RPO News

After 20 years as serving as the UVM Chair of the Behavioral & Social Sciences IRB, Dr. Ted Marcy is retiring on June 30, 2025.  Dr. Marcy retired in 2011 after 24 years as a pulmonary and critical care physician from UVMMC but continued his work on the IRB. He has continued to serve the University reviewing hundreds of the most complicated research protocols involving participants vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons. He has dedicated his time, lead classroom instruction and consulted on protocol development to numerous faculty, investigators and students during his tenure.  We wish Dr. Marcy a happy retirement and thank him for his leadership at the IRB.

The RPO welcome’s our new CHRBSS leadership team -

Jennifer Laurent, Ph.D., APRN, Holly D. and Robert E. Miller Endowed Professor of Nursing, has accepted the position as our new Chair of the IRB for Behavioral & Social Sciences starting July 1, 2025.

Erin Shoulberg, Ph.D., Clinical Assistant Professor in the Department of Psychological Sciences has accepted the position as our new Associate Chair of the IRB for Behavioral & Social Sciences starting July 1, 2025.

UVM Educational Research Opportunities

May 7, 2025 12:00 – 1:00 Waterman 427

Ask the IRB

The RPO office will be available for in-person questions and direct researchers to best practice guidance on UVM policies. No formal presentation, open question and answer session.  Researchers are encouraged to attend, bring lunch, listen/learn and bring any questions concerning;

  • submitting through the UVMClick system

  • protocol development questions

  • preparing for a quality assurance audit

  • navigating human participant regulations  

We’re here to help! No registration is needed.

Upcoming - June 3, 2025 12:00 – 1:00 HSRF 200

UVMMC Investigational Drug Services and IRB review

Did you miss the April IRB Education?

Research Conducted in Public Schools - Slides can assist investigators proposing to conduct research in public elementary and secondary schools.  Topics include federal and local research regulations around FERPA and PPRA and the requirements around obtaining parental consent and child assent in a public-school setting.

Common Findings During Quality Assurance Visits

The UVM IRB conducts routine post-approval protocol reviews to ensure human subject research activities are conducted in accordance with the IRB approved protocol, federal regulations, state laws and institutional policies regarding the protection of human subjects in research. The QA program has three goals:

  1. Enhancing the protection of human research participants
  2. Improving the quality of human research data
  3. Serving as a training/educational opportunity for research teams as they conduct research.

2024-2025 common findings requiring corrective actions include:

  • missing source documentation,
  • failure to report or document protocol deviations,
  • missing consent process forms or lack of documenting the consent conversation
  • enrolling of ineligible participants,
  • lack of documentation of adverse event assessment and attribution by an investigator
  • lack of protocol training documentation for study staff
  • failure to follow the Data Safety and Monitoring Plan,
  • not following the IRB approved protocol
  • incomplete data capture without notes to the file explaining discrepancies
  • not modifying the IRB protocol when changes arise 

The IRB recommends researchers conduct internal reviews of their collected data and regulatory documents to ensure the protocol is still up to date.  Review the QA policy and the education slides to best prepare for a QA visit and keep research compliant at UVM.

IRB Policy & Procedure Updates

1.2 Committee Membership v.4.15.2025

5.3 Retention of Research Records v.4.10.2025

5.7 Sharing Research Data and/or Biospecimens v.4.29.2025

8.6 Human Biospecimens for Research v.4.29.2025

9.0 General Requirements for Documenting Informed Consent v.3.18.2025

9.3 Consent Process for Enrolling Research Participants Who Are Legally Blind, Illiterate, or Cannot Speak or Write v.4.29.2025

9.9 Electronic Consent v.3.18.2025

13.2 Collaborative Agreements v.4.9.2025

13.2.1 Reliance Agreements in Place at UVM for Multiple Studies v.4.9.2025

20.4.  Controlled Substances Used in Research v.4.9.2025

26. Human Subject Quality Assurance Review Program v.4.10.2025

IRB Forms

Exemption 2, version 3.24.2025

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 Training Program, including, but not limited to; Research Coordinators, Research Nurses, Research Health Care Professionals, and Regulatory Staff, or individuals fulfilling these roles.  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.

Register for an upcoming session

May 2025 Session
Tuesday, May 6,   10am - 12:30pm
Tuesday, May 13, 10am - 12:30pm
Tuesday, May 20, 10am - 12:30pm
Tuesday, May 27, 10am - 12:30pm

August 2025 Session
Tuesday, August 5,   10:30am - 1:00pm
Tuesday, August 12, 10:30am - 1:00pm
Tuesday, August 19, 10:30am - 1:00pm
Tuesday, August 26, 10:30am - 1:00pm

NNE-CTR Research ECHO

The Clinical Research ECHO is a knowledge-sharing forum via monthly Zoom sessions. This is a great networking opportunity that features didactic and case presentations by colleagues sharing their research and engaging in lively problem-solving discussions.

May Research ECHO: “Exploring the use of TriNetX for Research” - May 28th, Noon – 1pm – Zoom

See past presentations here. To register for future sessions, click here

Research Professionals Network (RPN)

Join the Research Professionals Network (you do not have to be a member to participate in the workshops)

May Workshop: “Clinical Trial Budgeting for Industry Trials” - May 20th, 2:30- 4pm – Zoom

June Workshop: “Professionalism for Clinical Research Professionals” - June 16th, 2:30- 4pm – Zoom

Workshop Registration can be found - Workshop Series | Clinical Research Resources Office