Minors aged 15 to 17 cannot give adult consent but are normally asked to sign an assent form using the same language and information contained in their parent's consent form. Any project involving minors requires a signed consent form from either the child's parents or legal guardians before approaching the child for assent. Certain populations, such as non literate or vulnerable individuals, may require special informed consent procedures. A statement of oral consent must include the elements of a Written Consent Form and be signed by the participant and by a witness who observes the oral presentation of the material and the participant's signature. Every request for a waiver of Informed Consent must be accompanied by a rationale for the request.
Federal rules permit consideration of such a request only under the following two conditions.
The only record that links the subject to the research is the signed consent form and the principal risk to the subject would be a breach of confidentiality. In this case the subjects must be asked if they want to sign a consent form that links them to the research or if they do not wish to sign such a form. Subjects' wishes will govern as to whether or not they sign consent forms in these cases. The research presents no more than minimal risk to the subject and involves no procedures for which written consent would be required outside of the research context. In cases where the requirement for a signed written consent form is waived by the HRC, the HRC may require the investigator to provide subjects with a written statement about the research, e.g., an information letter that contains the information normally in a consent form but with no signature line.