IRB: Review Types and Timelines

Although the initial study application is the same for everybody, processing times vary by review type. The following timeline for approvals is only a guide. It may take more or less time, depending on the completeness of the application and the complexity of the research. With the exception of excluded work, the review type is determined by the IRB office and not by the research team. All submissions are typically screened within 5 business days and you may receive a preliminary response within 5-7 business days. 

You may not begin ANY recruitment, enrollment, or data collection until you have received a formal approval letter from the SJSU IRB, regardless of whether the review type is exempt, expedited, or full board. The IRB does not approve research retroactively.

For more detailed information about these review types, including help with understanding when IRB approval is needed, please review the video "An Introduction to the IRB: What and When" posted on our educational materials page.

Exclusion

Self-determination by Principal Investigator that submission of an IRB application is not needed. Use our Exclusion Decision Worksheet [pdf] to make this determination. No confirmation from the IRB Office is needed. 

Exempt Review 

IRB Office evaluates the submission and conducts an administrative review. See our table of exemption categories [pdf] to see what types of studies qualify. All applicable study documents, as outlined on our checklist [pdf], must be submitted.

Approximate Timeline: 1 week (not including any revisions requested by IRB staff). 

Note: Just because a study meets the exemption criteria does not mean that the IRB cannot review it or that ethical components like appropriate subject selection and consent are not important or unnecessary. 

Expedited Review

Individual IRB member conducts the review after screening by IRB analyst.  See the expedited review categories established by the federal regulations to see what types of studies qualify. All applicable study documents, as outlined on our checklist [pdf], must be submitted.

Approximate Timeline: 1 month.

Full Board Review

Convened IRB committee conducts the review. Any research that poses greater than minimal risk to participants must be reviewed by the full board. Any research that uses an investigational device that is not cleared by the FDA must be reviewed by the full board. Any research involving radiology procedures, such as DXA scans must be reviewed by the full board. All applicable study documents, as outlined on our checklist [pdf], must be submitted.

Approximate Timeline: 1-2 months, depending on when the protocol is submitted. Protocols are assigned to a primary reviewer for initial review before being added to a meeting agenda. Revisions may be required before a protocol is added to the full review agenda. Protocols are added to the agenda on a first come first serve basis The committee meets on the third Friday of every month during the Fall and Spring semesters and does not meet over the summer and winter sessions.