Review Process

Researchers use IRBNet to submit applications to the UC Davis IRB. Each application is evaluated by our intake team and then routed for review. Application will be assessed for review type (exempt, expedited, or full committee). IRB analysts and reviewers will use IRBNet’s Lock Feature to notify researchers of requests for revisions during the review process.

In This Section

• Intake and Screening
• Administrative Determinations
• IRB Review Types
• Requesting a Rush Review
• IRBNet Tip: The Lock Feature

Intake and Screening

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 mark revisions complete before the IRB can complete review of the application.

Once screening is complete the study will be routed for review. Some applications will go through an administrative determination process.

Administrative Determinations

Applications for non-human research and exemption determinations are not required to meet the federally defined criteria for approval, therefore a determination can be issued using an administrative review process. Some Reports of New Information also 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. For administrative processing purposes, the application may be assigned to an agenda date, but the date does not indicate when the research will be reviewed.

IRB Review Types

Federal regulations designate two types of IRB review:

• Expedited Review is appropriate for minimal risk research and minor modifications of greater than minimal risk research. Expedited review is conducted by a single designated review instead of a committee of reviewers. Applications routed for expedited review will be placed in the designated reviewer queue. For administrative processing purposes, the application may be assigned to an agenda date, but the date does not indicate when the research will be reviewed. These applications are reviewed based on the date they were received and the expertise of the available designated reviewers.
• Full Committee Review is used for greater than minimal risk research or studies that cannot be reviewed using the expedited procedure. There are two biomedical/clinical committees one social and behavioral committee. Full committee review takes place on specific meeting dates. Committee agendas are scheduled and sent out to reviewers about 7-10 days prior to the meeting date. Submissions will be assigned to an agenda based on this timeframe.

Regardless of the type of review, all applications are reviewed to determine if the criteria for approval are met. Review each Project Guidance topic to understand what the IRB is looking for when reviewing research.

Once the IRB has completed a review, an IRB determination letter will be issued in IRBNet.

Requesting a Rush Review

Requests for rush review or document processing will be evaluated on a case-by-case basis. Please use the Project Mail or submission comment box in IRBNet to contact IRB Administration with a rush request. Please be sure to include all of the following in your rush request message:

1. The justification for the rush,
2. A date by which the determination is needed, and
3. Any possible impacts on subjects’ rights or welfare.

IRBNet Tip: 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.