WCG conducts IRB and IBC reviews concurrently; IRB and IBC submissions may be submitted at the same time or in any order. The submission process for IBC review is outlined in the steps below.

Click here to see the submission process for IRB review.

Step 1: IBC Setup

If your site already has a WCG-administered IBC, you may begin with Step 2.

If your site does not already have a WCG-administered IBC, please follow this process:

  1. Download and complete IBC Services Submission Form – Part A.
  2. Appoint an Institutional Official and Institutional Representative from your site – these contacts must be included in the IBC Services Submission Form – Part A.
  3. Submit the IBC Services Submission Form – Part A to ibcservices@wcgirb.com. Please include blank letterhead showing your business address, to be used for official IBC communications.

Forming Your IBC Team

When WCG IBC Services creates the new IBC for your site, WCG will appoint a Chair, scientific experts, and community members to the committee roster. WCG IBC Services will be responsible for IBC registration, administration, scheduling, and record keeping.

Institutional Official: this person is authorized to sign contracts on behalf of the site (frequently an executive or CEO). The Institutional Official must sign two documents: the Institutional Agreement (Exhibit A) and the Institutional Acknowledgement letter to the NIH. The Institutional Acknowledgement is provided as a template. The Institutional Official should print the Acknowledgement on business letterhead, sign in ink per NIH requirements, scan, and return to WCG. (Other than for the Institutional Acknowledgement, WCG accepts electronic signatures on all documents).

Institutional Representative: this person will be a member of the IBC and a liaison between the committee and site staff. The Institutional Representative may or may not be involved in the research and may be engaged in a blinded or unblinded role. The Institutional Representative must provide a CV and must sign the Institutional Representative Agreement.

Step 2: IBC Study Submission

COMPLETE FORM

Download and complete IBCS Submission Form – Part B.

CREATE SITE MAP

Create an institutional site map as directed within IBCS Submission Form – Part B.

Learn more about site maps below.

SUBMIT

Submit all forms and documentation to ibcs@wcgclinical.com, including site name and PI name in the email subject line.

Site Map Guidance

The map should show the rooms in your research building where the vaccine will be received, stored, prepared, administered, and disposed.  The map may be hand-drawn or derived from a blueprint. If you can, please mark known safety features such as plumbed or unplumbed eyewash on the map. You may submit the map without fully annotating all safety features.  An analyst will help you complete the annotation later.

What Happens Next:

  1. After IBC Services receives your forms, a team member will contact you if there are any incomplete items in the submission that require clarification.
  2. A Biosafety Analyst will be assigned to your site to complete the site assessment for IBC approval.
  3. The IBC approval meeting with your Institutional Representative will be scheduled during business hours at your site.
  4. An approval decision will be communicated with an official determination letter after the meeting.

WCG IBC Services administrative and review teams will be ready to answer any questions you may have during the startup process. Our scientific advisor and lead subject matter expert for gene transfer and IBC matters at WCG will be happy to address any questions you have about rules, procedures, and best practices.