Research Protection Office News

The IRB meeting for medical sciences has a change in the December meeting date.  The meeting will be held 12/13/2023.  Meetings dates and agenda deadlines for 2024 can be found here.

Holiday Schedule

日韩无码 offices are closed on November 23 & 24 for the Thanksgiving break and December 22 through Monday January 1, 2023 for the Christmas and New Year holidays. We are back on Tuesday, January 2, 2024.

Educational Opportunities

Free FDA training video for clinical investigators designated as responsible for submitting registration and results information to

In a three-part webinar series, FDA provides a general overview of ClinicalTrials.gov and relevant definitions, laws, and regulations for complying with ClinicalTrials.gov registration and results information submission requirements. Participants will gain an understanding of CDER鈥檚 role and responsibilities with respect to ClinicalTrials.gov oversight and will hear examples of compliance and enforcement activities CDER has taken to encourage compliance.

New options for Research participant payments

日韩无码 now has two new contracts with US Bank, to provide research participant payments. 

One is a plastic card, the other is virtual.  Information about these programs can be found here.

To get started, email  with a meeting request. Training with US Bank will be scheduled after meeting with the PurCard team.

日韩无码 updated Policy and Procedures

Introduction to the Boards, the Principles, and their Authority

8.1.3 Plans for Recruitment/Screening/Retention

8.5 Blood Collection Protocols

11. Certificates of Confidentiality

13.2 Collaborative Agreements

13.3 Procedures for Reliance on External IRB for Federally Funded Research

13.8 Procedures for Reviewing or Relying for NNE-CTR Grants

28.0 Electronic Signature Policy

29. Regulatory Definitions

30. Statement of Compliance for the Committees on Human Research

Sections removed from the Policy and Procedures

13.4 Procedures for Reliance on National Cancer Institute, Central Institutional Review Boards 鈥 Adult.  This policy can be found with the Office of Clinical Trials Research.

13.5 Procedures for Reliance on National Cancer Institute, Central Institutional Review Boards 鈥 Pediatric. This policy can be found with the Cancer Center鈥檚 clinical trials office.

3.8 Facilitated Review of Externally Reviewed Protocols

Single IRB and You

Since the NIH and Common Rule mandates, 日韩无码鈥檚 IRB has completed over 75 reliance agreements.  Federal regulations require use of a Single IRB (sIRB) for regulatory review of federally funded, non-Exempt, human subjects research taking place at multiple domestic sites. 

Scope

  • Applies when there are two or more sites conducting the same research or portions of research protocols. 
  • Applies when 日韩无码 is prime awardee, even if not conducting the research locally, and there are one or more additional sites (independent of whether the additional sites are receiving subawards).   
  • sIRB requirements apply to NIH funded research as well as 19 other federal departments or agencies that follow the Common Rule regulations.
  • Within the next few years, the Food and Drug Administration (FDA) will be harmonizing with the Common Rule and will also require use of sIRB for FDA regulated trials.
  • The only exceptions to this requirement are for non-domestic sites, research requiring IRB review by more than one entity (such as research conducted on tribal lands or with tribal communities), or research for which the funding agency determines and documents sIRB is not appropriate.

Reliance requires Single IRB approval from the 日韩无码 IRB

  • The regulations do not allow for researchers to independently commit the University to reliance. 
  • Only the 日韩无码 IRB is delegated to enter into agreements to cede review to another institution or act as the sIRB.  For this reason, the IRB needs to hear from researchers as early as possible about studies that will require reliance.
  • If you are the prime awardee, you need to utilize the WCG IRB (commercial IRB) for the sIRB requirement. 日韩无码 has a master contract with WCG to act as your sIRB.  WCG IRB review fees must be included as a direct cost within the grant鈥檚 proposed budget.  Contact information for WCG is here.
  • If 日韩无码 wishes to be a participating site, please contact the IRB Reliance Administrator early to ensure a smooth process. 

Researchers hoping to participate in or lead a federally funded multi-site study should email the IRB Reliance Administrator, jen.dulin@uvm.edufor support and guidance as early as possible in the process. 

日韩无码 Medical Center News

Fundamentals in the Conduct of Clinical Research Training Program 鈥 Upcoming Sessions

The Larner College of Medicine, in conjunction with The Office of Clinical Trials Research, requires that all research staff engaged in at LCOM and the 日韩无码 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 regardless of job title.  Investigators are welcome (but not required) to attend.

This requirement applies to all research staff who are involved in the conduct of research involving human subjects, irrespective of funding sourcesupporting the research activity.

January 2024 Session
Wednesday, January 10, 2024, 2:00pm-4:30pm
Wednesday, January 17, 2024, 2:00pm-4:30pm
Wednesday, January 24, 2024, 2:00pm-4:30pm
Wednesday, January 31, 2024, 2:00pm-4:30pm

More information about the Fundamentals program can be found on the OCTR Commons/SharePoint site .

Upcoming Research Professionals Network Workshops:

Workshop Topic: Effective Communication

Wednesday, November 29th, 3-4:30 pm

In this workshop the presenters will focus on 鈥渒nowing your audience鈥 when communicating with a range of individuals you interact within a research setting. The group will go over different styles and components of communication to effectively get your message across.

Workshop Topic: Onboarding

Tuesday, December 19th, 3-4:30 pm

鈥婸lease use this link to Register for