Silence Is Not Agreement

Part of Pediatric Trials: Consent and assent.

About 3 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 lesson is about one sentence. It is short, and it settles a great many situations.

The sentence

The ICH E11(R1) glossary, having defined child assent as the affirmative agreement of a child, adds:

"Lack or absence of expression of agreement or disagreement must not be interpreted as assent."

ICH E6(R3), the current good clinical practice guideline, carries the same rule in its own glossary: the absence of an expression of agreement or disagreement should not be interpreted as assent.

Two separate international guidelines say the same thing, in almost the same words. That is unusually clear.

What it means in an ordinary room

A child who says nothing has not agreed.

A child who looks at the floor has not agreed. A child who shrugs has not agreed. A child who does not object while adults talk over them has not agreed. A child who has clearly stopped listening has not agreed.

Assent has to be given. It cannot be inferred from the absence of a protest.

Why the rule had to be written down

Because inferring agreement from silence is easy, comfortable, and often unintentional.

Children are frequently quiet with adults in medical settings. They may be frightened, tired, in pain, unwell, or simply unsure what is being asked. They may have learned that the adults are worried and that adding to it is unwelcome. They may not want to be difficult.

None of that is agreement. The rule exists precisely because it is so easy to treat it as though it were.

What good practice looks like instead

Signs that assent is being sought properly rather than assumed:

• someone speaks to your child, not only about them
• the explanation is in words your child actually uses
• your child is asked to say back what they think will happen, in their own words
• open questions are used — "what do you think about that?" — rather than questions that invite a nod
• silence is treated as a reason to slow down and ask again, not as a yes
• your child is told, clearly, that they may say no

What you can do

You know your child better than anyone in the room.

If you can see that they have not understood, or that they are agreeing to end the conversation, you can say so. You can ask for it to be explained again another day, or by someone else, or with pictures.

You can also ask for a moment alone with your child. Some children will not say what they think in front of a doctor, and will say it immediately to a parent.

None of this is obstructive. It is the process working.

Where this leads

If silence is not agreement, then a clear refusal is certainly not agreement — and refusal has its own rules. That is the whole of the next module.

In short

• International guidance states that the absence of an expression of agreement or disagreement must not be interpreted as assent.
• Silence, shrugging, looking away and not objecting are not agreement.
• Children are often quiet in medical settings for reasons that have nothing to do with agreeing.
• Good practice speaks to the child, uses their words, asks open questions, and treats silence as a reason to slow down.
• You may say when your child has not understood, and you may ask for a moment alone with them.