Reaching Majority, and Other Transitions

Part of Consent and Vulnerable Populations: Minors, Assent and Refusal.

About 5 minutes. Free, in your language, no account needed.

Why this matters

A child enrolled in a long trial becomes an adult during it. On that day the legal basis of their participation changes: parental consent no longer authorizes it, and their own consent is required.

This is straightforward in principle and it is missed more often than almost anything else in pediatric research, for the same reason capacity returning is missed in adults. Nothing in the trial's process announces it.

What changes at majority

Parental consent ceases to be the authority. The participant is an adult and decides for themselves.

Their own consent must be obtained, as a full consent process rather than a signature transfer. They are being asked, for the first time as an adult, whether they wish to continue.

Their data rights change. In many jurisdictions the participant now holds rights over their own data that their parent previously exercised, including over samples and any long-term storage.

Refusal is available, and a participant who has been in a trial since they were nine may have views their parents never held.

Why it is missed

The age of majority is not a trial event. Visits are scheduled by protocol day, not by birthday.

The file looks complete. Consent is on file and nothing indicates it has expired.

The participant does not raise it, because they have been in the trial since childhood and nobody has suggested there is a decision to make.

It is administratively unwelcome. A participant who has contributed years of data may decline, and losing them near the end of a long follow-up is costly.

Building the trigger

A report, run monthly, listing every participant who will reach the age of majority in the next 90 days, with an owner.

That is the whole mechanism, and it works because it converts a date nobody tracks into a task somebody owns. Without it, the only thing that would surface a participant's birthday is somebody happening to notice.

The other transitions

Majority is the clearest, and it is not the only point at which the basis of consent changes.

A child gains capacity to consent for themselves in jurisdictions that recognize a capable minor's consent for some purposes, which may occur before majority and is a judgment rather than a date.

A participant's legal guardian changes, which happens where a child moves between carers or a court order changes.

A protocol amendment changes what participants are agreeing to, requiring re-consent, and here the question of who re-consents depends on where the participant now sits.

A participant who is a child becomes incapacitated as an adult, which is a real path in trials of progressive neurological conditions, and moves them from parental consent to representative consent with no adult consent in between.

Each needs identifying at study design rather than being discovered.

In practice

A trial in a childhood chronic condition follows participants for up to ten years, enrolling from age eight.

At set-up the coordinator asks a question nobody had raised: how many participants will reach majority during follow-up.

The answer is most of them.

A monthly report is built listing participants reaching majority in the next 90 days. The consent process for that transition is written and approved in advance, with its own information sheet explaining what has happened so far and what continuing involves.

Over the trial's life, 61 participants transition. Fifty eight consent, two decline, and one cannot be contacted.

The two declines are handled cleanly: participation ends, and their data to that point is handled according to what was agreed. Without the report, all 61 would have continued on parental consent that had ceased to authorize anything.

What this looks like when it goes wrong

A long-term follow-up study enrolls children and follows them into adulthood, collecting annual data and storing biological samples.

Participants who enrolled at twelve are now twenty-four. Parental consent was obtained at enrollment and never revisited.

An ethics committee reviewing a request to use the stored samples for a new analysis asks who consented to the storage and who may consent to the new use.

The answer is that parents consented, when the participants were children, to storage and to future research. The participants are now adults who have never been asked anything.

The samples cannot be used for the new analysis without the participants' consent, and obtaining it means contacting people who may not know their samples were stored, and explaining that they have been held for twelve years on their parents' authority.

That conversation is manageable. It is much harder than it would have been at majority, and the study has been holding samples for years on a basis that stopped being adequate a long time ago.

Key takeaways