Question

A study that involves interviews of adults is eligible for expedited review. The researcher wants to add an adolescent population (aged 12 to 17) to the study and has designed a parental permission and assent process. No additional changes are planned. Which of the following statements about review of the revised protocol is accurate?

The research would only be eligible for expedited review if the adolescents are capable of understanding the same consent forms used for the adult population.


The research would only be eligible for expedited review if the adolescents have been declared to be emancipated minors.


The new research would need full review by a convened IRB because children are a protected population.


Unless the nature of the questions would raise the level of risk to more than minimal for adolescents, the research would still qualify for expedited review.

Answer 1

The correct answer is: "Unless the nature of the questions would raise the level of risk to more than minimal for adolescents, the research would still qualify for expedited review."

According to the rules published by the IRB regarding the applicability of the Expedited Review, this extends to all individuals, regardless of their age. This condition will not change unless the research involves activities or circumstances that increase the level of risk to human subjects to a level higher than minimal.