Characteristics of the Child/Youth Form, Non-Therapeutic Research

Characteristics of the Child/Youth Form, Non-Therapeutic Research
The appropriate method for obtaining assent from children and youth will vary depending on the age of the subject.

Federal regulations require that assent be obtained from children who are 6 years of age and older. The means of obtaining assent from children and youth, ages 6 through 18, must be appropriate to the age ranges and levels of mental development of the prospective subject pool. Although the method for obtaining assent will vary depending on the age of the subject, these are the characteristics that must be considered:

For children ages 6-7, a simple oral description of the study should be given to prospective subjects. The investigator should ask the child for verbal assent. The assent procedure may be documented on an assent form by the presence and signature of a witness.

For children/youth ages 8-18 a more complete description of the research should be given. The investigator should request verbal assent. The assent procedure may be documented on an assent form by the presence and signature of a witness.

A parent or guardian may not be a witness for a child’s verbal assent document.

The required elements of the assent form should be arranged sequentially in numbered sections.

The language, written at the age-appropriate level for the child, must be non-threatening and non-coercive.

Include a statement explaining that the child should consult with his/her parents and/or legal guardian before deciding whether or not to participate in the study.

The investigator must explain that the decision the child/ youth makes to participate in the study is voluntary.

State if the child will (or will not) receive a gift or payment for participating in the study.

State that the information obtained from the study will be confidential, and how confidentiality will be maintained.

Children must also be informed that they can withdraw from participating in the study at any time.

Older children and youth should be told their rights as research subjects, and provided contact information for the IRB.