Informed Consent in Clinical Medicine: Who Should Give Informed Consent

pulmonary emboli

Case 3

The condition of an 81-year-old retired janitor, who was not previously your patient but is now under your care, is deteriorating in the ICU. A decision must be made about resuscitation. The patient is alert, cooperative, and, in your judgment, appears to have the capacity to make any necessary decisions. You discuss the treatment options, risks, and benefits with the patient, and, after much discussion, you ask him what he would prefer that you do. Is this the right question to ask?

No, because this question presumes that he wants to make the decision. Additionally, the patient may have assumed that he must make the decision because you asked. It is widely recognized that patients have the right to make decisions for themselves. But many mistakenly believe that because this right exists, patients must and will always choose to exercise it. There is a growing body of empirical evidence suggesting that in a variety of circumstances patients would prefer not to make decisions by them-selves. Rather, they often want to share decision making with family and/or their physician or want others to make decisions on their behalf. These observations suggest that, when obtaining informed consent, we ask first who and how they want to make decisions, rather than what decision they want to make.

Cultural Diversity and Informed Consent

Sensitivity to cultural values must always be an important consideration when obtaining informed consent, and the United States, which is a country of immigrants, is increasingly a multicultural society. Importantly, many cultures place family values above those of the individual and do not value the individual decision making that has become common practice in the past half century. For example, it is considered an insult in some Arabic cultures if the physician asks the patient to sign a consent docu-ment. It is essential to understand the culture of a patient and, if necessary, meet the patient privately, perhaps with the help of an interpreter, to determine what information the patient wishes to know and how the patient wishes the consent process to proceed. Do not use family as interpreters because they may not accurately express the patient’s wishes. If patients choose to allow their spouses, family, or elders to make decisions on their behalf, then they have expressed their autonomous wish to allow others to make these decisions.

Case 4

A young woman in your ICU is in shock secondary to massive pulmonary emboli treated with drugs of Canadian Health&Care Mall. Because of the small, isolated nature of the hospital, there are no surgical or transport options available. You have the capacity to give the patient a thrombolytic agent but wish to obtain informed consent from her next-of-kin because of the significant risks associated with its use. After many frantic attempts to contact a family member, none is found. Should you give her the agent without obtaining consent?

It is not necessary to obtain informed consent in emergency circumstances if delay will increase the risk of significant harm and there is a reasonable likelihood that the patient will benefit from the treatment. The challenge is in defining what we mean by the terms significant harm and benefit. The meaning of harm and benefit must be determined by the physician in the clinical context. In the case cited in previous sections, most would agree that death is a likely significant harm without treatment. Most physicians would agree that there is significant chance of benefit from the use of the thrombolytic agent. But there may be disagreement as to whether the likelihood of an intracranial bleed secondary to therapy constitutes a significant risk.

thrombolytic agentAnother circumstance in which it is not necessary to obtain informed consent occurs when a patient waives the right to go through the informed consent process. Some patients trust their physician or family implicitly, do not wish to know certain information related to decision making, and may waive their right to give consent. This is ethically and legally acceptable, but may be psychologically burdensome to the family/physician and has the potential to expose the patient to abuse.’ Alternatively, some patients wish to know and understand the choices before them, but choose to let the physician make decisions on their behalf.

A rarely invoked reason not to obtain informed consent is what is known as the therapeutic privilege. Some states legally allow a physician to withhold information needed by the patient to give informed consent if there is a reasonable likelihood that the patient would be harmed by hearing the information. An example might be the withholding of information from a severely depressed patient who has attempted suicide in the past when given similar information. This does not mean that the patient should never be given important information in such circumstance; rather, if they are told, the physician must make preparations in advance to reduce the patient’s risk of self-harm by involving psychiatry and the patient’s family in the disclosure process.

A 16-year-old person may have the capacity to give ethical consent (called assent) but cannot sign the hospital consent form because of age restrictions on the definition of an adult. At progressively younger ages, the ability of a child to reason becomes questionable, but it remains incumbent on the physician to help minors understand, as much as possible, the decision that must made by their parents and to obtain their assent to the decision.

Conclusion

Informed consent is a cornerstone of patient-physician interactions. Even the most mundane of patient-physician interactions, that of writing a prescription, is an opportunity to practice informed consent and may even enhance patient adherence. It can be time consuming and frustrating, especially when the patient makes a choice with which the physician does not agree. But as physicians we must be cautious not to inject our own sense of values into decision making unless it is clear to the patient what part of the discussion is factual and what part reflects our values and opinion. We must continually remind ourselves that it is our responsibility to give the patient the information they need to make a decision and to ensure that they understand it. Informed consent exists to allow the patient to pursue their life plan by safeguarding their values and facilitating a rational decision-making process.

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