Ethical Issues in Urogynecology
L. Lewis Wall
Douglas Brown
WHAT IS “ETHICS”?
In its most basic form, medical ethics refers to the way we interact with each other as doctors, patients, and clinical colleagues and as members of health care teams, faculties, practice groups, and other institutions. Medical ethics lays out the priorities and responsibilities that should guide clinical performance and interpersonal behavior in the practice of medicine and surgery. Medical ethics helps us navigate difficult decisions by establishing a process by which to determine—and then to act on—what ought to be done, all things considered.
What priorities and responsibilities should guide us in clinical practice, be it in urogynecology or any other field of patient care? The anchoring admonition for the clinician is to put the best interests of the patient ahead of all other considerations. This observation may seem self-evident, but often, it is not. Many ethical dilemmas in clinical medicine today are fundamentally about whose interests are really being served by the way care is delivered or financed. Corporate and commercial interests have intruded into clinical care in ways that would have seemed incomprehensible to previous generations of clinicians.
Urogynecologists are fiduciaries for their patients.1 The term fiduciary stems from a concept in ancient Roman law in which one person acted as a trustee for another, accepting the obligation to oversee the object placed in trust for the benefit of the person who entrusted it to the fiduciary. Patients expect their doctors to act in a similar way, to give them unbiased medical advice that serves their best interests as patients. What that “best interest” may be in any given clinical situation depends on the patient’s free and full communication of her needs and desires to her doctor who respects her autonomy. However, this responsibility does not obligate the physician to “do whatever the patient wants.” Clinicians are obliged to provide objective information and to give their best clinical advice, even when the patient resists such information and advice. Clinicians are certainly not obligated to provide treatment that is dangerous, harmful, or unwarranted. Clinicians should fully understand the patient’s perspective and should tailor treatments (when possible) to patient preferences, but they are not obligated to override their own clinical judgment simply “because that’s what the patient wanted.”
SYSTEMATIC WAYS TO THINK ABOUT MEDICAL ETHICS
Ethicists have presented various systematic ways to help clinicians sort through ethical issues in clinical practice. One of the most commonly used systems, popularized by Tom Beauchamp and James Childress, is known as “principlism.”1 This approach—which is rooted in a highly legalistic background—proposes that the way to solve clinical ethical problems is to evaluate each situation using four landmark principles. These principles are (1) patient autonomy, or the right of patients to define the goals of their care, to have their wishes considered and respected (which is the basis for the practice of securing informed consent prior to undertaking operations or procedures); (2) nonmaleficence, or the obligation of clinicians not to inflict avoidable harm on their patients; (3) beneficence, or the responsibility to work to benefit the patients, striving always to act in the patients’ best interest; and (4) fairness (sometimes also called the “principle of justice”), or the expectation that patients should be treated fairly, that like cases should be treated similarly.
Fairness has two components. Procedural fairness requires the health care system to treat patients equally within the system. Distributive fairness requires patients to have access to the same kinds of medical care. Distributive justice and procedural fairness are emerging as major areas of conflict and distress in the American health care system and are likely to be areas of conflict for some time. Many dilemmas arise in this domain. Fiduciary duty demands that urogynecologists be vigorous advocates for their patients within the health care system, just as lawyers have similar duties to their clients within the legal system.
The principlist approach evaluates ethically challenging clinical scenarios by first examining the various aspects of a case through the lens of each principle (i.e., autonomy, beneficence, nonmaleficence, and justice)
and then, through a process of “balancing,” deciding where the most important aspects of each case lie, leading the way to a proper decision.
and then, through a process of “balancing,” deciding where the most important aspects of each case lie, leading the way to a proper decision.
Jonsen et al.’s2 approach is similar, but their four categories of evaluation resonate more clearly with clinicians, largely because their clinical background is much stronger than that of Beauchamp and Childress. They segment the evaluation of clinical cases into (1) medical indications (beneficence and nonmaleficence); (2) patient preferences (respect for autonomy); (3) quality of life (beneficence, nonmaleficence, and respect for autonomy); and (4) contextual features (loyalty and fairness). They argue that clinicians who work through each quadrant will uncover the salient aspects of each case and will arrive at a reasonable ethical resolution (Table 8.1).2
TABLE 8.1 The “Four Topics Chart” for Analyzing Ethical Decisions in Medicine | ||||||||||
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Both frameworks are very useful for determining where the problem areas lie in any particular clinical dilemma, but they are somewhat limited in making real-time decisions. Another approach to medical ethics is known as virtue ethics.3,4 This approach is less popular than principlism among professional academic ethicists who consult with hospital administrators, lawyers, and ethics committees during business hours but who also tend to have little experience on the wards or little interaction with working clinicians, particularly during the night or on weekends when pressing ethical dilemmas often arise. Virtue ethics, we believe, is as critical to the training of clinicians, medical students, residents, and fellows as is the more formal, legalistic approaches because virtue ethics focuses on the character and practice patterns of clinicians, their integrity,
and the characteristics on which trust is based—and trust is the ultimate foundation on which all clinical relationships rest.5
and the characteristics on which trust is based—and trust is the ultimate foundation on which all clinical relationships rest.5
Several often unspoken but highly consequential questions are pivotal in clinical training: What kind of doctor do you want to be? What reputation do you want to have? How do you want to be regarded by colleagues and patients? When you appear on a call list with other doctors, what do you want their reaction to be to having to work with you? These questions are part of what has been called the “hidden curriculum,” the unstated norms, values, beliefs, and behaviors that are enculturated informally by words and actions.6 Through this professional socialization, physicians in training gravitate toward clinical role models after whom they pattern themselves. Every medical student, resident, and fellow can name those doctors whom they admire and “who they want to be like,” either consciously or unconsciously. Selecting a role model is extraordinarily consequential. It is no surprise that a disproportionate percentage of doctors come from families where one or both parents are physicians themselves.
Virtue ethics concentrates on building the character of physicians and reinforcing the characteristics that make them active, reliable fiduciaries for their patients. This approach is ancient, going back to Aristotle.7
As an exercise, take out a piece of paper and make a list of the characteristics you would want in a doctor taking care of you. We expect that, at a minimum, the list will include compassion, professional competence, mindfulness (the ability to be fully present “in the moment” with patients, not distracted or “mentally elsewhere”), trustworthiness, courage, justice (fairness), integrity (having a strong set of ethical values and being willing to defend them), and also what Aristotle referred to as phronesis, “practical wisdom” (the ability to integrate these characteristics into a unified, coherent whole—the ability to “get your clinical act together”).
Virtue ethics is not incompatible with principlism. In fact, we would argue that those with a strong commitment to virtue ethics will be much more concerned with and adept at using a four-part system of analysis than those who dismiss the virtue ethics approach.
INFORMED CONSENT
Although widely recognized, many clinicians have an incomplete grasp of informed consent and the concept’s importance.8,9 The justification for obtaining informed consent before treatment is rooted in the principle of autonomy (often also called “respect for persons”). Commitment to informed consent implicitly acknowledges that patients have a right to participate in their own care, to have their views considered, and to give their consent to undergo treatment based on their understanding of the reasons and indications for that treatment. The necessity for obtaining informed consent was pushed to the forefront of ethical discussions in medicine by the discovery/disclosure of significant past abuses of patients as illustrated by the Nuremberg war crimes trials after World War II,10,11 the Willowbrook State School hepatitis studies,12,13 the Tuskegee syphilis study,13,14 and the New Zealand cervical cancer scandal.15 In each case, patients were subjected to involuntary treatment (or had proper treatment withheld) without their appropriate knowledge or consent. These studies were often poorly conceived from a scientific viewpoint, were carried out without proper oversight, and were abusive of the human subjects involved in them. Such instances led to the formation of institutional review boards (IRBs) for monitoring research and to the implementation of increasingly stringent requirements for obtaining and documenting patient consent before treatment.16
Informed consent is best understood as a process rather than as an event. Many clinicians regard obtaining informed consent as simply getting the patient to sign a document—a “permission slip”—before undergoing surgery. Once the form is signed, they think they have secured informed consent. In reality, all they have is a signed form. Truly informed consent is a process in which the patient and the clinician exchange information in dialogue in order to make sure the patient has the information she needs to consent to treatment.17
The urogynecologist’s role in this process is to act as a fiduciary, to safeguard the patient’s best interests. There are two standards in common use (varying by state) that clarify what should be communicated to the patient. One standard is the “reasonable patient standard,” which means that the information conveyed about treatment options should be what a “reasonable patient” would want to know under similar circumstances.17 The “prudent physician standard” proposes that the information conveyed to the patient should be what a “prudent physician” would be expected to communicate under similar circumstances. In reality, both of these standards have limited value. What should be communicated is what each individual patient needs to know about her specific circumstances and the proposed treatment. The volume and detail of information in the informed consent process should be tailored to the individual patient. Enough information has been imparted when the patient agrees that all of her questions have been answered and all of her concerns have been addressed.1,8,9,17,18,19
Meeting this standard of informed consent may require considerable time. Ideally, it should take place in advance of surgery as part of a thorough preoperative visit. The least appropriate time for this process is the morning of surgery in the preoperative holding area where the patient is handed a form to sign prior to the operation taking place. Responsibility for obtaining informed consent should never be delegated to a nurse because the surgeon “doesn’t have the time”; it is the
responsibility of the attending surgeon to make sure this process is completed. To reduce informed consent to a matter of routine paperwork is to court disaster. When an operation goes awry, if a reasonable and thorough informed consent process cannot be documented, the fact that a signed “permission slip” is present in the medical record will provide no protection to the surgeon at the center of the case, particularly if the patient has a shrewd and insightful lawyer.
responsibility of the attending surgeon to make sure this process is completed. To reduce informed consent to a matter of routine paperwork is to court disaster. When an operation goes awry, if a reasonable and thorough informed consent process cannot be documented, the fact that a signed “permission slip” is present in the medical record will provide no protection to the surgeon at the center of the case, particularly if the patient has a shrewd and insightful lawyer.
Informed consent is also critical in human subjects research in which conflicting interests may arise between the research subject (who may also be a patient) and the researcher (who may also be a clinician). In a research setting—such as in a clinical trial for a new pharmacologic preparation in which the researcher is being paid to enroll study participants—a potential conflict exists between the research subject’s best interests and the researcher’s potential financial gain. Researchers are often paid a set amount per subject enrolled by the drug company sponsoring the trial. A related ethical concern in human subjects research is that the compensation offered to research participants should not be so great as to cause unreasonable pressure to participate. This is of special concern in situations where the subjects of the study are from easily exploited or vulnerable populations. Populations considered “vulnerable” are those who cannot protect their own interests, such as disadvantaged ethnic groups, pediatric populations, persons with certain mental or physical disabilities that diminish their capacity, individuals with medical needs that are not being met adequately by the health care system that is tasked with serving them, and so on. Numerous instances of human subjects research abuse (such as the Nuremberg medical crimes referred to previously) led to the creation of IRBs to oversee human subjects research and to the virtually universal requirement for research protocols involving human subjects to be reviewed in advance and formally approved by an ethics oversight committee before they begin enrolling subjects.
It is important to differentiate between therapeutic and nontherapeutic research. In therapeutic research, the study subject herself potentially stands to gain from the research—such as by having the opportunity to take a new drug that is not otherwise available for a particular condition. In nontherapeutic research, the potential for therapeutic benefit of this kind does not arise. In this case, the study subject agrees to participate without the prospect of personal benefit, except perhaps for feeling good about participating in research or in return for a particular payment. An example of nontherapeutic research would be a study of a new drug in which volunteers are participating in an attempt to understand the pharmacodynamics of the medication: How much of a dose is metabolized? What effect does the drug have on blood-clotting or liver function tests? How rapidly and by what mechanism is it excreted? Answering these questions is scientifically important but conveys no therapeutic benefit to the study participant—and in early-stage drug studies of this kind, there may be substantial risks that are not yet known.
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