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 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. 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.
• B. The revised protocol must undergo full board review.
• C. The adolescents can be enrolled without any new assent.
• D. Expedited review is not possible when adolescents are added.

Answer: (A)

IRB review can use an expedited approach for small changes to an already approved study, including adding a new participant group, as long as the risk to that group remains no more than minimal. In this scenario, the study has adults and involves interviews with minimal risk. If the researchers include adolescents aged 12 to 17 and have designed a parental permission process plus adolescent assent, the key issue is whether the questions and procedures for the adolescent portion would raise the risk above minimal. Since no other changes are planned and the risk does not increase for adolescents, the revised protocol fits the expedited-review category. The use of parental permission together with the adolescent’s assent aligns with protections for minors under the regulations. This is why the option stating that the study would still qualify for expedited review is the best choice. It isn’t necessary to move to full-board review merely because a new population is added, provided risk stays minimal and proper consent/assent processes are in place. The idea that adolescents can enroll without any new assent is incorrect because minors require their own assent; the belief that expedited review isn’t possible is also incorrect.

IRB review can use an expedited approach for small changes to an already approved study, including adding a new participant group, as long as the risk to that group remains no more than minimal. In this scenario, the study has adults and involves interviews with minimal risk. If the researchers include adolescents aged 12 to 17 and have designed a parental permission process plus adolescent assent, the key issue is whether the questions and procedures for the adolescent portion would raise the risk above minimal. Since no other changes are planned and the risk does not increase for adolescents, the revised protocol fits the expedited-review category. The use of parental permission together with the adolescent’s assent aligns with protections for minors under the regulations.

This is why the option stating that the study would still qualify for expedited review is the best choice. It isn’t necessary to move to full-board review merely because a new population is added, provided risk stays minimal and proper consent/assent processes are in place. The idea that adolescents can enroll without any new assent is incorrect because minors require their own assent; the belief that expedited review isn’t possible is also incorrect.