In trials involving minors, which practice describes assent and consent?

• A. Age-appropriate assent information should be provided to minors, and assent should be obtained as appropriate, with a process for consent if the minor reaches the age of legal consent.
• B. Assent is optional for minors and consent must always be obtained from the parent.
• C. Minors do not require assent or consent to participate in research.
• D. Only the legal guardian may ever consent, regardless of the minor's age.

Answer: (A)

When researching with minors, it’s important to respect the developing autonomy of the child while ensuring protection through parental involvement. Minors who can understand the study should receive information that is appropriate to their age and be asked to give their assent, an affirmative, voluntary agreement to participate. At the same time, a parent or legally authorized guardian must give consent for the minor to be enrolled. The plan should include a process to obtain the minor’s own consent when they reach the age of legal consent, so their participation is governed by their own decision as they mature. This approach balances respect for the child’s growing capacity to decide with the legal and ethical requirement for parental permission.