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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 Workman@va.gov 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?

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 (listed below), 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 following content below is new

The forms listed below are required, when applicable, as part of the Principal Investigator/Study Chair (PI/SC) New Project submission:

  • 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:

  • 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
  • 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)

*Ensure you answer the IRB Information Sheet questions as it applies to your site NOT the overall project.

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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 if they apply to the entire 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 once the PI/SC application has been approved.

Below is a more detailed description of the two-part submission process:

PART I: Follow the steps below to submit a PI/SC New Project in IRBNet:

Step 1: Log in to IRBNet and “Create a New Project.” Review separate instructions on How to Create a New Project if needed.

Step 2: Compile the submission in IRBNet and submit the project to your local research administration office. This will be package -1 in IRBNet.

Step 3: After your local research administration review is complete, submit the project to the VA Central IRB. There are 2 ways the project can be submitted to the VA Central IRB:

  1. Local research administration submits package -1 on behalf of the Researcher to the VA Central IRB.

This option is best if all the documents that were reviewed locally are the same as the documents that need to be reviewed by the VA Central IRB.

or

  1. Researcher creates and submits a new package within the same project (this would be package -2) to the VA Central IRB.

This option is best if the local research office documents reviewed are different than the VA Central IRB documents. This would ensure the VA Central IRB does not receive local documents in the IRBNet submission.

NOTE: Whether a) or b) is followed, the package that is submitted to the VA Central IRB should only include documents that are required by the VA Central IRB (see above table).

Additionally, ensure that the PI or designee has signed the package in IRBNet before is it submitted to the VA Central IRB.

Step 4: VA Central IRB will review the PI/SC New Project.

The VA Central IRB Manager will perform an administrative review. Depending upon the type of project submitted, additional reviewers from the VA Central IRB will be assigned. At a minimum, the study will receive a review by the Regulatory Advisor to the VA Central IRB, the Privacy Officer Representative, the Information Security Officer Representative, and at least one voting member of the VA Central IRB. If the study is scheduled to be reviewed by the convened IRB, a Secondary Reviewer and an Informed Consent Reviewer may also be assigned. All comments will be consolidated as much as possible and forwarded to the PI/SC or designee via IRBNet for response. However, in the interest of not holding up communications, some reviewer comments may be forwarded separately depending upon receipt. This process will occur utilizing IRBNet’s “Unlock and Lock” function so that you can add, remove, or revise documents within the same package.

Step 5: After final VA Central IRB approval is received, the PI/SC will need follow VA and local R&D Committee policies to obtain final approvals at their local research administration.

Step 6: Upon receipt of their local approvals, they now will need to share the project with the LSI’s in IRBNet utilizing the “Multi-Site” function. See separate instructions How to Share a Multi-Site Project in IRBNet if needed.

PART II: Follow the steps below to submit an LSI New Project in IRBNet:

After a PI/SC New Project has been approved, the LSI submission process to the VA Central IRB may begin by following the steps below.

Step 1: Log in to IRBNet and go to the project that was shared by the PI/SC.

NOTE: If the PI/SC has not shared the project with the LSI in IRBNet contact the PI/SC directly and request that they share the project utilizing the Multi-Site function. If you are still unable to access the project, contact the VA Central IRB or IRBNet Support for assistance. Do NOT create a new project. The LSI project in IRBNet must be directly linked to the PI/SC project.

Step 2: Once in the project enter the name of the LSI in the Principal Investigator field, upload submission documents, and submit the project to your local research administration office. This will be package -1 in IRBNet.

The LSI project should mirror the PI/SC project aside from sections for study staff and site-specific information. If the LSI does not plan to deviate from the approved PI/SC project, in many sections, this can just be stated, and no further information needs to be completed. If the LSI plans to deviate from the approved PI/SC project, all deviations must be detailed and justified in Form 104. Any deviations made from approved wording must be indicated through the use of the "track changes" function, and justification provided within the Form 104. LSI projects should also include changes made in response to any requested modifications to the PI/SC Application as applicable.

Step 3: After your local research administration review is complete, submit the project to the VA Central IRB. There are 2 ways the project can be submitted to the VA CIRB:

  1. Local research office submits package -1 on behalf of the Researcher to the VA Central IRB.

This option is best if all the documents that were reviewed locally are the same as the documents that need to be reviewed by the VA Central IRB.

or

  1. Researcher creates and submits a new package within the same project (this would be package -2) to the VA Central IRB.

This option is best if the local research office documents reviewed are different than the VA Central IRB documents. This would ensure the VA Central IRB does not receive local documents.

NOTE: Whether a) or b) is followed, the package that is submitted to the VA Central IRB should only include documents that are required by the VA Central IRB (see above table).

Additionally, ensure that the PI or designee has signed the package in IRBNet before is it submitted to the VA Central IRB.

Step 4: VA Central IRB will review the LSI New Project.

The VA Central IRB Manager will perform an administrative review. The study will receive a review by at least one voting member of the VA Central IRB. All comments will be consolidated as much as possible and forwarded to the LSI or designee via IRBNet for response. This process will occur utilizing IRBNet’s “Unlock and Lock” function so that you can add, remove, or revise documents within the same package.

Step 5: After final VA Central IRB approval is received, the LSI will need follow VA and local R&D Committee policies to obtain final approvals at their local research administration. Upon receipt of their local approvals, they may begin the research.

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:

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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