The means of obtaining assent from minors must be appropriate for the age ranges and levels of mental development found within the proposed subject pool. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research expects that assent be requested from children who are 7 years of age or older. However, for children between the ages of 7 and 18, the appropriate method for obtaining assent will vary. A simple oral description of the child's involvement is given to the subject and oral assent is requested. The procedure may be documented on the informed consent form by the presence of the signature of a witness.
Verbal assent is requested.
The procedure may be documented on the informed consent form by the signature of a witness. Although age is used as the primary criteria in determining an appropriate means of obtaining assent, factors such as literacy and mental development must also be considered. The need for flexibility in the methods for obtaining assent from minors is universally recognized. Because a single method of obtaining assent may not be appropriate for all potential subjects, investigators may need to be prepared to use different approaches with different subjects. As in any consent process, the primary concern is that the subject is able to understand the explanation that is presented.