When adding an adolescent population to a study initially involving adults, which statement is correct regarding the protocol review?

The correct statement regarding the protocol review when adding an adolescent population to a study initially involving adults is that expedited review is possible unless risk levels are elevated for adolescents.

In the context of human subjects research, when a study is modified to include a more vulnerable population, such as adolescents, the risk level associated with that population is a critical factor in determining the type of IRB review required. If the research poses minimal risk to the adolescents and complies with the guidelines outlined for expedited review by the Institutional Review Board (IRB), then researchers may proceed with an expedited review. Expedited review is designed to facilitate faster approval for studies that involve minimal risk, making it a suitable option in many cases involving adolescents, as long as the level of risk does not exceed what is deemed acceptable.

In contrast, if the research presents elevated risks or if the protocols for obtaining consent or assent do not adequately protect the adolescents' rights and welfare, then a full review by a convened IRB would be mandated to ensure comprehensive oversight and ethical integrity in research. This review process further guarantees that the research meets the necessary ethical standards for protecting vulnerable populations.