A study including adolescents has designed a parental permission process. What is a true statement regarding the protocol's review status?

Involving adolescents in research often necessitates additional ethical considerations, particularly regarding parental permission and the vulnerability of the participants. A protocol that includes adolescents requires a careful review to ensure that the rights and welfare of these younger individuals are adequately protected.

When research involves children or adolescents, especially in situations where parental permission is a component, it typically elevates the need for scrutiny to ensure that all aspects of the study, including informed consent procedures and the management of any potential risks, are thoroughly evaluated. This is why requiring a full Institutional Review Board (IRB) review is a true statement in this context; it reflects the commitment to safeguarding vulnerable populations and emphasizes the importance of rigorous oversight in research involving minors.

In contrast, while expedited review processes exist for studies involving minimal risk, the presence of minors complicates matters, as they are regarded as a more vulnerable population. Therefore, unless specific conditions are met that entirely minimize the risk and ensure compliance with all ethical guidelines (which is rare), a full IRB review is typically mandated.