AP PSYCHOLOGY

Detailed explanation-1: -Exceptions to Informed Consent Several exceptions to the requirement for informed consent include (1) the patient is incapacitated, (2) life-threatening emergencies with inadequate time to obtain consent, and (3) voluntary waived consent.

Detailed explanation-2: -In principle, only persons able to freely understand and question, should consent. Vulnerable persons like mentally-deficient persons, severely-injured patients, etc should be excluded.

Detailed explanation-3: -The Regulations specify that for a minor (a person under the age of 16 years) to participate in a clinical trial, a person with parental responsibility or a legal representative must give informed consent and may withdraw the young person at any time.

Detailed explanation-4: -Mentally disabled participants and the competent adults acting on their behalf must be given the same information that is generally required when informed consent for participation in research is sought, and their permission and assent must be documented in writing.