When Your Child Reaches the Age of Legal Consent

Part of Pediatric Trials: Over time, and endings.

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This is general education about clinical research — not medical advice, and not a way to join a study. Talk to your own doctor about your situation.

If a study runs for years, a child in it may reach the age at which they can consent for themselves.

Guidance treats this as a real event with a required action, not as a technicality.

What the guidance says

The ICH E11(R1) Addendum states that during a study there is a requirement to obtain adequate informed consent for continued participation from a pediatric participant once that child reaches the age of legal consent.

ICH E6(R3), the current good clinical practice guideline, says the same in its own terms: a process for consent should be considered where, during the trial, a minor reaches the age of legal consent, in accordance with applicable regulatory requirements.

What that means in practice

On the far side of that birthday, your child is the person who decides.

They should be given the information in their own right, as an adult participant, and asked for their own consent to continue. Your permission no longer stands in for theirs.

They may say yes. They may say no. Saying no at that point is a legitimate exercise of a right they have just acquired, and it should carry no consequence for their care.

The age varies

There is no single international age. It is set by the law where you are. In some places it is 18, in others 16, and there are jurisdictions where it varies by the type of decision.

ICH E11 also notes that emancipated or mature minors, as defined by local laws, may be capable of giving autonomous consent before that age.

If your child is approaching the relevant birthday during a study, ask what the age is where you are and what the study's process for that transition looks like.

Why it can be missed

It is easy to overlook. The consent was signed years ago, visits have become routine, and nobody is watching the calendar.

Ask early. "My child will turn sixteen during this study — what happens then?" is a completely reasonable question, and asking it at the start means it will not be forgotten.

For you as a parent

This can feel abrupt. You may have carried the decision for years, and the responsibility moves in a single day.

It may help to know it is not really abrupt. If assent has been sought properly and revisited as your child grew, this last step is the end of a gradual handover rather than a sudden one. Your child has been building towards deciding for themselves the whole time.

Your role does not vanish. It changes from deciding to supporting.

In short