RPO News

The tradition of celebrating the National Research Administrator Day at the University of Vermont continues in 2025!  Please join us at the Andrew Harris Common, the green space in front of the Davis Center on Thursday, September 18th 2:30PM-4:30PM, for an exciting event, which brings together research administrators from across UVM. 

 

We are known by many titles, such as Research Administrators, Research Navigators, Award Acceptance Officers, Unit Administrators, Program Managers, Financial, Compliance, and Regulatory Analysts, Grant Specialists, Research Development Professionals, etc.; our expertise spans all aspects of the grant lifecycle, research compliance, electronic research systems, grantsmanship, cash management, financial reporting, sponsored audit, and research operations.  

We have changed the format to make this years’ experience more casual, with the focus on networking and socialization.  Ice cream and snack will be provided to all attendees.  Remote staff who RSVP will receive a digital gift card to use at their convenience.

Please help us prepare for the event by sending your RSVP via this link. 

New Policy Requires Free Public Access to NIH-Funded Research Immediately

NIH public access policy came into effect on July 1. Researchers funded by the U.S. National Institutes of Health (NIH) are required to make their research available and free to all citizens by depositing their published papers in the NIH repository, PubMed Central. Researchers must do so after publication in a peer-reviewed journal; embargoes on articles are no longer permitted.

How do UVM researchers achieve compliance?

There are a few ways that researchers can make their work freely available. Open access authors should make sure that their papers are deposited into PubMed Central as soon as they are accepted for publication (many open access publishers offer an automated deposit option). Authors who publish in closed, subscription-based journals should make sure that any signed agreements comply with the NIH policy. Some publishers of subscription-based journals allow authors to post the accepted version of their manuscript to PubMed Central as soon as it is published. Learn more about options and methods for submitting to PubMed Central with UVM libraries NIH 2024 Public Access Policy Guide.  

Did you miss the June or July IRB Education?

July Education - UVMMC Investigational Drug Services and IRB Review

June Education - OBTAINING AND DOCUMENTING INFORMED CONSENT OF NON-ENGLISH SPEAKING RESEARCH PARTICIPANTS

UVMClick User Guides

New to submitting protocols and changes through our UVMClick system?  Find step-by-step guidance and directions on how to submit through our online software. UVMClick is where UVM researchers and administrators will manage the lifecycle of IRB Protocols, IACUC Protocols, IBC Registrations, Controlled Substances Registrations, COI/COC/FCOI Disclosures, Proposal Submissions, and Agreements.

Log into UVMClick here to get started.

IRB Policy & Procedure Updates

Access to the complete P&P

5.1 Responsibilities of Principal Investigators v. 6.12.2025

8.10 Research Conducted in Public Schools v. 7.1.2025

9.4 Informed Consent and HIPAA Authorization Process for Non-English-Speaking Individuals v. 6.13.2025

10.5 National Institutes of Health Genomic Data Sharing Policy v. 5.27.2025

13.3 Procedures for Reliance on External IRB v. 6.12.2025

13.7 Collaborations with External Investigators (External Study Team Members) v. 6.12.2025

21.1. Expanded Access for Medical Devices v. 6.20.2025

20.2 Expanded Access of Investigational Drugs (compassionate use) v.5.27.2025

26.0 Human Subject Quality Assurance Review Program v.7.2.2025

IRB Forms

Access to the IRB Forms Library

Exemption 1 version 7.18.2025

Exemption 3 version 7.18.2025

Exemption 6 version 7.18.2025

Grant Proposals Lacking Definite Plan for Involvement of Human Subjects version 7.22.225

New Single IRB Request and Consultation Form v. 6.2.2025.

Required consultation form to determine whether it is appropriate for UVM to cede IRB review to an External IRB or to act as the IRB of Record for other institutions.  Complete this form first and email to jen.dulin@uvm.edu

Managing your protocol when leaving UVM

Leaving UVM/UVMMC? Student graduating? PI retiring? Don’t forget to close your protocols! 

Run a report of all the studies you are currently listed on as PI or key personnel.

You can  close a study or submit a modification to remove yourself as a key personnel. 

Managing Research Prior to Departure, Sabbatical, Medical Leave, or Other Absence

The IRB requires a qualified PI be always assigned to each protocol.  All investigators have the responsibility to manage the disposition of their studies before taking a leave or departing the University.  Department chairs or faculty sponsors are responsible to ensure protocols are closed, or the PI is changed prior to the investigator’s leave. 

LCOM has created a checklist that may be helpful for making a smooth transition when departing from UVM.

Researcher leaving UVM Checklist to review

Research Professionals Network (RPN)– Upcoming Workshops

Monday, September 29, 2025, Register for Trials and Errors: Lessons from a First Time Clinical Research Coordinator

NNE-CTR: Clinical Research ECHO

This is a knowledge-sharing forum via monthly Zoom sessions. It's a great networking opportunity that features didactic and case presentations by colleagues sharing their research and engaging in lively problem-solving discussions. Register for 2025-2026 sessions

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. 

October 2025 Session - Next training sessions (via Zoom) - Register Here

Monday, October 06, 1:00p - 3:30pm

Monday, October 13, 1:00p - 3:30pm

Monday, October 20, 1:00p - 3:30pm

Monday, October 27, 1:00p - 3:30pm

REDCap Resources

Visit the REDCap SharePoint site for new features, training resources, and templates.

REDCap Basics - September 3rd, 12-130pm  (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 - September 24th, 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 

EPIC Updates

Research studies can now be configured to allow documentation of adverse events using the CTCAE 4.03 or 5.0 data set. All researchers listed as members of the study team that has been configured to use adverse events will have the ability to add new adverse events for participants enrolled in the study and to edit those events. Documentation of each adverse event is maintained longitudinally with changes tracked, (such as what was changed, by whom, and when). Principal investigators can edit adverse event documentation and mark it as reviewed in the system. See the attached step-by-step directions or research coordinators can access this tip sheet and other Research related tip sheets by hitting the F1 key when they are logged into Epic (that brings up the Research Learning Home Dashboard).  Questions can be directed to - EpicResearch@uvmhealth.org

Updates from UVMHN Research Billing Compliance

Karen Brautcheck, MS, CHRC, CPC, a member of the University of Vermont Health Network Research Billing Compliance team, announced that she will be leaving UVMHN for a new opportunity with an organization in Florida. Her last day will be Tuesday, September 2. Please join us in expressing our deep gratitude for Karen’s extensive expertise, dedication, and hard work at UVMHN over the past 3 years. Thank you, Karen!

The Research Billing Compliance team is working to ensure a smooth a transition for the research community and will be working with stakeholders to modify existing workflows. If you have any questions about how this might affect your projects, please don’t hesitate to reach out to Lynn Combs, Network Director of Program and Research Integrity, UVMHN Compliance and Privacy Department (lynn.combs@uvmhealth.org).

To facilitate communications, we have a new Department email address: ResearchBillingCompliance@uvmhealth.org. If you have a question regarding research billing/billing compliance, please use this new email address.  Please note, we will also be rolling out a more standardized intake process for Coverage Analysis request using this email address. Stay tuned for details! As always, you may also reach out directly Lynn Combs or Trenda Jones, Network Research Compliance Analyst (trenda.jones@uvmhealth.org) for assistance at any time.