Office of Research IRB Review Process - Office of Research

IRB Review Process


Whether it’s an application for initial review or a report of study closure, all submissions to the IRB go through intake and screening. During this process, an IRB analyst checks the submission for essential elements, such as completed forms, a study protocol, required signatures, and completed human subjects protections training. If any of the elements are missing, the package will be unlocked in IRBNet and you will receive a message from an IRB analyst describing the missing elements or required action. You must respond to the requests and re-lock the package before the IRB can complete review of the application.

Once screening is complete the study will be routed for review. Applications that qualify for the expedited procedure will be routed to the non-committee queue and a designated reviewer will conduct the review. Applications that do not qualify for the expedited procedure will be routed for full committee review. Applications that do not require IRB approval will be routed for an administrative determination.

Applications for non-human research and exemption are not required to meet the federally defined criteria for approval, therefore a determination can be issued using an administrative review process. In addition, some required reports do not require IRB approval, therefore they will be acknowledged using an administrative review process. During this process, an IRB analyst will review the information provided for required elements. If needed, the analyst will unlock the package in IRBNet and send you a message requesting revisions, justification, or clarification. You must respond to the requests and mark revisions complete before the analyst can complete the review of the information.

Applications routed for expedited review will be placed in the designated reviewer queue. These applications do not get assigned to a meeting date; instead, they are reviewed based on the date they were received and the expertise of the available designated reviewers.  The designated reviewer will evaluate the application to determine if the criteria for approval have been met. If needed, the reviewer will unlock the package in IRBNet and send you a message requesting revisions, justification, or clarification. You must respond to the requests and re-lock the package before the IRB can complete the review of the application. Unlike the full committee review process, the designated reviewer’s process is not limited by the committee meeting date, therefore the reviewer will continue to request revisions and/or clarification until the criteria for approval are met. The reviewer will not issue a determination letter for the application until all revisions have been completed. Occasionally research routed to a designated reviewer cannot be approved using the expedited procedure; when this happens the application will be forwarded to the convened board for a determination.
Applications routed for full committee review will go through a thorough administrative review. The purpose of the administrative review is to resolve questions and concerns before the application is discussed at the convened meeting. During this administrative review process, an IRB analyst may contact you to request missing elements, justification, or clarification about the application. The package will be unlocked in IRBNet and you will receive a message describing the missing element or required action. It is important that these requests are addressed in a timely manner. The IRB members must have adequate time to review your response before the meeting date. A lack of responsiveness from the researcher during the administrative review process can cause an application to be bumped from an agenda because it is not ready for review.

The application will be assigned to a meeting date and the committee members will review the application. On the meeting date, the committee will discuss the application and determine if the criteria for approval are met. The committee will vote on an action for the application. Click here to see a list of actions the committee may take and an explanation of the correspondence you will receive. You may be required to submit revisions or additional information before the committee can approve the application. At this point the IRBNet package is locked and cannot be unlocked. To respond to the IRB you must create and submit a new package in IRBNet. Click here for more information about submitting a Response.


IRBNet Tips

The Lock Feature

The IRBNet lock feature serves as an indicator of when action is needed by the research team. Read each of the steps below to understand the unlock/mark revisions complete process.

All packages are locked upon submission. This allows IRB Administration to conduct an administrative review for completeness and evaluate the proposed research without changes being made to the application. The black lock indicates the package is locked and cannot be edited.

When IRB Administration requests revisions or information the package will be unlocked. The lock symbol will change from black to red. This alerts the research team that the package is available for edits and that the application requires attention. An IRB analyst will notify the research team of the action required via IRBNet Project Mail and/or IRBNet Board Documents. Click here for instructions to access IRB correspondence found in Board Documents. When the package is unlocked you can edit project details, update the electronic Initial Review Application, and upload documents in the Designer. You should address all IRB requirements at this time. Once you address all items clikc the words “Mark Revisions Complete”.

  

When you have completed all revisions re-lock the package by going to the Designer page and clicking the words “Mark Revisions Complete” found at the top of the page. It is important that you complete this step to alert IRB Administration that you completed the requested actions and the package is ready for review. Once you mark revisions complete the package is relocked. If you have marked revisions complete and discover that you have forgotten something or need to make additional edits contact the IRB analyst reviewing your application to request that the package be unlocked. DO NOT CREATE A NEW PACKAGE.

After you have marked revisions complete the package will be re-locked. The application will be reviewed. If needed the package may be unlocked and additional revisions/information may be requested. The package may go through several rounds of unlock/mark revisions complete while the package’s Board Action is “Pending Review.” Once a determination has been issued the package is permanently locked.

Once a determination has been issued the package can no longer be unlocked. This ensures that no edits are made after the determination is issued. If you need to respond to the IRB’s determination you will need to create and submit a new package.