Assent: Your Child's Own Agreement

Part of Pediatric Trials: Consent and assent.

About 4 minutes. Free, in your language, no account needed.

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.

This is the central idea of this course.

Assent is your child's own agreement to take part. It is separate from your consent, and it is not a formality.

The definition, exactly as written

ICH E11(R1) defines child assent as "the affirmative agreement of a child to participate in research or to undergo a medical intervention."

Affirmative means the child actively agrees. Something has to be given, not merely not withheld.

Why it exists at all

A child cannot give legal consent. That is a statement about legal capacity, and it is not a statement about whether the child's view matters.

Assent exists because a child is a person. They have a body that will experience whatever happens, a memory that will keep it, and a growing ability to form a view about it. Legal incapacity does not erase any of that.

So research ethics asks for two things: the permission of the person legally responsible, and the agreement of the person who will actually go through it.

What your child should be told

ICH E11 says all participants should be informed to the fullest extent possible about the study, in language and terms they are able to understand.

The E11(R1) Addendum adds that when obtaining child assent, the relevant elements of informed consent should be provided in a way that is appropriate to the child's capability to understand.

ICH E6(R3), the current version of the international guideline on good clinical practice, requires age-appropriate assent information to be provided and discussed with the child as part of the consent process, and assent to be obtained as appropriate.

The common thread: a child is entitled to a real explanation, pitched to them. Not a summary given to you and repeated at them.

Who decides the age at which assent is sought

There is no single international age. ICH E11 states that the age of assent is determined by the ethics committee, or is set to be consistent with local legal requirements.

So it varies by country and sometimes by institution. If it matters to you what applies to your child, that is a specific and answerable question to ask the study team.

Writing it down

ICH E11 states that participants of appropriate intellectual maturity should personally sign and date either a separately designed written assent form, or the written informed consent document.

In practice this often means a separate, simpler document written for children — sometimes several versions for different ages, sometimes using pictures.

Whether your child signs something is a question you can ask. So is whether you can see the assent document in advance.

Assent is not a one-time event

The E11(R1) Addendum states that over the course of a study it may be necessary to reassess a child's assent, in recognition of their advancing age, evolving maturity and competency — especially for long-term studies, or studies that involve keeping samples.

A seven-year-old who agreed is a ten-year-old three years later, with a different mind and different questions. The guideline expects that to be revisited, not assumed.

And they must be told they can stop

ICH E11 states that in all cases participants should be made aware of their right to decline to participate, or to withdraw from the study at any time.

That is your child's right, told to your child, in words your child can understand. The next module is about what happens when they use it.

In short