Table 4.

American Medical Association definition of informed consent

Informed consent is more than simply getting a patient to sign a written consent form. It is a process of communication between a patient and a physician that results in the patient’s authorization or agreement to undergo a specific medical intervention.
In the communications process, you, as the physician providing or performing the treatment and/or procedure (not a delegated representative), should disclose and discuss with your patient:
• 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.
• Alternatives (regardless of their cost or the extent to which the treatment options are covered by health insurance).
• The risks and benefits of the alternative treatment or procedure.
• The risks and benefits of not receiving or undergoing a treatment or procedure.
In turn, your patient should have an opportunity to ask questions to elicit a better understanding of the treatment or procedure, and therefore, he or she can make an informed decision to proceed or refuse a particular course of medical intervention.
This communications process, or a variation thereof, is both an ethical obligation and a legal requirement spelled out in statutes and case law in all 50 states. (For more information about ethical obligations, see the American Medical Association’s Code of Medical Ethics contained in the American Medical Association Policy Finder. Providing the patient relevant information has long been a physician's ethical obligation, but the legal concept of informed consent itself is recent.
The first case defining informed consent appeared in the late 1950s. Earlier consent cases were based in the tort of battery, under which liability is imposed for unpermitted touching. Although battery claims occasionally occur when treatment is provided without consent, most consent cases generally center around whether the consent was informed (i.e., whether the patient was given sufficient information to make a decision regarding his or her body and healthcare). Because informed consent claims, unlike battery claims, are based in negligence, they generally are covered by liability insurance.
To protect yourself in litigation, in addition to carrying adequate liability insurance, it is important that the communications process itself be documented. Good documentation can serve as evidence in a court of law that the process, indeed, took place. A timely and thorough documentation in the patient's chart by the physician providing the treatment and/or performing the procedure can be a strong piece of evidence that the physician engaged the patient in an appropriate discussion. A well-designed, signed informed consent form may also be useful, but an overly broad or highly detailed form actually can work against you. Forms that serve mainly to satisfy all legal requirements (stating, for example, that all material risks have been explained) may not preclude a patient from asserting that the actual disclosure did not include risks that the patient, unfortunately, discovered after treatment. At the other extreme, listing all of the risks may not be wise either. A comprehensive listing will be difficult for the patient to understand, and any omission from the list will likely be presumed undisclosed. If you are using a form that contains a list, consider, with your attorney, inserting language indicating that the list is not exclusive (such as included but not limited to) before the list begins. Medicare-participating physicians must also be cognizant of Center for Medicare and Medicaid Services' requirements for informed consent.
Again, this general knowledge can be used when you ask for additional information and advice from qualified attorneys and/or other professional consultants. If you need a referral to a qualified attorney, please contact your state medical society.