Introduction
Informed consent is the process by which a competent patient, after receiving adequate information, voluntarily agrees to or refuses a medical intervention. It is the practical expression of respect for patient autonomy and a legal and ethical requirement before almost any examination or treatment. This topic covers the elements of valid consent, its historical background, decision-making capacity, forms of consent, exceptions, refusal and consent in research. Consent for minors and advance directives are dealt with in later topics.
Definition and core elements
Consent is valid only when several conditions are met together. It is not just a signature on a form but an ongoing communication between doctor and patient. The core elements are:
- Disclosure: the clinician gives the information a reasonable patient would need.
- Comprehension: the patient understands the information, which is checked by asking them to explain it back in their own words.
- Capacity: the patient is able to make this particular decision.
- Voluntariness: the decision is free from coercion, undue pressure or manipulation.
- Decision: an explicit agreement or refusal, which is documented in the medical record.