VAIRRS / IRBNet
The VALBHS Research Office is pleased to announce the adoption of the VA Innovation and Research Review System (VAIRRS). VAIRRS is the VA's enterprise version of IRBNet, a web-based software used by administrators, committee members, and researchers for electronic protocol submission/management and review and oversight of research. VAIRRS is currently in a phased implementation at all VA medical centers with research programs.
All submissions to the IRB, IACUC, SRS, and RDC (e.g., new protocols, amendments, continuing reviews, closures) must be submitted electronically via VAIRRS. E-mail and hard copy submissions will not be accepted. Investigators can self-register for a VAIRRS account and submit protocols at gov.irbnet.org
Study forms and templates are located in VAIRRS. You can download blank copies from the VAIRRS Forms & Templates page. Certain forms that are submitted outside of VAIRRS are available on the LINK page.
ACCESSING VAIRRS
You can access VAIRRS from virtually any computer by visiting gov.irbnet.org. VAIRRS does not require a connection to the VA network.
All users must be registered to access VAIRRS. New users can create an account by clicking on the “Register Now to get started!” link located on the login page. Be sure to select VA Northeast Ohio Healthcare System as your organization when registering.
ALL Principal Investigators, Co-Investigators, study coordinators/primary contact personnel and study staff MUST create and activate a VAIRRS account.
For detailed guidance on how to create a new VAIRRS account, please refer to the New User Registration Training Energizer in the Resources section below.
IRBNet HOW TO
NEW REGISTRATION & USER PROFILE
Training Energizer: New User Registration (create an account, manage affiliations, maintain training records)
FOR RESEARCHERS / STUDY COORDINATORS
Training Energizer: Researcher 1 (create, share and submit a project; access review decisions & board documents)
Training Energizer: Researcher 2 (post-submission topics; create a new package for modifications, renewals, etc.)
Training Energizer: WIRB Submission (only for studies using Western IRB)
IRBNet Notes: Managing Training & Credentials
IRBNet Notes: Pasting into RTE
IRBNet Notes: Multisite (only applies to specific multi-site projects; contact Research Office first)
IRBNet Notes: Messages & Alerts
FOR REVIEWERS / BOARD MEMBERS
Training Energizer: Reviewers/Board Members
Training Energizer: PO/ISSO Review
WHERE TO BEGIN
CREATING AND SHARING A NEW PROJECT
For detailed guidance on how to submit a new project in VAIRRS, please refer to the Researcher Energizer 1 which provides step-by-step instructions on how to create, submit and manage your project. Training Energizers can be found in the “Resources” section above.
SIGNATURES REQUIRED IN VAIRRS
Packages must be electronically signed by the Principal Investigator before they are submitted. The “Designee” signature mode is not accepted. Signatures cannot be deleted once applied; they are part of the permanent audit record.
USING THE SIGN THIS PACKAGE FEATURE IN VAIRRS:
Enter your Username and Password at gov.irbnet.org
Enter the IRBNet ID in the search field and click on the study title to open the project
Review the necessary study details and documents
From the left-hand menu click “Sign this Package”
Use the dropdown list to select the appropriate role and click “Sign” Note: if you have previously signed this package, the system will ask you if you wish to sign it again. If you need to re-sign the package for any reason, click “OK”
Enter your username and password to validate your identity and click “Continue”
Your electronic signature has been applied to the contents of this package. IRBNet will send a notification to all users who have full access to this project.
After the package has been signed by the PI, you must submit the package to the Research Administration.
For additional guidance on how to sign a new project or submit your package in VAIRRS, please refer to the Researcher Energizer 1 which provides step-by-step instructions on this process. Training Energizers can be found under the “Resources” section above.
SIGNING INDIVIDUAL STUDY FORMS BEFORE UPLOADING INTO VAIRRS/IRBNet
Some forms that you will submit as part of your package have a signature field on the form itself, typically requiring PI signature. If an electronic signature box, simply click the box and you will be prompted to enter your VA PIV credentials. Otherwise, follow the instructions below to stamp any document with an official VA signature.
INSTRUCTIONS FOR ADDING A DIGITAL SIGNATURE TO A DOCUMENT USING ADOBE:
When you are ready to sign the document, if it is not already a PDF, save as PDF.
Open the PDF.
If using Adobe Reader: In the right panel, click the wrench for “More Tools.” Click the icon that says “Certificates.”
If using Adobe Acrobat DC (full program): In the righthand menu, click the search bar (Search tools) and search for “Digitally Sign”
At the top of the page, click “Digitally Sign” and follow the prompts to add your signature and save the document. NOTE: Your PIV card must be in the computer to add your digital signature to the document.
RESPONDING TO A REQUEST FOR CORRECTIONS/REVISIONS:
For detailed guidance on how to respond to corrections/revisions in VAIRRS, please refer to Researcher Energizer 2 which provides step-by-step instructions on this process. Training Energizers can be found in the “Resources” section above.
SUBMITTING A CONTINUING REVIEW, MODIFICATION/AMENDMENT, OR OTHER SUBMISSION FOR AN EXISTING PROJECT
If you need to submit a continuing review, modification, or other submissions (e.g., adverse event, DSMB report, closure, etc.) for an existing project, you need to create a new package within the existing project. DO NOT create a new project. For detailed guidance on how to create a new package in VAIRRS, please refer to Researcher Energizer 2 which provides step-by-step instructions on this process. Training Energizers can be found in the “Resources” section above.
ACCESSING REVIEW DECISIONS & BOARD DOCUMENTS IN VAIRRS/IRBNet
When a board issues an official determination or approved (stamped) document, it is published in the Board Documents section of VAIRRS. It is important that researchers read all correspondence and use only stamped, approved documents where applicable to ensure compliance.
To access these documents, log into VAIRRS, click the project title, and click “Reviews.” The Reviews section is organized by Committees. Submissions are listed by package number under the Committee that conducted the review. Locate the package number of the submission and scroll to the Board Documents section. Click the paper icon at the right of the screen to download, view, and save a document.