Parental Consent and the Child's Own Voice

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

About 6 minutes. Free, in your language, no account needed.

Why this matters

A child in a clinical trial has two things that must be obtained, and confusing them is the most common error in pediatric research.

Consent comes from the parent or legal guardian. It is the legally effective authorization for the child's participation.

Assent comes from the child. It is the child's own agreement, sought in a form proportionate to their age and understanding, and it is not a lesser version of consent. It is a different thing with a different purpose: it respects the developing autonomy of a person who cannot yet give legally effective consent but who is nonetheless the person the research happens to.

Treating assent as a formality to be obtained after the real decision has been made misunderstands both.

What the frameworks require

Regulation (EU) No 536/2014 addresses trials on minors and requires, among other conditions, that the minor receives information in a way adapted to their age and mental maturity from investigators or members of the team trained or experienced in working with children, and that the explicit wish of a minor who is capable of forming an opinion and assessing that information, to refuse participation or to withdraw at any time, is respected by the investigator.

Two things in that are worth isolating.

The information must be adapted, and delivered by someone trained to work with children. An adult consent form handed to a twelve year old is not adapted information.

A refusal must be respected. Not considered. Not weighed against the parents' wishes. Respected.

Assent proportionate to age and understanding

There is no age at which assent begins. There is a developmental spectrum, and the approach changes along it.

Very young children cannot assent in any meaningful sense, and can still express distress and refusal, which counts for the same reason it counts in an adult who cannot consent.

Younger school-age children can understand a simple explanation of what will happen to them, can agree or refuse, and need information about the concrete experience rather than about the study's purpose.

Older children can understand purpose, risk and the concept of randomization, and their assent approaches the substance of consent even where it lacks its legal effect.

Adolescents may have a full understanding, and in some jurisdictions may consent for themselves for some purposes.

The judgment about where a particular child sits is individual. Age is a poor proxy and it is the proxy everyone uses.

Who gives consent

Usually a parent or legal guardian. Two questions recur.

Do both parents need to consent? Jurisdiction-dependent, and often dependent on the risk level of the research. Some frameworks require both where research involves more than minimal risk without the prospect of direct benefit.

Who consents where a child is in care, or where parental responsibility is contested? A local authority, a court-appointed guardian, or a person with defined parental responsibility, and this must be established rather than assumed from who brings the child to the appointment.

The refusal that is overridden

The hardest situation in pediatric research: parents who want their child to participate and a child who does not.

Where a child capable of forming an opinion refuses, the frameworks are clear that the refusal is respected. The pressure against this is considerable, and it comes from parents acting from love, from clinicians who believe the trial offers the child a chance, and from a site that has worked hard to recruit.

The discipline is that the child's refusal ends the matter. It does not get revisited later in the visit, it does not get resolved by the parent persuading the child in the corridor, and it does not get recorded as the child being nervous.

In practice

A trial enrolls children aged 6 to 16 and prepares three assent documents: a picture-based one-page sheet for 6 to 9, a plain-language single page for 10 to 13, and a fuller document for 14 to 16.

The coordinator is trained in talking to children about research and does not use the documents as a script.

An eight year old is shown the picture sheet, has the visits explained, and asks whether the blood test will hurt. She is told it will hurt a bit, like the ones she has had before, and that she can say no.

She says she does not want to. Her mother is keen and says she will talk to her.

The coordinator stops the conversation there, records that the child declined, and explains to the mother that a child's refusal is respected and that the family should not feel any pressure either way.

The child is not enrolled. That is the process working.

What this looks like when it goes wrong

A site enrolls adolescents in a trial requiring monthly visits. The assent form is the adult consent form with a simplified first paragraph.

A fifteen year old signs it. His parents have consented and are enthusiastic.

At the third visit he tells a nurse he does not want to come any more and that he only signed because his parents wanted him to.

He was never asked separately from his parents. The assent conversation happened in the room with them present, after they had consented, framed as the last step before starting.

He had no realistic opportunity to refuse, and the assent form in the file records agreement he did not freely give.

Nothing in the documentation is wrong. The process gave a fifteen year old no moment in which declining was a real option.

Key takeaways