, guidance coming soon and will be added to the table.
New Guidance on Fraud Prevention When Using Research Survey Instruments
The UVM Office of Compliance and Privacy Services has issued guidance on ways researchers can safeguard their survey data from financial fraud associated with bots impersonating research participants. Researchers are strongly encouraged to use the UVM licensed versions of Qualtrics and RedCap when collecting survey data and paying subjects. Qualtrics Fraud Detection can be found here. Contact UVM’s RedCap administrator directly for questions on how to enable RedCap’s fraud prevention features.
New UVMMC Home Drive (H:) Data Migrations to OneDrive for Business
UVMMC will have all Home Drive (also known as H:) data migrated to OneDrive for Business over the coming weeks and months.
The migration to OneDrive is a prerequisite for the move to an overall Unified Domain across the Health Network. If your IRB approved study has data that will be moved, please update your Data Security Management Plan via a modification. Please contact your IT Support Center or enter a ticket in ServiceNow.
New UVM Material Transfer Agreement Portal
A Material Transfer Agreement (MTA) is required when a researcher wishes to send or receive tangible material from/to a third party. UVM Innovations reviews incoming and outgoing MTAs to ensure that the interests of UVM and its researchers are protected. UVM has recently partnered with other universities to streamline the MTA process via the MTAShare™ online portal.
MTAShare is a comprehensive, automated system for rapidly creating, processing, executing, and managing MTAs through a browser-based web portal. Researchers can use the MTAShare portal to request both incoming and outgoing material transfers.
If you have any questions about the portal or the MTA process contact, mta@uvm.edu.
UVMMC Material Transfers
Inquiries related to transfers of material from or to The University of Vermont Medical Center should be directed to the Office of Clinical Trails Research.
Fees for Committee Review
The University’s Institutional Review Boards have established policy and fees to help fund services provided by the IRB which include study review, educational initiatives, and compliance monitoring activities. The fees are commensurate and, in many cases, lower than other institutions. IRB fees are an expected cost of doing business and are necessary to ensure adequate resources. Please ensure you have worked with SPA or OCTR to include IRB review fees into your budget or contract.
Fees will be applied to these types of protocols:
- Industry/Pharmaceutical companies
- Other for-profit entities
- Non-profit entities where such fees are not prohibited (foundation funding)
- Investigator-initiated protocols with for profit sponsors
Fees will not be applied to these types of protocols:
- Federal or federal flow through
- State of Vermont
- Non-profit where fees are prohibited
- Investigator-initiated internally funded studies
IRB Policy & Procedure Updates
8.1 Elements Found in a Standard Protocol v.11.13.25
8.3 Qualitative Research Protocol v. 11.13.25
8.11 International Research v. 11.20.2025
8.12 Artificial Intelligence (AI) in Research v.9.17.25
8.9 Exceptions from Informed Consent for Emergency Research v.11.26.25
20.0 Investigational New Drug Applications (INDs) v. 11.10.2025
Revised IRB Forms
Access to the IRB Forms Library
External IRB - Request for Waiver or Alteration of HIPAA Authorization v.10.29.25
Qualitative Research Protocol Form v. 12.8.2025
Human Subjects Protocol Form v. 12.8.2025
Research Data Management & Security Plan Form v. 12.8.2025
Training and Education
Research Professionals Network
Monday, Dec 15, 2025, 2:30-4:00pm
Building Excellence: Professional Certification and Leadership in Clinical Research
Updates to IATA Training Requirements
The University of Vermont and the University of Vermont Health will no longer accept Mayo Clinic’s IATA training to meet the requirements for shipping biospecimens.
- For individuals who used Mayo Clinic’s IATA training to fulfill IATA certification, please complete the CITI IATA course prior to shipping any specimens.
- Individuals who completed their IATA training through UVM Health Lab’s MediaLab, this IATA training is no longer available to researchers due to limited licensing availability.
Please complete CITI IATA course prior to the expiration of your current IATA training. More information regarding IATA Training resources can be found 
here.
Fundamentals in the Conduct of Clinical Research Training Program
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)
January 2026 Session
Wednesday, January 7, 1:00p - 3:30p
Wednesday, January 14, 1:00p - 3:30p
Wednesday, January 21, 1:00p - 3:30p
Wednesday, January 28, 1:00p - 3:30p
Register for Fundamentals in the Conduct of Clinical Research (Staff Training)
REDCap Resources
Visit the REDCap SharePoint site for new features, training resources, and templates.
REDCap Basics – January 7, 2026 , 12-1:30pm (Description: Basics class will cover the following topics – REDCap Intro, logging in, creating projects, creating survey/database, online designer, creating fields/field types, action tags, record status dashboard, adding and editing data/records, data exports/reports, data imports, adding users to project/user rights, and production mode.
REDCap Advanced – January 21, 2026, 12 - 1:30pm (Description: Advanced Class** will cover the following topics - Data dictionary/XML project upload/copying and downloading projects, codebook, advanced branching logic, piping, action tags, embedding, smart variables (brief), Longitudinal setup/events, repeatable instruments, survey queue, advanced survey setup – invitations/survey log/automated survey invitations, scheduling module (brief mention), randomization, alerts/notifications, logging (brief), DAGs, data quality, and External Modules.
REDCap Classes - Registration Link