American College of Physicians
Ethics Manual
Ad Hoc Committee on Medical Ethics
Reprinted from Annals of Internal Medicine
August 15, 1989
CONTENTS
Preface 1
The Historical Evolution of Medical Ethics: An Overview 2
1.00 The Physician and the Patient 4
1.01 The Physician-Patient Relationship 4
1.02 Initiating and Discontinuing the Treatment Relationship 4
1.03 Medical Risk to the Physician 5
1.04 Financial Arrangements 5
1.05 Confidentiality 5
1.06 The Patient and His Medical Record 6
1.07 Disclosure 6
1.08 Consent 6
1.09 Consultation 7
1.10 Conflicts of Interest 7
1.11 Sharing Fees 8
1.12 The Physician and Non-Scientific Medical Systems 8
1.13 Secret Remedies 8
2.00 The Physician’s Relationship to Other Physicians 8
2.01 Teaching 8
2.02 Medical Students and Resident Physicians 8
2.03 The Impaired Physician 8
2.04 Criticism of a Colleague 9
2.05 Advertising 9
3.00 The Physician and Society 10
3.01 Obligations of the Physician to Society 10
3.02 The Relationship of the Physician to Government 10
3.03 Other Physician-Government Issues 10
3.03a Torture 10
3.03b Punishment 10
3.03c Execution 10
3.03d Distortion of Clinical Criteria 11
3.04 The Relationship of the Physician to Other Health Professionals 11
3.05 The Relationship of the Physician to the News Media 11
3.06 Strikes by Physicians 11
4.00 Research 11
4.01 Clinical Investigation 12
4.01a Others Concerned with the Ethics of Research 12
4.01b Innovative Medical Therapies 12
4.02 Scientific Publication 12
4.03 Public Announcement of Research Discoveries 13
5.00 Initiating and Foregoing Life-Sustaining Treatment 13
5.01 Who Should Make the Decision? 13
5.01a Competent Patients 13
5.01b Incompetent Patients 14
5.02 Importance of Advance Directives 14
5.03 Living Wills 14
5.04 Quality-of-Life Considerations 15
5.05 Special Clinical Situations and Life-Sustaining Treatment Decisions 15
5.05a Brain Death 15
5.05b Terminally Ill Patients 15
5.05c Irreversible Loss of Consciousness 15
5.05d Impaired Cognition 16
5.06 Withholding or Withdrawing Certain Types of Life-Sustaining Interventions 16
5.06a Orders Not to Resuscitate (DNR Orders) 16
5.06b Other Life-Sustaining Interventions 17
5.06c Fluids and Nutritional Support 17
5.07 Euthanasia 17
6.00 Responsibilities of Physicians 17
7.00 Other Ethical Issues
7.01 Ethics Committees and Ethics Consultants 18
7.02 Resource Allocation 18
7.03 Abortion and Contraception 19
7.04 Medicine and the Law 19
Conclusion 19
References 19
American College of Physicians Ethics Manual.
Part 1: History; The Patient; Other Physicians
The second edition of the Manual was developed by the College's Ethics Committee, whose members for the 1988-89 term were: Lawrence Scherr, MD, Chairman; Saul J. Farber, MD; Eugene A. Hildreth, MD; Richard J. Kahn, MD; Edmund D. Pellegrino, MD; Mark Siegler, MD; and Lee Dunn Jr., Esq. (consultant). Ex-officio members of the Committee were: Michael Bernstein, MD; Norton J. Greenberger, MD; Edwin P. Maynard, MD; Ralph 0. Wallerstein, MD; and John R. Ball, MD, JD. Staff contributions were made by Lois Snyder, JD; and Linda Johnson White. The Manual was approved by the College's Board of Regents on 10 April 1989.
PREFACE
In 1913 Dr. Heinrich Stern, a visionary young physician, visited the Royal College of Physicians of London and recognized that the United States needed an educationally oriented organization of "internists," an organization comparable to the distinguished English College. In the United States the progress of medicine had been slow, but the various specialties of medicine had begun to emerge.
Dr. Stern's vision led to the founding of the American College of Physicians in New York City in 1915. The ensuing years saw steady growth as the College began to mature as a nationally recognized professional society, and as the definition of the internist gained clarity with the establishment of the American Board of Internal Medicine in 1936. The College now includes 74 chapters/regions representing 50 states, the District of Columbia, branches of the Armed Forces and Department of Veterans Affairs, the U.S. Public Health Service, and regions of Canada, Central and South America, and the Caribbean. Since its inception, the College has stood for the highest standards in education, practice, and research.
Although in the College's early years no formal code of ethics had been published, conformity to rigorous moral and ethical standards had always been an unspoken aspect of College life. The College expects the highest levels of social responsibility, personal integrity, and professional excellence; these are the hallmarks of College membership.
This second edition of the ACP Ethics Manual is an effort to address major contemporary issues that confront every physician in practice. Medicine, law, and social values are not static; and so, additions, revisions, and some updating were in order. Like the first edition, this edition is designed to facilitate the process of making ethical decisions in the practice of medicine by suggesting relevant issues that need consideration. It is neither a comprehensive review of medical ethics nor a policy manual. The manual is not a statement of legal principles While medical ethical precepts may remain essentially uniform and stable over time throughout this country, the law can differ from state to state and change over time with regard to specific issues. It is important to understand that the manual should serve as a guide to making ethical decisions. For purposes of this manual, the terms "ethical" and "moral" are used interchangeably.
It is essential to remember that physicians are morally as well as legally accountable, and that the two may not be synonymous. Segregation and slavery, for example, were once legal in this country, but never morally defensible. Moreover, law rarely establishes positive duties such as beneficence. By contrast, professional medical ethics makes beneficence a primary obligation. Physicians must keep the distinctions and potential conflicts between legal and ethical duties in mind in their clinical decisions.
The physician who is concerned about the legal ramifications of acts undertaken on the basis of ethical precepts should seek appropriate legal counsel. When reference is made to the law in this manual, it is done solely for general, illustrative purposes, and those references should not be viewed as a statement of the law or of the legal consequences of a physician's actions.
The College's Ethics Committee, which is composed of practicing internists, medical ethicists, and educators, has written this manual for our colleagues in medicine. It presents some of the principles of medical ethics that have evolved in Western culture and are now widely accepted as guidelines for the protection and care of persons who are sick or vulnerable because of illness. Effective medical practice requires scientific knowledge and mastery of technology, as well as the art of taking care of the patient, but it must be guided by appropriate sensitivity to ethical issues.
The decision to produce and periodically update this manual was occasioned by a sharp increase recently in the number and complexity of ethical problems arising each day in the practice of medicine. Many of these questions are the consequence of new knowledge and technologic advancement. They also stem from a continuing analysis by physicians, ethicists, philosophers, the legal system, the public, and others, of the changing values of society as they relate to medicine. An additional purpose of this manual is to stimulate reasonable debate so as to widen the area of agreement on medical ethics. Such a debate may also stimulate a critical evaluation of law and public policy in accord with, and sensitive to, the difficult ethical issues facing patients and physicians.
There has been no attempt to include an exhaustive list of references or suggested readings within this manual. However, an annotated bibliography of medical ethics prepared by Drs. Mark Siegler and Peter A. Singer of the Center for Clinical Medical Ethics, University of Chicago, and Dr. David Schiedermayer of the Center for the Study of Bioethics and the Department of Medicine, Medical College of Wisconsin, is also available from the College. This list emphasizes recent articles written by clinicians that appeared in high-impact journals; it includes both empirical and analytic studies. These readings can enlarge the internist's view and knowledge of medical ethics, and may assist physicians in making sound clinical decisions within the framework of the physician's traditional commitment to moral principles of conduct and conscience.
The Historical Evolution of Medical Ethics: An Overview
One characteristic of a learned profession is its adherence to a code of ethics, to a set of specific standards of conduct by which it guides the behavior of its members. Since its earliest recorded history medicine has had such standards, conformity with which has been a hallmark of the good physician and a safeguard of the patient's welfare.
Medical ethics is grounded in the moral, religious, and philosophical ideals and principles of the society of which it is a part. In addition, physicians are held to certain special ethical standards that are determined by the nature of the decisions and personal relationships characterizing the practice of medicine.
Most medical codes have intermingled etiquette and ethics. Etiquette provides guidelines on relationships with other physicians and proper decorum in the presence of patients. Ethics concerns itself with the moral principles that underlie the physician's obligations to the sick and to society.
From very early times, society and physicians have been concerned with the moral aspects of medical practice. The first existing documents that mention the priest-physician are the Egyptian papyri (from about the 16th century BC); they outline methods of establishing diagnoses, making decisions about whether to treat, and what therapy is appropriate. As long as physicians followed the rules, they were held nonculpable should the patient die. On the other hand, if physicians transgressed, tried a new form of treatment, and the patient died, they might lose their own lives.
Medicine developed in Mesopotamia in parallel with its growth in Egypt. Hammurabi, one of the great kings of Babylon, devised in about 2000 BC an elaborate code of laws for those who practiced medicine and surgery. (This code was written 500 years before Moses brought the Ten Commandments down from Mount Sinai.) Hammurabi set surgical fees according to the social status of the patient and established punishment for poor technical performance. Thus, both Egyptian and Babylonian societies issued rules and sanctions to control the activities of physicians and surgeons.
The Jewish tradition in medical ethics is a rich one dating back to Biblical times. It derives medical ethics from the norms of the divine law as found in the written law (Torah) and its rabbinic interpretations and applications (Talmud). From the beginning, Jewish medical ethics has emphasized the close, relationship of medicine and religion and the primacy, in all its norms, of respect for human life. It also excelled in the judicious application of absolute norms to individual cases.
The Greeks absorbed the experiences of the Babylonians, Egyptians, and others with whom they traded. Their medical model was the deified Aesculapius, who was believed to have ministered, with his sons, to the Greek army at the siege of Troy. The priests of Aesculapius healed through art and magic and had little science. They stressed equality of care for rich and poor.
The writings of Hippocrates (460 to 377 BC) introduced the tradition of clinical observation and critical reasoning. From the Hippocratic school came the Oath, which has been the touchstone of medical ethics for 2500 years. The moral content of the Oath was based in the strict moral code of the Pythagoreans which was, however, not the credo of the majority of Greek physicians. The Oath was later supplemented by the many books of the Hippocratic Corpus. The ethical norms and the particular etiquette promulgated in the books of the Hippocratic Corpus became the Hippocratic ethic, the essential feature of which is the responsibility of the physician for the patient. This is the source for the benign paternalism that has characterized much of Western medicine up to our own times.
Greek medicine firmly separated itself from formal religion. Its spirit was pragmatic. It permitted withholding the truth from patient and family if it served the patient's good. In contrast with Aesculapian medicine, it tolerated different standards of care for the rich and the poor. Hellenic medicine carried forward the Hippocratic tradition and intermingled it with the ethical teachings of Plato, Aristotle, and the Stoics.
Hindu medical mores were akin to those of the Babylonians and the Greeks. A Hindu oath of initiation into the medical profession contains the following statements: "Day and night, thou shall endeavor for the relief of patients with all thy heart and soul. Thou shall not desert or injure thy patient even for the sake of thy living." This oath is similar to a statement from Hippocrates: "As to disease, make a habit of two things, to help or at least to do no harm."
Chinese medicine, with a heritage of over a thousand years, had established similar precepts. A canon of medicine written some time between 200 BC and AD 200 holds that the physician should have "mercy on the sick and pledge himself to relieve suffering among all classes. Aristocrat or commoner, poor or rich, aged or young, beautiful or ugly, enemy or friend, native or foreigner, educated or uneducated, all are to be treated equally. He should look upon the misery of the patient as if it were his own." This canon contains much that accords with Aesculapian ethics.
Roman medical ethics was strongly influenced by Stoic philosophy with its emphasis on virtue and duty. Galen (AD 130-201), who worked in Rome, was a Greek. Like Hippocrates, he sought to advance the science of medicine. His ethical stance combined Hippocratic, Stoic, and Hellenic ethics. After Galen, and largely due to his influence, dogmatism became the prevailing medical philosophy. There was little original inquiry and knowledge became static. All aspiring physicians were required to learn the protocols and teachings of Galen, especially in therapeutics. Galen's doctrines were not seriously questioned until Vesalius (1514-1564) published his monumental anatomical work, De Humani Corporis Fabrica Libri Septem, in 1543.
During the Middle Ages, medical science and philosophy were sustained and transmitted to the West by the Arabs and their allies as they moved along the Mediterranean littoral and into Spain. Two Persians, Avicenna (AD 980-1036) and Rhazes (AD 865-925), were renowned physicians, philosophers, and clinicians. Rhazes, for example, differentiated measles from smallpox, wrote more than 100 medical treatises and compiled his canon, a compendium of all the medical knowledge extant in his time.
At this time, also, the Hippocratic ethic particularly the Oath-was incorporated into the teachings of Moslum, Jewish, and Christian physicians and thus spread throughout Europe and the Middle East. In this same era, Moses Maimonides (AD 11351204), one of the greatest physician-philosophers, compiled his Canon of Jewish Law and Medicine, which has remained influential to this day. St. Thomas Aquinas (AD 1224-1274) integrated the philosophy and ethics of Aristotle with Christian theology in his Summa Theologica and developed the classical doctrine of virtue ethics to a high sophistication.
In AD 1200, Frederick II of Sicily involved the state in the governance of medicine. He established progressive rules for the education of future physicians, their method of practice, charges for their services, and mechanisms for assuring the purity of drugs.
In 1520, the Royal College of Physicians of London drew up a penal code for physicians, but in 1543 the word "penal" was changed to "ethical" to avoid the implication of criminality. When the American Medical Association was founded in 1847 "to elevate the quality of medical education and to improve the effectiveness of medical practice," its code of ethics was, in part, based on the code of the Royal College. It was based also on Samuel Bard's A Discourse upon the Duties of a Physician (1) and especially Thomas Percival's Medical Ethics: Or a Code of Institutes and Precepts Adapted to the Professional Conduct of Physicians and Surgeons (2), published in 1769 and 1803, respectively (3).
All these codes, including that of the British Medical Association (1858), mix rules of behavior and etiquette with elements of true ethics. The 1957 revision of the American Medical Association's ethical code begins by noting the physician's responsibility to his patient: "The principal objective of the medical profession is to render service to humanity with full respect to the dignity of man... rendering to each a full measure of service and devotion." The 1980 version begins, "A physician shall be dedicated to providing competent medical service with compassion and respect for human dignity."
In 1948, the World Medical Association adopted the Declaration of Geneva. This document, designed for those being admitted to the medical profession, represented a revision of the Hippocratic Oath. About the same time, the Nuremberg Code and the Declaration of Helsinki emphasized the concept of voluntary consent for human research subjects and expressed two significant characteristics of modern medicine: a heightened responsiveness to the needs, wants, and rights of patients as individuals and an acknowledgment of the need to balance the rights of the individual and of society. Both are general guidelines and do not help in resolving the difficult conundrums presented by many specific situations that occur in modern medical practice.
Medical morality and philosophy have evolved gradually, following a long and sometimes uneven pathway. Today, medicine and society face an unprecedented array of complex ethical problems. The convergence of many forces-scientific advances, public education, the rise of participatory democracy, the civil rights and consumer movements, the effects of law and economics on medicine, and the moral heterogeneity of our society-poses serious challenges to the long-held, noble vision of Hippocratic ethics. As a result, more change has occurred in medical ethics in the last two decades than in its entire preceding history. Neither the public nor the profession has yet assimilated all these changes. Sometimes they are confused by them and yearn for a return to the simplicity of the past. But such a return is no longer possible.
Each age views its own situation with alarm when change forces a reconsideration of cherished beliefs. Yet, never has medical ethics been forced to undertake a more searching examination and never has there been a greater need for heightened moral sensitivity than in our time. This latest revision of the manual tries to confront the magnitude and rapidity of change. It seeks to preserve what is vital from the past and add from the present what the past could not foresee, while at the same time preserving the noble spirit of the ancient tradition.
1.00 The Physician and the Patient
The primary goals of the physician are to prevent disease and untimely death and to care for the sick. The physician should treat and cure when possible, help patients cope with illness, disability, and death, and relieve suffering. In all instances, the physician must help maintain the dignity of the person. The patient's welfare must be the physician's main concern. All the physician's acts toward these ends stem from the patient-physician relationship. Ethical behavior toward patients furthers these goals and strengthens the patient-physician relationship and the relationship between the physician and society.
1.01 Patient-Physician Relationships
In the absence of a medical emergency, the relationship usually begins when the patient chooses a physician and the physician agrees to care for him or her; belief and confidence in the physician, essential ingredients of healing, come easier when choice is free. Whatever the treatment setting, at the beginning of a successful relationship the physician must discern the patient's complaints and underlying feelings and expectations. After defining the problem before them, the physician presents one or more courses of action. If agreeable to both parties, the patient may then empower the physician to initiate a course of action, and the physician accepts the responsibility. Through effective communication, the relationship is sealed by understanding, mutual acceptance, trust, and respect. The physician must be professionally competent; he or she should also be interested in the patient, who is to be treated with kindness and respect and as a unique person. The patient should understand and approve the treatment, and should participate responsibly in the care. The physician deserves compensation for services rendered. Professionalism and a sense of duty to the patient and to society should take precedence over concern about compensation; the physician's highest commitment is to the patient.
The physician's primary obligations to the patient remain unchanged, even though the patient-physician relationship may be affected in various ways by the system through which health care is delivered or other factors. The patient's interests should always be protected whether care occurs in the fee-for-service setting, health maintenance organizations, preferred-provider organizations, the Armed Forces, the Veteran's Administration, or publicly supported medical facilities; or whether the patient is mentally competent, incompetent, permanently unconscious, chronically or acutely ill, or a minor or elderly.
Physicians and patients often come from different cultures and may have different ideas of what the problem is and what they wish to accomplish. The care of the patient and satisfaction of both parties are best served if the physician and patient discuss their expectations and concerns openly. If the physician and patient develop differences that prevent a successful relationship, the physician must provide care to the patient until such time as the patient-physician relationship becomes comfortable or can be ended in an appropriate fashion (see "Initiating and Discontinuing the Treatment Relationship"). Since patient care is a dynamic process, a harmonious working arrangement between patient and physician requires continuing negotiation and modification. The physician cannot be asked to violate his or her standards of medical practice or the law. Patients may refuse any recommended therapy, but they cannot require the physician to do everything they want, particularly when it runs contrary to the physician's medical or moral standards or endangers others.
Spiritual needs and desires of patients vary greatly. The physician should respect the wishes of the patient and cooperate in all reasonable ways with religious representatives, insofar as this allows the provision of high-quality care to the patient.
There are occasions when the patient's beliefs dictate decisions that run counter to medical advice. The physician must judge whether acceding to the patient's wishes compromises his or her sense of medical responsibility to the patient to an unacceptable degree. The physician must try to understand clearly the beliefs and the viewpoints of the patient. If the physician is unable to carry out patient wishes, the physician must withdraw and transfer care of the patient or seek the assistance of the courts (see "Consent").
1.02 Initiating and Discontinuing the Treatment Relationship
A patient-physician relationship is based on mutual agreement to care for the patient. A physician may not discriminate against a class or category of patients, but has no ethical obligation to see an individual patient unless no other physician is available, as in some isolated communities; or emergency treatment is required, under which circumstances the physician is morally bound to provide care and, if necessary, to arrange for proper follow-up.
A patient is free to change physicians and is entitled to have the information contained in the medical records provided to him or her, or transferred to the new physician. The physician may discontinue the professional relationship by notifying the patient and, with the approval of the patient, transfer to another physician the information in the record, providing adequate care is available to the patient elsewhere and the patient's health is not jeopardized in the process. Continuity of care must be assured to the best of the physician's ability.
1.02 Medical Risk to the Physician
It is unethical for a physician to refuse to see a patient solely because of medical risk, or perceived risk, to the physician. Especially since the late 19th century, the ethical imperative to provide care has overridden risk to the treating physician. This was especially true in the early 20th century when many infections caused uncontrollable disease. In recent decades, with better control of such risks, generations of physicians have been trained when risk has not been a prominent concern. Recently, however, with the appearance of the acquired immunodeficiency syndrome (AIDS), this has changed, necessitating reaffirmation of the ethical imperative and related concerns. The College's position paper on AIDS (4) examines issues raised by AIDS and the human immunodeficiency virus (HIV) and emphasizes the following principles: Health professionals and institutions are obligated to provide competent and humane care to all patients; the denial of appropriate care to a class of patients is unethical; health professionals must be aware of risks involved, how to avoid risk, and how to respond if exposed, thus minimizing danger to all; and HIV testing should be done only when it will benefit the patient or contacts to whom the organism may have been transmitted or for the protection of the public.
1.04 Financial Arrangements
Financial relationships between patients and physicians vary (for example, fee-for-service, government contractual arrangements, and prepaid insurance). At the beginning of patient-physician contact, it is good practice for patients to have a general knowledge of physicians' fees and the probable overall costs of medical care. Financial arrangements should be clarified and means of payment or inability to pay should be established. Once the patient-physician relationship has been established, however, the physician's duty is to see that appropriate care is rendered, unless the relationship is discontinued.
As a professional dedicated to public service, the physician also has a moral obligation to contribute services to the neglected and poor and to give quality medical care to all patients.
Another aspect of free care relates to "professional courtesy": Its recipients may feel that they are imposing on the physician, thus crippling the healing process. Physicians should assure these patients that they have full rights to physicians' time, knowledge, and interest in them. Patients who remain uncomfortable receiving professional courtesy, should, at their request, be charged a mutually agreeable fee. All participants should also be aware of another risk related to such "professional courtesy." In such arrangements, the patient often initiates questioning in informal settings, putting the treating physician in a less than ideal position to provide optimal care. Both parties should prevent such inappropriate practice.
1.05 Confidentiality
The patient's right to the confidentiality of his or her medical record is a fundamental tenet of medical care. The physician must not release information without the patient's consent, unless required by the law or fulfilling a duty to warn another. Confidentiality should be protected to the greatest extent possible, consistent with the duty to protect others and to protect the public health. Confidentiality may have to be broken, for example, to warn sexual partners that a patient is infected with the AIDS virus. If the physician thinks that commitment to the patient's welfare overrides duty to the law, the physician can ethically refuse to give information not released by the patient, but must recognize that this is an act of conscientious objection that may have legal consequences.
The loss of privacy in modern societies, computerized record keeping and electronic data processing, third-party payment for medical services, and the sharing of the patient's care among numerous medical professionals and institutions have made confidentiality increasingly difficult to maintain. Physicians should keep abreast of these developments and work to prevent increased invasion of patients' privacy. Also, within their own institutions, physicians should advocate policies and procedures to secure the confidentiality of patients' records.
Physicians should know the laws of their state regarding the right of adolescent patients to confidentiality and the adolescent's legal ability to consent to treatment. Family involvement is important in caring for the adolescent patient, but it must be balanced with need for confidentiality and the right of the adolescent to exercise autonomy and self-determination in health-care decisions and in his or her relationships with health-care providers (5).
The discussion of the problems of an identified patient by professional staff in public violates patient confidentiality and is unethical.
1.06 The Patient and the Medical Record
Legally, the patient has the right to know what is in his or her medical record. The actual chart is the property of the physician or institution. Whether the patient should be allowed personal access to the medical record is debatable; the legal right in this regard varies from state to state. In practice, physicians generally exercise the clinical prerogative of deciding how chart information should be provided, but they have the obligation to release information to the patient or to a third party at the patient's request. To protect confidentiality, information should only be released with the written permission of the patient.
Physicians should assure that, at all times, patients have easy access to information concerning their critical health-care needs. In addition, travelers, military personnel, and patients who may require treatment away from home should be encouraged to have a summary of their medical records.
1.06 Disclosure
The patient must be well informed to make health-care decisions and work intelligently in partnership with the physician. The patient is seeking expert knowledge and professional opinion. Effective physician-patient communication can dispel uncertainty and fear. Healing and the satisfaction of the patient are enhanced.
Information that the patient needs for decision making should be given in terms the patient can understand. The physician should heed cues from the patient in setting the pace of disclosure, particularly when the illness is grave. If for some reason the patient is unable to comprehend, there should be a full disclosure of the patient's condition to his or her authorized representative. Disclosure should never be a mechanical or perfunctory process. Distressing news and information should be presented to the patient in a way that minimizes despair.
In general, full disclosure is a fundamental ethical requirement. However, ethicists recognize the "therapeutic privilege," which is an exemption from the most detailed disclosure when such disclosure might inflict serious emotional damage, impair rational decision-making, or otherwise harm the patient. On balance, the therapeutic privilege should be interpreted narrowly; if it is invoked without justification, it can undermine the whole concept of informed consent.
1.07 Consent
The issue of patient consent is a complex and changing one, with both ethical and legal aspects. It has received heightened attention in recent years for many reasons, including increased recognition of patient autonomy, and efforts toward improved risk management. Most simply it is the physician's obligation to ensure that the patient or his or her surrogate be appropriately informed as to the nature of the patient's medical condition, the objectives of proposed treatment, treatment alternatives, and the risks involved.
Most medical care is provided within the implied consent context: The patient presents for evaluation and care, the nature of the underlying condition and treatment is explained or known to the patient, and treatment is rendered and not refused. Under such circumstances, the physician may proceed on the basis of implied consent. Express consent most often occurs in the hospital setting where express written or oral consent is given to undergo a particular procedure.
If the patient is incapable of giving consent, consent should be obtained from someone who is legally authorized to consent for the patient. In medical emergencies, consent to treatment necessary to maintain life or health can be implied.
The doctrine of informed consent goes beyond the question of whether consent was given for a particular treatment. Rather, it focuses on the content of that consent: specifically, on whether the patient knew enough about the nature of the treatment, the alternative methods of treatment, and what would happen in the absence of treatment to make an informed decision. The legal theory is that the physician knows far more than the patient about the true nature of the patient's condition, the nature and extent of the proposed or alternative treatment, and the effects which these treatments (or no treatment at all) would have upon the patient. Given the imbalance in knowledge and expertise between the physician and the patient, the physician must provide the patient with enough knowledge to allow the patient to make an informed judgment as to how to proceed. The physician's presentation should be understandable and unbiased; the patient's or surrogate's concurrence must be obtained without coercion; the physician must not take advantage of a situation in which he or she may hold psychological dominance.
Truly informed consent is most apt to be achieved through effective communication between patient and physician; it is not achieved by the perfunctory signing of a "legal" consent form. The thoughtful physician communicates with the patient in a warm, comfortable, and open manner that conveys competence, loyalty, and respect for the patient in an attitude that engenders trust and confidence. Using language that can be understood, the physician endeavors to present the patient with a basic understanding of the problems they face together and makes it clear that the patient has the right to make the final choice in accepting or rejecting the proposed plan of diagnosis and treatment. Physicians must not abandon patients who do not accept their advice. If the patient rejects the physician's recommendation, the physician may seek the assistance of the courts if he or she feels morally or legally constrained to do so; the physician may withdraw from the case only after providing notice and when alternate care is assured.
Physicians should also be aware that the tests as to what constitutes informed consent may vary from state to state, and, therefore, they should seek local counsel as to the law in the jurisdiction in which they practice.
Physicians should also obtain consent of the patient with respect to the disposal and use of tissue, organs, or other portions of the patient's body removed during diagnostic or operative procedures. The law in this area is changing, but it is consistently protective of the patient's property rights to his or her own body.
1.09 Consultation
A physician should obtain consultation when the physician feels the need for assistance in caring for the patient. When consultation is requested by the patient or legally authorized representative, it should be obtained.
The level of consultation required should be established from the beginning: a one-visit opinion, continuing cooperative care, or total transfer of authority to the consultant. The consultant should carefully and respectfully explain any recommendations to the referring physician and obtain concurrence for major procedures or the calling in of additional consultants. The patient and the proper records should be transferred back to the referring physician when the consultation is completed. Care must be taken not to undercut the authority and dignity of the referring physician in this process.
The welfare of the patient is always paramount in the consultation process. When the consultant is convinced that he or she, rather than the referring physician, should have temporary charge of the patient's care, the consultant should tactfully attempt to obtain the referring physician's cooperation and assent. Both the primary physician and the consultant should have the patient's interest as their main concern. The referring physician who does not agree with the consultant's recommendations is free to call in another consultant. Any differences between referring physician and consultant should be resolved in the light of what is best for the patient. The referring physician should receive no fee from the consultant.
Under certain circumstances a complex clinical situation may require several consultations. These must be defensible on the basis of medical necessity. They must also be defensible against charges of collusion for profit. One physician must remain in charge of the overall management of the patient and the utilization of information derived from the consultations. Unless he or she has formally transferred authority elsewhere, the ultimate responsibility for the patient's care lies with the referring physician.
1.10 Conflicts of Interest
When conflicts arise, the moral principle is clear. The welfare of the patient must at all times be paramount, and the physician must insist that the medically appropriate level of care take primacy over fiscal considerations imposed by other institutions or by the physician's own practice, investments, or financial arrangements.
Activities of physicians relating to the business aspects of practice should be guided by the principle that such activities be intended for the reasonable support of the practice and for the effective provision of quality care to patients. The physician should avoid any business arrangement that might, because of personal gain, influence his or her decisions in the care of a patient. Collusion with any health-care provider for personal gain is morally reprehensible.
With the above principles in mind, the issue of investment in a hospital or other facility in which the physician practices or to which he or she refers patients poses complex ethical dilemmas. If such investments are made, they should be undertaken for the purpose of making available necessary services for patients. Otherwise, these investments make the physician vulnerable to the accusation that his or her actions are influenced by such ownership. The wisest course is to avoid all ethically compromising situations.
Gifts, hospitality, or subsidies offered by medical equipment, pharmaceutical or other manufacturers or distributors ought not to be accepted if acceptance would influence the objectivity of clinical judgment.
As long as the care of patients is not compromised, there is no ethical objection to a physician being engaged in any proper business unrelated to his or her medical practice.
1.11 Sharing Fees
A physician's professional fees should be received for the services rendered directly to a patient. The offering or receiving of a shared fee from another physician involved in the care of the patient is unethical. It is also unethical for a physician to receive a commission or "kickback" from anyone, including a company that manufactures or sells medical instruments or medications that may be used in the care of patients.
1.12 The Physician and Non-Scientific Medical Systems
Requests by patients for care outside the recognized methods of medical care pit the physician's commitment to provide optimal medical care against the patient's acknowledged right to choose what care he or she wishes and from whom. Such a request warrants the physician's considerate attention. Before advising a patient, the physician should determine the reason for the change: dissatisfaction with current care or merely inducement by claims for the nonscientific treatment. Next, the physician should be sure that the patient understands, in the spirit of informed consent, his condition, treatment, and outlook. The physician and the patient can then discuss realistically and dispassionately what the patient can expect from the two methods of care. The physician should not abandon the patient who elects to try a nonscientific remedy and should accept the patient's decision with grace and compassion. The physician should not participate in such treatment. Where the treatment is clearly harmful to patients, the physician should seek the best route by which to protect the patient and, where possible, have the dangerous therapy challenged.
1.13 Secret Remedies
In keeping with the principle of the open sharing of knowledge, the use of secret remedies cannot be condoned, whether or not there is financial gain. Development and sale of a secret remedy are unethical.
2.00 The Physician's Relationship to Other Physicians
The physician entering the profession shares with all other physicians a commitment to care for the sick. This traditional bond between physicians is a powerful aid in the service of patients and must never be used for personal advantage. In daily professional interactions between physicians this standard must be upheld (see "Consultation").
2.01 Teaching
The very title "doctor," from the Latin docere, "to teach," implies a responsibility to share knowledge and information with colleagues and with patients. This sharing includes the teaching of clinical skills and reporting of results of scientific research to colleagues, medical students, resident physicians, other physicians, and other health-care providers. It includes communicating clearly with and teaching patients so that they are properly prepared to participate in their own care and in the maintenance of their health.
2.02 Medical Students and Resident Physicians
It is the responsibility of the physician to teach what he or she knows of the science, art, and ethics of medicine to medical students, resident physicians, and others. It is also the physician's obligation to supervise those in training. In the teaching environment, graded authority for management can be delegated to residents under conditions of appropriate supervision. However, it is unethical to delegate the authority for the care of a patient to anyone, including another physician, who is not appropriately qualified and experienced. In a teaching service, ultimate responsibility for the welfare of a patient remains with the patient's attending physician of record who must assure appropriate supervision and care of the patient.
2.03 The Impaired Physician
It is the responsibility of every physician to protect the public from an impaired physician and assist a colleague whose professional capability is impaired because of ill health. Such assistance may sometimes take the form of offering medical care to the sick physician or providing care for the physician's patients until he or she has recovered.
A physician's incapacity may result from the use of habit-forming agents (including alcohol and other abuse substances) or from psychiatric, physiological, or behavioral disorders that interfere with patient care. Physician impairment may also be the result of disease entities that affect the physician's ability to function with the cognitive or motor skills necessary to meet standards of care. All steps must be taken to assure that no patient is harmed because of actions or decisions made by an impaired physician. The physician who feels unable to help an impaired colleague should suggest other sources of help. The legal responsibility of a physician to act and to report such incapacity varies, but there is a moral responsibility to report the incapacitated physician to an appropriate authority (such as chief of service, chief of staff, an institutional committee, state medical authorities, or regulatory authorities). In all instances the reporting physician must follow procedures dictated by the hospital, state laws and regulations, and by his own conscience.
The warning of patients about a specific, impaired physician should be tailored to the particular circumstances and, at a minimum, should include warnings to an identifiable patient if the risk of harm is direct and immediate.
2.04 Criticism of a Colleague
It is unethical and harmful for a physician to disparage without good evidence the professional competence, knowledge, qualifications, or services of another physician to a review body or a patient. It is also unethical to imply by word, gesture, or deed that a patient has been poorly managed or mistreated by a colleague without good evidence. Such improper behavior, especially when used to induce a person to become one's patient, is unethical. Care to avoid such inducement is especially necessary for the physician who has been called into consultation by another physician (see"Consultation").
Equally, it is unethical for a physician not to report fraud, professional misconduct, incompetence, or abandonment of a patient by another physician. lt is here that professional peer review becomes critical in assuring fair assessment of physician performance for the benefit of the patient. The trust invested in physicians by patients and the public requires such disclosures to the appropriate authorities and to patients at risk of immediate harm.
2.05 Advertising
Advertising is defined as a form of communication designed to inform the general public about the availability and nature of products and services. Below are examples of the types of useful information that could be included in "ethical advertising." These are examples only and should not be interpreted as excluding other relevant information consistent with the ethical guidelines described in this manual.
1. Type of practice or specialty.
2. Specialty residency training, fellowships, and professional society memberships.
3. Specialty board certification.
4. Hospitals to which a physician admits patients.
5. Office hours and after-hours coverage.
6. Appointment requirements.
7. Office location, telephone, and conveniences (such as proximity of public transportation, parking facilities, ramp, elevator, wheelchair).
8. Description of services (such as in-office roentgenograms, other diagnostic tests, prescription of birth-control devices).
9. Ranges of fees for specific services and tests.
10. Acceptance of Medicare and Medicaid patients.
11. Acceptance of credit cards.
12. Languages spoken.
American College of Physicians Ethics Manual.
Part 2: The Physician and Society; Research; Life-Sustaining Treatment; Other Issues
3.00 The Physician and Society
The professional prerogatives of the physician are conferred by society. In turn, the physician is responsible and accountable to society for his or her professional actions. Society grants to the physician the rights, privileges, and duties pertinent to the patient physician relationship. This grant can be withdrawn by society from the individual physician or from the entire profession. Society has a significant interest in the professional activities of physicians and others in the health-care field and will seek to control and regulate such professional activities to suit what it perceives as its own best interests. Society has conferred great authority on the medical profession in the belief that physicians will use such power for the benefit of patients. Society has the right to require that physicians be competent and knowledgeable and that they practice with consideration for the patient as a person.
3.01 Obligations of the Physician to Society
Like any other good citizen, the physician should strive for the well-being of the community and of society. He or she should work toward ensuring the availability of adequate medical care for all persons and should support community health endeavors. In particular, the physician should seek to make optimal use of all health-related resources in a technically appropriate and effective manner. The physician's conduct, both as a professional and as a citizen, should merit the respect of the community. He or she should help the community increase its capacity to recognize and deal with social and environmental causes of disease.
In addition, the physician has the following special obligations:
1. To fulfill, with his or her colleagues, the profession's collective responsibility to be advocates for the health of the public.
2. To be aware of the availability, accessibility, and quality of health services in the area in which he or she practices and to participate in reasonable efforts to correct defects in such availability, accessibility, and quality.
3. To encourage, support, and assist efforts to provide the general public with accurate knowledge relative to its health and health-care needs.
4. To act for the protection of society by reporting those diseases, as required by law, to the responsible public-health authorities.
5. To be aware of limitations of health-care resources but to assure the provision of quality care. If conflict arises over the expenditure of resources on a particular patient, the physician is obligated to protect the patient's welfare.
3.02 The Relationship of the Physician to Government
The physician should lend his or her expertise to the development of health policy at the local, state, and national levels by expressing views as both a citizen and a professional.
Efforts at cost containment may cause physicians to be caught between their traditional commitment to serve their patients' interests and their new, resource allocation role (see "Resource Allocation" below). The challenge for society and its physicians will be to redefine the level of care that can be made available to all patients regardless of their financial resources. Physicians should not become agents of the state for the rationing of beneficial medical care. If a treatment is unavailable for economic reasons, the patient should be informed; otherwise a political decision assumes the appearance of a medical decision. More than ever before, the physician will have to be the advocate of the patient in these times of limited resources. Patients must know that their best interests are being served.
3.03 Other Physician-Government Issues
3.03a Torture
Under no circumstances is it ethical for a physician to be used as an instrument of government for the purpose of weakening the physical or mental resistance of another human being.
3.03b Punishment
Participation in, or tolerance of, punishment of a prisoner by a physician beyond the punishments allowed by the United Nations Standard Minimum Rules for the Treatment of Prisoners is unethical (6).
3.03c Execution
Participation by physicians in the execution of prisoners is unethical.
3.03d Distortion of Clinical Criteria
It is unethical for a physician to participate in the formulation or application of diagnostic, therapeutic, or prognostic principles that are subverted or distorted for the purpose of punishing prisoners.
3.04 The Relationship of the Physician to Other Health Professionals
The interests of the patient have primacy in all aspects of the patient-physician relationship. The physician should act as an advocate and coordinator of care for the patient and should assume appropriate responsibility, especially when utilizing the help of other health professionals. The physician should collaborate only with competent health professionals when sharing the care of the patient. Delegation of treatment or technical procedures must be limited to persons who will conduct such procedures with skill and thoughtfulness; the physician who has primary charge of the patient's care must retain ultimate responsibility for all aspects of the patient's management. Society has identified the physician as possessing the necessary training to undertake this responsibility, and such responsibility is implied in the relationship between patient and physician.
Physicians and nurses both strive to serve the patient. The lines of communication between physicians and nurses must always be open, and communication must always be characterized by mutual respect. Whereas the physician's expertise on technical and scientific matters may be greater than that of the nurse, when it comes to moral judgment, physicians and nurses are equal. When a nurse believes a physician's order is contrary to his or her personal values or to usual medical and nursing practice, the nurse must share this opinion with the physician so that the matter can be discussed. Conflict-of-opinion policies and procedures in hospitals should be developed to further guide the resolution of such conflicts.
Medical capability has not always progressed hand-in-hand with medical availability. The unevenness and disparity in patient-to-physician ratios across the country have been factors in the remarkable increase in nonphysician practitioners who represent a broad spectrum of educational background, training, experience, and skill. Limits imposed by licensure for nonphysician practitioners vary.
3.05 The Relationship of the Physician to the News Media
Certain patients will be in the public eye either because they seek public acclaim and attention through their work, or have been thrust there by events beyond their control. Physicians attending such patients should remember that they are not free to discuss or disclose information about a patient's health without the express consent of the patient. The physician always has the ethical and legal obligation to maintain the confidential nature of the physician-patient relationship, and this obligation does not change simply because the patient may be in the public eye.
Commentary by physicians on medical subjects within their areas of expertise can help keep the public properly informed. Those physicians who are able to help provide the public with accurate information should regard interacting with the news media as an obligation to society and, in a manner of speaking, an extension of medical practice.
3.06 Strikes by Physicians
The withholding of medical services by physicians through strikes is a serious action; it is unethical and cannot be condoned. Physicians, both individually and as a group, have sufficient social position, political awareness, and initiative to find alternative ways of dealing with problems that would seem to justify drastic social and political action.
4.00 Research
Scientists have a responsibility to provide research results of high quality; to gather facts meticulously; to keep impeccable records of work done; to interpret results realistically, not forcing them into preconceived molds or models; and to report new knowledge through appropriate scientific channels. Self-aggrandizement, public acclaim, recognition by professional peers, or financial gain should never be the primary motivating factors for carrying out scientific research. Coauthors of research reports must be well enough acquainted with the work of their coworkers that they can personally vouch for the integrity of the study and the validity of the findings and must have been active in the research itself.
The basic principle underlying all research is honesty. Institutional protocols must be in place to assure this. Jacob Bronowski has said in The Common Sense of Science (7), "The institution of science involves an implicit social contract between scientists so that each can depend upon the trustworthiness of the rest.... The entire cognitive system of science is rooted in the moral integrity of aggregates of individual scientists."
Advances in medical knowledge and technology can occur rapidly. Often it is possible for the clinical application of such progress to proceed swiftly, even before the medical community has had an opportunity to establish guidelines for appropriate and ethical use. It is the responsibility of the medical profession to ensure verification of the safety and efficacy of new technologies and treatment. Medical consensus development should be open to public scrutiny.
4.01 Clinical Investigation
Advances in the diagnosis and treatment of disease are based on well-designed, carefully controlled, and ethically conducted clinical studies. The medical profession must assume the responsibility for ensuring that the experiment is worth doing. Subjects must be instructed concerning the nature of the research; consent must be truly informed and given freely; research must be planned thoughtfully, so that it has a high probability of yielding significant results; risks to patients must be minimized; and the risk/benefit ratio must be sufficiently low to justify the research effort.
Generally, clinical research is of three types: individual research projects, collaborative clinical studies, and drug trials. Each institution where clinical research is conducted with federal support is required by federal law to create an institutional review board for the protection of human subjects. All proposed clinical research, regardless of the source of support, should be approved by the local institutional review board, which has the responsibility of ensuring that the research plans are reasonable and that mechanisms for providing protection for research subjects are adequate and operative.
Although this formal system of review is designed to protect research subjects, the premise on which all ethical research is based is mutual trust and respect between research subjects and researchers. This premise requires that physician-investigators who design or carry out research plans have primary concern for the subjects of these investigations.
4.01a Others Concerned with the Ethics of Research
Although the responsibility for ensuring reasonable protection of human subjects resides with the planners of the research and the local institutional review board, the clinical-research community as a whole is involved indirectly through the advocacy of enlightened attitudes and support of ethical research. Physicians referring their patients for participation in research protocols must satisfy themselves that the program follows established ethical guidelines and provides for informed consent, reasonable assurances of safety, and an acceptable risk/benefit ratio. If the research risks become too great or if continued participation cannot be justified, the physician must be willing to advise the patient to withdraw. The physician of record does not abdicate overall responsibility for the patient whom he or she has referred to a research project.
In addition to the above, local or national agencies (such as the Food and Drug Administration) may, in certain circumstances, enter into design and interpretation of research. Finally, the peer-review process in medical research is a fundamental aspect of design, oversight, and results review. Peer review contributes in a major way to the quality, safety, and ethical principles vital to research.
4.01b Innovative Medical Therapies
Somewhere along the continuum that lies between established practice and research falls the problem of innovative medical therapy. Physicians who are fully engaged in clinical practice outside the academic arena will obviously confront the ethical dilemmas of innovative practice more frequently than the ethical problems attached directly to medical research itself. Within the category of innovative therapies lies a wide range of activities, including the use of unconventional dosages of standard medications, previously untried applications of known procedures, and the use of approved drugs for nonapproved indications.
In ethical terms, deviating from standard therapy is clearly not fully equivalent to conducting research, when research is defined by the intent to produce generalizable knowledge. Using unconventional dosages of standard medications, for example, is not traditionally seen as requiring institutional review board oversight because, in the strict sense, this is not thought to constitute research. At the same time, certain fundamental principles of research and practice ethics are very much involved in considerations of innovative therapy (8).
Thus, innovation is viewed positively because the history of medicine is replete with examples of important advances that emerged from successful innovations. However, innovation should always be approached with circumspection. Especially when there is no precedent for an innovative therapy, it has been suggested that some type of consultation with peers, an institutional review board, or other expert group is necessary to assess whether the innovation is in the patient's best interest; the risks of the innovation; and probable outcomes of not using a standard therapy (8). The expectations of informed consent are particularly important and may be particularly vexing when innovative therapies are at issue.
4.02 Scientific Publication
Scientists must use valid scientific methods in making their discoveries or in confirming the work of predecessors. As stated earlier, scientists can proceed with confidence only if they can assume that the previously reported facts on which their work is premised have been reported accurately. All scientists have a professional responsibility to their contemporaries, as well as to future investigators, to record their observations, to ensure that their conclusions are justified by the data, and then to publish the material in peer- reviewed journals. Again, the guiding principle governing the ethics of authorship is honesty: Only observations that were actually made can be reported; the manuscript must make clear what information derives from the author's work and what comes from the work of others (and where it was published); readers must be assured that research has been carried out in accord with ethical principles; and authorship must be assigned only to persons who merit and accept it.
Plagiarism is unethical. To consciously incorporate the words of others, either verbatim or through paraphrasing without appropriate attribution, is unacceptable in scientific literature.
4.03 Public Announcement of Research Discoveries
In this era of rapid communication and intense media and public interest in medical news, it has become commonplace for clinical investigators to call press conferences and make public announcements of new research developments. Although it is desirable that the media obtain valid, factual information about newsworthy scientific developments, it is incumbent upon researchers to approach public pronouncements with caution and circumspection. Announcements must be presented in language that does not invite misinterpretation or extrapolation beyond what the investigator intended.
Most public knowledge about medicine is derived through the media, and the pronouncements of scientists receive a great deal of media attention. An "announcement of preliminary results," although couched in the most careful terms, is frequently reported as a "breakthrough." Besides creating false expectations in the public mind and causing embarrassment to the scientists involved, such pronouncements can result in the loss of credibility of the scientific community as a whole.
Ethical guidelines for public announcement are indistinct because it is unfamiliar terrain for most scientists. Thus, some caveats may prove useful: The risk/ benefit ratio of the event must be carefully contemplated; cautious assurance must be given that conclusions are justified from data (which have satisfied rigorous scientific methodology); and carefully chosen language must be incorporated into all decisions about public pronouncements.
5.00 Initiating and Foregoing Life- Sustaining Treatment
Considerations about initiating or foregoing life-sustaining treatment arise most frequently in patients who are severely and critically ill, terminally ill, permanently unconscious, or who suffer from irreversible cognitive or physical impairment. These cases (about which the law varies from state to state) frequently present perplexing clinical and ethical challenges to patients, physicians, and families for the following reasons: They involve life and death matters; certain types of decisions (for example, do-not-resuscitate [DNR] issues) arise more frequently; patients are often not capable of participating in the decision-making process and may never regain decision-making capacity; and there is frequently need to involve decision-makers other than the patient. For these reasons, such cases have a clinical and psychological intensity that distinguishes them from more routine clinical encounters in physicians' offices or in hospitals. Although this section highlights some of the special features of end-of-life decision-making, this central point must be remembered: The basic principles of informed consent, shared decision-making, and the use of surrogate decision-makers when necessary that have been described earlier in this manual apply to end-of-life decisions as well.
In the light of this crucial proviso, clinical-ethical issues relating to life-sustaining treatment will be examined under the following five headings:
1. Who should make the decision?
2. In which special clinical situations are such decisions frequently made?
3. What are the types of life-sustaining interventions being considered?
4. Euthanasia.
5. What are the responsibilities of physicians in such cases?
5.01 Who Should Make the Decision?
5.01a Competent Patients
Patients who have decision-making capacity and who have been adequately informed of their clinical situation and options usually have the right to accept or refuse any recommended medical treatment, including life- sustaining treatment. The only exception is when the law forces a patient to accept treatment over his or her objections, as in, for example, certain cases involving members of Jehovah's Witnesses. This right of the patient is based on the philosophical concept of autonomy, the common-law right of self-determination, and the more recently enunciated constitutional right to privacy. The crux of the issue is that the competent patient's (rather than the physician's) assessment of the benefits and burdens of treatment should determine what treatment is administered or withheld.
Generally, patients with decision-making capacity will accept physician recommendations about life-sustaining treatment, but, in some instances, particularly those of terminal or irreversible illness, competent patients may elect to forgo life-sustaining interventions. Because physicians invest so much in acquiring the necessary knowledge for making diagnostic and therapeutic decisions, it is often difficult for them to accept the fact that what is the "best" decision for a particular patient (in the opinion of the patient) may not be the "right" decision for that patient (in the opinion of the physician).
5.01b Incompetent Patients
In contrast to decisions made by competent patients, decisions regarding life-sustaining treatment for patients thought to lack decision-making capacity are very complicated for the following reasons: There is no reference standard-legally or clinically-for assessing decision-making capacity and competence; there is lack of agreement on how the determination of decision-making capacity should be made and whether it should be done at the bedside by clinicians or in courts by judges; even when all agree that a patient lacks decision-making capacity (for example, when the patient is comatose), there is no consensus on who should serve as a surrogate decision-maker for the patient-a relative, a friend, the physician, or a court appointed guardian; and, even when all agree that a particular surrogate decision-maker is the right one (for example, a loving spouse), there remains considerable uncertainty about how to apply the criteria the surrogate should use in reaching a decision for patients without decision-making capacity.
Surrogate or proxy decision-makers must be morally as well as legally valid representatives of the incompetent patient's interests. They should know the patient's values well and be free of obvious fiscal or emotional conflicts with the patient. The physician should take reasonable care to ensure that the surrogate's decisions are motivated by respect for the patient's interests and values. The physician is the patient's advocate and has a duty to the patient and to no other person during the interim.
One approach adopted by the courts is that of "substituted judgment" in which the surrogate attempts to make the judgment that the patient, if competent, would have made. Other courts have adopted a "best interests" approach in which the surrogate, or the court, attempts to determine the choice that is in the patient's best interest. The physician should seek counsel as to the applicable standards in the state in which he or she practices.
In these cases, clinicians should be guided by the following suggestions:
1. It is never easy to reach life-and-death decisions for patients who lack decision-making capacity and who have not left clear advance directives. Therefore, clinicians should work with the family and guardians of such patients to reach the best decisions in light of the patient's medical condition, prognosis, and the presumed preferences of the patient as articulated by the surrogate.
2. Physicians should diminish the need for speculating about life-and-death decisions for patients without decision-making capacity. To accomplish this, physicians should, when the patient is competent, attempt to obtain, either orally or preferably in writing, the treatment preferences of their patients in circumstances where the patient later may be unable to participate in such decisions.
3. Whenever possible, these decisions should be reached in the clinical setting by responsible physicians, family, and other caregivers.
5.02 Importance of Advance Directives
Recognizing the difficulty of assessing preferences when a patient lacks decision-making capacity, physicians should encourage competent patients to make plans about treatment in advance of medical crises. This advance planning should specifically address two key points: the type of treatment the patient would wish to receive in different circumstances and the person whom the patient wishes to have serve as a surrogate decision-maker when he or she becomes unable to participate in decision-making. This process of discussion with the patient informs the physician of the patient's preferences and values, improves communication between physician and patient, and often reduces the patient's anxieties because the patient knows the physician is willing to discuss these highly sensitive issues and will be responsive to the patient's wishes. Discussions about the wishes of patients should be documented in the medical record. Patients should be encouraged to formalize their advance directives, for example, by using a living will (see below) or through a durable power of attorney.
5.03 Living Wills
These documents are valid ethically because they provide insight into a patient's preferences at a time when the patient lacks the capacity to communicate. Physicians must apply clinical judgment to know whether the general language of a living will applies to the specific circumstances of a particular patient. Therefore, when a patient prepares a living will, the patient should be encouraged to provide a copy of it to the physician, so that it can be discussed and understood and entered in the medical record. This will ensure that the patient's wishes are known, even when the patient comes under the care of different physicians in various institutional settings. Because patients can and do change their minds, both oral conversations and written directives should be updated periodically so that choices made by the patient are contemporary with the progress of treatment, and thus carry greater weight.
5.04 Quality-of-Life Considerations
Individuals often take account of their own quality of life in reaching decisions about their care. By contrast, when quality-of-life standards are used by parties other than the patient to reach a clinical decision, decision-makers must be aware of the personal and subjective values that may influence such quality-of-life evaluations. Thus, an assessment of a patient's quality of life may vary according to the decision-maker's age, present health, history of personal illness, cultural background, religion, and long-standing personal knowledge of the patient. Clinical decisions that hinge on assessing quality of life should be undertaken with great care, with full cognizance of the subjectivity of the assessment, and with full participation of the patient, or, in cases of incompetent patients, with participation of knowledgeable and concerned relatives or guardians.
5.05 Special Clinical Situations and Life- Sustaining Treatment Decisions
5.05a Brain Death
Irreversible death of the entire brain, including the brain stem, is now accepted by most clinical, legal, and religious groups as an acceptable standard for determining death when the use of cardiopulmonary life support precludes the use of traditional criteria. There may arise circumstances, such as the need to preserve organs for transplantation, the need to counsel and comfort the family, or the presence of a viable fetus, in which physicians may elect to support the body when clinical death of the whole brain has occurred. Definitions of death vary from state to state (and may be statutorily defined), and, therefore, physicians should avail themselves of legislative, judicial, or professional guidance regarding the use of brain-death standards.
5.05b Terminally Ill Patients
Terminally ill (dying) patients are those whose condition is irreversible whether treated or not and who have a high probability of dying in a relatively short time (for example, 3 to 6 months). The general guidelines for shared decision-making proposed for initiating and forgoing life-sustaining treatment apply also to cases of terminal illness. Although the underlying disease cannot be cured, the physician must work closely with the patient to make the patient as comfortable as possible by reducing physical and psychological suffering, discomfort, and dysfunction. Palliative care, such as is emphasized by the hospice concept, often includes pain relief and psychological and social support but also may include surgery, radiation therapy, and the administration of antibiotics when any of these are needed to make the patient more comfortable. It appears that many physicians continue to undertreat pain even in terminally ill patients. Therefore, it is essential for physicians to become more knowledgeable and skilled in the appropriate use of narcotics and other methods of pain relief, particularly in the treatment of terminally ill patients. Finally, the physician must not forget the important responsibility to provide support to the patient's family, friends, and care providers.
5.05c Irreversible Loss of Consciousness
The question of discontinuing life support for persons who are permanently unconscious but are not terminally ill or brain dead (such as persons in a persistent vegetative state) remains a perplexing one. The current legal and ethical mainstream position is to make treatment decisions about such patients in the same manner as for other patients, insofar as that is possible. If the patient's previous wishes for or against life-sustaining treatment are known, the physician has a presumptive obligation to act on these wishes. Unfortunately, most permanently unconscious patients have not provided unambiguous advance statements of preferences. The best clinical recommendation in these difficult cases is for the physician to elicit the opinions of the patient's family, friends, clergy, primary-care physician, and other caregivers in an effort to determine what the patient would wish in these circumstances. Failing at that, there has emerged a tendency to withdraw more complex interventions such as ventilators, renal dialysis, and intensive-care nursing from permanently unconscious patients. When such patients continue to survive, clinicians are divided about when antibiotics, fluids, and nutritional support should be withheld. In recent years, when such cases have been brought to court, they sometimes have been decided under a "best interests" standard in which the treatment is discontinued because the burdens of continued interventions are seen as disproportionate to the minimal benefits (primarily continuation of physical life) that patients derive from such treatment. A physician who has strong moral feelings about this matter must follow his or her own conscience in making a decision in a particular case (see "Medicine and the Law").
5.05d Impaired Cognition
Currently, except in cases where advance directives have been provided, patients with severe and irreversible cognitive impairment who are not permanently unconscious should continue to receive basic supportive care. In the current medical environment, which emphasizes cost containment, physicians should not use quality-of-life standards that may lead to the undertreatment of various groups of patients, including those with physical and cognitive disabilities, unconsciousness but still unsettled prognosis, and severe dementia. Patients whom some perceive to be responsible for their own illness (such as those who suffer from alcohol abuse, drug abuse, or the acquired immunodeficiency syndrome [AIDS]) must be treated with the same care and according to the same ethical considerations as others.
5.06 Withholding or Withdrawing Certain Types of Life-Sustaining Interven- tions
5.06a Orders Not to Resuscitate (DNR Orders)
The goal of DNR orders is to provide optimum quality care to patients. A decision to withhold cardiopulmonary resuscitation (CPR) does not imply that other aggressive therapies should be withheld or withdrawn, and a DNR order should not affect any other aspects of the patient's care. There is general agreement that it is not good medical practice to carry out CPR on all patients who experience a cardiac or respiratory arrest (9): "The purpose of cardiopulmonary resuscitation (CPR) is the prevention of sudden unexpected death. Cardiopulmonary resuscitation is not indicated in certain situations, such as cases of terminal irreversible illness where death is not unexpected."
For both clinical and historical reasons, DNR orders that override the presumption of carrying out CPR in patients who sustain cardiac or respiratory arrest have become the paradigm for institutional protocols that address the problem of providing or withholding life-sustaining therapies. The unique clinical feature of CPR is that it is an emergency treatment that must be applied immediately to be successful. Because there is limited time during the crisis for deliberation and decision-making, all decisions about the use or withholding of CPR should be determined in advance of the clinical crisis. When it is agreed that CPR should be done, physicians and nurses should not carry out half-hearted efforts (so-called "slow codes"). When appropriate procedural safeguards exist, including proper documentation so that members of the health-care team are aware of the decisions, DNR orders and other decisions about withholding life-sustaining therapies have been widely accepted as reasonable standards of clinical practice. Recently, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has mandated that accredited acute-care and long-term-care facilities develop and implement institutional policies on withholding CPR. The JCAHO requires that institutions develop DNR policies that ensure that patients' rights are respected; provide procedures for resolving conflicts; make the physician responsible for writing the DNR order; and require that the DNR order be documented in the patient's medical record (10).
The two guiding principles that should determine whether a DNR order is written for a competent patient are the medical indications and the patient's preferences. Ideally, these considerations are discussed by the patient and physician, and they reach a joint and acceptable decision. Discussions of a DNR order can be initiated either by the physician or the patient at any time but are essential in clinical situations where a cardiorespiratory arrest is likely. Such discussions that have occurred when patients are relatively stable often provide physicians with guidelines for developing a comprehensive treatment plan for the patient. When treatment is judged useless, or when CPR would only prolong the dying process, then, if the patient agrees with the plan, an order not to resuscitate such a patient is ethical. In cases of conflict between the competent patient and the physician, the patient's wishes should prevail. For reasons of conscience, the physician may elect to withdraw from the case.
A DNR order should not be discussed with a competent patient's family unless the patient authorizes such a discussion. If the patient signifies his preference for a DNR order, this preference becomes the paramount consideration. If the competent patient's preference is contrary to the desires of the spouse or others, the latter have no legal, ethical, or moral standing to enforce their desires unless a court declares the patient to be legally incompetent and appoints a guardian to make treatment decisions for the patient.
A DNR decision for an incompetent patient or for a patient who lacks decision-making capacity raises the same issues discussed earlier in this section regarding incompetent patients. For persons who have been declared legally incapacitated, DNR orders must never be written solely on the basis of the mental condition but for the same reasons as for competent patients. Family members and friends often serve as representatives of the patient's moral community and frequently are most knowledgeable about the patient's values and preferences. Physicians should work closely with family and friends of incompetent persons to determine the patient's preferences. Legally, the physician would be well advised to recommend to the patient's family that they have one member of the family appointed as the patient's guardian so that the physician will have a person to deal with who has the legal authority to make all treatment decisions for the patient.
Even when resuscitation would provide no medical benefit, the family should be told the medical situation, and the physician should attempt to persuade them of the reasonableness of a DNR order. Full discussion with the spouse or other close relatives about the indications for CPR, the DNR order, the legal aspects of such orders, and the physician's role as the patient's advocate will nearly always result in a decision that is ethically correct.
5.06b Other Life-Sustaining Interventions
The general rules developed for competent and incompetent patients, and their specification regarding DNR decisions, apply also to decisions about other complex and simple life-sustaining interventions such as ventilators, dialysis, transfusion of blood products, and antibiotic administration. When possible, •physicians should work with their patients in advance of a clinical crisis to develop a mutually agreeable, general-care plan that considers which, if any, life-sustaining interventions should be withheld or withdrawn in various clinical circumstances. These discussions should be documented in the patient's medical record. Such information is especially important if, at a later time, the patient lacks decision-making capacity.
5.06c Fluids and Nutritional Support
Another debate has focused on the withholding or discontinuation of artificial feeding. It is not unethical to discontinue or withhold fluids and nutritional support under certain circumstances. An emerging clinical and judicial position is that enteral and parenteral nutrition and hydration should be likened to other medical interventions and may be withheld or withdrawn according to the principles developed in this section. The most difficult situation involves a nonterminally ill, permanently unconscious patient whose previous wishes are not known. In such cases, some hold that there is no obligation to provide fluids and nutrition because the burdens of even such simple interventions exceed the limited benefits of sustaining organic life in a person who will never recover cognitive function. Another viewpoint cautions that in withholding simple interventions like fluids and nutrition, physicians may be contributing to the death of nonterminally ill persons, and that such a policy may be dangerous for various groups of vulnerable patients. In deciding between these two positions, the physician must exercise his or her own judgment about what is morally permissible and should seek guidance concerning the law in his or her locale.
5.07 Euthanasia
Recently, the Council on Ethical and Judicial Affairs of the American Medical Association (11) made the following statement about euthanasia: "What is termed 'active euthanasia' is a euphemism for the intentional killing of a person; this is not part of the practice of medicine with or without the consent of the patient. Legally, a person who kills another person under these circumstances is guilty of homicide. A motive of mercy is not a defense." The Ethical and Judicial Council (11) also reaffirmed their policy statement on euthanasia made in 1977: "The intentional termination of the life of one human being by another-mercy killings-is contrary to public policy, medical tradition, and the most fundamental measures of human value and worth."
Physicians should draw a firm line between the forgoing of life-sustaining interventions (sometimes called "passive euthanasia") and medical killing (sometimes called "active euthanasia," "mercy killing," or "assisted suicide"). Medical killing would involve the administration of a lethal agent (such as a deliberate overdose of morphine) to a patient with the clear intention of causing the patient's immediate death. Although a patient may refuse a medical intervention and the physician may comply with this refusal, the physician must never intentionally and directly cause death or assist a patient to commit suicide. Active euthanasia remains illegal in all jurisdictions of the United States. Even if legalized, however, such an action would violate the ethical standards of medical practice (see "The Relationship of the Physician to Government").
6.00 Responsibilities of Physicians
The primary responsibility of physicians is to apply medical knowledge to help patients identify and achieve their medical goals. Medical goals frequently sought jointly by patients and physicians may include prevention of disease, cure of disease, prolongation of life, relief of symptoms, restoration or maintenance of function, and, at times, the withholding or withdrawing of life-sustaining treatment. The factors that define the goals of a particular patient-physician encounter include the nature of the disease and its prognosis, the values and preferences of the patient and physician, and the social, economic, and legal constraints on possible choices. This view of excellent modern medical practice imposes the following specific responsibilities on conscientious physicians:
1. Physicians must be knowledgeable, competent, and skilled in determining the patient's diagnosis, prognosis, the range of treatment choices (including the risks and benefits of alternative choices), and the patient's preferences.
2. Physicians must be capable and willing to communicate effectively with and advise patients so that patients can make informed decisions regarding their own treatment or nontreatment preferences.
3. Physicians have a responsibility to respect the treatment decisions of all patients who retain decision-making capacity. If unable to honor the wishes of a competent patient, the physician may seek the assistance of the courts if he or she feels morally constrained to do so, or the physician may withdraw from the case if the patient is provided sufficient advance warning and alternate care is assured.
4. Physicians should elicit from all competent patients-but especially from those patients at high risk of dying or of becoming incompetent-the patient's treatment preferences regarding life-sustaining treatment and the patient's choice of a surrogate decision-maker. These discussions should be documented in the medical record.
5. Physicians should encourage patients to prepare a legally valid advance directive.
6. The physician should periodically review and update oral and written advance directives with the patient so that the preferences of patients are contemporary.
7. Physicians should participate in assessing the decision-making capacity of patients because such an assessment determines how physicians ought to respond to a particular choice made by a patient. In emergency and life-threatening situations, when psychiatric consultation and judicial intervention are not feasible, the treating physician is solely responsible for determining if a patient retains sufficient decision-making capacity to make a choice to receive or refuse life-sustaining treatment.
8. In those cases where patients lack decision-making capacity, the physician must determine which surrogate decision-makers should be consulted and whether institutional or legal guidance is necessary.
9. Physicians should not breach the confidential nature of the patient-physician relationship by discussing the competent patient's care with persons who are not authorized by the patient to be made aware of the patient's diagnosis, prognosis, and treatment.
7.00 Other Ethical Issues
7.01 Ethics Committees and Ethics Consultants
Ethics committees and ethics consultants offer two different approaches to the same goal: improving the care of patients by attending to the ethical issues that frequently arise in clinical settings. Ethics committees and consultants contribute to achieving the goals related to patient care primarily by developing educational programs in the institution, by coordinating institutional resources, by providing a forum for discussion among medical and hospital professionals, and by assisting institutions to develop sound policies and practices. Although it is generally agreed that neither ethics committees nor consultants should have decision-making authority, it is less well established whether they should serve in an advisory capacity for physicians who are confronted with difficult ethical matters about particular patients. Neither ethics committees nor ethics consultants have been adequately evaluated prospectively to know whether they can serve a useful advisory function. The legal status and potential legal liability of ethics committees remain unclear, and physicians are strongly advised to seek legal counsel about the current state of local law in this unsettled area.
When a conflict arises over a treatment decision, and the conflict is thought to include ethical issues, physicians have the discretion to seek consultation from clinical colleagues, review committees on patient care, ethics committees, ethics consultants, or legal advisors. Of course, final moral responsibility for the decision rests with the patient and the attending physician and not with a consultant or a committee.
7.02 Resource Allocation
The physician has a responsibility to serve the best interest of the patient, even in a world of limited resources. The guiding principle should always be care consistent with humanistic, scientific, and efficient medicine. If external pressures arising from limited institutional resources prevent the provision of optimal care, the physician should inform the patient of the nature of the situation. In the final analysis, no external factors should interfere with the dedication of the physician to provide optimal care for his or her patient.
Physicians, nevertheless, also have a responsibility to avoid unnecessary expenditures by careful planning of workups, and by avoiding unnecessary medication, operations, and consultations. Good medicine is still the most economical medicine and a primary obligation of the physician.
Finally, physicians have a collective obligation through their professional associations to be advocates for a just allocation of resources to the sick. They should participate in local and national decisions affecting the distribution of society's resources between health care and other social goods and among various kinds of health care.
7.03 Abortion and Contraception
A physician who objects to abortion on moral, religious, or ethical grounds need not become involved, either by proffering advice to the patient or by involvement in the surgical procedure. The physician does have a duty to assure that the patient is provided the option of receiving competent medical advice and care from a qualified colleague who does not impose his or her personal convictions upon the patient.
Social, political, and religious beliefs have extended the issue of abortion beyond medical considerations. The physician must be familiar with the law relating to abortion in his or her locale.
If a patient who is a minor requests termination of pregnancy without her parents' knowledge, the physician may have a conflict between the ethical duty to maintain confidentiality and the physician's responsibility to the patient's parents or guardian under the law. In this case, the physician should seek local counsel as to the specific requirements of state and federal law.
Recommendations similar to those discussed relating to physician's participation in decisions about abortion also apply to the physician's responsibility regarding the prescribing of contraceptive measures or devices to adults, or to minors without obtaining parental consent.
7.04 Medicine and the Law
Physicians should remember that all citizens are equal under the law, and the fact that a patient may be ill does not diminish his or her right or expectation to be treated like all other persons. Stated another way, illness does not, in and of itself, change a patient's legal rights or permit a physician to ignore the fact that the patient's legal rights must be observed at all times.
The physician holds an honored, respected, and, in certain aspects, unique position in society. There may be instances in which the physician's ethics are in conflict with the law or with the patient's legal rights. In those situations, the physician must decide if he or she is willing to violate the law for the sake of what he or she considers to be the dictates of medical ethics, thereby possibly jeopardizing his or her own legal position or the legal rights of the patient. It should be remembered that ethical concepts are not always fully reflected in or adopted by the law. Violation of the law for purposes of complying with one's ethical standards may have significant consequences for the physician and should only be undertaken after thorough consideration and, most often, after obtaining professional legal counsel.
Conclusion
It is the hope of the College that this updated handbook will help practicing physicians address some of the challenging ethical dilemmas that confront them each day as they deal with patients. As was stated in the beginning, this is a manual written by physicians for physicians to help us all find our way through this difficult terrain. The ultimate intent of any ethical guideline is to improve the quality of care provided to patients. We hope that in some small measure this manual will help to achieve that goal.
References
1. Bard S. A Discourse upon the Duties of a Physician with Some Sentiments on the Usefulness and Necessity of a Public Hospital: Delivered before the President and Governors of King' College at the Commencement Held on the 16th of May, 1969, as Advice to Those Gentlemen Who Then Received the First Medical Degrees Conferred by That University. New York: A. & J. Robertson; 1769.
2. Percival T. Medical Ethics: Or Code of Institutes and Precepts Adapted to the Professional Conduct of Physicians and Surgeons. Manchester, England: J. Johnson; 1803.
3. Pellegrino ED. Percival's Medical Ethics: the moral philosophy of an 18th-century English gentleman. Arch Intern Med. 1986; 146:2265-9.
4. Health and Public Policy Committee, American College of Physicians and the Infectious Disease Society of America. The acquired immunodeficiency syndrome (AIDS) and infection with the human immunodeficiency virus (HIV). Ann Intern Med 1988; 108:460-9.
5. Health and Public Policy Committee, American College of Physicians. Health care needs of the adolescent. Ann Intern Med. 1989; 110:930-5.
6. United Nations, First Congress on the Prevention of Crime and the Treatment of Offenders. Standard Minimum Rules for the Treatment of Prisoners; 1955.
7. Bronowski J. The Common Sense of Science. Cambridge, Massachusetts: Harvard University Press; 1978.
8. Lind SE. Innovative medical therapies: between practice and research. Clin Res. 1988; 36:546-51.
9. National Conference Steering Committee. Standards for cardiopulmonary resuscitation (CPR) and emergency cardiac care (ECC). JAMA. 1980; 244:453-509.
10. Joint Commission on Accreditation of Healthcare Organizations. Accreditation Manual for Hospitals. Chicago, Illinois: JCAHO; 1988.
11. The Council on Ethical and Judicial Affairs of the American Medical Association. Chicago: American Medical Association; 1988; AMA Council Report C/A-88.
A reprint of the manual will be available from the College in late September. Ordering information may be obtained from the American College of Physicians, Subscriber Services, Independence Mall West, Sixth Street at Race, Philadelphia, PA 19106-1572. Telephone inquiries may be directed to (800) 523-1546, extension 2600 or (215) 351-2600.