Relying on Advarra or the WCG IRB

The NIH is willing to rely on the Advarra or WCG IRBs and has an existing Reliance Agreement with both.

NIH study teams typically submit to Advarra or WCG in the following scenarios:

When the NIH Study Team plans to serve as a Participating Site. In this case, an external Sponsor has chosen the commercial IRB, and the NIH investigator wants to join a new/existing multi-site study.
When the NIH Study Team plans to serve as both a Sponsor and Participating Site. Here, an NIH investigator initiates a multi-site study, and the NIH IRB does not serve as the single IRB.

NIH Study Teams must follow the steps in NIH is a Participating Site and relying on an External IRB when relying on Advarra or WCG. Additionally, there are further considerations to keep in mind:

NIH study teams are responsible for confirming the budget and payment of commercial IRB services as these will not be covered by the NIH IRB office.

Add the NIH site after the protocol has received initial approval via a Modification
Submit the Modification after the NIH Institutional Review Memo is issued
Submit the necessary documents through the Advarra/WCG electronic system (CIRBI/ CONNEXUS), identifying the NIH as a Participating Site.
Include the following NIH site-specific documents in the submission:
- NIH site-specific Protocol Addendum
- NIH site Consent and/or Assent document(s) i.e., Model Consent/Assent with NIH required language added
- NIH Institutional Review Memo
Begin research activities at the NIH site after receiving IRB approval from the external IRB and completing the institutional review process in PROTECT.

Obtain initial approval for the protocol before adding Participating Sites through subsequent Modifications.
Submit the initial protocol after the NIH Institutional Review Memo is issued.
Include the following documents in the initial submission:
- Master/Core protocol
- Model consent document(s)
- Model recruitment material(s)
- NIH Institutional Review Memo
After the Initial Review, add NIH and other institutions as Participating Sites to the study.
Begin research activities at the NIH site after receiving IRB approval from the external IRB and completing the institutional review process in PROTECT.

Commercial IRBs need to understand NIH’s specific policies, local norms, special requirements, culture to conduct its review. This is known as “Local Context”.

The NIH Study Team and NIH IRBO collaborate to identify pertinent local context information.
Advarra and WCG have already been provided NIH Institutional local context information by IRBO.
The NIH PI provides study-specific information on how the protocol will be implemented at NIH through the NIH site-specific documents.

Only the IRB review is being ceded to Advarra or WCG.

NIH study teams must therefore follow the IRB policies of the External IRB (Advarra IRB Handbook or WCG IRB Guide for Researchers) as well as applicable NIH institutional policies.