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* From the Program on Ethics in Clinical Practice, Phoebe R. Berman Bioethics Institute, Johns Hopkins University, Baltimore, MD.
Correspondence to: Joseph A. Carrese, MD, MPH, Johns Hopkins University, Division of General Internal Medicine, 4940 Eastern Ave, Baltimore, MD 21224; e-mail: jcarrese{at}jhmi.edu
Abstract
Key Points
1. Historically, medical ethics focused on the proper conduct of physicians as members of a profession.
2. Bioethics has emerged as a distinct field over the past several decades and has a broader scope than traditional medical ethics. The field of bioethics includes research ethics, public health ethics, organizational ethics, and clinical ethics.
3. Several factors contributed to the emergence of bioethics, helping to shape it, including the following: abuses of human subjects in research; advances in medical therapeutics and medical technology; and complex societal changes.
4. Principlism is an important approach to ethics, and in bioethics it includes the following core principles: respect for autonomy; beneficence; nonmaleficence; and justice.
5. Clinical ethics is a major part of bioethics and is concerned with ethical issues encountered in the care of patients.
6. Clinicians should recognize that every interaction between a doctor and a patient has a moral component, and that competency in bioethics is required to competently practice medicine.
7. Deficiencies exist in bioethics knowledge and performance among practicing clinicians and trainees; therefore, bioethics education is needed for learners at all levels (ie, medical students, trainees, and practicing clinicians).
8. Bioethics is a dynamic, multidisciplinary field with several dedicated journals, a national organization, and numerous centers and institutes
9. Important scholarly work in bioethics, both empirical and conceptual, is being conducted and disseminated, providing important information for practicing clinicians.
Key Words: bioethics • clinical ethics • medical ethics • research ethics
Every interaction between a doctor and a patient has a moral component that may or may not be obvious. For example, when clinicians wrestle with determining how aggressively to treat a patient with severe COPD and advanced dementia, there is no mistaking that ethics is involved. At the center of this difficult scenario is the following ethical question: what is the correct decision for this particular patient? Yet, even routine clinical interactions, while less dramatic, entail ethical considerations, because every patient encounter involves the clinician’s ethical duties, such as benefiting the patient and minimizing harm. Similarly, every clinical decision involves the values of those involved, including patients, clinicians, and family members. Being aware of these values and factoring them into decision making reflects ethical sensitivity and skill.
Considering such duties and values, and determining whether decisions are ethically acceptable, is the territory of bioethics. Some have argued that "ethics is an inherent and inseparable part of good clinical medicine."1 If true, we would expect to find the quality of patient care and patient satisfaction tied to competence in bioethics. This link between ethical competence and quality of care is documented in at least the following two areas of medical practice: care at the end of life234; and disclosure of medical errors.5 Such data underscore the need for clinicians to obtain competency in bioethics.
Accepting the premise that bioethics is inherent to the competent practice of medicine, in this article we first review the available evidence concerning bioethics knowledge and skill among clinicians. Next, we describe the emergence of bioethics as a field and the current approaches used in the field. Finally, we examine the status of the education and training of clinicians in bioethics, suggesting areas for improvement.
Bioethics Knowledge and Skill: Current Status
Awareness of, knowledge and attitudes about, and skills pertaining to clinical ethics are highly variable among practicing physicians and trainees, and are often significantly lacking. For example, for some time there has been a broad consensus concerning the obligation of clinicians to respect the preferences of patients when administering care at the end of life. Nevertheless, the Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatment trial,6 a nationwide study enrolling several thousand patients in ICUs, demonstrated serious deficits in physician performance, both at baseline and after an intensive intervention, with respect to knowledge of patients’ preferences about end-of-life care. Similarly, despite the widely recognized ethical duty to disclose information to patients about medical errors, studies5 have shown that rates of disclosure by doctors are low.
Among trainees, a study assessing the responses of emergency medicine residents to ethical issues in simulated patient encounters concluded there was much room for improvement. Overall, only 54% of targeted behaviors and activities were successfully completed (eg, in one exercise five of six residents breached confidentiality).7 A survey8 of internal medicine residents and fellows to assess knowledge of and comfort level with 11 clinical scenarios addressing ethical issues identified significant learning needs. A survey9 of Canadian program directors about how informed consent was taught and assessed, and an evaluation of residents from one of these programs via an objective structured clinical examination, led researchers to conclude that there was an "urgent need" for explicit training in informed consent.
In summary, ethics knowledge and performance in clinical practice and in training is uneven at best, and at times deficient. While additional data would be desirable to map more comprehensively the current state of affairs, there seems sufficient evidence to conclude there is room for improvement in clinicians’ knowledge and skill regarding bioethics. Understanding the historical context from which bioethics emerged helps to clarify the required knowledge and skill base for practicing clinicians.
Historical Context
Many factors contributed to the creation of bioethics as a field. These factors fall into several domains, including, but not limited to, the following: clinical medicine; medical research; and societal influences. In this section, we describe selected events and developments from each of these domains that contributed to shaping the field of bioethics.
Prior to the middle of the 20th century, ethics in medicine was primarily limited to concerns about professional conduct. Professional codes of conduct, ranging from the Hippocratic oath to the American Medical Association code of ethics, established rules and ideals to govern the conduct of members of the profession. For example, the Hippocratic oath states "Whatever houses I may visit, I will come for the benefit of the sick, remaining free of all intentional injustice, of all mischief and in particular of sexual relations with both female and male persons, be they free or slaves."10
The inaugural code of ethics of the American Medical Association in 1847 outlined in detail the duties of physicians to their patients. One such duty involved being "the minister of hope and comfort to the sick." The guidance offered in the inaugural code urged doctors not to make "gloomy prognostications," noting that "the life of a sick person can be shortened not only by the acts, but also the words... of a physician. It is therefore a sacred duty to... avoid all things which have a tendency to discourage the patient and to depress his spirit."11 It was therefore customary for doctors to withhold "bad news" from their patients in order to protect them. The fact that doctors took it as their obligation not to share such information with their patients is one example of the paternalistic nature of the doctor-patient relationship during this era.
Empirical data from 1950s to 1960s documented that clinical practice continued to reflect this view of doctors’ obligations to their patients. An article12 published in 1953 showed that 69% of physicians never told, or usually did not tell, their patients that they had cancer; another study13 published in 1961 revealed that 90% of physicians did not tell patients they had cancer. While well intended, such practices reflected a lopsided doctor-patient relationship in which it was assumed that physicians knew what was best for patients. Taken to the extreme, this paternalistic model created a climate that fostered devastating abuses in both clinical medicine and medical research.
For example, the eugenics movement of the early part of the 20th century included involuntary sterilization of those with "undesirable" traits, and undermined the rights and interests of some of the least well off members of society. This was followed by the racial hygiene movements, and practices of euthanasia and other human rights atrocities that occurred during World War II, including the medical experiments that took place in the concentration camps.14 These actions by physicians ultimately led to the generation of the Nuremberg Code,15 a statement of principles regarding the appropriate behavior of investigators and the treatment of human subjects involved in medical experiments. The first principle of the Nuremberg Code requires the voluntary consent of human subjects who participate in medical experiments.
Ultimately, the Nuremberg Code greatly influenced thinking about medical ethics and human rights.16 Yet, at the time it was issued it apparently had little effect on the international medical research community.17 In fact, the Nuremberg Code was dismissed as irrelevant by most in the US medical community. One author18 summarized this perception as follows: "It was a good code for barbarians but an unnecessary code for ordinary physicians." In hindsight, of course, this reaction was misguided, since at that very time, and in the years to follow, there were many instances of mistreatment of human subjects in biomedical research in the United States. These included, but were not limited to, the US Public Health Service Study on Syphilis, conducted at Tuskegee, Alabama,19 the studies of hepatitis at the Willowbrook State School in New York,20 and many others that were documented by Henry Beecher in 1966.21
As these studies became widely known, there was public outcry, and in 1974 the US Congress passed the National Research Act (Public Law 93–348). The National Research Act provided the foundation for the regulations that later governed the requirements for institutional review boards to oversee research. It also established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. A major charge of the Commission was to "identify the basic ethical principles which should underlie the conduct of biomedical and behavioral research involving human subjects," and to "develop guidelines which should be followed in such research to assure that it is conducted in accord with such principles... . "22 In meeting its charge, the Commission prepared the Belmont Report,22 which argued for the consideration of the following three core ethical principles in research with human subjects: respect for persons; beneficence; and justice.
Despite egregious behavior among some researchers, it is critical to acknowledge the incredible scientific progress that was made during this period of time, including the discovery of innovative treatments such as antibiotics and effective chemotherapies for cancer. However, major advances in technology raised difficult questions about care at the margins of life, such as questions about the definition of death, life-sustaining treatments, organ transplantation, and reproductive technology. For example, when hemodialysis first became available there was a shortage of machines to handle the need, raising difficult questions about fair and appropriate access to this scarce, life-saving technology.23 In addition, as the use of respirators became more widespread, clinicians and family members were faced with deciding when it was appropriate to discontinue their use. Perhaps the most notable case involved Karen Ann Quinlan, a young woman who was in what would now be termed a persistent vegetative state. After it became clear that she would not recover, Quinlan’s parents sought to have her physicians remove her from the ventilator. The physicians refused, suggesting that their obligation was to maintain life, regardless of quality. The Quinlans persisted. Ultimately, the New Jersey Supreme Court ruled that the Quinlans could act in their daughter’s interests and have the ventilator removed, thereby challenging the traditional authority of physicians.24
By this time, it was clear that a new field, the field of bioethics, had been born.25 The complexity and scope of bioethics went beyond the narrow focus of traditional medical ethics on professional conduct alone. In part, this was due to difficult questions raised by technological advances. But it was also a function of sweeping changes in US society. For instance, challenges to conventional authority in US society (eg, the civil rights, feminist, and antiwar movements)26 played a part in shifting the locus of authority in the doctor-patient relationship. This shift in authority had direct implications for medical decision making. Consistent with the principle of respect for persons of the Belmont Report,22 respect for patient autonomy was established as a one of the key principles in bioethics,27 and clinical practice reflected this change in patients’ status. One marker of this change is data concerning whether or not patients were told they had cancer. In contradistinction to the customary practice 2 decades earlier, a study published in 1979 showed that 97% of physicians reported routine disclosure of such diagnoses.28 In part, this finding likely reflected advances in the ability of clinicians to provide better care to patients with cancer, but it also represented an increased recognition of the need for doctors to respect the autonomous preferences of patients by providing them with the necessary information to make good decisions. It also represented a step away from the paternalism of the past.
The scope of bioethics today is quite broad, including, but not limited, to ethical issues encountered in research, organizational ethics, public health, and clinical practice. Clinical ethics is concerned with ethical issues encountered in the care of patients, and may involve the work of ethics committees, ethics consultations, and clinical ethicists.29 Clinical ethicists hail from a variety of backgrounds: clinical (eg, medical, nursing, and social work), legal, and graduate training in philosophy or theology. Clinical ethicists serve one or more of the following roles: as members of ethics committees; performing ethics consultations; writing and reviewing ethics policies; teaching courses about bioethics; and doing scholarly work in clinical ethics. Scholarly work has been both empirical and conceptual.
There have been several other developments in the field of bioethics. Bioethics centers and institutes have proliferated. Most (but not all) are university based, and affiliated faculty reflect the multidisciplinary nature of the field, coming from disciplines such as medicine, nursing, law, the social sciences, philosophy, and theology. There are multiple journals dedicated to the field of bioethics, some with a clinical focus, others with a theoretical, philosophical orientation. In addition, mainstream medical journals regularly publish articles that address ethical issues. During the 1980s and 1990s, several national organizations devoted to bioethics were created, including the American Association of Bioethics, the Society for Bioethics Consultation, and the Society for Health and Human Values. These three associations formally merged in January 1998, creating the American Society for Bioethics and Humanities, which today is arguably the main national association in the field. The American Society for Bioethics and Humanities Web site has a number of links to helpful bioethics-related resources (Table 1 ).
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An important approach to bioethics, principlism, is based on the framework described in the Belmont Report22 and was further elaborated on by Beauchamp and Childress.27 They argued that there are four key principles in bioethics, as follows: respect for autonomy; beneficence; nonmaleficence; and justice.
Respect for autonomy is the ethical foundation for several standard clinical practices, including informed consent, truth telling, confidentiality, and advance care planning. It is also consonant with current thinking about the doctor-patient relationship and clinical decision making (ie, patients are likely to have an active role, if not the controlling voice, in what happens to them). This, of course, follows naturally if a guiding principle emphasizes self-rule and self-determination, and it is a clear departure from the paternalistic tradition in medicine.
The principle of beneficence has it roots in ancient medical codes and oaths. At the heart of medicine must be the goal of helping patients.30 Consequently, few situations in medicine are more challenging than a patient’s refusal of recommended care, be it evaluation or treatment.31 Such cases bring into focus the complex relationship between the principles of respect for autonomy and beneficence, demonstrating that they are not always aligned. In addition, these cases necessitate examining the meaning of the term benefit for any given patient; for some patients, what is beneficial may be something other than what is available biomedically, such as adhering to the tenets of one’s religion.32
The principle of nonmaleficence derives from the obligation not to harm patients. This principle serves as a reminder that patients may well be harmed as a consequence of being cared for and that some treatments may be unnecessarily or inappropriately burdensome. Accordingly, clinical decision making should consider the proportionality of burdens to benefits in arriving at the best course of action. While present in many aspects of medical care, these considerations are especially germane in end-of-life care.
The principle of justice often points to questions of health policy, such as how to distribute scarce medical resources. Yet, questions of justice and fairness are also present in aspects of everyday clinical practice. Given that individual clinicians are a limited resource, with only so much time and energy, how does one decide to apportion that time and energy for the many patients encountered on any given day? Is this done fairly? And what exactly is meant by fair and just? Is it an equal amount of time given to each patient, or whatever time is needed by each patient, or is it based on some other consideration, such as how well patients are liked? Similarly, justice is relevant in regard to providing care to patients without health insurance, or to patients whose health-care insurer does not cover a needed benefit. Meeting the requirements of fairness inherent to the principle of justice is part of the professional responsibility of practicing clinicians.33
While principlism has been a popular and helpful approach in bioethics, it is not without rivals or critics.34 Alternative approaches exist and have been advanced to address some of the perceived limitations of principlism. It is beyond the scope of this article to describe comprehensively these alternative approaches, but we will make brief comments about a few of them.
Casuistry, or case-based ethics, stresses the importance of appreciating the particular features of specific cases, and then comparing the case at hand to previous, typically well-known, cases.35 Supporters contend that this approach is more likely to help resolve an ethical problem than appealing to abstract and, some would argue, vague principles. Feminist approaches to bioethics question basic sociocultural assumptions that inform the core principles constituting principlism. For example, respect for autonomy emphasizes individualism and self-determination, while feminist thinking emphasizes the relational aspect of being human. Feminist approaches to bioethics also focus on freedom, caring, and justice,36 and critique existing power structures affected by gender. Virtue theory as applied to clinical bioethics emphasizes the qualities that a physician should exhibit in daily interactions with patients, such as compassion, honesty, respect, loyalty, and altruism, to name a few.37
As in any field in which multiple approaches try to make sense of complex phenomena, these approaches in bioethics are not mutually exclusive and do not necessarily conflict with each other. Instead, these approaches address important and, to some extent, distinct aspects of the larger whole, and can be utilized concurrently.
Education in Bioethics for Clinicians: Current Status and Looking Forward
Studies have demonstrated that certain outcomes improve as a consequence of bioethics education. The existing literature shows that learner awareness,38 attitudes,39 knowledge,40 confidence,41 decision making,42 and, to some extent, moral reasoning43 improve with educational interventions. However, studies examining the relationship between bioethics education and physician performance, or, ideally, patient outcomes, are needed. Despite these limitations, the current body of evidence supports doing more with respect to bioethics education to address the deficits in knowledge and skill identified earlier in this article. Such education should occur at all levels (ie, medical students, trainees, and practicing physicians).
Bioethics education has been a formal part of the curriculum in US medical schools for more than a decade. In the academic year 2005, 124 of 125 medical schools required a course in bioethics.44 Yet, there is evidence of considerable variability in the objectives and content of these curricula, as well as concerns about uneven quality.45 In addition, some data demonstrate that medical students actually lose ground with respect to moral sensitivity46 and moral development during their education.47
The Accreditation Council for Graduate Medical Education Outcome Project requires training for residents in six core competencies, the following three of which explicitly refer to ethical principles in their definitions: professionalism; interpersonal and communication skills; and patient care. For example, the interpersonal and communication skills competency requires "creating and sustaining a therapeutic and ethically sound relationship with patients." The patient care competency makes reference to trainees learning to "make informed decisions... based on patient information and preferences"; and it also discusses "demonstrating caring and respectful behaviors when interacting with patients and their families."48 However, despite this mandate, available national survey data4950 have indicated that bioethics education in residency training programs is lacking.
Educational programs in bioethics for clinicians at any educational level must incorporate the following considerations (Table 2 ): the actual issues encountered; core behavioral skills; analytic methods; and cultural diversity in bioethics. We discuss each of these in turn.
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Clinicians will encounter many ethical issues in the course of their work (Table 3 ). Certain issues, like informed consent, transcend all fields of practice. Such issues require of every doctor an acceptable level of familiarity and competence. Other issues are more likely to be encountered in certain fields than in others. For example, issues related to organ donation and the allocation of scarce resources are more likely to be relevant for nephrologists and transplant surgeons than rheumatologists. Still, other issues may be encountered only in specific disciplines (eg, maternal-fetal conflict in obstetrics and gynecology, and whether to resuscitate patients in the operating room in surgery and anesthesiology).
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"Coverage" of bioethics topics (either in the literature or in ethics courses) has typically emphasized inpatient settings and dramatic situations, such as whether patients should be resuscitated or whether to withdraw life-sustaining care. Only in the past few years has attention turned to the outpatient setting and "everyday ethics."51 The ethical issues encountered in outpatient settings, while perhaps less striking, are no less important and usually are far more common. Some examples include the following: inappropriate requests by patients (eg, requests for privileges like handicap stickers or exemption from jury duty); ethical concerns related to health promotion (eg, balancing our desire to change patient behavior with respect for patient autonomy); potential conflict of roles (eg, being a gatekeeper as well as a patient advocate); interactions with pharmaceutical representatives; and potential conflicts of interest (eg, placing patients’ interests first in a capitated system when clinicians’ end-of-year bonuses are tied to limiting costs).
There is some evidence of incongruity between what is experienced in actual clinical settings and what medical students and residents are taught. For example, one study52 documented that commonly observed professional lapses did not correspond to the commonly taught topics in ethics courses. Some of these lapses included the following: communication violations (eg, referring to patients using derogatory terms and delivering information to patients insensitively); resisting expected professional duties (eg, not providing cross-coverage for a colleague); objectification of patients (eg, not acknowledging a patient’s presence when discussing a case); problems with accountability (eg, failure to communicate test results to patients in a timely manner); and being caught in the "crossfire" (eg, of a struggle between superiors).52 Findings like these highlight the important role for empirical research in describing what is actually being experienced by trainees as well as practicing doctors.
More generally, there is a very extensive body of literature in bioethics, both empirical and conceptual, that has been accumulating for several decades on a multitude of topics. Practicing physicians should be aware of this literature and approach it as they would the literature for any topic in clinical medicine (ie, as a way to apprise themselves of current thinking, best evidence, areas of consensus, and points of debate).
Core Behavioral Skills
In addition to key issues, an argument can be made for "core behavioral skills" in bioethics.53 Behavioral skills, by definition, can be taught, learned, practiced, improved on, and ideally mastered. In addition, behaviors can be observed and measured. Competency in skills requires not only a satisfactory cognitive knowledge of the topic, but also an ability to perform the behaviors required to successfully and appropriately complete the associated task. Candidates for core bioethics behavioral skills include the following: obtaining informed consent; assessing capacity; discussing resuscitation status and the use of life-sustaining therapies; advance care planning; breaking bad news; disclosing mistakes to patients and apologizing; resolving conflict; and effective communication.
Analytic Methods
During the course of clinical care, clinicians will invariably encounter cases that raise difficult ethical issues. Such cases can be accompanied by uncertainty about what to do. Particularly troubling are cases in which important obligations or principles appear to be in conflict. For example, what is the morally correct action when a competent patient is refusing what is judged to be necessary, potentially life-saving care? What if, in such a case, the level of competency, or the decision-making capacity, is in doubt or is deemed to be insufficient for the gravity of the situation? With cases that present challenging ethical issues, as in other areas of medicine, it is useful to have a systematic approach to work through each case. The approach adopted should account for the relevant facts and unique features of the case, and it should reliably facilitate careful analysis that ultimately leads to a morally defensible plan of action.
In the area of clinical ethics, several possible "methods" or "models" are available for approaching, analyzing, and resolving ethical problems.545556 Strong consideration should be given to selecting one approach, becoming familiar with it, and using it regularly.
A widely disseminated and well-established approach is the four-topics method.57 This approach directs clinicians to systematically consider each of the following four topics: (1) medical indications (this involves identifying the medical problems, treatment options, and goals of care); (2) patient preferences (this includes eliciting and clarifying the patient’s preferences with respect to goals of care and treatment options); (3) quality-of-life considerations (this involves assessing the effect of medical conditions and/or treatment decisions on the patient’s quality of life, while carefully monitoring one’s potential biases about what constitutes an acceptable quality of life); and (4) contextual features (this involves taking account of the many factors that bear on a case that are beyond the doctor-patient relationship, including family, legal considerations, cultural and community factors, economic considerations, and spiritual or religious beliefs). Once the key features of a case have been clarified using this approach, the clinician can then more readily characterize the central ethical issue or conflict, and then turn to the ethics literature, expert opinion, or paradigm cases to help determine what should be done.
Cultural Diversity and Bioethics
There is an important connection between bioethics and culture: basic values, preferences, and perspectives, all of which are critically relevant to bioethics, are influenced, if not largely determined, by one’s culture. Accordingly, it is essential for all clinicians to appreciate that cultural diversity is a fact of American society and clinical medicine.58 Culturally based values and views have important implications for health and health care in terms of how patients think and behave, and in terms of what they expect.59606162 There is also evidence of important differences between patients and the doctors from whom they seek care with respect to these culturally based values and views.636465
How health-care professionals think about and approach these issues has very real consequences for patients, since, if cultural differences are ignored or poorly addressed, they can result in conflict, decreased patient satisfaction, problems with diagnosis and compliance, and even disparities in health care.6667686970 On the other hand, approaching cultural differences with sensitivity and skill can lead to better understanding7172 and better outcomes.73
Some authors have proposed "cultural humility" as an essential quality of clinicians practicing medicine in a multicultural society.7475 Cultural humility begins with self-awareness, self-reflection, and self-critique. It requires an open and respectful attitude toward diversity, and it recognizes the legitimacy of alternative ways of thinking and being. Cultural humility involves a willingness to learn about the unique perspectives of individual patients and the communities they come from; and it allows for the possibility that clinicians themselves might grow and change as a result of appreciating others in this way.
Conclusion
Ethics is an essential component of good clinical medicine, and competency in bioethics is required to competently practice medicine. Bioethics, therefore, is inescapably relevant to the practicing clinician. However, data indicate deficiencies in knowledge and performance among practicing clinicians and trainees with respect to bioethics. These data argue for efforts in bioethics education with learners at all levels (ie, medical students, trainees, and practicing clinicians). Nonetheless, the extent to which education alone will address deficiencies in ethics knowledge and performance is unclear. In some settings, it may be necessary to make major changes to the systems of care to achieve such ends. However, such approaches are beyond the scope of this article.
Bioethics is a dynamic, multidisciplinary field with several dedicated journals, a national organization, and numerous centers and institutes. Important scholarly work, empirical and conceptual, is being conducted and disseminated, and will likely continue to inform the way practicing clinicians should be communicating with and caring for their patients.
Acknowledgements
The authors wish to acknowledge Mary Catherine Beach, MD, MPH, Thomas Finucane, MD, and Curt Naser, PhD, for critically reviewing an earlier version of this article and making numerous helpful suggestions.
Footnotes
Dr. Carrese is supported by the Morton K. and Jane Blaustein Foundation, Inc. as a Blaustein Scholar of the Phoebe R. Berman Bioethics Institute.
The authors have reported to the ACCP that no significant conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article.
Received for publication May 3, 2006. Accepted for publication September 13, 2006.
References
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