Clinical Research Glossary

assent form assent form

CDISC

A document used to explain the details of a research study to children or people who are unable to give legal consent.

Example of assent form in a sentence

An assent form provides information about the research in a way that is easy to understand.

More Info

An assent form provides research study information in a way that children and others who may have impaired decision-making can understand.

Giving children and people with impaired decision-making an assent form that is designed for them helps them to understand the research and decide how they feel about the study.

Other info to think about when joining a study

If you are the parent or guardian of a child, you will be deciding about the study and signing the consent form. You can ask the study team if there is an assent form for the child to understand the study.

A similar process can be followed if a study is enrolling adults who are not able to make decisions on their own about being in a research study.

You can use the assent form to guide a conversation to make sure the potential participant agrees with being in the research study.

Version 2.0 September 2024

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