RPOHuman Subjects ResearchSingle IRBWestern IRB

 

Introduction

As of January 25, 2018, NIH policy (opens in a new window) requires that all NIH multi-site protocols use a single IRB of record. Institutional Officials have decided that UVM will subcontract with Western IRB (WIRB) (opens in a new window) for single IRB services where UVM researchers wish to be the lead single IRB for their NIH proposals. Proposals should include the use of WIRB as the IRB of record for the multi-site research activities and budgets must be developed to include the expense for the use of this commercial IRB.

UVM Principal Investigator (PI) is Lead on a Grant

 

Prior to Grant Application (as early in the process as possible)

  1. UVM PI needs to identify the project as a domestic multicenter trial with two or more sites.
  2. UVM PI determines, with other sites, who they wish to be the IRB of record. 
  3. If UVM takes on that responsibility, UVM PI contacts Charles Eibeler, phone 919-244-9887, to assist with budget development. A complimentary, detailed, quote will be provided for the submission.
  4. UVM PI should contact their assigned SPA Research Administrator to assist with the proposal development and submission process.

Just-in-Time Received, Site Start Up Materials

  1. UVM PI works with account manager, Jon Gellert, phone 360-570-1309, to provide necessary start up materials.  The following are a few examples of what may be requested/required:
  • UVM PI may request for WIRB to provide administrative support if needed.  This service is free of charge at this time.
  • Point of contact information for the UVM protocol.
  • UVM PI or designee needs to set up MyConnexus access for applicable UVM study personnel (this is the electronic portal that WIRB uses for all submissions).
  • If requested, aPDF icon Communication Plan (PDF) can be provided.
  • If requested, a File Local context information (DOCX) (e.g. state law, etc) can be provided.

If Awarded See Additional Information

Additional information can be found in the IRB Policies and Procedures Manual - Section 13.3. Procedures for Relying on External IRB for NIH Research.