Mr. D, age 45 with a history of schizophrenia, is admitted to an inpatient psychiatric unit. The psychiatrist recommends an antipsychotic to help Mr. D with fears that the FBI has implanted a radio signal device into his tooth filling. She explains the risks and benefits of the proposed drug and alternate medications, as well as the risks of no treatment.
Mr. D calmly but consistently declines the treatment. He states that he recognizes the antipsychotic is used to treat psychotic symptoms, can help people who hear voices, and can have side effects such as tardive dyskinesia. His thoughts become disorganized and difficult to follow, however, as he explains that he does not believe the medication is needed for his situation because the FBI is involved in tracking his behavior.
Informed consent in clinical settings is designed to allow patients to make rational choices about their treatment before it begins. When a psychiatric patient such as Mr. D declines a treatment you recommend, how can you balance the 2 ethical principles in medicine: beneficence toward the patient and respect for individual autonomy?1
Some authors have raised concerns that informed consent in physician-patient interactions are at times an empty exercise undertaken solely to satisfy a legal expectation.2 If executed properly, however, informed consent can enhance the therapeutic alliance and help improve treatment adherence.
Patient-centered treatment
As patients have become more informed consumers, the “doctor knows best” model of care has given way to an expectation that patients know best what they would want done regarding their health. Lawsuits related to informed consent generally allege that physicians failed to provide appropriate informed consent for treatment the plaintiffs received. These complaints suggest that had the patient been more appropriately informed, he or she might have made a different choice and would not have suffered harm related to treatment.
In a patient-centered approach to treatment, informed consent allows the patient to make an autonomous decision with the appropriate information. Providing treatment without the patient’s expressed consent could be viewed more seriously, potentially even as battery.3 Recent informed consent cases tend to rely on negligence theories, however, rather than on claims of battery. Negligence cases helped set the stage of evolving expectations—first seen with surgical procedures, then medical interventions, then medication treatment, and now even with psychotherapy (Box 1)—that informed consent should be obtained in clinical settings.4
How to reduce risk when obtaining informed consent
Because failure to provide informed consent can be grounds for a negligence claim, consider strategies to reduce the chance of successful litigation.
Although a written form can provide some proof that informed consent occurred, it may not prove that you conveyed adequate information or that your patient understood the information. Overly simplistic or complex forms can pose other difficulties in malpractice claims. Documenting aspects of the informed consent dialogue often provides the best “proof” that such a conversation occurred.
In retrospect, helpful evidence that adequate informed consent was obtained may include information related to the disclosed information and the patient’s response to the information (such as might be seen in a quote that indicated his or her understanding of a particular side effect). Although a full accounting of the conversation would not be a reasonable expectation for documentation, you might wish to consider the risks and benefits inherent to the particular treatment and tailor the note related to the informed consent accordingly.
3 components of informed consent
Informed consent includes 3 components: voluntariness, disclosure, and competence.5
Voluntariness implies that the patient must make treatment-related choices of his or her own free will and without coercion. In Kaimowitz v Michigan Department of Mental Health,6 the court ruled that involuntarily committed persons living in what was considered an inherently coercive institutional environment were not capable of providing voluntary consent to a high-risk experimental procedure. This case had a major impact on prison research.
In treatment settings as well, a patient’s circumstances might be considered coercive. Historically, civilly committed patients did not have the right to refuse treatment. A movement in the 1980s helped to separate civil commitment and the right to refuse treatment, which is well-established in most jurisdictions today.7 In psychiatric inpatient settings, even an involuntarily committed patient generally has a right to refuse recommended medications unless a legally permissible mechanism overrides the refusal.
Disclosure means that a person requires certain information to make a rational decision to accept or reject treatment. The question is: How much information needs to be disclosed for a patient to be adequately informed?