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LEGAL DICTIONARY

Child Assent

What Is Child Assent?

Child assent is the term used to signify a child's agreement to participate in an activity, such as medical treatment, that is part of a research study or clinical trial.

In the United States, someone who is 18 and over is typically considered an adult. Adults may give their legal consent to participate in an activity. Individuals under the age of 18 usually are considered minors. Minors and their parents or legal guardians must follow the assent process.

Assent from children requires that underage participants have a basic understanding of what might happen during the proposed research activity and what might be asked of them. The minor child may demonstrate their willingness to take part in the activity, which is their assent. Or they may say they are unwilling to participate, which is their dissent.

How Is Child Assent Determined?

The Institutional Review Board (IRB) is the organization that determines child assent. The IRB considers each minor child's age, maturity level, and mental state when making a decision.

The IRB recommends the use of a concise information sheet to help explain the research to older children and teens and an oral script for younger children. Federal law requires the use of 45 CFR 46, Subpart D and Subpart D of the FDA child assent forms to obtain child medical consent.

Minors who meet the following conditions may give legal consent to their care and treatment. The requirements for an emancipated minor are:

  • high school graduate
  • married
  • currently pregnant or previously pregnant

Why Is Child Assent Needed?

The child assent process should demonstrate a reasonable effort to help a child to understand –to the extent they are capable– what their participation in a clinical trial or research activity would involve.

In addition to physical and mental challenges, the procedure may involve other risks that the child needs to understand. These risks might include the following:

  • sensitive information from participants, including questions on substance use or sexual activity
  • legal risks if the research has not received specific legal protection
  • stress and stress-related risks
  • strained social relations

In addition to obtaining the assent of a minor child who would participate in a research study, medical personnel must gain parental permission. A parental consent form follows the same format as an adult consent form, except that it references "your child" instead of "you."

Parents or guardians must have the opportunity to learn about the study, ask questions, and decide whether or not they want their child to participate.

What Happens When Child Assent and Parental Permission Conflict?

Sometimes there may be an inconsistency between child assent and parental permission. In most cases, a dissent ("no") from the child overrides a consent ("yes") from a parent. On the other hand, a child typically cannot participate in a research study over a parent's objections.

The overall goal is that a child should not be not forced into taking part in a research study. However, there may sometimes be individual exceptions to child assent guidelines, including when experimental treatments for a life-threatening disease are under consideration. These circumstances are handled on a case-by-case basis.

Helpful Resources:

NCI - Children's Assent

Columbia University - The Assent Process with Minors

University of Illinois - Assent from Children

eCFR - 45 CFR 46.402

HHS - Research with Children FAQs

NIH - Child assent and parental permission in pediatric research

Penn State - IRB Guideline I - Parental Consent and Child Assent

Human Subjects Research Office - The Informed Consent Process with Children

What Is Child Assent?

Child assent is the term used to signify a child's agreement to participate in an activity, such as medical treatment, that is part of a research study or clinical trial.

In the United States, someone who is 18 and over is typically considered an adult. Adults may give their legal consent to participate in an activity. Individuals under the age of 18 usually are considered minors. Minors and their parents or legal guardians must follow the assent process.

Assent from children requires that underage participants have a basic understanding of what might happen during the proposed research activity and what might be asked of them. The minor child may demonstrate their willingness to take part in the activity, which is their assent. Or they may say they are unwilling to participate, which is their dissent.

How Is Child Assent Determined?

The Institutional Review Board (IRB) is the organization that determines child assent. The IRB considers each minor child's age, maturity level, and mental state when making a decision.

The IRB recommends the use of a concise information sheet to help explain the research to older children and teens and an oral script for younger children. Federal law requires the use of 45 CFR 46, Subpart D and Subpart D of the FDA child assent forms to obtain child medical consent.

Minors who meet the following conditions may give legal consent to their care and treatment. The requirements for an emancipated minor are:

  • high school graduate
  • married
  • currently pregnant or previously pregnant

Why Is Child Assent Needed?

The child assent process should demonstrate a reasonable effort to help a child to understand –to the extent they are capable– what their participation in a clinical trial or research activity would involve.

In addition to physical and mental challenges, the procedure may involve other risks that the child needs to understand. These risks might include the following:

  • sensitive information from participants, including questions on substance use or sexual activity
  • legal risks if the research has not received specific legal protection
  • stress and stress-related risks
  • strained social relations

In addition to obtaining the assent of a minor child who would participate in a research study, medical personnel must gain parental permission. A parental consent form follows the same format as an adult consent form, except that it references "your child" instead of "you."

Parents or guardians must have the opportunity to learn about the study, ask questions, and decide whether or not they want their child to participate.

What Happens When Child Assent and Parental Permission Conflict?

Sometimes there may be an inconsistency between child assent and parental permission. In most cases, a dissent ("no") from the child overrides a consent ("yes") from a parent. On the other hand, a child typically cannot participate in a research study over a parent's objections.

The overall goal is that a child should not be not forced into taking part in a research study. However, there may sometimes be individual exceptions to child assent guidelines, including when experimental treatments for a life-threatening disease are under consideration. These circumstances are handled on a case-by-case basis.

Helpful Resources:

NCI - Children's Assent

Columbia University - The Assent Process with Minors

University of Illinois - Assent from Children

eCFR - 45 CFR 46.402

HHS - Research with Children FAQs

NIH - Child assent and parental permission in pediatric research

Penn State - IRB Guideline I - Parental Consent and Child Assent

Human Subjects Research Office - The Informed Consent Process with Children