If a researcher wishes to add adolescents to a study initially involving adults, which statement is true regarding expedited review?

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When considering the addition of adolescents to a study that initially involved only adults, the concept of expedited review is significant. If the potential risks associated with the addition of these adolescent participants remain minimal and the overall design, safety protocols, and protections continue to ensure their welfare, the study can retain its expedited status. This means the changes do not require a full board review, provided that the modifications do not elevate the risk level beyond what was initially assessed.

Maintaining expedited review reflects the understanding that not all additions or modifications to a study automatically entail increased risks or necessitate comprehensive oversight, especially if careful considerations are made to protect the new group of participants. Thus, as long as the parameters of risk remain unchanged or low, the expedited review process is appropriate.

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