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Patients may not be able to precisely remember all the facts disclosed during a discussion. Therefore, a physician must document the content of informed consent sessions.
- The informed consent discussion and its documentation should be done by the physician who is going to perform the procedure.
- By delegating the responsibility of obtaining consent to someone else, the physician is not exempted of liability if that consent session is incomplete or ineffective.
- The physician should note the date and time of the written summary of what was said and to whom. Presence of relatives, friends or support staff such as nurses or interpreters should be documented.
- All elements of the discussion should be written down: Diagnosis, proposed treatment with its risks and benefits, and alternative treatments with their risks and benefits.
- It does not suffice just to state that ‘the risks and benefits were discussed’ in the absence of further description of the specifics.
- The physician should write down that the patient understood the concepts that were discussed, and agreed to move further.
- The physician should also document that the patient was provided with appropriate literature, the patient had the opportunity to ask questions, and that the questions were answered.
- In its generic form, the standard consent document means little. The real work of obtaining informed consent is documented in office or in hospital notes.
- Documentation is of particular significance when patients refuse an intervention. The physician must document the specific risks associated with delay or refusal which were disclosed.
- In situations where informed consent cannot be obtained, such as due to an emergency situation or diminished capacity due to intoxication, trauma or disease, physicians must document in the written record the facts that were considered in ascertaining the patient’s ability to process information and make reasonable decisions.