Components of informed consent:
(1) A complete description of the procedure or treatment to be performed.
(2) The material risks and hazards of the procedure or treatment that a "reasonable person" would want to know about the procedure/treatment that might influence the decision whether or not to undergo the procedure.
(3) The expected benefits of the procedure/treatment.
(4) The consequences of not undergoing the procedure/treatment.
(5) Alternatives to undergoing the procedure/treatment, including not having anything done.
The person giving consent must be the patient (if capable and competent) or an agent legally able to give consent on behalf of the patient (guardian, court appointed decision maker, other).
Operational features:
(1) The consent should be in writing and signed by the patient or other person giving consent.
(2) The consent should be obtained by the physician.
(3) The patient should have sufficient time to reach a decision.
(4) The patient should have an opportunity to ask questions.
(5) The discussion may be done in the presence of a spouse or family member.
(6) The signatures should be witnessed by someone who is competent and capable to serve as a witness.
Common failures:
(1) Having someone other than the physician obtain the permission.
(2) Pressuring the patient.
(3) Failure to disclose a pertinent risk.
(4) Obtaining the consent after the patient has been medicated.
(5) Not choosing a suitable time or environment (public, immediately before a procedure, other)
(6) Failure to preserve the consent in the medical record.
