For research approved under an expedited category, what is true regarding continuing review?

For research that is approved under an expedited category, the continuing review requirements are guided by the revised Common Rule. Under this regulation, for studies that fall into certain categories, continuing review is not a blanket requirement; it is only mandated if specifically determined necessary by the Institutional Review Board (IRB). This means that for many studies considered minimal risk or that fit specific criteria, the IRB can decide that ongoing review is not necessary.

This new flexibility reflects an acknowledgment that some studies may not need rigorous oversight through continuing reviews due to their low risk and straightforward design. Therefore, the stipulation about continuing review being unnecessary under the revised Common Rule unless specified accurately represents the current regulatory landscape for expedited research.

Other options misrepresent the requirement: stating that it is always required once a year would not account for the variability based on the research's nature and risks, asserting that it must occur every two years does not accurately capture the nuance of IRB discretion, and not requiring continuing review if risk is minimal misrepresents the contextual decision-making made by the IRB regarding continuing review.