November 19, 2019

Please join us in welcoming Ryann Guayasamin, Ph.D., to the Research Protections team as our newest IRB Research Review Analyst! Ryann has extensive research background with over a decade of mentoring, teaching and hands-on laboratory experience. She recently relocated to the Burlington area from Boston where she was a lecturer for Boston University’s Undergraduate Program in Neuroscience. We’re excited to have Ryann on our team! Welcome!

NEW - Common Rule Cooperative Group Research Requirement
Single IRB for other Federally Sponsored Research

IRB oversight for most federally-funded collaborative research projects in the U.S. will be required to use a single IRB as of January 20, 2020.  The IRB has developed guidance over the past year based upon experience gained by relying for studies where the NIH was the sponsor.   For reliance guidance, please see section 13.3 of the research manual and reach out to your IRB analyst for assistance. 

For NIH proposals, researchers are required to provide a single IRB plan at time of proposal.  The requirements for these other funding mechanisms are not yet clear.  Work with your program officer to understand the requirements.

The ̽̽ IRB is not prepared at this time to act as the lead IRB in these situations.   ̽̽ has a subcontract with Western IRB for single IRB services when ̽̽ researchers wish to be the lead site.  Western IRB can act as the lead IRB in these situations.   Information in this regard is located at /rpo/western-irb.

CITI Training Triennial Refresher Requirement: Your Help is Needed

Problem

  • PI’s and key personnel are falling out of compliance with the triennial refresher requirement. 
  • CITI reminds personnel via email beginning 90 days prior to expiration, but the reminders do not appear to be heeded. 
  • IRB staff no longer receive notice of expiration to assist with compliance.
  • This results in noncompliance for the PI’s and key personnel.

Fix

  • A designated person should periodically check the “Training” tab of the ̽̽Click protocol record to ensure PI and key personnel are up-to-date. 
 

  • The IRB does not approve new key personnel if training has not been completed.
  • If noncompliance with this requirement is discovered at time of continuing review or a modification, the IRB cannot release approval until the requirement has been met.  Additionally, if it is the PI’s training that has expired, a notice of the expiration and request to cease protocol activities will be sent to the PI with a copy to the department chair. 

Consent Template Changes

We have recently updated our consent template (dated 11/7/19) to better coordinate the New Common Rule language and the HIPAA regulatory language changes.  Previously, future research was discussed in three different areas of the consent.  This was causing confusion.  Therefore, we have consolidated the regulatory requirements into one area now on page 4.  Please reference this revised template when you are preparing new protocol submissions.  /rpo/uvmclick-irb-forms-library


Educational Opportunities

What you Need to Know about Single IRB – Bag Lunch

Donna Silver, CIP, RPO Director

November 22, 2019 12:00 – 1:00 HSRF 200

Research Data Management Plans – Bag Lunch

Darcy Pientka, Assistant Director, Information Security Officer

December 12, 2019 12:00 – 1:00 HSRF 400

This is a 20-minute YouTube presentation explaining when institutions are engaged in human subjects research.  It also explains when a Federalwide Assurance is required and when IRB review is required. 

Reminders About the Continuing Reviews Post Common Rule Change

If you have a protocol where the continuing review requirement was lifted since the implementation of the new Common Rule, please take a moment to review either the Medical or Behavioral self-assessment checklists that we created to assist researchers in remaining compliant. As announced, an email will be sent out to all PIs and Key Personnel in January to remind you to complete the annual self-assessment if you haven’t already done so. The assessments are for your use only and do not need to be returned to the IRB. If you discover that materials need to be submitted to the IRB as a result of your assessment, this can be done by submitting those materials through ̽̽Click-IRB.

IRB Policies and Procedures Manual Changes

In keeping with our new quarterly manual update, the list below indicates the sections that have been revised.  Changes are minor in nature and we have added two new sections.  If you have any questions, please do not hesitate to contact irb@uvm.edu

·       1.2 Committee Membership

·       1.3 Operations of the Committee

·       2.0 Coordination with Other Compliance Committees (addition of Research Integrity Office)

·       3.6.1 New! Case Studies

·       3.8 New! Facilitated Review

·       5.4 Training Requirements

·       8.1.1 Elements Found in a Standard Protocol

·       9.0 Consent

·       13.3 Procedures for Relying on External IRB for Federally Funded Research

·       13.4 Procedures for Reliance on NCI CIRB (reflects ̽̽Click procedures)

·       13.5 Procedures for Reliance on NCI CIRB (reflects ̽̽Click procedures)

·       14.6 Fees for Committees on Human Research Review (changes in IRB fees as of July 1st)

·       17.0 Closing or Reopening a Protocol

·       19.1 Standard Procedures for Studies Including MRI (pregnant populations)

·       20.2 Expanded Access of Investigational Drugs (Compassionate Use)

·       23.0 Emergency Use of an Investigational Drug or Biologic or Device