If an investigator proposes research involving adolescents and minimal risks are considered, what is required for IRB approval?

For research involving adolescents, it is essential to ensure that both the rights of the participants and the ethical standards of research are upheld. In this context, assent from the child and permission from both parents are required for several reasons.

Assent indicates that the adolescent is able to understand the research and agrees to participate. It is crucial to involve the child in the decision-making process, respecting their developing autonomy and ensuring that they are aware of what participation entails, even if they are not legally able to provide consent themselves.

In parallel, parental permission is also necessary. This safeguard ensures that the rights and welfare of the child are protected by adults who can make informed decisions on their behalf. By requiring permission from both parents, the IRB acknowledges the importance of family involvement in such decisions, especially since the adolescents may not yet have the life experience necessary to fully understand the implications of the research.

This dual requirement of assent and parental permission strikes a balance between protecting the interests of adolescents in research while also allowing them to have a voice in the process. It is a fundamental aspect of ethical research practices involving vulnerable populations.