Risk Management

Most Frequently Asked Questions About Informed Consent

By James F. Holzer, JD

[Digest, Summer, 1992]

Q  Do I need to get informed consent for every single procedure I do?
A  This is actually a misleading question. The correct answer is that physicians must always get informed consent for every treatment, procedure or test, regardless of how simple. How extensive the documentation should be, however, will vary with the type of procedure being performed.

Most ophthalmologists who ask this question are really asking whether a form has to be used for every single procedure, and clearly the answer is no. Most surgical procedures requiring general anesthesia and selected major procedures under locals, including cataract extractions, should have the consent process comprehensively documented on a form. Consent for other minor treatments, including many brief office procedures, can generally be recorded as a thorough note in the patient’s chart.

It is important to remember that “patient consent” first occurs verbally during the process. The signature on a form, or entry on the chart, merely memorializes in writing the patient’s decision and the fact that the consent process took place.

Q  How much information do I ultimately have to convey about the risks of a procedure?
A  Unfortunately, the answer is “it depends.” Many states provide little guidance to physicians about the amount and type of information necessary to satisfy a legal challenge. Most jurisdictions now indicate that “material” information be disclosed to the patient. The term “material” generally means information that a particular patient might consider significant in deciding whether or not to undergo the procedure or treatment. The doctor is not required to be a mind reader or to provide a “minicourse in medical science.” Some courts have even formally opined about not making a consent obligation an “undue burden on physicians.” Clearly, many juries and courts may look at the manner and extent of the consent documentation more as an indicator of a doctor’s overall credibility with respect to the time and attention he or she spent with the patient.

Q  Have many malpractice cases been lost solely on the issue of informed consent?
A  No, because a legal allegation of improper consent is usually accompanied by numerous other complaints. Juries, as a general rule, do not have to specify which pieces of evidence or allegations they regarded as most significant in determining that a doctor was negligent. More often than not, problems surrounding the consent process are aggravating or complicating factors which interfere in the successful defense of a malpractice claim. That’s why documentation which shows good consent process can play a significant role in supporting the physician’s overall believability and credibility if a claim does go into litigation.

Q When should informed consent and accompanying documentation be obtained from the patient?
A For elective procedures, the process should be started at the earliest possible opportunity. Documentation should be ongoing in the patient’s chart. Signatures on a consent form should also be obtained at the earliest opportunity. However, completed forms that are more than three or four weeks old might be re-initialed by the patient prior to the procedure to ensure the patient has no further questions.

Q  Do I need a witness to sign the consent form?
A In most every situation and jurisdiction, there is no legal requirement or necessity to have a witness involved in the signing of a consent form. Witnesses are used primarily to testify that the signature on the form was indeed the patient’s. Frankly, in this day of expert handwriting analysis, very few patients ever allege that the signature is not theirs.

Witnesses can be valuable, however, if the legal competency of the patient is called into question such as with very sick, elderly or mentally disabled patients who may not fully understand the nature and scope of what they are signing. In most situations, it is a good idea to have a member of the patient’s family present during the consent process (with the patient’s permission of course).

Q  What do I do if a patient doesn’t want to know about the risks, benefits and alternatives, but wants the procedure done anyway?
A  Make a complete notation to this effect in the medical record and send a letter to the patient confirming your mutual understanding. Do not force the patient to sign the form merely to comply with hospital policy. Work out an alternative procedure with your hospital’s risk manager if the institution requires a consent form before permitting the O.R. to be used.

Q  How should I handle patients who refuse procedures or diagnostic tests that I believe are critically important to the patient’s life or well-being?
A  There is an emerging medicolegal doctrine called “informed refusal” which would require a physician to disclose to the patient the possible risks of refusing needed care. This doctrine generally is not applicable for most elective procedures and could well be interpreted as harassment if used every time a patient disagreed with a physician’s recommendation. But when certain clinical situations would otherwise indicate that the patient may be exposing himself or herself to significant harm, the patient’s refusal to have the test or procedure should be thoroughly noted in the chart. Some providers use a form requiring the patient’s signature, but physicians should be alert as to whether the use of such a form would be more antagonistic than helpful.