The writers of the federal regulations mandating IRB review recognized that not all research rises to the level of full board review. In some cases, a protocol needs IRB approval but the level of risk in the protocol is considered minimal and the review can be expedited. One of the key elements to defining an expedited protocol for the Social and Behavioral Sciences is determining if the protocol's risk level is minimal (aka "minimal risk"). If the protocol meets the definition for minimal risk in addition to the expedited categories defined by OHRP, the Board can expedite a protocol’s review.
No full board review: An expedited protocol does not need full board review; modifications do not need to be reviewed at a full board meeting unless the protocol modifications change the level of risk to participants.
Shorter review time: Expedited review time should be shorter, generally two to four weeks depending on the protocol load. A full board protocol is reviewed at the full board as well as any continuations or major modifications (some minor edits can be approved administratively), which can take a month or longer.
Continuation review not required: Expedited protocols only need to be reviewed once (unless a protocol needs to be modified or there is an unexpected adverse event). Our office will contact you annually to verify that the protocol is still active; if it is no longer active, please close the study.
- Submission requirements and pre-review requirements are the same.
- Modifications: Your protocol should always reflect your study's practice and if it doesn't, you need to modify the protocol. Expedited modifications receive expedited review but please consider grouping modifications into one submission. If you are changing personnel, use the Personnel Management Tool instead of submitting a modification for this change.
- Update Protocol Status: Expedited protocols do not require an annual continuation review; rather you will be asked on an annual basis to update your protocol's status (if you haven't submitted a modification for review over the previous year). You will receive an email notification one month prior to your protocol's annual notification date with information about how to complete the simple Protocol Status Update form. Failure to complete the form could result in study closure.
- Unexpected Event Report: Research doesn't always go according to plan and if that happens, you may need to submit an unexpected event report.
- Study Closure: Once a study is complete, the protocol needs to be closed.