Research with Children & Adolescents

For research involving children or minors (<18 years of age), the federal regulations require that assent of the minor child and the permission of the legal parent/guardian are received.

Developing Parental/Guardian Consent

The Parental/Guardian Consent generally includes the same elements of a research consent form, but is directed to the parent/guardian of the minor. Informing the parent/guardian of the purpose of the study, why their child fits the study inclusion criteria, steps for human subject protections, and benefits/risks should be provided.

Template Consent Form (Researchers are free to use this template as a guide to develop their parental/guardian Consents.)

What is assent?

“Assent” means a child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. This means the child must actively show his or her willingness to participate in the research, rather than just complying with directions to participate and not resisting in any way. A child’s authority to say “No” to participate in research. 45 CFR 46.402(b), 21 CFR 50.3(n)
Why must IRBs and researchers consider assent?

Federal regulations require, “The IRB shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent.” The IRB must make the determination for each protocol that includes children. The IRB must require child assent unless it can be appropriately waived. 45 §46.408 & 21 § 50.55
Sample Assent Forms
- Assent Template
  - Sample of Completed Template

Developing the Child/Minor Assent

Important: The process of getting assent from the child participants should be provided in the IRB application. Assents can be verbal or in written format (depending on the age of the participant). Use the following guidelines to develop your child assent plan.

Suggested Approaches for Child Assent

Children less than 5 years of age
- A simple oral explanation of the study should be offered to the child before study-related procedures are conducted. A signed Parent/Guardian form is required as well.
- Researchers should let the children know they can ask to stop their participation at any time.
Children between the ages of 5 and 12 years
- Informed voluntary assent should be obtained without pressure from parent/guardian or investigator. The protocol review package should include an example of the explanation to be offered to the child. A signed Parent/Guardian consent form is required as well.
- Researchers should give children the opportunity to verbalize their willingness to participate and respect that choice.
- Researchers should let the children know they can ask to stop their participation at any time.
Children between the ages of 12 and 17
- Investigators should submit a permission form for parents and a separate assent form for the child (suggested 6^th grade reading level) to read and sign. An assent form should be written as simply as possible and cover the following points.
  - What is the study about
  - Why he/she qualifies for the study
  - The voluntary nature of the study
  - The procedures that will be done
  - Potential benefits and potential risks
  - An assurance that he/she will be treated the same whether or not he/she agrees to join the study
  - An invitation to ask questions
  - Assurance that he/she may withdraw from the study at any point

Resources retrieved and adapted from Virginia Tech.

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