Author: Erica Doruska

The VA Central IRB
Review Process
November 2010

Step 1
PI Application submitted to the
VA Central IRB

Step 2
PI Application reviewed by
convened IRB or via
expedited review

No

Is PI
Application
approved?

Step 3a
Local sites have 30 days to provide
comments on VA Central IRB
Review of PI Application

Yes

Step 3b
Local Site Investigators (LSIs)
submit LSI Applications to the VA Central IRB through the PI

Step 4a
VA Central IRB reviews local site
comments and requires PI or LSIs to make changes as applicable

Step 5
PI and/ or LSI make changes as required or provides comments as requested and submits final versions of applications to VA Central IRB

Step 4b
VA Central IRB reviews LSI
Applications and requires LSIs to make changes
as applicable

Step 6
PI and/or LSI Application given final approval by the VA Central IRB

Step 7
Local Sites have 10 days to
make a decision whether or not
to participate in the project

Color Key
Investigators
Local Sites
VA Central IRB
Decision Points and / Administrative Action

Note: Local accountability occurs throughout the
centralized review process, specifically in steps 3a, 3b, and 8.

Local Sites provided with a copy of approved PI and LSI Applications and any VA Central IRB response to local site comments

Study
reviewed at local site per VA and local policies

Does site agree to
participate?

No

Yes

Step 8
VA Central IRB Meeting minutes sent to designated local site VA Central IRB Liaison for Local Site review

Site does not
participate in the study

Key Steps in the VA Central IRB Review Process
November 2010

Step 1. The Principal Investigator of a VA Office of Research and
Development (ORD)-funded study submits a PI Application with all applicable documents to the VA Central IRB. The PI
Application includes the following as applicable:
Co-PI and Coordinating Center Supplements
Model Informed Consent Form and HIPAA Authorization
Waiver Requests (HIPAA/Informed Consent)
Vulnerable Population Supplements
CVs and Conflict of Interest Statements for PI
Model Recruitment Materials
Other documents as per study design
Step 2. Review Of the PI Application by the VA Central IRB at a convened meeting or by expedited review; if approved or
approved contingent upon minor modifications, the PI and
participating local sites are informed.
Step 3. This step consists of 2 parts that take place
simultaneously:
Step 3a. Local Site Review
Local sites have 30 days to review the VA Central IRB
approved PI Application and submit comments to the VA
Central IRB.
Step 3b. Local Site Investigator (LSI) Applications
LSIs may begin to submit LSI Applications to the VA Central IRB. LSI Applications include the following as applicable:
Informed Consent Form
CVs and Conflict of Interest Statements for LSIs
Recruitment materials to be used at local site
Other documents as applicable
Step 4. VA Central IRB reviews Local Site comments and LSI
Applications
Step 4a. Review of submitted local site comments; VA
Central IRB may:
Refer comments to PI
Require changes in PI and/or LSI Applications
Take no action
Step 4b. Review LSI Applications and include any changes from step 4a.
Step 5. PI and/or LSI submits changes or provides comments.
Step 6. VA Central IRB makes final approval decision and all relevant materials sent to the Local Site, to include the approved PI and the relevant LSI Application and the VA Central IRB
response to any local site comments, so the Local Site can
determine whether or not it will participate in the project.
Step 7. The Local Site has 10 days to decide whether or not it will participate in the study and to submit a participation
decision to the VA Central IRB.
Step 8. The applicable VA Central IRB meeting minutes are
provided to the Local Site and the Local Site processes the study in accordance with VA and local requirements.
Note: A VA study cannot begin at a given local VA facility until the PI and LSI applications have been approved by the VA Central IRB, and the local VA facility has complied with the requirements of VHA Handbook 1200.01.