When adding adolescents to a study already eligible for expedited review, which statement is true?

The choice stating that the nature of the questions must be re-evaluated for risk levels is accurate because the addition of adolescents to a study that is already eligible for expedited review necessitates a reassessment of the potential risks involved. Expedited review is applicable to research that poses minimal risk to participants. Incorporating a new population, such as adolescents, can change the risk profile of the study, as this group may have different vulnerabilities and considerations compared to adults.

For instance, assessments related to informed consent, confidentiality, and the nature of the interventions may require careful scrutiny to ensure that the rights and welfare of adolescent participants are safeguarded. By evaluating the specific questions and their potential impact on adolescents, the IRB can ensure that the study maintains its eligibility for expedited review while adequately protecting the new subjects involved.