VA Central IRB Submissions

VA Central IRB and the VA Innovation and Research Review System
(VAIRRS, which is the VA implementation of IRBNet)

The VA Central IRB is accepting all IRB submissions in IRBNet. This includes new studies, amendments, local site applications, continuing review, reportable events, etc.

1. If you have a multi-center study that is not funded by ORD, please contact the VA IRB Network Director at [email protected] with an abstract of the study to inquire about the availability of the Central IRB for review of that study before preparing and submitting a New Study Application for the VA Central IRB.
2. If you are new to IRBNet, please register for a user account here (va.gov credentials are required for access). Additional training resources are also available on the VAIRRS SharePoint portal (VA network access only).
3. All guidance documents are posted in the Forms and Templates library in IRBNet. Please review our guidance documents prior to submitting in IRBNet.

Submitting a New Project to the VA Central IRB

• What projects are submitted to the VA Central IRB?
• What forms do I need to submit and where can I find them?
• How do I submit a New Project to the VA Central IRB?
• Can the VA Central IRB conduct a pre-review before I submit in IRBNet?

What projects are submitted to the VA Central IRB?

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.

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What forms do I need to submit and where can I find them?

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 [email protected] 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:

Project Cover Sheet – IRBNet Wizard IRB Information Sheet – IRBNet Wizard Form 108 – PISC New Project Application Form 102 – Local ACOS/ R&D Review Supplement Form 112a – Waiver of Informed Consent Form 112b – Waiver of Documentation of Informed Consent Form 103 – Waiver of HIPAA Authorization Protocol MODEL Informed Consent Form or Combined Informed Consent/HIPAA Form Form 10-0493 – MODEL HIPAA Authorization Form Enterprise Research Data Security Plan (ERDSP) CV/ Biosketches – Study Teams in the Investigator Role COI Determination(s) – Do not submit the OGE Form 450

Other Documents: Form 110 series – Vulnerable Population Form (Pregnant Women/Prisoner) Investigator's Drug Brochure/Device Information MODEL Recruitment Material/Phone Scripts Survey/Questionnaires

The forms listed below are required, when applicable, as part of the Local Site Investigator (LSI) New Project submission for non-exempt projects:

Project Cover Sheet – IRBNet Wizard IRB Information Sheet – IRBNet Wizard* Form 104 – LSI Application Form 102 – Local ACOS/ R&D Review Supplement Site Specific Informed Consent Form or Combined Informed Consent/HIPAA Form Form 10-0493 – Site-Specific HIPAA Authorization Form Enterprise Research Data Security Plan (ERDSP) CV/ Biosketches – Local Study Team Members in the Investigator Role COI Determination(s) – Local Study Team Members in the Investigator Role - Do not submit the OGE Form 450

Other Documents: Local Recruitment Material/Phone Scripts Local Request for Waivers (Form 112a, Form 112b, Form 103 - ONLY when PI/SC Waiver does not apply. For example, accessing data in a site specific database)

*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.

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How do I submit a New Project to the VA Central IRB?

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:

• FLOWCHART - PI/SC and LSI New Project Submission Process
• INSTRUCTIONS - PI/SC and LSI New Project Submission Process

Exempt Research Projects:

• FLOWCHART - PI/SC and LSI Exempt Project Submission Process
• INSTRUCTIONS - PI/SC and LSI Exempt Project Submission Process

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Can the VA Central IRB conduct a pre-review before I submit in IRBNet?

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.

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