Ethical and medical considerations
Although this case seems too strange for fiction, the basic facts are taken from events that did occur at a major institution. The puzzling features of this case are meant to be a cautionary tale: it is easy in the rush with the pressure of clinical practice to view informed consent as a bothersome technical detail. Yet as the following discussion suggests, adhering closely to the tenets of informed consent protects not only the fundamental interests of the patient but also the physicians and medical institutions.
Informed consent serves as protective communication
Informed consent at its core is a “process of communication” that involves you as the health care provider and the patient. It provides authority for an activity based upon an understanding of what that activity entails.1,2 Aspects of informed consent, from the physician−patient perspective, include the following:
- disclosure
- comprehension
- voluntary choice
- authorization.
In one other sense, informed consent is based on a fiduciary relationship between the ObGyn and patient.3 Overall, the process consists of an educational communication by the physician to the patient. Ideally, providers perceive the process from an ethical point of view that has been formalized by cases and statutes.4
Informed consent protects one of the most basic values of medicine and society: autonomy. From the perspective of moral philosophers, the principle of autonomy establishes the moral right to choose and follow one’s own plan for life and action.5,6 For ObGyns, the patient’s autonomy and her ability to participate in the medical decision-making process is of paramount importance. Informed consent is also a reflection of trust inherent to the physician−patient relationship.4
Informed consent is too often viewed as a mere legal formality. In truth, it melds legal and ethical values and concerns. The President’s Commission reflected this, noting that informed consent is rooted in “the fundamental recognition that adults are entitled to accept or reject health care intervention(s) on the basis of their own personal values and in furtherance of their own personal goals.”7
The historic perspective of informed consent dates back to Egyptian, Greek, and Roman eras. Dhar and Dhar suggest that the concept of “physicians’ love for humanity—philantropia” dates back to Plato and is complemented by the term “philotechnia” (love of medicine), all of which have evolved into today’s use of the terms “risks, benefits, and alternatives.”8
We emphasize that informed consent is much more than a legal concept. It has strong clinical roots because it provides an opportunity for physicians to improve communication with their patients. Informed consent is not a form; it is a process to be taken seriously.
Legal principles of informed consent
The famous New York case of Mary Schloendorff v. Society of New York Hospital, in 1914, heralded a principle that remains central in American law. Justice Benjamin Cardozo, writing for the majority, held that, “Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault for which he is liable in damages.”9 The surgeon in the Schloendorff case had undertaken a gynecologic procedure—removal of a fibroid tumor—without patient consent. (In that case the hospital rather than the physician was sued, but the principle clearly applied to the physician.)
Over the last century, the American law of informed consent has developed in a number of ways.10 Lack of informed consent is now almost always considered a form of negligence rather than an intentional tort of battery. The details of the legal requirements vary from state to state as a result of statutory changes and court decisions. But in one way or another, to be “informed,” consent generally must include 4 things:
- a description of the procedure or intervention that is proposed
- the risks and benefits of the proposal—the focus here is generally on the risks of the treatment
- alternatives, if there are any (eg, pharmacologic vs surgical treatment)
- the consequences of not undertaking the proposed treatment (eg, the refusal to have a Papanicolaou smear).
A fifth point might be added—the offer to answer any questions or provide additional information.
These 4 or 5 basic items and the expanded list are efforts to simply describe the information that a reasonable person would need in order to make a decision that represents the patient’s values, personality, and preferences. (Informed consent is in some ways an ongoing process—since a patient may withdraw his/her consent.)
Exceptions to the informed consent requirement
Before turning to the facts in the hypothetical case, it is worth noting that there are 2 common exceptions to the informed consent requirement. The first is an emergency exception. When someone requires immediate attention and the patient is not conscious or capable of consent (nor is a “next of kin” available), treatment may proceed.
The second is therapeutic exception. Its designation is narrow, and it is risky to rely on it except in extreme circumstances. But when the very process of informing the patient of all the risks of a proposed treatment would create significant additional risks for the patient, the consent process may be modified. For example, for an extremely suggestable patient, describing certain risks might, in a psychosomatic way, cause the risk to be realized. In such cases, the record must be clearly documented. It is generally best to discuss the matter with a family member or other surrogate decision maker.