Initial and Continuing

Expedited review procedures are appropriate for certain kinds of research involving no more than minimal risk. A list of the research that may be reviewed through an expedited review procedure is published as a Notice in the Federal Register.

Under an expedited review procedure, an IRB Chairperson or an OHRA Review Specialist reviews the research protocol.  When the protocol is ready, a Chair will grant final approval. In conducting expedited review, the IRB reviewer(s) may exercise all of the authorities of the IRB, including "approve", "require modifications", or "defer" except that they may not "disapprove" the research.  A research activity may be disapproved only after review by the convened IRB.

The reviewer(s) may at any time refer the application to the full Board if necessary.  All Expedited protocols are reviewed at least once annually.

If you have questions about expedited review procedures or a specific protocol underway, feel free to contact an IRB Review Specialist.

IRB Review Actions

Approve:
The IRB may approve research when all of the relevant regulatory requirements are satisfied. This means that the IRB approves the research protocol and research consent form and other documents as submitted, with no change.

Require Modifications:
The IRB may require modifications in the research to secure approval if the IRB determines that all of the relevant regulatory requirements would be satisfied if the investigator modifies the research protocol and research consent form as required by the IRB.  This means that the IRB provides the investigator with explicit modifications, and does not ask for additional information or for clarification of issues that may affect the risk benefit assessment or other regulatory requirements for IRB approval. In order to obtain IRB approval, the investigator must simply concur with the IRB's required modifications and make the specific changes to the affected documents.

Defer:
When the IRB needs additional information from the investigator in order to determine whether all of the relevant regulatory requirements are satisfied, the IRB must defer action until the information is provided.  If the research was initially reviewed by the full board, the PI's response and revised materials must be reviewed at a subsequent convened meeting.

Disapprove
When the IRB has all of the information it needs to determine whether all of the relevant regulatory requirements are satisfied, and determines that the requirements cannot be satisfied by making modifications in the research, the IRB must disapprove the research. This action cannot be used if the research is being reviewed on an expedited basis.

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