Office of Research & Development |
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The VA Central IRB is accepting all IRB submissions in IRBNet. This includes new studies, amendments, local site applications, continuing review, reportable events, etc.
The VA Central IRB mainly reviews ORD-funded VA research projects that have more than one VA site engaged in human subjects research. The VA Central IRB will also review single site pilot studies that, if successful, will eventually have multiple VA sites engaged in human subjects research. The applicable ORD Funding service should be consulted if you have a question concerning whether your study should be submitted to the VA Central IRB.
Studies funded by other sources may be considered for review by the VA Central IRB on a case-by-case basis.
All VA Central IRB forms are available in IRBNet under Forms and Templates. When filling out any of the forms, you may contact the VA Central IRB general e-mail address at vacentralirb@va.gov with any questions that you may have. If able, include the name of your study, funding source, principal investigator’s name, and number of VA sites that will be participating in the study. One of our VA Central IRB staff will get back to you to answer your questions.
The forms listed below are required, when applicable, as part of the Principal Investigator/Study Chair (PI/SC) New Project submission for non-exempt projects:
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The forms listed below are required, when applicable, as part of the Local Site Investigator (LSI) New Project submission for non-exempt projects:
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*Ensure you answer the IRB Information Sheet questions as it applies to your site NOT the overall project.
The VA Central IRB requires different forms to be completed and submitted for Exempt projects. If submitting an Exempt project, please follow the form requirements in the instructions provided in the following section under Exempt Research Projects.
The VA Central IRB application process involves two parts. The first part pertains to the submission of the protocol and supporting documents by the Principal Investigator/Study Chair (PI/SC). In addition, the PI/SC submits all waiver requests as they apply to the study, as well as model informed consent documents, HIPAA authorizations, and recruitment materials as applicable. The second part involves the submission of Local Site Investigator (LSI) Applications after the PI/SC application has been approved.
A simplified flowchart and detailed instructions guiding the entire VA Central IRB application and review process for PI/SC and LSI New Project submissions can be found by clicking on the files below:
Non-Exempt Research Projects:
Exempt Research Projects:
The VA Central IRB has an optional pre-review process. Drafts of the applicable forms and protocol can be submitted, and a courtesy pre-review will be performed by one of the VA Central IRB Managers. This pre-review is not a determination of the VA Central IRB and is meant to assist the study team in ensuring the application will be complete at the time of submission. To request a pre-review, please contact the VA Central IRB Administrator.