IRB Review Process

Turnaround Times for Staff and IRB Review

In general, Seattle Children’s IRB turnaround times have remained consistent over the past two years with slight increases for some submission types during 2024.

Turnaround times are measured in calendar days from the time of submission to the time the final approval or determination letter is sent, excluding all time spent with the study team.

Median turnaround times

January 2023 to December 2023
Review Type	Median Turnaround Time (Days)
Initial Exempt and Other Status Determinations	12
Expedited Initial Studies	28
Full Board Initial Studies	61
Exempt and Other Status Modifications	4
Expedited Modifications	5
Full Board Modifications	32

January 2024 to December 2024
Review Type	Median Turnaround Time (Days)
Initial Exempt and Other Status Determinations	16
Expedited Initial Studies	35
Full Board Initial Studies	67
Exempt and Other Status Modifications	7
Expedited Modifications	8
Full Board Modifications	28

Tips for a timely review

• Plan ahead. The above turnaround times are provided to assist with planning, but they are not guaranteed review timelines. Review times vary depending upon the type of review, complexity of the study, IRB Office staffing resource, submission volumes, etc. Keep in mind that the above turnaround times do not include the amount of time the submission spends with the study team. Be sure to allow enough time for review by the IRB and for your team to respond to IRB requests.
• Check for completeness. Carefully read all instructions in the Click templates. Be sure that you provide all information requested in each section of the protocol and in IRB correspondence.
• Check for consistency. Submission approval is often delayed because of inconsistent information across study documents. Review all study materials before submitting to ensure they provide consistent information.

Review Levels

• Other Status: A category of determinations for projects that do not require IRB review. These determinations include the Click states, “Not Human Research and “Human Research, Not Engaged.”
• Exempt: Certain categories of human research may be exempt from regulation but require IRB review. It is the responsibility of the IRB, not the investigator, to determine whether human research is exempt from IRB review. Refer to HRP-312-Worksheet - Exemption Determination under the “Worksheets” tab of the Click Library for more information about the categories of research that qualify for exempt determination.
• Expedited: IRB review conducted by a designated voting member (generally a Human Subjects Protection Analyst) rather than by the convened committee. It is used for minimal risk research that fits into one or more of the permitted expedited review categories. Refer to HRP-313-WORKSHEET - Expedited Review under the “Worksheets” tab of the Click Library for more information.
• Full Board: IRB review by the convened committee at a scheduled meeting. This is required for research that is not eligible for exemption or expedited review. The meeting date for which a submission has been assigned is viewable in Click in the submission workspace once assigned to a meeting.

Priority Review Requests

Submissions are general prioritized according to their submission date. In limited circumstances, priority review requests are approved by IRB office management. These approvals are reserved for submissions involving:

• Time sensitive participant/patient need or risk
• Time sensitive research on illnesses/conditions (e.g., COVID, seasonal illnesses like flu and RSV)
• Other time sensitive circumstances

If you believe a priority review is needed, the Principal Investigator (PI) or someone from the study team on behalf of the PI (the PI should be CCed) must contact the IRB Office ([email protected]) with the following information:

1. Click ID (if applicable)
2. A compelling rationale for your request (be sure to address one of the criteria above)
   • If requesting priority review due to funding, include communication from the funding agency documenting their IRB review timeline requirements.
3. The date by which you are requesting review or an outcome (be as specific as possible based on the facts involved)