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.
Comparing expedited and full board protocols
- No full board review: An expedited protocol does not need full board review; any future requests for continuation or 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 Our office will contact you annually to verify that the protocol is still active; if it is no longer active, please close the study.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.