IRB

IRB Meeting Dates: How and When to Submit

All IRB submissions should be routed through the online submission system, AURA-IRB. Please access AURA-IRB through the AURA webpage: http://aura.uchicago.edu

Incomplete protocol submissions will not be reviewed until all necessary materials have been received regardless of the date the initial submission was received.

To be accepted for IRB processing, all applicable required documentation must be provided:

In addition, to be assigned for review at an IRB meeting, all applicable required documentation must be provided:

Accepted for IRB Processing: Checklist

updated Jan 2024

Assigned to IRB Meeting: Checklist

updated Jan 2024

After a protocol is accepted for processing, the administrative staff will perform a "pre-review" to identify any potential issues prior to IRB review.

Please also see our home page for links to news and policy changes.

New Protocols

How to submit

Please ensure that the most current version of the AURA Smart Form is used. The current version is version 3.
New protocols may be submitted at any time and are processed weekly by the IRB office.
Responses to administrative comments must be submitted to the IRB by noon at least 9 calendar days before an IRB meeting to be considered for review at that meeting. Incomplete submissions will be returned and considered for a meeting following completion of the submission.
Deferral responses should abide by the deferral letter instructions as to when to submit the deferral response.

Protocol Review and Monitoring Committee (PRMC)

Per IRB policy, protocols requiring review by the Protocol Review and Monitoring Committee (PRMC) (formerly the CTRC) must be approved by the PRMC or approved with stipulations prior to review by the IRB. Deferred studies or studies which have not yet undergone review by the PRMC may be returned to the PI if submitted to the IRB. For clarification regarding what studies require review by the PRMC, please see the guidance document below.

PRMC 2024 Meeting Dates

PRMC Submission Guidance and Workflow

updated March 2024

For further information on the PRMC, please contact the UC Comprehensive Cancer Center.

IRB Meeting Dates

August 6, 2024 - Committee A

August 27, 2024 - Committee B

September 10, 2024 - Committee A

September 24, 2024 - Committee B

Researcher will be notified by IRB staff if an upcoming agenda has availability. The earliest complete responses will be added to the agenda first. Submissions will be capped at a certain number of complete protocols; any protocols submitted after the agenda is full will be placed on the next available agenda.

Amendments

There are no set deadlines for amendment submissions. Amendments may be submitted at any time and are processed weekly by the IRB office. Amendments requiring full review will be placed on the next available meeting agenda. Amendments that are able to be expedited are sent to the reviewers weekly. Amendments must be complete, requiring no administrative revisions, by 11 business days prior to a meeting to be guaranteed review at the meeting. Similarly, amendments must be complete to be sent to the IRB reviewer for expedited review. If administrative or other revisions are needed, amendment review will be postponed until the following meeting (or until all concerns are adequately addressed).

Based on the specific type of change proposed, certain documentation is needed for a complete submission, as detailed in the guidance below. Please use this guide when determining what to submit with an amendment:

Amendment Guidance

After submission of an amendment, the administrative staff will perform a "pre-review" to identify any potential issues prior to IRB review. The IRB staff utilize a standard format to complete a pre-review. The amendment pre-review form is provided below for reference:

IRB Administrative Pre-Review for Amendments

Continuing Reviews

To ensure completeness of your continuing review submission, please see the checklist below for the details that are required in the submission form:

CR Processing Checklist

For studies that require continuing review, the continuing review submission materials are due to the IRB 90 days prior to the current expiration date of the study. This applies both to submissions for expedite and full Committee review. We also recommend submitting no earlier than 120 days prior to expiration to ensure that information is current for the IRB reviewers. All submissions are due by the end of business day on the deadline, unless otherwise noted.

To determine when to submit a continuing review, researchers should locate their study’s expiration date in the original approval letter or most recent continuing review letter. Expiration dates can also be located on the main page of each protocol’s workspace in AURA-IRB, under the heading “Review Determination.”

Note, certain studies are approved for less than 12 months. For these short approvals, which often require a faster turnaround time than 90 days, a specific deadline for the next continuing review submission will be included in the short approval letter.

The IRB makes every effort to review late submissions prior the expiration date. However, the IRB cannot guarantee that late submissions of renewals will be reviewed.

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After submission of a continuing review, the administrative staff will perform a "pre-review" to identify any potential issues prior to IRB review. The IRB staff utilize a standard format to complete a pre-review. The continuing review pre-review form is provided below for reference:

IRB Administrative Pre-Review for Continuing Reviews