Urgent Review procedures may be requested only under limited circumstances. These are when: 1. A federal or state agency, foundation, or funder requires IRB approval prior to issuing a funding award, 2. A federal or state agency, foundation or funder has imposed a deadline by which funds must be expended or data collection activities must be completed, 3. Data collection must be undertaken immediately because the opportunity is ephemeral.
1. Federal or State Agency, Foundation, or Funder Requires IRB Approval Prior to Issuance of an Award
When a federal or state agency, a foundation or a funder specifically and in writing communicates that proof of IRB approval is required prior to issuing an award, the investigator may request an Urgent Review. Supporting documentation from the funding agency must be submitted with the iStar application. If documentation is not provided or the documentation does not clearly indicate that IRB approval is required, the study will not qualify for urgent review.
2. A Federal or State Agency, Foundation, or Funder has Imposed a Deadline by Which Funds Must be Expended or Data Collection Activities Must be Completed
When a federal or state agency, a foundation or a funder specifically and in writing communicates that funds must be expended or data collection must be completed by a date certain, the investigator may request an Urgent Review. Supporting documentation from the funding agency must be submitted with the iStar application. If documentation is not provided or the documentation does not clearly indicate that IRB approval is required, the study will not qualify for urgent review.
3. Data Collection Must be Undertaken Immediately Because the Opportunity is Ephemeral or Finite
When an investigator has a data collection window that is defined/constrained by factors outside of the investigator’s control, Urgent Review may apply:
a. The investigator has submitted a new study application or amendment with adequate time for a review to be undertaken and the wait time for IRB review will prevent data collection from taking place in the data collection window targeted.
i. Adequate time is defined based on the average wait time for assignment to an IRB analyst. The average wait time is 5 weeks.
b. For reasons beyond the investigator’s control, the investigator was unable to submit to the IRB with adequate time for a review to be undertaken and the data collection window is finite.
Examples of data collection activities that might qualify for urgent review if one of the above conditions applies include:
Data collection in K-12 classrooms that must take place at the beginning or before the end of the school year.
The population of interest will disappear if the data collection activities are not launched immediately (within 2-3 week timeframe).
A funding agency awarded a contract or grant within days or weeks of the data collection window.
For projects that satisfy the Urgent Review criteria, the applications will be reviewed within 5 business days. Note: this does not imply IRB approval will be received within 5 business days.
Urgency that is a result of negligence or delay on the part of the investigator or staff to submit an iStar application in time for the regular review process to be completed does not meet the criteria for Urgent Review.
In the event that a new study application is initially submitted without an Urgent Review request and the funding agency informs the investigator of imminent funding and the need for IRB approval, the IRB should be notified via the “send message to IRB” function in iStar. Supporting documents must be uploaded with the request.
Best Practices for Urgent Review Submissions
When considering submitting an application for urgent review, the investigator should:
- Carefully review the funding officer’s request. Officers may include specific changes to a grant that must be fulfilled prior to submitting an IRB application or may require the changes to be incorporated into the application submitted to the IRB. Even within agencies, funding officers’ requirements may differ. It is the responsibility of the investigator to make sure the agency’s requirements are fulfilled.
- Make sure all of the required documents have been included with the iStar application and the application is fully completed. Required documents include, but are not limited to, the email from the funding agency indicating the request and the agency deadline, the grant application and budget detail, instruments, questionnaires, recruitment, consent documents, etc. All sections and subsections of the iStar application must be accurately completed.
- If a review/risk determination cannot be made, and/or the application is incomplete, it will be returned to the investigator with contingencies. The review process will not be facilitated in response to investigator delays in responding to contingencies.
- The application should be submitted with adequate time to allow the review process to be fully completed. This includes allowing time for contingency responses as well as review by a designee (Chair or Vice Chair). The investigator must be cognizant that the IRB office can receive multiple requests for urgent reviews at any given time.
Considerations for Studies Where the Funding Agency Has Imposed a Review Deadline (Conditions 1 and 2 above)
- The iStar application should indicate there is an IRB review and approval deadline request from the funding agency. When completing the application, answer question 4.1.1. indicating that an urgent review request will be submitted.
- The documentation from the funding officer requesting IRB approval should be uploaded in response to 188.8.131.52. The date of the request and the expected approval date should be included in this document.
- If any of the funds will come from the National Institutes of Health (NIH), indicate yes in response to 4.1.2.
- Submissions without the required documentation will not be reviewed out of order.
- In order to allow the IRB adequate time to complete the review process, the application should be submitted within 5 business days of receipt of the funding agency request. The IRB may not honor the Urgent Review request if the investigator has not submitted the application to the IRB in a timely fashion.
- NIH pre-award documents often include a 90-day turn-around for the investigator to submit the required documents to the grants officer.
- If the application is a “development” study (i.e., a study where no human subjects activities are conducted the first year), the investigator should verify with the funding agency what type of IRB determination is acceptable.
Considerations for Studies with Data Collection Window Constraints (Condition 3 above)
- If Urgent review is being requested because the data collection window is impending and short lived or limited and the study application or amendment was submitted within adequate time for review, the investigator should use the send message to IRB function indicating that the study application or amendment was submitted within adequate time for review and that the data collection window targeted is ephemeral and will be irreversibly lost if approval is not received. Documentation must substantiate this claim. Documentation would include the initial application or amendment date and an explanation of the constraints that exist with respect to data collection.
- If Urgent Review is being requested because the data collection window is impending and short lived or limited and, for reasons beyond the investigator’s control, the investigator was unable to submit to the IRB with adequate time for a review, the investigator should use the send message to the IRB function. Documentation must demonstrate that it was not possible to submit the application earlier. Documentation may be in the form of an email or letter from the funder demonstrating the level of urgency.
Please note it is at the discretion of the IRB to determine whether a request is urgent and applications submitted under these guidelines will not be automatically reviewed.
If investigators have questions about the process and/or submission type, please contact the IRB Office (323) 442 0114 or firstname.lastname@example.org for guidance.
Non-Urgent Review Guidelines
Circumstances under which an Urgent Review is not Available
- Funding of an award by the sponsor (e.g., NIH, NSF, Foundation) is conditioned upon IRB approval and no supporting documentation from the funder has been provided to the IRB to substantiate urgency of the review.
- Funding of an award by the funding agency is conditioned upon IRB approval, but no deadline has been set by the funding agency.
- Funding of the award by the sponsor is not conditioned upon IRB approval.
- Funds will not be released by DCG before the study team complies with university policies and practices.
- Unspecified delays on the part of the study team that translate into perceived urgency to undertake study activities requiring IRB approval.
This is not a comprehensive list. Urgent Review requests may be considered or denied at the discretion of the IRB.
Considerations for all Studies Eligible for Grants/Awards
- To ensure the most expedient review process, the investigator should submit an iStar application when grant applications are likely to be funded or as soon as they are informed by the funding agency to do so.
- If USC DCG officers recommend an iStar application be submitted, the investigator should do so within 5 business days in order to prevent delay of the review process.
- If the investigator intends to submit the same type of grant application to various funding agencies, the investigator may want to consider submitting an iStar application without the funding information. Once the study is funded, an amendment can be submitted with the relevant revisions, including funding information, study title, etc. This may expedite the review process.
- If the investigator is unsure of the type of IRB approval acceptable to the funding agency, the investigator should contact the agency’s awards officer directly.