Make sure your patient's consent is truly informed

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The concept of informed consent stems from the principle that a patient has the right to prevent unauthorized contact. Thus a physician has a duty to disclose information so the patient can make a reasoned decision regarding treatment.

This is a legal principle, stemming from a 1914 New York Court of Appeals case, Schloendorff v. Society of New York Hospital. In that case, the plaintiff, Mary Schloendorff, consented to being examined under ether to determine if a fibroid tumor was malignant. It was, but she withheld consent for removal. The doctor removed it despite her protest. Schloendorff sued the hospital (not the physicians who treated her), and won.

Justice Benjamin Cardozo wrote in the opinion: "Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient's consent commits an assault for which he is liable in damages. This is true except in cases of emergency where the patient is unconscious and where it is necessary to operate before consent can be obtained."

Legal requirements for consent vary by state. To avoid confusion, and a possible lawsuit, physicians would be wise to follow the AMA's guidelines for informed consent and to document every part of the process.

The guidelines state the informed-consent discussion should include:

• The patient's diagnosis, if known.
• The nature and purpose of a proposed treatment or procedure.
• The risks and benefits of a proposed treatment or procedure.
• Treatment alternatives, regardless of their cost or the extent to which they are covered by insurance.
• The risks and benefits of those alternatives.
• The risks and benefits of not receiving a treatment or undergoing a procedure.

The patient should have the opportunity to ask any questions or discuss any concerns. The physician should use lay terms and ensure the patient understands what is being said.

All of this dialogue should be memorialized in writing.

In many states, written documentation of the patient's verbal consent is treated as presumptively valid consent, with the burden on the patient to rebut the presumption.

This written documentation should exist in two forms.

First, the communication process should be documented and included in the patient's file. This documentation should be written by the physician treating the patient, or the physician who will be performing a procedure. Including this in the patient's file is strong evidence that the physician engaged the patient in a meaningful discussion.

Second, the patient should sign and date the informed consent form. One copy should be given to the patient, and another placed in the patient's file. The following is a template of an introductory paragraph I often use when drafting an informed consent form for a practice:

"It is very important to ABC Medical Group and Dr. Jones that you understand and consent to the treatment Dr. Jones, his assistant, or his designees will be rendering. Please sign this form only after you understand the procedures, the anticipated benefits, the risks, the alternatives, and the risks associated with the alternatives, and all of your questions have been answered. By signing and dating this agreement, you are indicating you understand this agreement and consent to the procedures recommended by Dr. Jones."

A well-designed, signed informed consent form can be useful in documenting the communication process. However, an overly broad or overly detailed form could work against the physician. For example, listing all possible risks associated with a procedure might be difficult for a patient to comprehend. But any omission might be presumed as nondisclosure.

I explicitly indicate a list of risks is not exhaustive: "The risks of procedure X include, but are not limited to, A, B, C, D, E and F."

Additionally, it is strongly recommended that the informed consent form be signed by a witness who attests to the fact that the patient has read the form, or had it read to him or her. The witness also attests the patient understands the information and has no further questions. That can be powerful evidence.

Harris, a partner at McDonald Hopkins in Chicago, concentrates on health care law and has counseled physicians, physician networks and health care groups nationally. The author and publisher are not rendering professional advice and assume no liability in connection with its use. He can be reached at 312-280-0111, or by e-mail (sharris@mcdonaldhopkins.com).

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