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Additional information can be found on VAIRRS.
VA Central IRB Forms and Process Updates
Update as of June 28, 2023
The VA Central IRB has released the 1st and 2nd phase of new forms which are posted in the VA Central IRB IRBNet Forms and Templates library. As a reminder please continue to always download VA Central IRB forms directly from IRBNet Forms and Templates library (VA Central IRB Administration, Washington, DC – Documents for Researchers) when they are needed to ensure the current version is being used and submitted with a package.
1st Release: Continuing Review Forms
New Continuing Review Forms were released on June 14, 2023. Prior to using these new forms, please read the Summary of Changes – PI and LSI Continuing Review. For additional information regarding these changes, you may also refer to the VAIRRS Webinar from June 13, 2023 titled “CIRB Continuing Review Process and Form Changes.” All new Continuing Review forms must be used by August 14, 2023. On this date, any package submitted with an old version of a Continuing Review form will be returned for the new form to be submitted. It is recommended that the PI work with local sites when planning to submit a Continuing Review during this transition period to ensure all sites are informed as to what form (new or old) should be used as all sites should submit on the same form. If there are any questions or if assistance is needed while compiling a Continuing Review submission during this time, please contact Mary Eckart mary.eckart@va.gov or Mikaela Myers mikaela.myers@va.gov for support.
2nd Release: Post Approval Submission Forms
New Post Approval Submission Forms were released on June 28, 2023. Prior to using these new forms, please read the Summary of Changes – Post Approval Submission Forms for a detailed list of forms changes. For additional information regarding these changes, you may also refer to the VAIRRS Webinar from June 27, 2023 titled “CIRB Process and Form Changes.” All new Post Approval Submission Forms must be used by August 14, 2023. On this date, any package submitted with an old version of a form will be returned for the new form to be submitted. If there are any questions or if assistance is needed while compiling a submission during this transition time, please contact the CIRB Manager responsible for your project, a CIRB Administrator or the VA Central IRB general mailbox at VACentralIRB@va.gov for support.
3rd Release: Remaining New Project Forms (Date TBD)
The VA Central IRB will announce the 3rd release of the remaining New Project submission forms on the VA Central IRB Website (VA Central Institutional Review Board (IRB)), VAIRRS Newsletter, and email communications in late July or early August. The release of these remaining forms is pending a concurrent update to the VAIRRS IRB Information Sheet Wizard. Please stay tuned.
Purpose: The purpose of the VA Central IRB is two-fold. First and foremost its purpose is to enhance the quality of human research protection in multi-site human research projects by performing appropriate ethical and scientific review while ensuring local issues are addressed. In this role, the VA Central IRB also provides the single IRB oversight required for multi-site studies by the 2018 Common Rule. The second is to enhance the efficiency of these reviews across participating sites.
VA Facilities: Each VA facility that plans to use the VA Central IRB must add the VA Central IRB to its Federalwide Assurance (FWA) and sign a Memorandum of Understanding (MOU) with the VHA Central Office (VHACO) Human Research Protection Program (HRPP). The MOU clearly delineates the respective roles and responsibilities of each entity. The local VA has ultimate and immediate responsibility for its HRPP. Instructions for adding the VA Central IRB as an IRB of Record are also included on this website, as are the VA Central IRB SOPs and forms.
In addition, any affiliated Nonprofit Research and Education Corporation (NPC) for a VA site that has entered into an MOU with the VHACO HRPP, should also sign the MOU and update its FWA to add the VA Central IRB as an IRB of Record.
VA Investigators: Investigators whose studies are being funded by VA ORD should consult the ORD funding service to determine whether their study should be submitted to the VA Central IRB. Investigators who are new to the VA CIRB and whose studies will be reviewed by the VA Central IRB should contact the VA Central IRB mailbox (vacentralirb@va.gov), as far in advance of the planned submission as possible to request an introductory meeting and pre-submission consultation in order to submit the most likely application for approval. Information concerning the operations of the VA Central IRB can also be found on this website under the Important Links box on the right-hand side of this page.