Step 1: Design the Application
Users will need to log into IRBNet using the user name and password created. For new applications, users will select “Create a New Project” and follow the prompts.
During this step, researchers will upload all documents required for the application (e.g. IRB Application, Consent Forms or Waiver Request, Recruitment Materials, Data Collection Instruments, etc). Please note there have been updates to the previously used forms. All forms utilized by the VCOM IRB can be found on the IRB Webpage under IRB Forms, as well as in the Forms and Templates Library of IRBNet.
- The new IRB application form has been revised to include all information previously submitted in the Research Protocol Document, as well as Forms A, B or C. Researchers are now required to submit only one document titled IRB Application, along with consent forms and supporting documents.
Step 2: Share this Package
Once a researcher has completed designing their package, the package will need to be shared with any team member who will be working as an investigator or collaborator on the study. The list of project team members in IRBNet should match that which is reported in th response to question 1.5 of the IRB application. You will only be able to share a package with individuals who have registered for an account in IRBNet.
- HHS definition of an investigator and responsibilities
- Co-Author = Co-Investigator
You may provide individuals with FULL, WRITE or READ access
- FULL Access - Users that are granted FULL access can perform all functions without restriction. This includes editing the project documents, sharing the project with other users, submitting document packages for review [Modification Requests, Continuing Review Requests, Close Out Requests] and deleting packages. Only Project Owners with day-to-day responsibility for this project should be granted FULL access. Users with FULL access will receive automatic email copies of all project notifications and alerts that are sent to the project owners.
- WRITE Access - Users that are granted WRITE access can view and edit project documents, collaborate with other users and add their signature, but may not grant access to other users, submit packages for review or perform any other administrative functions.
- READ Access - Users that are granted READ access can view project documentation, collaborate with other users and add their signature, but may not edit project documents or perform any other administrative functions.
For additional information on granting access to individuals, please contact the IRB Administrator.
Step 3: Sign this Package
The electronic signature becomes a permanent part of your electronic audit trail. Before a package can be submitted to the VCOM IRB Review, the package must be signed by the Principal Investigator as acknowledgement that he/she has reviewed the package for accuracy and completeness, and is accepting the responsibility for primary oversight of the project. Once the package has been e-signed by the PI, any individual with FULL access may proceed to Step 4.
Step 4: Submit this Package
After the package design is complete (all required documents have been uploaded) and the package is signed by the Principal Investigator, you may submit your project’s package to the VCOM IRB for review. When submitting your package, please be sure the default board highlighted for submission is Edward Via College of Osteopathic Medicine. Once the package has been submitted, the VCOM IRB will be notified of your submission and given access to view your electronic documents. The VCOM IRB will also be permitted to electronically record their review decision, which will be saved as a permanent part of your project record. You will automatically be notified when the review decision is electronically recorded.
- Once a package has been submitted for review, the package will be locked from editing. To unlock a package prior to a review determination, please contact the IRB Administrator.
Step 5: Post-Submission Actions
Revising an approved protocol
Any change to an approved protocol must be reviewed and approved by the IRB prior to the implementation of changes (recruitment procedures, personnel changes, inclusion/exclusion criteria, data elements collected, etc). To revise an approved [existing] protocol, log into IRBNet and go to “My Projects”. Find and open the protocol requiring revisions. You will want to select “Create a New Package”. This will allow you to prepare new or modified documents (such as Modification Requests-Form G, Continuing Review/Close out Reports-Form D, Adverse Event Reports-Form E) by creating a new document “package” on an existing project.
You will then be taken to the Designer page where you will be able to upload [Attach a New Document] any documents that need to be revised.
- The VCOM IRB asks that ALL revised documents be submitted with track changes or changes highlighted to assist with the review process
After uploading the revised documents, please sign and submit the package to the Edward Via College of Osteopathic Medicine IRB for review. As with new submissions, you will automatically be notified when the review decision is electronically recorded.