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.
In This Section
- IRBNet Registration
- IRBNet Training
- Initial Review Application
- Sharing a Project
- Signatures Accepted on IRB Applications
- Responding to a Request for Submission Corrections/Revisions
- IRBNet Board Documents
- IRBNet Account Deactivation
- UC Davis IRBNet Guidance Documents
- IRBNet Support Team
- IRBNet Training Resources (video, PDF) (Kerberos account required; video playback works best with Google Chrome and Firefox browsers)
- UC Davis IRBNet Demonstration Videos
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.
Initial Review Application
The Initial Review Application (IRA) is an online data entry Document Wizard required for all New Projects. It is found within IRBNet on the Designer page. The IRA is a dynamic form that changes based on your responses. Once you have completed the entire application the “Form Complete” page will list the documents that should be included in the submission. The IRB will review a PDF output of the answers you have provided as well as all other documents uploaded into the package. During the review or after the initial approval of a project, you may be required to make modifications to the IRA. Review these instructions for creating and editing the IRA.
Creating an Initial Review Application
When submitting a new project on IRBNet, the IRA should be the first item filled out. Your submission cannot be screened if the IRA is missing. Follow these instructions if you are creating an IRA for the first time:
- Log into IRBNet, click the project title or create a new project and click the word “Designer” from the left hand menu.
- Click “Start a New Wizard.”
- Select “UC Davis- Initial Review Application” from the dropdown list.
- The first page provides general instructions, click “Next” to move through the form.
- The form automatically saves each time you move to the next page. You may also save and exit at any time.
- You may use the “Jump To” drop down menu to return to previous pages.
- The Form Complete page provides a list of documents that should be included in the package.
- The last page is the PI Attestation. The PI is required to sign using IRBNet “Sign this Package” feature.
Refer to the IRBNet User Manual: Initial Review Application for visual assistance.
Editing the Initial Review Application
You may be asked to make changes to the IRA during the initial review of the research, or you may need to make changes after the research has been approved. Follow these instructions when make changes to the IRA.
- Locate the IRA on the Designer page.
- Click the pencil icon at the far right to open the document to open for editing.
- Use the “Jump To” dropdown in the top right corner to select the page you wish to edit.
- After making changes, be sure to click “Next” to advance to the next page and save changes. Some changes will require additional information in subsequent pages.
Helpful Tips for the Initial Review Application
Use these helpful tips to make sure your IRA is filled out correctly:
- Before completing the PI information page, make sure to read our guidance on Principal Investigator Qualifications. If you are a student and/ or medical resident and are the PI of the project, write “Student” for your Title.
- For help completing the Review Information page, please take a look at our Single IRB and Reliances guidance.
- For help completing the Additional Personnel page, please take a look at our Research Personnel List guidance.
- For help completing the Related Financial Interest page, review our Financial Conflicts of Interest guidance.
- Mark “yes” on the External Sites page if you will be conducting research outside of UC Davis and its affiliates. If part or all of the research will take place outside of the U.S., mark “yes” on the International Study page also.
- The Study Information page will alert you to ancillary approvals that may be required for your project.
- For help completing the Recruitment Information and Screening Script, please take a look at our subject selection and recruitment guidance. Please note, if you pl to use a screening script, you will be required to submit a transcript of the screening questions for IRB review.
- If your plan to access or use Protected Health Information (PHI) for research, review our HIPAA
- Before completing the Consent page, make sure you understand the different options for obtaining and documenting consent in research.
- Before completing the Consent Language page, please make sure you review our Overcoming Language Barriers guidance.
- If your research involves investigational drugs or devices, learn about FDA requirements.
- All subject-facing documents including advertisements and recruitment documents that will be used in this study must be submitted.
- If your study does not have a sponsor protocol, please complete and upload one of our HRP-503 Protocol Template. There are three versions of this template available. Select the one that is best suited to your project. Do not submit more than one HRP-503 Protocol Template. These templates can be found in the Library section of IRBNet or on our IRB Forms
- Once all documents are uploaded, use the IRBNet Document Type and Description Guide to choose the correct IRBNet Document Type from the drop down menu.
- Do not download the PDF of the IRA and upload it into IRBNet. Their should only be one IRA.
If you need more assistance or wish to see examples of projects please visit our New Project page.
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?
- New Project Submissions (Initial Review Application)
- The PI must sign using IRBNet’s “Sign this Package Feature”
- The Faculty Advisor must sign using IRBNet’s “Sign this Package” feature
- The Department Chair and/or Dean may use any approved signature method.
- Post Approval Submissions
- If using the Post Approval Submission Form, the PI must sign using IRBNet’s “Sign this Package” Feature
- If using HRP-212, HRP-213, and/or HRP-214, the PI may use any approved signature method
Approved electronic signature methods
- IRBNet’s “Sign this Package” feature,
To ensure the signatures are completed using an accepted format, IRB Administration will screen such signatures using these guidelines:
- IRBNet’s “Sign this Package”
- Signature is applied after all documents have been uploaded into IRBNet
- “Designee” signature mode is not accepted
- Adobe Signatures:
- On the left there will be an image of the signature or the printed name of the person signing.
- In the middle of the background there will be a faded watermark of the Adobe symbol.
- On the right of the image there will be printed information about the signature with a time and date stamp.
- DocuSign Signatures:
- Will have the DocuSign “frame” around the left side of the signature.
- Will have a unique identifier below the signature.
- Will have the words “DocuSigned by:” above the signature.
Step-by-step Signature Instructions
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.
When providing physical signatures, follow these instructions:
- Print the HRP-226 Administrative Approvals Form
- Collect necessary signatures
- Scan the form
- Upload the signed copy to the Designer
When using IRBNet’s Sign this Package feature, follow these instructions:
- 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.