Research Protection Office News

RPO welcomed Jen Ather, PhD as our new IRB Regulatory Analyst this month.  She comes to us from the Vermont Lung Center with extensive experience as a senior lab technician in biosafety oversight, animals, human subjects and grant writing. Please welcome Dr. Ather when you have an opportunity. 

The Director of the Research Protections Office, Donna Silver, released the January 2024 annual summary report of RPO research accomplishments, collaborations, changes, and future initiatives.  This report covers human subjects, vertebrate animals, and biosafety committees. Research Protections Office Inaugural Annual Report

Managing your Protocol

Leaving UVM/UVMMC? Student graduating? 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.

Projects with exempt determinations greater than 3 years old without any updates to the IRB will be automatically closed as part of a UVMClick data cleanup.

ClinicalTrials.gov

PIs are required to register, update, post results and consents to ClinicalTrials.gov. This is a consumer-friendly database with information on clinical studies funded and/or sponsored by the NIH, other federal agencies, and private industry. The database was developed by NIH, through its National Library of Medicine (NLM), in collaboration with the Food and Drug Administration (FDA). The National Library of Medicine outlines PI responsibilities:

  • Who Is Responsible for Registering Trials and Submitting Results?
  • Which Trials Must Be Registered on ClinicalTrials.gov?
  • When Do I Need to Register?
  • Which Trials Must Have Results Information Submitted to ClinicalTrials.gov?
  • When Do I Need to Submit Results Information?
  • Are There Potential Legal Consequences If I Fail to Register or Submit Results?

Educational Opportunities

Roles and Responsibilities of Research Investigators & Faculty Sponsors 

March 27, 2024 Room HSRF 200

Institutional Review Board (IRB) and the Protocol Review and Monitoring Committee (PRMC) – What’s the Difference?

April 16, 2024 Room 300 HSRF

UVMClick News

Our UVMClick system will be upgraded the weekend of May 3rd.   It is a large effort affecting the entire UVMClick suite and will require three full days to complete.  These upgrades not only keep us on current code, but they provide important new features that complement, and build upon, our current processes. Please plan for the UVMClick system to unavailable all day Friday May 3rdthrough Sunday May 5th.  More details to come.

Updated IRB Forms

Blood Collection Protocol for Non-Clinical Laboratory Research (version 12.7.23)

University of Vermont Cancer Center is hiring!

Regulatory Specialist - Prepare and track regulatory documentation. Provide guidance and subject matter expertise to other members of the research team for regulatory and compliance aspects of conducting clinical research. Maintain documentation in compliance with federal and local regulations and distribute materials to local and affiliate sites. Bachelor’s degree and one to three years related experience with or demonstrated ability to learn federal regulations and guidelines required. Ability to make independent decisions in a fast-paced, regulated environment required. Ability to work collaboratively with investigators, staff, and regulators required. Effective written and verbal communication skills and editorial skills required.

OCTR Commons/SharePoint

 Looking for help, resources, or templates regarding clinical research? Visit the OCTR Commons/SharePoint site.

 Having trouble logging in? Contact commons.support@med.uvm.edu

Research Professionals Network (RPN)– Upcoming Sessions

Join the Research Professionals Network Next Workshops  (via Zoom)

03/25/2024, 3:00-4:30: ​Using of REDCap for Electronic Remote Consenting

04/30/2024, 3:00-4:30: Under-Utilized REDCap Features

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 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.

Next training sessions (via Zoom)

April/May Session

  • Tuesday, April 30, 2024, 10:00am-12:30pm
  • Tuesday, May 7, 2024, 10:00am-12:30pm
  • Tuesday, May 14, 2024, 10:00am-12:30pm
  • Tuesday, May 21, 2024, 10:00am-12:30pm

Please use this link for more information and to Register for an upcoming session.

This free comprehensive fundamental clinical research training was created to ensure essential knowledge for staff involved in clinical research at LCOM/UVM HN. Comparable trainings would cost hundreds of dollars from an outside source and would not be adapted to LCOM/UVM HN processes and policies. We hope you appreciate the value this course is bringing to Researchers and their staff, and that the time investment will elevate the quality and compliance of clinical research at our institutions.

Epic

Did you know that you can upload multiple consents at a time to UVM MC SharePoint site for uploading consents/HIPAA to Epic per Research3 policy? Visit the OCTR Commons/SharePoint page Research and Epic for instructions ( How to upload Consent/HIPAA to Epic   Video).