Projects Not Requiring IRB Review Self-Determination Tool Update

The tool was developed to assist researchers in identifying when their activity requires IRB review.  The difference between research requiring IRB review, research that does not involve human subjects by the regulatory definition, and those activities categorized as quality assessment/improvement projects, program evaluation and public health services can sometimes be difficult to determine. 

IRB staff through their interactions with researchers and recent review of the survey data have identified areas that we feel would benefit from additional context and definitions, thus making the tool easier to use with more accurate results.  An updated tool was released at the end of March.  This tool is for your convenience; however, you should always contact your Regulatory Analyst if you are unsure about how to answer a question. 

Educational Opportunities

Roles and Responsibilities of Research Investigators & Faculty Sponsors

Slides can be found here

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

Slides can be found here (PDF). 

UVMClick News

Over the last several months the UVMClick Tech Team has been testing, configuring, and preparing for the deployment of UVMClick v10, a platform upgrade from v9.

Change in the upgrade schedule – UVMClick will not be available starting at 4:30pm, Thursday, June 6, 2024 and will be back on-line Monday, June 10, 2024.       Questions can be directed to UVMClick@uvm.edu

Updated IRB Forms

Materials Required for IRB Review & Relying on an External IRB (DOCX) New

Exempt 4 Determination, Secondary Research (DOCX) (version 4.4.2024)

Research Data Management and Security Plan (DOCX) (version 2.7.2024)

Accounting of Disclosures of Protected Health Information (PHI) New UVMHN form

Researchers can complete this form if disclosing UVMHN PHI. The HIPAA Privacy Rule requires there must be an accounting of each disclosure including repeated disclosures; this is relevant for the initial study and any study modifications when the following three criteria apply to a research study (Note: An accounting of disclosures is not needed when the research participant has signed a HIPAA/consent authorization):

• PHI will be disclosed by the investigator AND,
• the research disclosure involves at least 50 records (i.e. 50 unique patients/subjects) AND,
• either provisioning of access to the PHI has been approved by an IRB/Privacy Board through a HIPAA Waiver of Authorization, OR the research utilizes information for a population explicitly defined as requiring records for deceased individuals only. 

Completed forms and questions can be directed to: DataGovernance@UVMHealth.org

Updated IRB Policies

1.2 Committee Membership

3.4 Exemption Determinations

5.0 Eligibility to Perform Research at UVM UVMMC

5.5 Data Management and Security

5.6 Managing Research Prior to Departure

8.1.4 Participant Compensation

9.5 Waiver of Informed Consent, Alteration of Informed Consent, or Waiver of Documentation

9.7 Guidance for Researchers Using Deception or Incomplete Disclosure in Research

13.7 Collaborations with External Investigators (External Study Team Members)

26. Human Subject Quality Assurance Review Program

26.1 Human Subject Quality Assurance Reviews on External IRB Studies

UVMMC Updates

UVMHN has launched access to Epic Cosmos, a powerful tool which brings together patient data from many health systems who use Epic to support both Research and Quality Improvement. It is the largest integrated database of clinical information in the United States (see recent NEJM Article for an example of the type of work being facilitated).

Note you must have Epic access in order to use Cosmos.

Because Epic requires that we maintain a 10:1 ratio of Super Users to general users, we are first offering access to individuals willing to serve as Super Users. 

What are the Cosmos Super User Responsibilities?

• Regular access/use in the Cosmos portal to build experience with tools and processes.
• Attendance at monthly Epic “Slice of the Month” Cosmos meetings  to bring questions and collaborate with users at other organizations.
• Direct communication with Epic Systems on feedback or questions for time-sensitive or significant topics.
• Support of UVMHN general Cosmos users, including helping with SlicerDicer queries and peer review of findings.

How do I become a Cosmos Super User?

• Undergo initial training to earn the Cosmos Super User Badge.
• Training requires an Epic UserWeb account and consists of self-paced e-learnings followed by an on-line assessment. Plan on 30 minutes to 1 hour.  

Steps to Follow

Create Epic Userweb account using your work email address 

Email TrainingUserUpdates@epic.com to:

• Request an Epic University account (if you have never done an Epic training before)  
• Let them know you plan to take the Cosmos Super User badge

Complete the first part of the badge (Cosmos Responsible Use Self-Assessment) here: Epic training Super User Badge Training Track

Request Cosmos access from the Data Management Office using ServiceNow. In the form, please let us know that you've finished the Cosmos Responsible User Self-Assessment and are ready to continue Cosmos Super User training.

· You will receive an email when you are granted access to Cosmos. Requests are processed and access is granted on a weekly basis.

·Log in to Cosmos following the instructions provided, complete and submit your project. 

How Can I Learn More About Cosmos?

1. See the Cosmos portal
2. Learn more about Cosmos on the Data Management Office website. 

Research Professionals Network (RPN)– Upcoming Sessions

The RPN was developed in collaboration with Boston University, the University of Florida, and the Medical University of South Carolina to enhance the quality of clinical research at UVM, UVM Health Network by supporting the professional development of clinical research faculty and staff.

Information about the Research Professionals Network and registration for our workshops can be found on the OCTR SharePoint site Here.

Please use this link to Join the Research Professionals Network

Our next workshop  (via Zoom) - Navigation Research Excellence: Applying GCP through Real-World Case Studies

6/11/2024, 3:00pm-4:30pm

REDCap Resources

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

REDCap Basics Class

05/22/2024, Noon -1:15pm
Class 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. Registration Link

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)

 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.

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

FY25 UVM Research Credentialing:

Emails regarding FY25 UVM Researcher Credentialing will be distributed soon!

We are taking this opportunity to remind you about the UVM Researcher Credentialing Policy (Research5). 

This policy is a regulatory requirement to ensure that UVM research faculty and staff have the appropriate orientation, competency, and oversight when accessing UVM Health Network resources.

UVM research faculty and staff who are currently credentialed, their UVM Medical Center research ID badges/credentialing expires on June 30, 2024.

If you have any questions about UVM Researcher Credentialing, please call or email the Office of Clinical Trials 656-8990 or clinical.trials@med.uvm.edu