A female patient specifically indicates on a consent form that she doesn't want medical students to treat her. Despite her wishes, the supervising doctor lets a trainee participate in her surgery. The procedure ends with her esophagus having been torn. Now what?

This is a real scenario; it happened in December 2000 in an Indiana hospital. In that case, the court found for the hospital in ruling that the standard of care had been sufficient, skirting the issue of consent. Don't count on dodging a bullet. You'd do much better to implement protocols for flagging qualified consents and acting on them appropriately.

But when is consent truly informed? Who is in a position to grant informed consent? And what does informed consent comprise?

Clinical consent
A physician has a duty to disclose to his patient enough information to make a decision about whether to undergo surgery, receive alternative treatment or refuse treatment altogether. Failure to do so can lead to a potential claim of negligence or even criminal battery. There are four general requirements for informed consent:

• The individual must have the capacity to make the decision;
• the physician must disclose information on the treatment or surgery in question, including the expected benefits and risks, and their likelihood of occurring;
• the patient must comprehend the relevant information; and
• the consent must be voluntary.

A major question that arises in informed consent cases is whether you've given the patient enough information for him to be considered fully informed when signing the consent form. The rule of thumb calls for the disclosures a reasonable medical practitioner would make under the same or similar circumstances. Generally speaking, that means you should address the following factors:

• nature and purpose of the proposed treatment or surgery and the desired outcome;
• likelihood of success;
• risks involved;
• alternatives available and the benefits and risks of those alternatives; and
• consequences of the patient's choosing not to consent.

A patient's express consent isn't required in every situation; consent is usually waived or implied in an emergency situation if a delay in treatment needed to obtain the patient's consent would result in considerable harm to the patient. Common issues

This exception will rarely come into play in an outpatient surgery facility, however. Certain issues tend to present themselves in this context more often than others. Here are the major ones.

• Capacity to consent - minors. You'll usually obtain consent to treat a minor from a parent or legal guardian. State-by-state exceptions to this rule let minors consent on their own behalf, usually when the minor is emancipated or the nature of the treatment is sensitive (such as medical care related to pregnancy).
• Capacity to consent - impaired patients. If you doubt a patient's ability to fully comprehend the nature of treatment, have that patient also consult with another qualified physician to avoid the appearance of a conflict of interest. When doubts persist, seek the consent of a surrogate, most likely a relative (state law will be key in determining the extent of family involvement). Many of our clients err on the side of caution, routinely obtaining written consent from the patient and his spouse (or other close family member) when they suspect a problem with comprehension.
• Disclosing risks of refusing treatment. Be sure to advise patients of potential risks if the patient refuses the surgery or treatment. It's certainly not enough to merely document a patient's refusal of treatment. In a much-discussed California case, a physician informed a patient she should have a pap smear test, but didn't inform her of the risks involved if she refused. The patient refused on several occasions and later died of cervical cancer - and the court found that the physician could be held liable for failing to inform the patient of the potential risks involved.
• The danger of forms. Patient consent forms often contain spaces where patients can indicate preferences regarding treatment. In other cases, patients alter existing forms to reflect their desires. In a time when patient choice and rights are heralded, such patient input is reasonable, but imposes the added burden that you must actually read and act on such forms rather than merely filing them.

A shifting landscape
Though the necessity of obtaining informed consent as part of virtually all medical treatment is universally accepted, surgery centers and other practitioners must resist complacency when ensuring that it's actually obtained. State statutes frequently change, and new cases that define the standards that providers must live by are regularly being decided. Those providers who are nimble enough to monitor the changing standards and react to them will be those who see more of their patients and less of their lawyers.