Guide :: Expedited Research
Expedited Research
The federal regulations (CFR 45.46) allow the Board to review protocols outside of a full board meeting if the level of risk to participants is minimal. The protocol can be reviewed by a Board Member who determines if the protocol can be approved. The Board Member can request that the researcher make revisions to the protocol, but if the Board Member does not feel he or she can approve the protocol, it is sent to the full board for review. For more information on review procedures, please see Submission: Review.
Can my protocol be expedited?
The easy answer is that if your protocol is “minimal risk”, than it can be expedited (and in some cases it can be exempted; please see Exemption). However, what is “minimal risk”? The federal regulations define “minimal risk” as the following: “Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” This offers some ambiguities. For example, whose “daily life” should be considered? If a study involves interviewing juvenile delinquents who deal drugs, the level of risk encountered in their daily lives could be significantly different from the average teenager. Does that mean that these participants deserve less protection than the average teenager? The Board sets the “average person” as the standard for determining “minimal risk.” Do not expect your protocol to be expedited. Review time for full board protocols generally takes one month.
What is the difference between an expedited and a full board protocol?
An expedited protocol does not need full board review or do any requests for continuation or modifications need to be reviewed at a full board meeting unless the protocol modifications change the level of risk to participants. The benefit of an expedited review is that your 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). Otherwise, the protocols have the same requirements for submission, pre-review, etc.
How do I submit an expedited protocol?
Expedited protocols follow the same submission procedures that all other protocols require. Please see Submission for more information.
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Guide :: Expedited Research |
