Before a physician can focus on bringing clarity to an informed consent discussion, the reality of the situation needs to be taken into account. Is the patient cognitively impaired? Too young? How does a special circumstance or clinical advance factor into what’s necessary to say?
The AMA Ethics Group has answers on how to cope with those and other situations in its newly released, for-credit CME module. It provides physicians, residents, medical students and others with an enhanced and actionable understanding of the steps and sensitivities that are required to fulfill this fundamental professional and legal obligation.
“Informed consent occurs when communication between a patient and physician results in the patient’s authorization or agreement to undergo a specific medical intervention,” is AMA’s concise ethical guidance on the objective of these conversations. However, to achieve that goal, the physician is faced with the task of tailoring that interaction to the needs of an individual patient—or, often, a surrogate—amid circumstances that many require specialized guidance.
Four consent competencies. The module is divided into four micro-modules, with guidance based on the recently updated AMA Code of Medical Ethics. Using animation, infographics, and scenario-based learning, the completed course is designed to enable the learner to:
Define each step of the informed consent process. A fundamental determination is whether a patient is able to understand what’s being said, and then make an independent and voluntary decision. With either a patient or surrogate, there are fundamentals to cover—including diagnosis, treatment recommendations, the risks and anticipated benefits, along with a discussion of forgoing treatment—and the exchange and outcome must be documented in the medical record.
In an example of how the module takes guidance to a deeper level, it includes insights on how a single meaningful discussion need not be the same as an exhaustive one. As AMA ethical guidance notes, “The obligation to communicate truthfully does not mean that the physician must communicate the information immediately or all at once. Information may be conveyed over time in keeping with the patient’s preferences and ability to comprehend the information.”
Identify a physician’s role in decision making for adults who lack capacity to give informed consent. Not all impairments are absolute and patients in such situations might still take some active role in the decision making about their care. However, physicians should be prepared to discuss and receive informed consent from a surrogate with full decision making authority. That must be done within the framework of the law, for example through a durable power of attorney for health care.
The module covers frameworks that can guide the informed consent process when a surrogate is needed. Substituted judgment is based on the known values and preferences of adult patients who have lost decision-making ability. It can be in the form of an advanced directive, notations in the medical record or based on what’s known about patient’s attitudes on quality of life, suffering or specific interventions.
In advanced care planning, physicians can inform and support patients before a health crisis or impairment, helping them to specify a surrogate and make their preferences known through advanced directives. A best interest framework applies when nothing is known or can be reasonably inferred about a patient’s wishes. At that point, the focus of the discussion will be on the potential and degree of benefit from an intervention; possible pain, suffering or impairment from it; and quality of life.
Identify a physician’s role in pediatric decision making. The module looks at the “three-way relationship” consisting of the minor patient, parents or guardians, and the physician. While the decision making is legally up to parents or guardians—and should be based on a best interest framework—the module looks at how physicians can appropriately include their minor patients in the process and provide support to families.
Review a physician’s responsibilities when handling informed consent in special situations. This section includes ethical guidance on challenges posed by innovation in medical practice (for example, when introducing a new therapy), telemedicine, research, or the genetic testing of children. Depending on the situation, those discussions might include points typically not included in most informed consent discussions, such as conflict of interest.
Once registered to learn more about these and other insights covered in the module, learners can save their progress and proceed at their own pace. AMA PRA Category 1 Credit™ is available. The module is free to AMA members and available to non-members for $20.
The AMA Code of Medical Ethics is a living document, updated periodically to address the changing conditions of medicine. The new edition, adopted in June 2016, is the culmination of an eight-year project to comprehensively review, update and reorganize guidance to ensure that the Code remains timely and easy to use for physicians in teaching and in practice.