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Bringing common sense to informed consent
by: LAWRENCE M. SHUER
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In the recent past, questions have arisen regarding the consent form we have used at the medical center, as well as our policy for obtaining informed consent. To study the issue, a task force was convened about two years ago and has proposed some revisions to our informed consent policy as well as the form itself. The revised policy was recently approved by all the appropriate boards and committees, including the ethics committees, operating room committees and medical boards of both Lucile Packard Children's Hospital and Stanford Hospital & Clinics.
The central idea of the revised policy is that informed consent is not a one-time event, but rather an ongoing communication process in which the physician or other clinician gives the patient the information he/she needs to make a well-informed decision about whether to proceed with a particular treatment. This information should include an explanation of the risks, benefits and alternatives to the recommended treatment or procedure. The patient's signature on the consent form indicates that the patient has been given the necessary information and has had all of his/her questions answered.
What is new for our institution is that the physician or other health-care provider who has explained the procedure and the risks, benefits and alternatives will sign the same form as the patient, thus documenting that the clinician has obtained the patient's informed consent. The form should be filled out at the time of the informed consent discussion, whether it occurs in the doctor's office, the patient care ward, the emergency room or another location.
Here at Stanford, we have had a somewhat unusual practice whereby a nurse - not the physician - asked the patient to sign the consent form and acted as a witness to the signature, even though the nurse is usually not present during the informed consent discussion. This practice led us to develop a separate attestation form to be signed by the clinician, indicating that he/she had indeed held that discussion.
With the new policy and form it is expected that the person obtaining the patient's signature will be the person signing as having given informed consent. Ideally this will be the person who is performing the procedure, or a resident or fellow who is part of the team performing the procedure. If the responsibility of obtaining informed consent is delegated to another member of the team, that person must have sufficient understanding of the procedure and the particular circumstances of the patient involved to obtain adequate informed consent.
The revised policy spells out who can give consent as well as what procedures should be followed in an emergency situation or when the patient is unable to give consent. It also includes a helpful algorithm regarding how to gauge what types of risks should be presented in the risk discussion. Suffice it to say that all major risks, as well as minor risks with a high probability of occurring, should be discussed with the patient. Minor risks and those with a low probability of occurrence should be discussed at the clinician's discretion, based on the assessment of the patient.
Some physicians may view this revised policy as an inconvenience because it places yet another demand on their time. But it is important to note that most hospitals around the country already obtain informed consents this way for a simple reason: common sense. It makes sense that the physician, and not a surrogate, should document the informed consent discussion because it is the physician's responsibility to conduct this discussion in the first place.
If you have comments or suggestions regarding the revised policy on informed consent, please contact Larry Shuer at lshuer@stanford.edu or give me a call at 723-5371.
