• Assuming informed consent has been obtained from an appropriate guardian or
supervising agency, an incompetent subject may participate in research involving
greater than minimal risk only if there is an acceptable level of direct therapeutic
benefit to the subject.
• Assuming informed consent has been obtained from an appropriate guardian or
supervising agency, an incompetent subject may participate in research involving
slightly above minimal risk without direct subject benefit.
Consent/Assent Procedures: Individuals who lack the capacity to give informed consent cannot participate as a research subject unless proxy consent is obtained. A legally authorized representative of the potential research subjects includes the parent or parents having custody of the person, the legal guardian, or any individual with power of attorney or durable power of attorney who is authorized to consent on behalf of a prospective subject. Researchers also should obtain assent from prospective subjects to participate in the study. The procedure and/or form used are similar when children and youth are being sought as subjects.
