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Patients may not accurately remember all the facts disclosed in a discussion. Thus, a physician must document the content of informed consent sessions.
- The informed consent discussion and its documentation should be done by the physician who will be performing the procedure.
- Delegating the responsibility to obtain consent to someone else does not absolve the physician 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 noted.
- All elements of the discussion should be reduced to writing: Diagnosis, proposed treatment with its risks and benefits, and alternative treatments with their risks and benefits.
- It is not sufficient to state that “the risks and benefits were discussed” without further description of the specifics.
- The physician should document that the patient understood the concepts as discussed, and agreed to proceed.
- In addition, the physician should document that the patient was provided with appropriate literature, the patient had the opportunity to ask questions, and that those questions were answered.
- The standard consent document means little, particularly in its generic form. The real work of obtaining informed consent is documented in office or in hospital notes.
- Documentation is particularly important when patients refuse intervention. The physician must note in the record the specific risks associated with delay or refusal which were disclosed.
- When informed consent cannot be obtained due to an emergency situation or diminished capacity due to intoxication, trauma or disease, physicians must document in the written record what facts were considered in determining the patient’s ability to process information and make reasonable decisions.