Mentally Disabled Person
A mentally disabled person (sometimes referred to as an incompetent subject) is an individual who has either been adjudicated to lack the capacity to give informed consent or who lacks the capacity to give informed consent.
The following must be considered when conducting research with mentally disabled persons:
• 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.