Informed Consent: Remember Your Obligations

An inpatient psychiatrist was baffled and indignant when a patient’s legal advocate lodged a complaint accusing the psychiatrist of violating the patient’s informed consent. On the psychiatrist’s unit, patients are placed on a level system with level one being the most restrictive and level four, the least. Patients on level one are restricted to the unit, while those on level four can access the hospital grounds without staff supervision. Levels in between one and four involve periods of staff supervision when patients leave the unit for any activity. The legal advocate’s patient was stuck on level two because, as stated by the psychiatrist, the patient had refused to accept prescribed psychotropic medication. The psychiatrist had tied access to increased freedom with acceptance of prescribed medications.

Informed consent is a process for getting permission from individuals before conducting a health care intervention on them or disclosing their personal information. One of the cardinal principles of medical ethics, informed consent reflects physicians’ respect for the individuals we treat, and affirms the autonomy of patients to make decisions regarding the acceptance or rejection of recommended treatment. Providing treatment interventions without obtaining informed consent not only is unethical but also could be illegal; the offending physician could attract charges of malpractice or battery. Merely having a patient sign a consent form before commencement of treatment is not obtaining an informed consent. A valid informed consent must satisfy three elements: type and amount of information provided to the patient, voluntariness of the patient’s decision-making, and the patient’s competence to make the requisite decisions. The most important exception to obtaining informed consent is in emergency situations.

As medicine becomes increasingly complex, leaflets describing side effects now run several pages, from the serious to the mundane. Most psychiatrists do not have time to discuss the detailed information contained in the leaflets with patients and often wonder about how much information to share. Additionally, psychiatrists worry that discussing potentially serious or lethal side effects could scare patients from accepting lifesaving care. The concern is understandable but irrelevant. The required standard for what information to share with patients is what an average person would like to know about the proposed treatment, not what an average physician would like to share—Reasonable Person Standard versus Professional Standard. At minimum, a reasonable person would want to know the risks and benefits of the proposed treatment, the risks and benefits of alternative treatments, and the risks and benefits of no treatment. A rare side effect of a proposed treatment may not be discussed unless it is associated with severe morbidity or mortality.

It is important that an informed consent be freely given without any elements of coercion or manipulation. The case scenario described earlier exemplifies the challenges involved. It would be understandable if the patient described were held at level two due to concerns of physical aggression while off the unit. It is also understandable that consistent adherence to prescribed medication could decrease the risk of aggression. However, the patient still retains the right to refuse medications and should not be punished for exercising that right. Policies or incentives that coerce/manipulate patients to accept medications they do not want just so they can access more freedom or other privileges are problematic as they infringe on the patients’ autonomy and chip away at their ability to provide informed consent. It is preferable to state that the patient was on level two due to risk of aggression while continuing to encourage the patient to voluntarily accept all interventions that could decrease aggression, including psychotropic medications.

Finally, for a consent to be informed and valid, the patient must demonstrate sufficient present ability to appropriately manipulate information provided and to understand the nuances of the discussion. In other words, the patient must be competent. A patient’s competence to make decisions could be negatively impacted by cognitive deficits (congenital or acquired), developmental or intellectual disability, age of maturity (for children), and psychosis or severe mood disorders. The rights of patients with impaired capacity to give informed consent are protected by the appointment of a substitute decision-maker, a conservator or a guardian, by the probate court. Notably, however, competence assessment for decision-making is often dependent on the seriousness of or risks associated with a task. For example, the competence needed to provide consent for admission into a psychiatric hospital is quite different from that needed to consent to ECT or vagus nerve stimulation.

An issue that occurs frequently on inpatient units is the administration of medication when a patient assents rather than consents. Far too little effort is expended to determine if a patient who agrees (assents) to take prescribed medication has the capacity to consent to it. Only when such patients begin to refuse treatment do the staff determine their incapacity and subsequently apply to the probate court for approval of medication over the patients’ objection. While this practice is rampant and difficult to change given the sheer volume of seriously ill patients in need of treatment, psychiatrists should be alert to complicated situations where they should apply for a substitute decision-maker even if the patient assents to treatment. Respecting the personhood of our patients and enhancing their autonomy are important ethical obligations we should strive to uphold even in challenging situations. ■

Charles C. Dike, M.D., M.P.H., is chair of the APA Ethics Committee and former chair of the Ethics Committee of the American Academy of Psychiatry and the Law. He is also an associate professor of psychiatry; co-director of the Law and Psychiatry Division at the Yale University School of Medicine; and medical director in the Office of the Commissioner, Connecticut Department of Mental Health and Addiction Services.