How to Submit for IBC Review
WCG is by far the most experienced and knowledgeable provider of IBC administration and review. Our team of high-level experts in human gene transfer research supports WCG’s IBC review process to ensure the safety of research personnel, participants and their community.
WCG conducts IRB and IBC reviews concurrently; IRB and IBC submissions may be submitted at the same time or in any order. To learn about the difference between IRB and IBC review, read the article “IRB vs. IBC: What’s the Difference.” The submission process for IBC review is outlined in the steps below.
How Do I Submit for IBC Review
For gene transfer protocols, WCG accepts both study-level submissions from the sponsor/CRO and site-level submissions from each investigator’s study team. Find the chart below for the applicable steps for submitting for IBC review.
How to Submit for IBC Review as a Site or Institution
Sites and institutions are encouraged to contact ibcservices@wcgclinical.com for assistance before beginning their submission.
Registration
To submit a protocol for IBC review, a site must confirm or establish site registration with WCG. Please contact ibcservices@wcgclinical.com to find out if your site is already registered.
If your site is already registered, you do not need to register again. If your site is not yet registered, you may register at no cost using the IBC Registration Form.
The registration form requires the site to identify an Institutional Official. That official is required to sign Page 2 of the form in ink (electronic signature is not accepted by NIH).
The signed form may be submitted to ibcservices@wcgclinical.com
Important Note: Once submitted, WCG IBC Services will handle the complete registration with the NIH, appoint committee members, and manage all scheduling and record-keeping to relieve your operational pressure.
Site-level Study Submission
For sponsored research, the sponsor may have already arranged for central IBC review of the respective protocol. In those cases, WCG will send you a prefilled site-level submission form. If you received a prefilled form from WCG, please provide requested information and have the principal investigator sign (electronic or ink signature accepted).
If you have not received a prefilled submission form, you may download the site-level submission template from here:
Please contact ibcservices@wcgclinical.com for assistance with completing the site-level submission template. The IBC will require a map or diagram of relevant research areas as part of the review. Please check with IBC services to determine whether your site already has a map on file. If the relevant map is not on file, please follow the instructions on the submission template to create a site map. Have the principal investigator sign (electronic or ink signature accepted). The executed form should be submitted to ibcservices@wcgclinical.com.
After submission, our team supports your study at every step in your planning and review process to ensure successful trial completion.
- Clarify Details: A team member will contact you if any incomplete items require clarification.
- Site Assessment: A dedicated Biosafety Analyst is assigned to your site to complete the site assessment for IBC approval.
- Approval Meeting: An IBC approval meeting with your Institutional Representative will be scheduled during regular business hours at your site.
- Receive Determination: Following the meeting, you will receive an official determination letter communicating the approval decision.
How to Submit for IBC Review as a Sponsor/Clinical Research Organization (CRO).
Please contact ibcservices@wcgclinical.com for advice and assistance with study-level submission.
Sponsors and CROs may select Standard (IBC) or Expedited (IBC+) study-level submission for IBC review. We will be happy to explain the different options. There is no cost for study-level IBC submission – WCG only invoices for services provided to each site on a study.
To complete the study-level submission, the following documentation is required:
- Protocol
- Investigator’s Brochure
- Pharmacy Manual or product handling instructions
Sponsors completing study-level submissions will receive a weekly tracker showing progress of each selected site toward IBC approval. WCG is also happy to arrange kick-off meetings for any new study upon request.