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

A minor change should not affect the risk-benefit ratio nor substantially change the study design or scope.  Examples of minor changes can include, but are not limited to, changes in study title; PI (assuming s/he has comparable experience/expertise); study staff; funding source; study aims (assuming they remain within the overall scope of the study), and study materials, i.e., study advertisements, consent forms, etc.

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.

If you have questions about expedited review procedures, 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.

This page is maintained by the Office of Human Research Administration. For web-related suggestions, comments, and questions, please email the OHRA webmaster.

For any other questions, please contact OHRA.