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Child assent and parental permission in pediatric research

Child assent and parental permission in pediatric research 2025

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The document outlines the process of obtaining assent from children participating in research studies. It defines 'assent' as a child's agreement to participate and details the necessary components of the assent process, including age-appropriate explanations of the study's purpose, requirements, experiences, risks, and benefits. The document emphasizes the importance of parental consent and specifies guidelines for different age groups regarding assent documentation. It also addresses situations where a child's capability to provide assent may be limited and outlines regulatory requirements for parental signatures based on the level of risk involved in the research.

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What is the difference between assent and parental permission?

If a child is capable of assent and the IRB requires that assent be sought, it must be obtained before the child can participate in the research activity. Thus, if the child dissents from participating in research, even if his or her parents or guardian have granted permission, the childs decision prevails.

What impact does assent have on a research study with children?

The assent procedure should reflect a reasonable effort to enable the child (youth or adolescent) to understand, to the degree they are capable, what their participation in research would involve.

What is the meaning of parent permission?

Parental consent is something that needs to be requested before adults can carry out any activity with a child. Since minors cannot make binding decisions for themselves, you would need to obtain formal authorization from parents or guardians before their wards can take part in some activities.

Do parents give consent or assent?

Assent is the agreement of someone not able to give legal consent to participate in the activity. Work with children or adults not capable of giving consent requires the consent of the parent or legal guardian and the assent of the subject.

What is the purpose of an assent form?

An assent form is different from an informed consent form, and is specifically designed to simply indicate that the minor is willing to participate in the study and understands what he or she will be expected to do as part of the study.

What is parental permission and child assent in research on children?

As a general guide, consent should be obtained for minors 12 years and above if they have sufficient understanding and intelligence, whereas assent should be obtained for minors between 6 to 11 years of age. Minors below 6 years of age do not need to provide written agreement to participate in the research study.

What is consent assent for research with pediatric patients?

In general, one or both parents or a guardian must be provided with the information ordinarily required for informed consent, so that they may decide whether to allow the child to participate, and children capable of assent must also express their willingness to participate.

What is the difference between assent and permission?

Assent and permission are uniquely bound together, each serving a different purpose. Parental permission protects the child from assuming unreasonable risks. Assent demonstrates respect for the child and his developing autonomy.

Child assent and parental permission in pediatric research 2025

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