Understanding Informed Consent

The law implicitly recognizes that a person has a strong interest in being free from nonconsensual invasion of bodily integrity. In short, the law recognizes the individual’s interest in preserving the “inviolability of the person,” an interest protected within the context of medical malpractice with the doctrine of informed consent. It has long been accepted that a patient must agree to any procedures or treatment. However, earlier it was accepted that the physician could steer the patient in the direction that he or she wanted. This has changed: it is now recognized that “[I]t is the prerogative of the patient, not the physician, to determine the direction in which his … interests lie.” Consequently, a body of law that dictates the manner in which the patient’s consent or refusal needs to be obtained has developed. Some consider the right to informed consent to be the most important aspect of patients’ rights.

If patients are to intelligently exercise control of their bodies and attendant medical care, they must be provided with appropriate and complete medical information on which to base their decision. The dilemma facing medical practitioners is the determination of when such informed consent needs to be obtained and the manner in which to obtain it. This requires knowledge of the type and extent of information to be given to an individual patient and the manner in which it is to be presented.

Although the vast majority of claims of medical malpractice focus on errors in diagnosis and improper treatment and performance of procedures, a recent analysis found that allegations of failure to inform and breach of warranty were present in 6% of cases.

The Legal Framework for Informed Consent

Complete informed consent should be obtained for all therapeutic and diagnostic procedures. Any course of treatment that carries with it the risk of permanent injury requires a full disclosure before consent. Full informed consent should precede medical treatment even for procedures with a risk of temporary injury alone. Only under emergency conditions or in situations in which there are no therapeutic options should informed consent be omitted. There is no excuse to fail to obtain informed consent for an elective procedure.

The physician performing the procedure is the appropriate person to meet with the patient. Of course, other health care providers are of great assistance to reaffirm the consent, answer additional questions a patient may have, and continue a dialogue. To enable a patient to make an informed decision, “the physician owes to his patient the duty to disclose in a reasonable manner all significant medical information that the physician possesses or reasonably should possess that is material to an intelligent decision by the patient whether to undergo a proposed procedure.” The specific law varies somewhat from jurisdiction to jurisdiction. Use of this language facilitates discussion of the two perspectives involved in the decision-making process: the physician and the patient.

Role of the Physician

The major role of the physician in the process of obtaining informed consent is that of an expert. Through education and experience, the physician is able to recognize the risks and benefits of the proposed treatment. Because the patient has limited knowledge of the medical and technical aspects of the procedure, the physician should begin the discussion with a reasonable explanation of the medical diagnosis—an obvious but often overlooked point. Thereafter, significant information includes the nature and probability of risks involved in the procedure, expected benefits, the irreversibility of the procedure, the available alternatives to the proposed procedure, and the likely result of no treatment. Whether a physician has provided appropriate information to a patient generally will be measured by what is customarily done or by the standard of what the average physician should tell a patient about a given procedure. It often is essentially the same information that the physician has imparted to countless previous patients. In general, the duty to disclose does not require the physician to disclose all possible and/or remote risks, nor does it require the physician to discuss with a patient the information that he believes the patient already has, such as the risk of infection or other inherent risks of a procedure.

Recent studies have focused on the manner in which informed consent is obtained. For example, in a prospective, randomized, controlled study conducted by Bennet and colleagues, 99 out of 109 patients undergoing imaging-guided spinal injections agreed to particpate and were assigned to one of three groups. The control group was given informed consent in the customary manner at the investigators’ institution with 12 key points of consent discussed conversationally. The “teach-the-teacher” group had to repeat the 12 key points back to the investigator before informed consent could be completed. The third group viewed a set of diagrams illustrating the 12 key points before signing the informed consent. Following the procedure, all participants completed a survey to test knowledge recall, anxiety, and pain during the procedure. Statistically significant results included a lower survey score for the control group. Not surprisingly, it took significantly longer to obtain informed consent in the “teach the teacher” group than in the control group or in the diagram group. Overall, the diagram method was optimal and required less time and had improved patient-physician communication.

The manner in which information is given and how much information is offered, are both important considerations. Too much information may actually increase anxiety just prior to a procedure. A recent review on informed consent in Pain Practices found that although “disclosure has improved, but is still uneven, comprehension is often poor, for both patients and research subjects.” An important factor is not only the improvement of consent forms, but also improving the consent process. A group of Swiss researchers studied the effect of combined written and oral information versus just oral information when obtaining informed consent. In this study, participants who were given the written information as well as the oral instructions rated the quality of information they received as higher than the oral-only group.

Role of the Patient

Although explanations to patients may be nearly identical for a given procedure, the law often also requires that the conversation be tailored to the particular patient. It is incumbent on the physician to have an appreciation of what information is important to a particular patient. The patient has the right to know all information that he or she considers material to his or her decision. Materiality is defined as the significance a specific patient attaches to the disclosed risks in deciding whether to undergo the proposed procedure. Materiality of information about a side effect or consequence is a function not only of the severity of that consequence, but also of the likelihood that it will occur. Remote risks whose likelihood of occurrence is not more than negligible need not warrant discussion. In summary, provide the patient with a realistic appreciation of his or her medical condition and an appropriate explanation of the treatments available. Never forget that however unwise his or her sense of values may be in the eyes of the medical profession, every patient has the right to forgo treatment or even cure if it entails personally intolerable consequences or risks.