The Institutional Review Board (IRB) is pleased to announce the adoption of the IRBNet suite of tools, accessible via the internet, bringing electronic protocol management, online submission and many other important research oversight features to the University of California, Davis, research community.
IRBNet brings a robust set of electronic tools supporting the management, submission, review and oversight of our research protocols. Some of IRBNet’s many features include an online initial application, electronic document management, web-based protocol sharing and collaboration, automatic notifications, electronic submissions and reviews, integrated training and credential management, and important audit capabilities including electronic revision histories, electronic signatures and event tracking.
- NEW UC Davis IRBNet Demonstration Videos
- How to Submit to the IRB (instructions and guidance)
- IRBNet Registration
- IRBNet Training
- Online Initial Review Application
- Sharing a Project
- Electronic Signatures
- Responding to a Request for Submission Corrections/Revisions
- IRBNet Board Documents
- IRBNet Account Deactivation
- UC Davis IRBNet Guidance Documents
- IRBNet Support Team
ALL Principal Investigators, Co-Principal Investigators, and primary contact personnel MUST create and activate an IRBNet account and complete CITI Integration.
Creating an IRBNet account is very simple and should take approximately 5 minutes. Follow these steps:
- Go to www.irbnet.org
- Click on “New User Registration“
- Provide the information requested
- On the “Add Affiliation” page select University of California Davis, Davis, CA
- Continue until you have completed registration
- When you receive an email from firstname.lastname@example.org, follow the link contained in the email to complete the account activation process*
Linking CITI Credentials to IRBNet Account
UC Davis is utilizing the IRBNet enhancement that will link your CITI training credentials to your human subjects research protocols. In order to activate your CITI Integration please do the following:
- Enter your username and password at www.irbnet.org
- Click the “User Profile” link in the top right corner of the screen
- In the “External Accounts” section (near the bottom of the page), click “Add an External Account“
- In the pop-up, enter your associated CITI Member ID from your CITI account. This number can be found at the top of your CITI Program homepage upon login
- To verify your ownership of the CITI account, you will receive a verification link from email@example.com at the institutional email address associated with your CITI affiliation
- Once you receive the email, click the verification link and you’re all set! Your coursework will be automatically pulled into IRBNet over the next 24-hours*
*If you do not receive an activation email, please review our guidance document “Updating your CITI Institutional Email.”
IRBNet has developed training videos that give step-by-step instruction on how to create, submit, and manage protocols. These videos should be used in conjunction with the UC Davis specific guidance provided on this website. See the IRBNet Training Resources guidance document for more information on how to access these training videos.
The training resources provide the following instructions:
- New User Registration instructions
- New Project submission (9 min video)
- Post-Submission Advanced Topics (Modifications, Continuing Review, Reportable New Information) (7 min video)
The IRB has developed the following videos on a variety of IRBNet topics that give step-by-step instructions from a UC Davis researcher point of view. Each video contains UC Davis specific instructions that guide you through different aspects of the IRBNet submission process and system.
This new online form has simplified and streamlined the initial review application process by combining several documents into one easy to use form. The form was designed to use its “SmartForm” capabilities to the fullest by using the information you provide to determine whether additional information is needed. Based on how you answer a question, the form may or may not request additional information. For example: under the “Vulnerable Participants” section, if you answer “none of the above” the form will not ask you to complete any of the next 11 sections.
The online initial review application replaces the HRP 211 Application for Initial Review and the HRP 215 Research Personnel Template forms. The application also gathers much of the information that was previously gathered in the HRP 503 Protocol Template. Whenever the online initial review application is used:
• You do not need to submit a Form HRP 211 Application for Initial Review.
• You do not need to submit a Form HRP 215 Research Personnel.
• You do not need to submit an HRP 503 Protocol Template, if you have a sponsor protocol;
• You can submit our new abbreviated Form HRP 503 Protocol Template Form if you do not have a sponsor protocol.For step by step instructions, please see our How to submit an initial review
Principal Investigators, Co-principal Investigators, and Faculty Advisors are required to have Full access to projects in IRBNet. Research coordinators, administrators and anyone responsible for correspondence with the IRB may also benefit from having access to the study in IRBNet. Anyone with Full access to a project can share it with another user. To share a project in IRBNet follow these steps:
- Enter your user name and password at irbnet.org.
- Click the project title to open the project.
- From the left hand menu click “Share this Project.”
- Click the blue word “Share.”
- Choose Organization, this will default to “University of California, Davis”
- Click “Select Organization”
- Type in the name of person*
- Click on the radial button next to the appropriate share access level
- Click “Save“
UC Davis Demonstration Video: How do I share project access with other personnel?
IRB Administration is accepting either physical or electronic signature on all forms except the new online Initial Review Application, which must be signed electronically by the PI. In addition, when submitting a new study, HRP 226 Administrative Approvals MUST be signed electronically by the faculty advisor, however, Department Chairs and Deans may sign either physically or electronically.
If providing electronic signature, follow the directions below. Please check with your PI and other signatories prior to routing for electronic signature and provide them the guidance document “Adding Your Electronic Signature,“ if necessary.
- When uploading any form that requires signature type the name of the individual and the words “electronic signature” in the space where a signature would have been collected.
- If necessary, share the protocol with each signatory at the appropriate level of access.
Adding your Electronic Signature
- Enter your Username and Password at 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 user name and password to validate your identify 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.
UC Davis Demonstration Video: How do I get electronic signatures?
When an IRB analyst has requested revisions the package will be unlocked (red unlock symbol) and detailed instructions will be found in IRBNet Messages and Alerts.
- Enter your user name and password at irbnet.org.
- Click the study title to open the protocol.
- To edit existing study documents, go to the “Designer” and download the current version. Make revisions and save the document. Upload the new version by clicking the pencil icon next to the document and completing the process to upload the updated version.
- NOTE: Uploading a new version of a document in an unlocked package will REPLACE the version that was in that package. It will not effect versions from any other packages.
- To edit the Initial Review Application go to the “Designer” and click the pencil icon to open the online version of the document. Use the “Jump To” dropdown menu to select the page that requires editing and click “Jump.” Once revisions have been made, click “Next” to ensure all subsequent pages are complete. When finished click “Save and Exit.”
- DO NOT download and edit the PDF file of the Initial Review Application. The data must be entered in the online document.
- DO NOT “Start a Wizard” unless instructed to do so by an IRB analyst. Each project should have one Initial Review Application.
- NEVER click the red X to the right of the Initial Review Application unless instructed to do so by an IRB analyst. Once deleted the document cannot be recovered.
- Either upload the new version of the document or edit the on-line document within the system.
- To add a new study document, go to the “Designer“ and click “Add New Document.” Enter the document information, choose the file from your computer and click “Attach.”
- Edit other project information, as appropriate.
- If you need contact the IRB Analysts, please use the IRBNet “Send Project Mail” function.
- Once all corrections and correspondence are complete go to “Designer” and click “Mark Revisions Complete.“
UC Davis Demonstration Video: How do I respond to an IRB Analyst request for revisions to my package?
Approval Letters, Stamped Documents, IRB Correspondence
When the IRB issues an official determination or stamped consent form is published in the Board Documents section of IRBNet. It is important that researchers read all correspondence from the IRB and use stamped consent documents to ensure compliance. To access these documents log into IRBNet, click the project title, and click “Reviews.” The Reviews section is organized by IRB 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.
Removing Access to Projects
When an individual should no longer have access to a study, s/he must transfer ownership to another individual.
Follow these steps:
- Enter your user name and password at irbnet.org.
- Click the study title to open the project.
- Click “Share this Project.”
- Click the blue word “Transfer.”
- Choose Organization will default to “University of California, Davis,” click “Select Organization.”
- Use the dropdown list to locate the name of the Principal Investigator or another person who has full access to the study and click “Save.”
- You will receive a message that says “Are you sure you wish to transfer ownership of this study?” Click “OK.”
This will not change the access for the person to whom ownership was transferred.
Deactivating Affiliation with UC Davis
When an individual leaves the institution s/he should deactivate the IRBNet affiliation with UC Davis. Follow these steps:
- Enter your username and password at IRBNet.org.
- Click “User Profile” in the top right corner of the screen.
- Under the heading “Affiliations” find “Researchers at University of California Davis, Davis, CA.”
- Click the work “Deactivate.”
This will deactivate the affiliation with UC Davis. UC Davis studies can no longer be shared with this person.
- IRBNet User Manual: Initial Review Application *screen-by-screen instruction on completing our new online Initial Review Application, including bookmarks labeled with the page of the application, for easy quick reference.
- UC Davis IRBNet Demonstration Videos
- Accessing IRBNet Training Resources (videos)
- Adding your Electronic Signature *instructions for Principal Investigators and other signatories
- Generating a New Activation Email * for use when you lost or did not receive an IRBNet activation email
- Updating your CITI Institutional Email *for use when you lost or did not receive an CITI Integration activation email
- IRBNet Document Type and Description Guide *to use when uploading documents to Designer
If you need assistance or have questions, please contact the IRBNet Team Support or at (916) 703-9158.