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

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