Obtaining assent from children or youth as research participants means that the investigator is obtaining the agreement of the child to participate in the research. Additionally, because children cannot legally give consent on their own behalf, consent of their parent(s) or a legal guardian also is required before children and youth can participate in research projects. Note: in the state of Nebraska consent and assent must be obtained for all subjects age 18 and younger.
Obtaining Parental Consent
Follow these guidelines for obtaining parental consent for children as research subjects.
- If the proposed research involves no more than minimal risk, or the research is of possible direct benefit to the child, the consent of one parent is required.
- If the research involves greater than minimal risk without direct individual benefit, permission must be obtained from both parents unless there is only one reasonable available parent, or when only one parent has legal responsibility for the care and custody of the child.
See the Characteristics of Parental Consent and the Sample Parental Consent Form for Non-Therapeutic Research.
Procedure for Obtaining and Documenting Assent
The means of obtaining assent from children must be appropriate for the age ranges and levels of mental development of the proposed subjects. The National Institutes of Health proposes the following guidelines:
- Age 6-7: A simple oral description of the child’s involvement in the research is given to the child, and verbal assent is required. The procedure may be documented on the informed consent form by the presence and signature of a witness.
- Age 8-13: A more complete oral description of the research using layman’s terminology is given to the child. Verbal assent is required. The procedure may be documented on the informed consent form by the presence and signature of a witness.
- Age 13-18: Written assent is required using age-appropriate and background-appropriate documents.
Although age is used as the primary criteria to determine the appropriate procedure for obtaining assent, factors such as literacy and mental development must be considered. Because a single procedure for obtaining assent may not be appropriate for all potential subjects, investigators should be prepared to use different approaches with different participants.
The primary goal of assent is that the participant is able to understand the explanation of the study as presented. The requirement for a witness to document verbal assent procedures depends on the complexity of the research and the risks to the potential subjects.
A parent or guardian may not be the witness for a child’s verbal assent document. A child’s deliberate objection should be regarded as a veto of their involvement in the research.
Review the Characteristics for Obtaining Child/Youth Assent and the Consent/Assent Checklist before submitting protocol to the IRB.
See Sample Child Assent Form for Non-Therapeutic Research and Sample Youth Form for Non-Therapeutic Research.