Risk
Management
Reference Library
Informed Consent
The
informed consent process educates patients to bring them to a level of understanding and
involvement so that they can make decisions concerning their care and treatment. Informed
consent is the authorization given by one individual (patient or patient representative)
which allows another individual (provider) to do something after a reasonable transfer of
information has occurred. Informed consent is not the piece of paper signed by the
patient, or the patient's representative. The patient should be made aware of the nature
of the procedure, the risks associated with the procedure, the alternative(s) to the
procedure and the risks associated with the alternative(s). Only when this information is
communicated through direct discussion and understood are patients
"informed" and competent to give their consent. Informed consent needs to be
documented.
Informed consent is the responsibility of the physician and can not be delegated. Informed consent involves the disclosure of the following information: 1) diagnosis, 2) treatment plan, 3) treatment options, 4) material risks and complications, and 5) anticipated outcome. It is acceptable to use a written consent form after discussing the necessary elements of informed consent with the patient and/or the patient's representative. If you do not use a form, be sure to make an entry in the record such as "nature, alternatives, risks of procedure/treatment discussed, patient understands and accepts," or "patient advised of proposed treatment and potential risks, understands and accepts." In addition, it is important to discuss and document these patient responsibilities: 1) adherence to instructions, 2) compliance with recommendations, and 3) notification of signs/symptoms of complications.
You may find that a patient's understanding of a procedure increases if the patient receives written information, views a videotape or listens to an audiotape. There are also computer software packages designed for use by the patient in the physician's office that provide information about a proposed procedure. The teaching aide materials used should be on file in the office and the information documented in the patient's chart. Even when using such patient education materials, you are required to have a face-to-face meeting with the patient to discuss the procedure and answer any questions.
An extension of informed consent is informed refusal. Patients have the right to refuse to undergo a recommended procedure or diagnostic study. If a patient elects not to follow medical recommendations, the physician has an obligation to explain to the patient the possible consequences of that decision. When a patient chooses not to consent to a procedure, that information should be documented in the chart and should include a description of the possible outcomes that might occur if the procedure is not done. Under those circumstances, you may want to ask the patient to sign a form stating that, although a certain procedure is recommended and has been explained, they have refused to consent.