The members of the IRB Office wanted to use this month’s IRB Corner to remind researchers of a number of issues related to the IRB review process using IRBNet. The University of Phoenix IRB adopted IRBNet as the web-based system to conduct all IRB reviews in November 2014; as of January 2015, all IRB reviews have been conducted in IRBNet.
IRB User Profiles
Researchers create their own User Profiles in IRBNet (http://irbnet.org) and affiliate with the University of Phoenix IRB. If you have questions about IRBNet registration or the University of Phoenix Institutional Review Board, you can find more here http://research.phoenix.edu/content/institutional-review-board.
Forms and Templates
All IRB review guidance and support materials are available in IRBNet within the Forms and Templates library, which can be accessed from the left menu when you log in to IRBNet. The Forms and Templates library is a “just-in-time” resource that is updated regularly as the office revises and improves processes to best align with the federal human subjects regulations (45 CFR 46).
Creating an IRB Project
Researchers select a submission type when they create their IRB project in IRBNet. A few different submission types include:
- New Project: Used when a project is receiving its first IRB review in IRBNet.
- Revision: Used when a project is being resubmitted to address a Board Action.
- Amendment/Modification: Used when a project is being resubmitted to ask for a review of a change to an already reviewed and approved (or exempt) study.
- Continuing Review/Progress Report: Used when a project is being resubmitted to request a review for IRB continuation.
- Response/Follow Up: This submission type is used for those studies where the researcher had received an IRB review prior to our adoption of IRBNet (prior to 1/1/15) and now need an additional IRB review. The request for the IRB review might be to respond to a previous request for revisions, for a Change of Study, or for a Continuing Review. NOTE: If you are transitioning a project into IRBNet after receiving a review using our former IRB processes (prior to 1/1/15), please see our GUIDANCE – Transitioning a Review into IRBNet document.
Making Revisions to a Project Under Review
We continue to receive questions about how to make revisions to a project under review in IRBNet. In previous IRB Corner columns, we explained the differences between “lock-unlock” revisions that take place prior to a Board Action, and resubmissions that take place after a Board action. As a reminder, we have three guidance documents that discuss elements of the revision and resubmission process: the GUIDANCE – Understanding IRB Actions and Decision Letters document, the FAQ guidance document, and the GUIDANCE – IRBNet Instructions for Resubmissions. Again, all IRB guidance material is located in the IRBNet Forms and Templates library, which you can access from the left menu once logged into IRBNet.
We hope this recap of important IRB information addresses some lingering questions about the IRB review process in IRBNet. After reviewing the guidance materials and discussing the project with your Chair (students), researchers are encouraged to contact the IRB Office at IRB@phoenix.edu, or through IRBNet, with additional questions.