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?a. 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.b. The research would only be eligible for expedited review if the adolescents have been declared to be emancipated minors.c. The new research would need full review by a convened IRB because children are a protected population.d. 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

Answer: Option (D)

Explanation:

From the given case or scenario, we can state that since there are no additional changes are made then the following statement in accordance with the review of revised protocol is correct, i.e. Unless or until nature of these questions would tend to keep the scale of the risk to mere more than the minimal for the adolescents, then the research would be more likely to still qualify for the expedited review.