If a researcher adds adolescents to a study originally involving adults for expedited review, what is a key requirement?

The key requirement when a researcher adds adolescents to a study initially involving adults for expedited review is that the nature of the research questions must not raise risks above minimal. This is particularly important because when involving a vulnerable population such as adolescents, researchers must be meticulous in ensuring that the risks associated with the study do not exceed what is typically considered minimal. This principle aligns with ethical guidelines, which prioritize the protection of participants, especially those who may not be able to provide informed consent in the same way adults can.

In research involving minors, it is crucial to maintain a low-risk threshold to safeguard their well-being while still allowing for valuable data collection. When the research questions raise the risk level, additional safeguards or protocols may be necessary, potentially changing the review required for the study.

In contexts where adolescents are involved in research, issues surrounding parental permission, the necessity for consent, and review levels are all crucial but secondary to the overarching requirement to minimize risks. Thus, ensuring that the nature of the questions remains at a minimal risk level is foundational to the ethical conduct of the study.