Federally-funded studies being conducted at more than one U.S. site involving non-exempt human subjects research may be subject to the NIH Single IRB policy and/or Common Rule cooperative research regulations (§46.114). Institutional Officials have decided that UVM will subcontract with WCG IRB for single IRB services when UVM researchers are the lead on a federal grant and no other participating site agrees to act as the Reviewing IRB. Proposals should include the use of WCG IRB 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.

1. UVM PI needs to identify the project as a domestic, multicenter, non-Exempt study with two or more sites.
2. UVM PI determines, with other sites, who they wish to be the IRB of Record: a participating site’s IRB or WCG IRB.
3. Only the UVM Research Protections Office may decide whether the institution will cede review to an External IRB. The UVM PI must complete the “Single IRB Request and Consultation Form” and email it to the IRB Reliance Administrator at least 2 weeks in advance of the funding proposal due date. The request will be discussed via email or meeting to determine if reliance on the External IRB is approvable and discuss an appropriate budget for IRB fees.
4. If the UVM investigator is approved to rely on WCG IRB, the UVM PI should contact Todd Lachiatto (phone 609-250-7655), to assist with budget development. A complimentary, detailed, quote will be provided for the submission.
5. UVM PI should contact their assigned SPA Research Administrator to assist with the proposal development and submission process.

1. UVM PI works with Institutions Partnership Advisor, Glori Schmeckpeper (email link), phone 855-818-2289, to provide necessary start up materials.  The following are a few examples of what may be requested/required:
   1. UVM PI may request for WCG IRB to provide administrative support if needed.  This service is free of charge at this time.
   2. Point of contact information for the UVM protocol.
   3. UVM PI or designee needs to set up MyConnexus access for applicable UVM study personnel (this is the electronic portal that WCG IRB uses for all submissions).
   4. If requested, a Consent/HIPAA Checklist for Required Language (PDF) can be provided.
   5. If requested, a UVM Institutional Profile (PDF) (e.g. state law, etc) can be provided.

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