Medicine, law, and social values are not static.Reexamining the ethical tenets of medical practice and their application in new circumstances is a necessary exercise. The fourth edition of the American College of Physicians Ethics Manual covers emerging issues in medical ethics and revisits old ones. It reflects on many of the ethical tensions faced by internists and their patients and attempts to shed light on how existing principles extend to emerging concerns. In addition, by reiterating ethical principles that have provided guidance in resolving past ethical problems, it may help physicians to avert future problems. The Manual is not a substitute for the experience and integrity of individual physicians, but it may serve as a reminder of the shared obligations and duties of the medical profession.
"... the secret of the care of the patient is in caring for the patient."
Francis Weld Peabody [1]
Some aspects of medicine are fundamental and timeless. Medical practice, however, does not stand still. Clinicians must be prepared to deal with changes and reaffirm what is fundamental.
The fourth edition of the American College of Physicians Ethics Manual examines emerging issues in medical ethics and revisits older issues that are still very pertinent. Changes in the Manual since its last revision in 1992 include new sections on genetic testing, the changing practice environment and managed care, organ donation, and disability certification. A case method for ethics decision making has also been added (Appendix). Such issues as patient responsibility and discrimination are discussed more extensively, and the section on decisions near the end of life (which includes physician-assisted suicide) has been revised substantially. The literature of biomedical ethics expands at a rate that does not allow a bibliography to remain current [2]; therefore, an exhaustive list of references or suggested readings is not included in this edition of the Manual.
The Manual is intended to facilitate the process of making ethical decisions in clinical practice and medical research and to describe and explain underlying principles of decision making. Because ethics must be understood within a historical and cultural context, the second edition of the Manual included a brief overview of the cultural, philosophical, and religious underpinnings of modern medical ethics. In this edition, we refer the reader to that overview [3,4] and to other sources [5-8] that more fully explore the rich heritage of medical ethics.
The Manual raises ethical issues and presents general guidelines. In applying these guidelines, physicians should consider the circumstances of the individual patient and use their best judgment. Physicians are morally and legally accountable, and the two may not be concordant. Physician participation in torture, for example, is legal in some countries but is never morally defensible. Physicians must keep in mind the distinctions and potential conflicts between legal and ethical obligations when making clinical decisions and must seek counsel when they are concerned about the potential legal consequences of decisions. We refer to the law in this Manual for illustrative purposes only; these references should not be taken as a statement of the law or of the legal consequences of a physician's actions, which can vary from state to state. Physicians must develop and maintain an adequate knowledge of key components of the laws and regulations that affect their patients and practices.
The law does not always establish positive duties (that is, what one should do) to the extent that professional ethics, especially medical ethics, does. Our current understanding of medical ethics is based on the principles from which positive duties emerge.
These principles include beneficence, a duty to promote good and act in the best interest of the patient and the health of society, and nonmaleficence, the duty to do no harm to patients. Also included is respect for patient autonomy-the duty to protect and foster a patient's free, uncoerced choices [9]. From the principle of respect for autonomy are derived the rules for truth-telling, disclosure, and informed consent. The relative weight granted to these principles and the conflicts among them often account for the ethical problems that physicians face. Physicians who will be challenged to resolve dilemmas must have such virtues as compassion, courage, and patience in all aspects of their practice.
In addition, considerations of justice inform the physician's role as citizen and clinical decisions about resource allocation. The principle of distributive justice requires that we seek to equitably distribute the life-enhancing opportunities afforded by health care. How to accomplish this distribution is the focus of intense debate. More than ever, concerns about justice challenge the traditional role of physician as patient advocate.
The environment for the delivery of health care is changing. Sites of care are shifting and managed care continues to grow, yet the U.S. health care system does not serve all of its citizens well and major reform is needed. It is unclear how to reform the system to achieve that goal. Health care financing is a serious concern, and society's values will be tested in decisions about resource allocation.
Ethical issues attract widespread public attention, and debate about them is covered regularly in the press. Through legislation, administrative action, or judicial decision, government is increasingly involved in medical ethics. Today, the convergence of various forces-scientific advances, public education, the civil rights and consumer movements, the effects of law and economics on medicine, and the heterogeneity of our society-demands that physicians clearly articulate the ethical principles that guide their behavior, whether in clinical care, research, or teaching or as citizens. It is crucial that a responsible physician perspective be heard as societal decisions are made.
From genetic testing before conception to dilemmas at the end of life, physicians, patients and their families are called upon to make difficult ethical decisions. The 1970s saw the development of bioethics as a field, followed by a series of reports by the U.S. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Important issues then and now included informed consent [10,11], access to health care [12], genetic screening and engineering [13,14], and forgoing life-sustaining treatment [15,16]. These and other issues-AIDS, physician-assisted suicide, increasing computerization of medical records, and the physician as entrepreneur-challenge us to periodically reconsider such topics as the patient-physician relationship, decisions to limit treatment, and confidentiality.
This Manual was written for our colleagues in medicine. The College believes that the Manual provides the best approach to the challenges addressed in it. We hope that it will stimulate reasoned debate and serve as a reference for persons who seek the College's positions on ethical issues. Debates about medical ethics may also stimulate critical evaluation and discussion of law and public policy on the difficult ethical issues facing patients, physicians, and society.
The patient-physician relationship entails special obligations for the physician to serve the patient's interest because of the specialized knowledge that physicians hold and the imbalance of power between physicians and patients.
The physician's primary commitment must always be to the patient's welfare and best interests, whether the physician is preventing or treating illness or helping patients to cope with illness, disability, and death. The physician must support the dignity of all persons and respect their uniqueness. The interests of the patient should always be promoted regardless of financial arrangements; the health care setting; and patient characteristics, such as decisionmaking capacity or social status.
At the beginning of a patient-physician relationship, the physician must understand the patient's complaints, underlying feelings, goals, and expectations. After patient and physician agree on the problem and the goal of therapy, the physician presents one or more courses of action. If both parties agree, the patient may authorize the physician to initiate a course of action; the physician can then accept that responsibility. The relationship has mutual obligations: The physician must be professionally competent, act responsibly, and treat the patient with compassion and respect, and the patient should understand and consent to the treatment that is rendered and should participate responsibly in the care. Although the physician should be fairly compensated for services rendered, a sense of duty to the patient should take precedence over concern about compensation when a patient's well-being is at stake.
By history, tradition, and professional oath, physicians have a moral obligation to provide care for ill persons. Although this obligation is collective, each individual physician is obliged to do his or her fair share to ensure that all ill persons receive appropriate treatment. A physician may not discriminate against a class or category of patients [17].
An individual patient-physician relationship is formed on the basis of mutual agreement on medical care for the patient. In the absence of a preexisting relationship, the physician is not ethically obliged to provide care to an individual person unless no other physician is available, as is the case in some isolated communities or when emergency treatment is required. Under these circumstances, the physician is morally bound to provide care and, if necessary, to arrange for proper follow-up. Physicians may also be bound by contract to provide care to beneficiaries of participating health plans.
Physicians and patients may have different concepts of the meaning and resolution of medical problems. The care of the patient and satisfaction of both parties are best served if physician and patient discuss their expectations and concerns. Although the physician must address the patient's concerns, he or she is not required to violate fundamental personal values, standards of scientific or ethical practice, or the law. When the patient's beliefs-religious, cultural, or otherwise-run counter to medical recommendations, the physician is obliged to try to understand clearly the beliefs and the viewpoints of the patient. If the physician is unable to carry out the patient's wishes after seriously attempting to resolve differences, the physician should transfer the care of the patient.
Under exceptional circumstances, 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, provided that adequate care is available 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. Physician-initiated termination is a serious event, especially if the patient is acutely ill, and should be undertaken only after genuine attempts are made to understand and resolve differences. A patient is free to change physicians and is entitled to the information contained in the medical records.
Confidentiality is a fundamental tenet of medical care. It is a matter of respecting the privacy of patients, encouraging them to seek medical care and discuss their problems candidly, and preventing discrimination on the basis of their medical conditions. The physician must not release information without the patient's consent (often termed a "privileged communication"). However, confidentiality, like other ethical duties, is not absolute. It may have to be overridden to protect individual persons or the public-for example, to warn sexual partners that a patient has syphilis or is infected with HIV-or to disclose information when the law requires it. Before breaching confidentiality, the physician should make every effort to discuss the issues with the patient. If breaching confidentiality is necessary, it should be done in a way that minimizes harm to the patient and that heeds applicable federal and state law.
Confidentiality is increasingly difficult to maintain in this era of computerized record keeping and electronic data processing, faxing of patient information, third-party payment for medical services, and sharing of patient care among numerous medical professionals and institutions. Physicians should be aware of the increased risk for invasion of patients' privacy and should help ensure confidentiality. Within their own institutions, physicians should advocate policies and procedures to secure the confidentiality of patient records.
Discussion of the problems of an identified patient by professional staff in public places (for example, in elevators or in cafeterias) violates confidentiality and is unethical. Outside of an educational setting, discussions of a potentially identifiable patient in front of persons who are not involved in that patient's care are unwise and impair the public's confidence in the medical profession. Physicians of patients who are well known to the public should remember that they are not free to discuss or disclose information about a patient's health without the explicit consent of the patient.
In the care of the adolescent patient, family support is important. However, this support must be balanced with confidentiality and respect for the adolescent's autonomy in health care decisions and in relationships with health care providers [18]. Physicians should be knowledgeable about state laws governing the right of adolescent patients to confidentiality and the adolescent's legal right to consent to treatment.
Occasionally, the physician receives information from a patient's friends or relatives and is asked to withhold the source of that information from the patient [19]. The physician is not obliged to keep such secrets from the patient. The informant should be urged to address the patient directly and to encourage the patient to discuss the information with the physician. The physician should use sensitivity and judgment in deciding whether to use the information and whether to reveal its source to the patient. The physician should always act in the best interests of the patient.
Ethically and legally, patients have the right to know what is in their medical records. Legally, the actual chart is the property of the physician or institution, although the information in the chart is the property of the patient. Most states have laws that guarantee the patient personal access to the medical record. The physician must release information to the patient or to a third party at the request of the patient. Physicians should retain the original of the chart and radiographic studies and respond to a patient's request with copies unless the original record is required by law. To protect confidentiality, information should only be released with the written permission of the patient or the patient's legally authorized representative.
To make health care decisions and work intelligently in partnership with the physician, the patient must be well informed. Effective patient-physician communication can dispel uncertainty and fear and can enhance healing and patient satisfaction. Information should be disclosed whenever it is considered material to the patient's understanding of his or her situation, possible treatments, and probable outcomes. This information often includes the costs and burdens of treatment, the experience of the proposed clinician, the nature of the illness, and potential treatments.
However uncomfortable to clinician or patient, information that is essential to the patient must be disclosed. How, when, and to whom information is disclosed are important concerns that must be addressed.
Information should be given in terms that the patient can understand. The physician should be sensitive to the patient's responses in setting the pace of disclosure, particularly if the illness is very serious. Disclosure should never be a mechanical or perfunctory process. Upsetting news and information should be presented to the patient in a way that minimizes distress [20,21]. If the patient is unable to comprehend his or her condition, it should be fully disclosed to an appropriate surrogate.
In addition, physicians should disclose to patients information about procedural or judgment errors made in the course of care if such information is material to the patient's well-being. Errors do not necessarily constitute improper, negligent, or unethical behavior, but failure to disclose them may.
Any unauthorized touching of a person is battery, even in the medical setting. The patient's consent allows the physician to provide care.
Consent may be either expressed or implied. Expressed consent most often occurs in the hospital setting, where written or oral consent is given for a particular procedure. In many medical encounters, when the patient presents to a physician for evaluation and care, consent can be presumed. The underlying condition and treatment options are explained to the patient, and treatment is rendered or refused. In medical emergencies, consent to treatment that is necessary to maintain life or restore health is usually implied unless it is known that the patient would refuse the intervention.
The doctrine of informed consent goes beyond the question of whether consent was given for a treatment or intervention. Rather, it focuses on the content and process of consent. The physician is required to provide enough information to allow a patient to make an informed judgment about how to proceed. The physician's presentation should be understandable to the patient, should be unbiased, and should include the physician's recommendation. The patient's or surrogate's concurrence must be free and uncoerced.
The principle and practice of informed consent rely on patients to ask questions when they are uncertain about the information they receive; to think carefully about their choices; and to be forth-right with their physicians about their values, concerns, and reservations about a particular recommendation. Once patients and physicians decide on a course of action, patients should make every reasonable effort to carry out the aspects of care that are in their control or to inform their physicians promptly if it is not possible to do so.
The physician is obligated to ensure that the patient or the surrogate is adequately informed about the nature of the patient's medical condition and the objectives of, alternatives to, possible outcomes of, and risks involved with a proposed treatment.
All adult patients are considered competent to make decisions about medical care unless a court declares them incompetent. In clinical practice, however, physicians and family members usually make decisions without a formal competency hearing in the courts for patients who lack decision-making capacity. This clinical approach can be ethically justified if the physician has carefully determined that the patient is incapable of understanding the nature of the proposed treatment; the alternatives to it; and the risks, benefits, and consequences of it.
When a patient lacks decision-making capacity (that is, the ability to receive and express information and to make a choice consonant with that information and one's values), an appropriate surrogate should make decisions with the physician. Ideally, surrogate decision makers should know the patient's preferences and act in the best interests of the patient. If the patient has designated a proxy, as through a durable power of attorney for health care, that choice should be respected. When patients have not selected surrogates, standard clinical practice is that family members serve as surrogates. Some states designate the order in which family members will serve as surrogates. Physicians should be aware of legal requirements in their state for surrogate appointment and decision making. In some cases, all parties may agree that a close friend is a more appropriate surrogate than a relative.
Physicians should take reasonable care to ensure that the surrogate's decisions are consistent with the patient's preferences and best interests. When possible, these decisions should be reached in the medical setting by physicians, surrogates, and other caregivers. Physicians should emphasize to surrogates that decisions should be based on what the patient would want, not what surrogates would choose for themselves. If disagreements cannot be resolved, hospital ethics committees may be helpful. Courts should be used when doing so serves the patient, such as to establish guardianship for an unbefriended, incompetent patient; to resolve a problem when other processes fail; or to comply with state law.
Most adult patients can participate in, and thereby share responsibility for, their health care. Physicians cannot properly diagnose and treat conditions without full disclosure of patients' personal and family medical history, habits, ongoing treatments (medical and otherwise), and symptoms. The physician's obligation to confidentiality exists in part to ensure that patients can be candid without fear of loss of privacy. Physicians must try to create an environment in which honesty can thrive and patient concerns and questions are elicited.
The ethical duty to disclose relevant information about human reproduction to the patient may conflict with the physician's personal moral standards on abortion, sterilization, or contraception. A physician who objects to these services need not become involved, whether by offering advice to the patient or by involvement in a procedure. As in any other medical situation, the physician has a duty to refer the patient to an appropriate source for the full range of options so that the patient's legal options are not constrained.
If a patient who is a minor requests termination of pregnancy, advice on contraception, or treatment of sexually transmitted diseases without a parent's knowledge, the physician may wish to attempt to persuade the patient of the benefits of having parents involved but should be aware that a conflict may exist between the legal duty to maintain confidentiality and the obligation toward parents or guardians. Information should not be provided to others without the patient's permission [22]. In such cases, the physician should be guided by his or her conscience in light of the law.
Presymptomatic and diagnostic testing raises issues of education, counseling, confidentiality, and justice. Such testing may allow clinicians to predict diseases or clarify susceptibility at a time when medicine may not have the ability to prevent or cure the conditions that are identified. Both the public and health care professionals often have a limited grasp of the distinction between prediction and susceptibility or risk. Genetic testing presents unique problems by identifying risk for disease that has special meaning for patients and for family members who may not be under the care of the clinician providing the test.
Clinicians should discuss with patients the degree to which a particular genetic risk factor correlates with the likelihood of developing disease. Testing should not be undertaken until these issues are fully explored with the patient and the potential consequences of the test, from its impact on the patient's well-being to implications for other family members and use by insurers or other societal institutions, are fully understood.
Because the number of trained genetic counselors is small and is unlikely to match the exponential growth in genetic testing, the generalist clinician is increasingly responsible for conveying genetic test results. Only physicians who are familiar with the skills necessary for pretest and post-test education and counseling should engage in genetic testing [23]. All primary care physicians should develop these skills.
As more information becomes available on the genetic risk for certain diseases, physicians must be aware of the need for confidentiality concerning results of genetic tests. Many state governments and the federal government are promulgating rules and regulations that cover access of employers and insurers to such information. Additional complex ethical problems exist, such as which family member should be informed of the results of genetic tests. Physicians should be sensitive to these ethical problems, and testing should not be undertaken until issues are fully discussed and their consequences are well understood.
The potential for stigmatization and insurance and job discrimination require that physicians ensure the confidentiality of data. However, the presence of a genetic risk factor or genetic disease in a family member raises the possibility that other blood relatives are at risk. The physician should seek the affected patient's consent in encouraging potentially affected family members to seek genetic counseling if it may affect treatment or major life decisions.
Traditionally, the ethical imperative for physicians to provide care has overridden the risk to the treating physician, even during epidemics. In recent decades, with better control of such risks, physicians have practiced medicine in the absence of risk as a prominent concern. However, potential occupational exposures such as HIV, multidrug-resistant tuberculosis, and viral hepatitis necessitate reaffirmation of the ethical imperative [24].
Physicians should evaluate their risk for becoming infected with pathogens, both in their personal lives and in the workplace, and implement appropriate precautions. Physicians who may have been exposed to pathogens have an ethical obligation to be tested and should do so voluntarily. Infected physicians should place themselves under the guidance of their personal physician or the review of local experts to determine in a confidential manner whether practice restrictions are appropriate on the basis of the physician's compliance with infection control precautions and physical and mental fitness to work. Infection does not in itself justify restrictions on the practice of an otherwise competent health care worker. Health care workers are expected to comply with public health and institutional policies.
Because the diseases mentioned above may be transmitted from patient to physician and because they pose significant risks to physicians' health and are difficult to treat or cure, some physicians may be tempted to avoid the care of infected patients. Physicians and health care organizations are obligated to provide competent and humane care to all patients, regardless of their disease state. Physicians can and should expect their workplace to provide appropriate means to limit occupational exposure through rigorous application of infection control methods. The denial of appropriate care to a class of patients for any reason is unethical [25].
Whether physicians should disclose their condition depends on the likelihood of risk to the patient and relevant law or regulations in their locales. Physicians should remove themselves from care if it becomes clear that the risk associated with contact or with a procedure is significant even if appropriate preventive measures are taken. Physicians are also obligated to disclose their condition after the fact if a clinically significant exposure has taken place.
Physicians have several obligations concerning nosocomial risk of infection. They should help the public to understand the low level of this risk and put it in the perspective of other medical risks while acknowledging public concern. Physicians provide medical care to health care workers, and part of this care is discussing with health care workers their ethical obligation to know their risk for such diseases as HIV or viral hepatitis, to voluntarily seek testing if they are at risk, and to take reasonable steps to protect patients. The physician who provides care for a seropositive health care worker must determine the health care worker's fitness to work. In some cases, seropositive health care workers cannot be persuaded to comply with accepted infection control guidelines, or impaired physicians cannot be persuaded to restrict their practice. In such exceptional cases, the treating physician may need to breach confidentiality and report the incident to the appropriate authorities in order to protect patients and maintain public trust in the profession, even though such actions may have legal consequences.
Alternative or complementary medicine is a common term for health practices that generally are not available from U.S. physicians, are not offered in U.S. hospitals, and are not widely taught in U.S. medical schools [26]. The physician should not abandon the patient who elects to try an alternative treatment. Requests by patients for alternative treatment require balancing the medical standard of care with a patient's right to choose care on the basis of his or her values and preferences. Such a request warrants careful attention from the physician. Before advising a patient, the physician should ascertain the reason for the request: for example, whether it stems from dissatisfaction with current care [27]. The physician should be sure that the patient understands his or her condition, standard medical treatment options, and expected outcomes.
The physician should encourage the patient requesting alternative treatment to seek literature and information from reliable sources. The patient should be clearly informed if the option under consideration is likely to delay access to effective treatment or is known to be harmful. The physician need not participate in the monitoring or delivery of alternative care to the patient. However, physicians should recognize that some patients may select alternative forms of treatment; this decision alone should not be cause to sever the patient-physician relationship.
Some patients have chronic, overwhelming, or catastrophic illnesses. In these cases, society permits physicians to justify exemption from work and to legitimize other forms of financial support.
In keeping with the role of patient advocate, a physician should assist a patient who is medically disabled in obtaining the appropriate disability status [28]. Disability evaluation forms should be completed factually, honestly, and promptly.
Physicians will often find themselves confronted with a patient whose problems may not fit standard definitions of disability but who nevertheless seems deserving of assistance (for example, the patient may have very limited resources or poor housing). Physicians should not distort medical information or misrepresent the patient's functional status in a misguided attempt to help these patients. The trustworthiness of the physician is jeopardized, as is his or her ability to advocate for patients who truly meet disability or exemption criteria.
Physicians should avoid treating themselves, close friends, or members of their own families. Physicians should also be very cautious about assuming the care of closely associated employees. Problems may include inadequate history taking or physical examination as a result of role-related discomfort on the part of patient or physician. The physician's emotional proximity can result in a loss of objectivity. If a physician does treat a close friend, family member, or employee out of necessity, the patient should be transferred to another physician as soon as it is practical. Otherwise, requests for care on the part of employees, family members, or friends should be resolved by assisting them in obtaining appropriate care. Fulfilling the role of informed and loving adviser, however, is not precluded.
Issues of dependency, trust, and transference and inequalities of power lead to increased vulnerability on the part of the patient and require that a physician not engage in a sexual relationship with a patient. It is unethical for a physician to become sexually involved with a current patient even if the patient initiates or consents to the contact.
Even sexual involvement between physicians and former patients raises concern. The impact of the patient-physician relationship may be viewed very differently by physicians and former patients, and either party may underestimate the influence of the past professional relationship. Many former patients continue to feel dependency and transference toward their physicians long after the professional relationship has ended. The intense trust often established between physician and patient may amplify the patient's vulnerability in a subsequent sexual relationship. A sexual relationship with a former patient is unethical if the physician "uses or exploits the trust, knowledge, emotions or influence derived from the previous professional relationship" [29]. Because it may be difficult for the physician to judge this influence, we advise consultation with a colleague or other professional before becoming sexually involved with a former patient [30].
End-of-life care is an important aspect of medical practice. Individual physicians and the medical community must be committed to the compassionate and competent provision of care to dying patients and their families [31]. Patients rightfully expect their physicians to care for them and provide them medical assistance as they are dying. Good symptom control; ongoing involvement with the patient; and physical, psychological, and spiritual support are the hallmarks of quality end-of-life care. Care of patients near the end of life, however, has a moral, psychological, and interpersonal intensity that distinguishes it from most other clinical encounters.
To care properly for patients near the end of life, the physician must understand that palliative care entails addressing physical, psychosocial, and spiritual needs and that patients may at times require palliative treatment in an acute care context [32-34]. To provide palliative care, the physician must be up to date on the proper use of opioids and the legality and propriety of using high doses of opioids as necessary to relieve suffering. The physician should know how to refer patients to appropriate palliative care, know how to use home-based and institution-based hospice care, and be aware of the palliative care abilities of the nursing homes to which patients are referred.
Informed adults with decision-making capacity almost always have the legal and ethical right to refuse any recommended life-sustaining medical treatment [35]. The patient has this right regardless of whether he or she is terminally or irreversibly ill, has dependents, or is pregnant. The patient's right is based on the philosophical concept of respect for autonomy, the common-law right of self-determination, and the patient's liberty interest under the U.S. Constitution [36].
Many patients, particularly those with terminal or irreversible illness, elect to forgo certain treatments or pursue treatments that their physicians may consider unwise. These situations demand empathy, thoughtful exploration of all possibilities, negotiation, or compromise and may require time-limited trials and additional consultations.
In the unusual circumstance that no evidence shows that a specific treatment desired by the patient will provide any benefit from any perspective, the physician need not provide such treatment. The more common and much more difficult circumstance occurs when the treatment will offer some small prospect of benefit at a great burden of suffering or financial cost, but the patient or family nevertheless desires it. If the physician and patient cannot agree on how to proceed, there is no easy, automatic solution. Timely transfer of care to another care provider who is willing to pursue the patient's preference may resolve the problem. Consultation with an ethics committee may be helpful. Infrequently, resort to the courts may be necessary.
Patients without decision-making capacity (see the section on informed consent) have the same rights concerning life-sustaining treatment decisions as mentally competent patients. Treatment should conform to what the patient would want on the basis of written or oral advance directives. If these instructions are not available, care decisions should be based on the best evidence of what the patient would have chosen (substituted judgments) or, failing that, on the best interests of the patient. Physicians should be aware that hospital protocols and state legal requirements affecting end-of-life care vary.
Advance care planning allows a competent person to indicate preferences for care or choose a surrogate in the event that the patient cannot make health care decisions. It allows the patient's values and circumstances to shape the plan and allows specific arrangements to be made to ensure implementation of the plan.
Physicians should routinely raise the issue of advance planning with competent adult patients during outpatient visits and encourage them to discuss their values and preferences with their surrogates and family members. These discussions let the physician know the patient's views, enable the physician to update the medical record, and allow the physician to reassure patients that he or she is willing to discuss these sensitive issues and will respect their choices. The patient and the physician should negotiate plans to make sure patient wishes are implemented. Discussions about patient preferences should be documented in the medical record. The Patient Self-Determination Act of 1990 requires hospitals, nursing homes, health maintenance organizations, and hospices that participate in Medicare and Medicaid programs to ask if the patient has an advance directive, to provide information about advance directives, and to incorporate advance directives into the medical record.
Advance planning takes place in conversations with the physician (with documentation in the medical record) or through written advance directives, such as a living will or durable power of attorney for health care [37]. The latter enables a patient to appoint a surrogate who will make decisions if the patient becomes unable to do so. The surrogate is required to act in accordance with the patient's previously expressed preferences or best interests.
Living wills enable persons to describe the kind of treatment they would like to receive in the event that they lose decision-making capacity. Uncertainty about a future clinical course complicates the interpretation of living wills and emphasizes the need for physicians and patients to discuss patient preferences before a crisis arises. Talking about future medical care is an effective method of planning. Some state laws limit the application of advance directives to terminal illness or deem the advance directives not applicable if, for example, the patient is pregnant. Many states have documents that combine the living will and the durable power of attorney for health care into one document. Some specify requirements for witnessing the document. The primary care physician and other key heath care personnel should have a written advance directive in the patient's medical record.
When there is no advance directive and the patient's values and preferences are unknown or unclear, decisions should be based on the patient's best interests whenever possible, as interpreted by a guardian or by a person with loving knowledge of the patient. When making the decision to forgo treatment, many people give the most weight to reversibility of disease or dependence on life support, loss of capacity for social interaction, or nearness to death. Family members and health care workers should avoid projecting their own values or views about quality of life onto the incapacitated patient. Quality of life should be assessed according to the patient's perspective.
Withdrawing and withholding treatment are equally justifiable, ethically and legally. Treatments should not be withheld because of the mistaken fear that if they are started, they cannot be withdrawn. This practice would deny patients potentially beneficial therapies. Instead, a time-limited trial of therapy could be used to clarify the patient's prognosis. At the end of the trial, a conference to review and revise the treatment plan should be held. Some health care workers or family members may be reluctant to withdraw treatments even when they believe that the patient would not have wanted them continued. The physician should prevent or resolve these situations by addressing with families feelings of guilt, fears, and concerns that patients may suffer as life support is withdrawn.
Intervention in the case of a cardiopulmonary arrest is inappropriate for some patients, particularly those with terminal irreversible illness whose death is expected and imminent. Because the onset of cardiopulmonary arrest does not permit deliberative decision making, decisions about resuscitation must be made in advance. Physicians should especially encourage patients who face serious illness or who are in advanced old age, or their surrogates, to discuss resuscitation.
Although a do-not-resuscitate order applies only to cardiopulmonary resuscitation, discussions about this issue often reflect a revision of the larger goals and means of the care plan. The entire health care team must be carefully apprised of the nature of these changes. Do-not-resuscitate orders or requests for no cardiopulmonary resuscitation should specify care strategies and must be written in the medical record along with notes and orders that describe all other changes in the treatment goals or plans. It is essential that patients or surrogates understand that a do-not-resuscitate order does not mean that the patient will be ineligible for other life-prolonging measures, both therapeutic and palliative. However, the appropriateness of a do-not-resuscitate order during and immediately after any procedure needs to be individually negotiated. It is unethical for physicians or nurses to perform half-hearted resuscitation efforts ("slow codes").
Sometimes a patient or surrogate insists on a resuscitation effort, even when they are informed that it will almost certainly fail. A family's religious or other beliefs or need for closure under such circumstances deserve careful attention. Although the physician need not provide an effort at resuscitation that cannot conceivably restore circulation and breathing, the physician should help the family to understand and accept this position. It is more controversial whether physicians may unilaterally write a do-not-resuscitate order when the patient may survive for a very brief time in the hospital. Some institutions, with forewarning to patients and families, allow physicians to write orders against resuscitation over the patient's or family's objections. Empathy and thoughtful exploration of options for care with patients or surrogate decision makers should make such impasses rare. Full discussion about the issue should include the indications for and outcomes of cardiopulmonary resuscitation, the physical impact on the patient, implications for caregivers, the do-not-resuscitate order, the legal aspects of such orders, and the physician's role as patient advocate. Physicians who write a unilateral do-not-resuscitate order must inform the patient or surrogate.
The irreversible cessation of all functions of the entire brain is an accepted legal standard for determining death when the use of life support precludes the use of traditional cardiopulmonary criteria. After a patient has been declared dead by brain-death criteria, medical support should ordinarily be discontinued. In some circumstances, such as the need to preserve organs for transplantation, to counsel or accommodate family preferences, or to sustain a viable fetus, physicians may temporarily support bodily functions after death has been determined.
There is an increasingly unmet need for organs and tissues. Physicians should be involved in community efforts to make potential donors aware of their option to make a gift that would enhance life, health, or sight by organ or tissue donation. Physicians should obtain consent from the patient for the disposal and use of tissue, organs, or other body parts removed during diagnostic or operative procedures. All potential donors should communicate their preference to their families and have it listed on such documents as driver's licenses or organ donor cards.
Physicians caring for dying or brain-dead patients who are potential donors should inquire about whether the patient had expressed preferences about donation [38]. Federal and state law and health care accreditation bodies require that hospitals have procedures to ensure that families of hospitalized potential donors are made aware of the option to consent to organ donation. The issue of organ donation often arises in very difficult circumstances and may carry significant symbolic import for the family. Physicians should approach families with sensitivity and compassion.
Furthermore, organ procurement raises ethical concerns about the determination of death that have been partly addressed by legislation that defines brain death. It can also create conflict or the appearance of conflict between the care of a potential donor and the needs of a potential recipient. The care of the potential donor must be kept separate from the care of a recipient. The potential donor's physician should not be responsible for the care of the recipient nor be involved in retrieving the organs or tissue. However, the potential donor's physician may alert an organ-tissue procurement team of the existence of a potential donor. Once brain death has occurred and organ donation is authorized, the donor's physician should know how to maintain the viability of organs and tissues in coordination with the procurement team. Before declaration of brain death, treatments proposed to maintain the function of transplantable organs may be used only if they are not expected to harm the potential donor, whether by causing symptoms or by compromising the chance of survival.
Persons who are in a persistent vegetative state are unconscious [39,40] but are not brain dead. Because their condition is not progressive, patients in a persistent vegetative state are not terminally ill. They lack awareness of their surroundings and the ability to respond purposefully to them. The prognosis for these patients varies with cause. Some physicians and medical societies believe that there are no medical indications for life-prolonging treatment or access to intensive care or respirators when patients are confirmed to be in a persistent vegetative state [41]. They conclude that these patients cannot experience any benefits or suffer any discomfort and that all interventions should therefore be withdrawn. However, many patients or families value life in and of itself regardless of neurologic state. For these reasons, goals of care should guide decisions about life-prolonging treatment for patients in a persistent vegetative state in the same manner as for other patients without decision-making capacity.
Artificial administration of nutrition and fluids is a life-prolonging treatment. As such, it is subject to the same principles for decisions as other treatments. Some states require high levels of proof before previous statements or advance directives can be accepted as firm evidence that a patient would not want these treatments in the setting of terminal illness, permanent unconsciousness, or advanced dementia. For this reason, physicians should counsel patients to establish advance care directives and complete these parts of living wills especially carefully. Clinically, there is unfounded concern that discontinuing use of feeding tubes will cause suffering from hunger or thirst despite research findings to the contrary. Physicians should carefully address this issue with family and caregivers.
The debate over physician-assisted suicide is very important to physicians and patients. Both groups favor easing the dying process, providing adequate pain control, and avoiding unwanted overtreatment and protracted suffering. Patients and physicians may find it difficult at times to distinguish between the need for assistance in the dying process and the practice of assisting suicide.
Physician-assisted suicide occurs when a physician provides a medical means for death, usually a prescription for a lethal amount of medication that the patient takes on his or her own. In euthanasia, the physician directly and intentionally administers a substance to cause death. Physicians and patients should distinguish a decision by patients or their authorized surrogate to refuse life-sustaining treatment or an inadvertent death that occurs during an attempt to relieve suffering from physician-assisted suicide and euthanasia. Laws concerning or moral objections to physician-assisted suicide and euthanasia should not deter physicians from honoring a decision to withhold or withdraw medical interventions in appropriate situations. Fears that unwanted life-sustaining treatment will be imposed continue to motivate some patients to request assisted suicide or euthanasia.
In the clinical setting, all of these acts must be framed within the larger context of good end-of-life care. Many patients who request assisted suicide are depressed, have uncontrolled pain, or have potentially reversible suffering or fears [42]. In the setting of providing comfort to a dying person, most physicians and patients should be able to address these issues. For example, with regard to pain control, the physician may appropriately increase medication to relieve pain, even if this action inadvertently shortens life (the "double effect").
Physician-assisted suicide may be legalized in some states, although no consensus currently exists among patients or physicians [43] or within the College. Many fear that physicians are inadequately trained to arrive at such a conclusion with patients. Concerns focus in particular on vulnerable populations-poor persons, persons with costly chronic diseases, demented persons, disabled persons, and very young children. Physicians and patients must continue to search together for answers to these problems without violating the physician's personal and professional values and without abandoning the patient to struggle alone. For now, the policy debate continues to evolve rapidly, and physicians should urgently strive to greatly improve the quality of end-of-life care [44].
Many individual persons, groups, and institutions play a role in and are affected by medical decision making in the current practice environment. Tension and competition among the interests of clinicians, insurers, patients, and institutions for available social and health care resources unavoidably influence the patient-physician relationship. Although this section of the Manual will focus specifically on the obligations of physicians in this changing context, it is essential to note that others, such as insurers and health care institutions, bear responsibility for ensuring that the fundamental ethical commitment between physicians and patients is not undermined. Insured patients and their families should try to understand the possible implications of their insurance. Concern about the changing practice environment for physicians and insured patients should not distract our attention from the problems faced by persons who lack insurance.
Physicians must promote their patients' welfare in an increasingly complex health care system. This entails forthrightly helping patients to understand clinical recommendations and to make informed choices among all appropriate care options. It includes management of the conflicts of interest and multiple commitments that arise in any practice environment, especially in an era of cost concerns. It also includes stewardship of health care resources so that finite resources can meet as many health care needs as possible, whether in the physician's office, the hospital, the nursing home, or home care.
The patient-physician relationship and the principles that govern it should be central to the delivery of care. These principles include beneficence, honesty, confidentiality, privacy, and advocacy when patients' interests may be endangered by arbitrary, unjust, or inadequately individualized institutional procedures. Health care, however, does take place in a broader context beyond the patient-physician relationship. A patient's preferences or interests may conflict with the interests or values of the physician, an institution, a payer, other members of a managed care plan who have equal claim to the same health care resources, or society.
The physician's first and primary duty is to the patient. Physicians must base their counsel to patients on the interests of the individual patient, regardless of the insurance or medical care delivery setting in which physicians find themselves. Whether financial incentives in the fee-for-service system prompt physicians to do more rather than less or managed care arrangements encourage the physician to do less rather than more [45], physicians must not allow such considerations to affect their clinical judgment or counseling on treatment options, including referrals, for the patient. The physician's professional role is to make recommendations on the basis of their medical merit and to pursue options that comport with the patient's unique background and preferences [46].
Physicians should also contribute to the responsible stewardship of health care resources. With clinical authority and discretion come responsibility. Parsimonious care that utilizes the most efficient means to diagnose a condition and treat a patient respects the need to use resources wisely and to help ensure that resources are equitably available. The recommendations of physicians to patients, in the design of practice guidelines and formularies, and to medical benefits review boards should reflect the best clinical literature. Recommendations should, as much as possible, consider data on the cost-effectiveness of different clinical approaches. When patients ask, they should be informed of the rationale that underlies the physician's recommendation.
Health plans are not obliged to underwrite approaches that patients may value but that are not justifiable on clinical or theoretical scientific grounds or that are relatively cost-ineffective compared with other therapies for the same condition or other therapies offered by the health plan for other conditions. However, the plan must have in place a fair appeals procedure. In instances of disagreement between patient and physician for any reason, the physician is obligated to explain the basis for the disagreement, to educate the patient, and to meet the patient's needs for comfort and reassurance.
The physician's duty further requires that the physician serve as the patient's agent in the health care arena as a whole. In the managed care context, for example, advocacy can operate at many levels. At the individual level, the physician advocate must pursue the necessary avenues to obtain treatment that is essential to the individual patient's care, regardless of the barriers that may discourage the physician from doing so. When barriers diminish care for a class of patients because the patients themselves are less capable of self-representation, physicians must advocate on their behalf for equitable treatment.
Patients may not understand or may fear conflicts of interests for physicians and the multiple commitments that can arise from cost-containment under managed care. Health care plans have duties to foster an ethical practice environment. They should hold physicians accountable for the quality of care and not simply for economic performance. Managed care plans should not restrict the information or counsel that physicians may give patients.
Although the physician must provide information to the patient about all appropriate care and referral options, the health plan must disclose all relevant information about benefits, including any restrictions, and about financial incentives that might negatively affect patient access to care [47].
When patients enroll in insurance plans, they receive a great deal of information on rules governing benefits and reimbursement. Patients should familiarize themselves with this information. Physicians cannot and should not be expected to advise patients on the particulars of individual insurance contracts and arrangements. Patients should, however, expect their physicians to honor the rules of the insurer unless doing so would endanger the patient's health. Physicians should not collaborate with a patient or engage in efforts to defraud the insurer.
As professionals dedicated to serving the sick, all physicians should do their fair share to provide services to uninsured and underinsured persons.
Financial relationships between patients and physicians vary from fee-for-service to government contractual arrangements and prepaid insurance. Financial arrangements and expectations should be clearly established in advance. Fees for physician services should accurately reflect the services provided. Physicians should be mindful that forgiving copayment may constitute fraud.
When physicians elect to offer professional courtesy to a colleague, physicians and patients should function without feelings of constraints on time or resources and without shortcut approaches. Colleague-patients who initiate questions in informal settings put the treating physician in a less-than-ideal position to provide optimal care. Both parties should avoid this inappropriate practice.
The physician must seek to ensure that the medically appropriate level of care takes primacy over financial considerations imposed by the physician's own practice, investments, or financial arrangements. Trust in the profession is undermined when there is even the appearance of impropriety.
Potential influences on clinical judgment cover a wide range and include financial incentives inherent in the practice environment (such as incentives to overutilize in the fee-for-service setting or underutilize in the managed care setting) [48], drug industry gifts, and business arrangements involving referrals. Physicians must be conscious of all potential influences and their actions should be guided by appropriate utilization, not by other factors. A fee paid to one physician by another for the referral of a patient, historically known as fee-splitting, is unethical. It is also unethical for a physician to receive a commission or a kickback from anyone, including a company that manufactures or sells medical instruments or medications that are used in the care of the physician's patients. Physicians should not refer patients to an outside facility in which they have invested and at which they do not directly provide care [49].
Physicians may, however, invest in or own health care facilities when capital funding and necessary services are provided that would otherwise not be made available. In such situations, in addition to disclosing these interests to patients, safeguards must be established against abuse, impropriety, or the appearance of impropriety [49].
Physicians may invest in publicly traded securities. However, care must be taken to avoid investment decisions that may create a conflict of interest or the perception of a conflict of interest.
The acceptance of individual gifts, hospitality, trips, and subsidies of all types from the health care industry by an individual physician is strongly discouraged. The acceptance of even small gifts has been documented to affect clinical judgment and heightens the perception (as well as the reality) of a conflict of interest [50]. While following the Royal College of Physicians' guideline, "Would I be willing to have this arrangement generally known?" [51], physicians should also ask, "What would the public or my patients think of this arrangement?"
Physicians must critically evaluate medical information provided by detail persons, advertisements, or industry-sponsored educational programs. Physicians with ties to a particular company should disclose their interests when speaking or writing about a company product. Most journal editors require that authors and peer reviewers disclose any potential conflicts of interest. Editors themselves should be free from conflicts of interest concerning particular papers.
Advertising by physicians or health care institutions is unethical when it contains statements that are unsubstantiated, false, deceptive, or misleading, including statements that mislead by omitting necessary information.
Society has conferred professional prerogatives on physicians with the expectation that they will use their position for the benefit of patients. In turn, physicians are responsible and accountable to society for their professional actions. Society grants each physician the rights, privileges, and duties pertinent to the patient-physician relationship and has the right to require that physicians be competent and knowledgeable and that they practice with consideration for the patient as a person.
Physicians have obligations to society that in many ways parallel their obligations to individual patients. Physicians' conduct as professionals and as individual citizens should merit the respect of the community.
All physicians must fulfill the profession's collective responsibility to advocate the health and well-being of the public. Physicians should protect public health by reporting diseases, as required by law, to the responsible authority. They should support public health endeavors that provide the general public with accurate information about health care and comment on medical subjects in their areas of expertise to keep the public properly informed. Physicians should regard interaction with the news media to provide accurate information as an obligation to society and an extension of medical practice but must always be mindful of patient confidentiality.
Physicians should help the community recognize and deal with the social and environmental causes of disease. They should work toward ensuring access to health care for all persons and help correct deficiencies in the availability, accessibility, and quality of health services in the community.
Medical care is delivered within social and institutional systems that must take overall resources into account. Increasingly, decisions about resource allocations challenge the physician's primary role as patient advocate. There have always been limits to this advocacy role: For example, a physician is not obligated to lie to third-party payers for a patient or to provide all treatments regardless of their effectiveness [52]. Resource allocation pushes these limits further by compelling physicians to consider the best interests of all patients and of each patient. The just allocation of resources and changing reimbursement methods present the physician with ethical problems that cannot be ignored. Two principles are agreed upon:
1. As a physician performs his or her primary role as a patient's trusted advocate, he or she has a responsibility to use all health-related resources in a technically appropriate and efficient manner. He or she should plan workups carefully and avoid unnecessary testing, medications, surgery, and consultations.
2. Resource allocation decisions are most appropriately made at the policy level rather than entirely in the context of an individual patient-physician encounter. Physicians should participate in decisions at the policy level; should emphasize the value of health to society; and should base allocations on medical need, cost-effectiveness of treatments, and proper distribution of benefits and burdens in society.
Physicians must not be a party to and must speak out against torture or other abuses of human rights. Participation by physicians in the execution of prisoners except to certify death is unethical. Under no circumstances is it ethical for a physician to be used as an instrument of government to weaken the physical or mental resistance of a human being, nor should a physician participate in or tolerate cruel or unusual punishment or disciplinary activities beyond those permitted by the United Nations Standard Minimum Rules for the Treatment of Prisoners [53].
Ethics committees and consultants contribute to achieving patient care goals by facilitating resolution of conflicts in a respectful atmosphere through a fair and inclusive decision-making process, helping institutions to shape policies and practices that conform with the highest ethical standards, and assisting individual persons with handling current and future ethical problems by providing education in health care ethics [54,55]. Although it is generally agreed that neither ethics committees nor consultants should have decision-making authority, they can advise clinicians, patients, and family members on ethical matters.
Physicians should remember that the presence of illness does not diminish the right or expectation to be treated equally. Stated another way, illness does not in and of itself change a patient's legal rights or permit a physician to ignore those legal rights.
The law is society's mechanism for establishing boundaries for conduct. Society has a right to expect that those boundaries will not be disregarded. In instances of conflict, the physician must decide whether to violate the law for the sake of what he or she considers to be the dictates of medical ethics. Such a violation may jeopardize the physician's 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 be undertaken only after thorough consideration and, generally, after obtaining legal counsel.
Physicians have specialized knowledge and expertise that may be needed in judicial or administrative processes. Often, expert testimony is necessary for a court or administrative agency to understand the patient's condition, treatment, and prognosis. Physicians may be reluctant to become involved in legal proceedings because the process is unfamiliar and time-consuming. Their absence may mean, however, that legal decisions are made without the benefit of all medical facts or opinions. Without the participation of physicians, the mechanisms used to resolve many disputes may be ineffective and patients may suffer.
Although physicians cannot be compelled to participate as expert witnesses, the profession as a whole has the ethical duty to assist patients and society in resolving disputes [56]. In this role, physicians must give an honest and objective interpretation and representation of the medical facts. Physicians should only accept noncontingent compensation for the time and expenses incurred as expert witnesses.
Physicians should not participate in a strike that adversely affects access to health care. In general, physicians should individually and collectively find alternatives to strikes to address workplace concerns.
Physicians share a commitment to care for ill persons with an increasingly broad team of clinicians. The team's ability to care effectively for the patient depends on the ability of individual persons to treat each other with integrity, honesty, and respect in daily professional interactions regardless of race, religion, ethnicity, nationality, sex, sexual orientation, age, or disability [57]. Particular attention is warranted with regard to certain types of relationships and power imbalances that could be abusive or exploitative or lead to harassment, such as those between attending physician and resident, instructor and medical student, or physician and nurse [58].
The very title doctor, from the Latin docere, "to teach," implies that physicians have a responsibility to share knowledge and information with colleagues and patients. This sharing includes teaching clinical skills and reporting results of scientific research to colleagues, medical students, resident physicians, and other health care providers.
The physician has a responsibility to teach the science, art, and ethics of medicine to medical students, resident physicians, and others and to supervise physicians in training. Attending physicians must treat trainees with the same respect and compassion accorded to other colleagues. In the teaching environment, graduated authority for patient management can be delegated to residents, with adequate supervision. All trainees should inform patients of their training status and role in the medical team. Attending physicians, chiefs of service, or consultants should encourage residents to acknowledge their limitations and ask for help or supervision when concerns arise about patient care or the ability of others to perform their duties.
It is unethical to delegate authority for patient care to anyone, including another physician, who is not appropriately qualified and experienced. On a teaching service, the ultimate responsibility for patient welfare and quality of care remains with the patient's attending physician of record.
In almost all circumstances, patients should be encouraged to initially seek care from their principal physician. Physicians should in turn obtain competent consultation whenever they and their patients feel the need for assistance in caring for the patient [59]. The level of consultation needed should be established first: a one-visit opinion, continuing co-operative care, or total transfer of authority to the consultant. Patients have the option to seek an independent consultation from another physician but may be held financially responsible for their decision.
The consultant should respect the relationship between the patient and the principal physician, should promptly and effectively communicate recommendations to the principal physicians, and should obtain concurrence of the principal physician for major procedures or additional consultants. The care of the patient and the proper records should be transferred back to the principal physician when the consultation is completed, unless another arrangement is agreed upon.
Consultants who need temporary charge of the patient's care should obtain the principal physician's cooperation and assent. The physician who does not agree with the consultant's recommendations is free to call in another consultant. The interests of the patient should remain paramount in this process.
A complex clinical situation may call for multiple consultations. To assure a coordinated effort that is in the best interest of the patient, the principal physician should remain in charge of overall care, communicating with the patient and coordinating care on the basis of information derived from the consultations. Unless authority has been formally transferred elsewhere, the responsibility for the patient's care lies with the principal physician.
Physicians who are impaired for any reason must refrain from assuming patient responsibilities that they cannot discharge safely and effectively. Whenever there is doubt, they should seek assistance in caring for their patients.
Every physician is responsible for protecting patients from an impaired physician and for assisting an impaired colleague. Fear of being wrong, embarrassment, or possible litigation should not deter or delay identification of an impaired colleague [60]. The identifying physician may find it helpful to discuss the issue with the departmental chair or a senior member of the staff or community.
Impairment may result from use of habit-forming agents (alcohol or other substances) or from psychiatric, physiologic, or behavioral disorders. Impairment may also be caused by diseases that affect the cognitive or motor skills necessary to provide adequate care. The presence of these disorders or the fact that a physician is being treated for them do not necessarily imply impairment.
Although the legal responsibility to do so varies among states, there is a clear ethical responsibility to report a physician who seems to be impaired to an appropriate authority (such as a chief of service, chief of staff, institutional committee, state medical board, or regulatory agency). Physicians should aid their impaired colleagues in identifying appropriate sources of help. While undergoing therapy, the impaired physician is entitled to full confidentiality as in any other patient-physician relationship. To protect patients of the impaired physician, someone other than the physician of the impaired physician must monitor the impaired physician's fitness to work. Serious conflicts may occur if the treating physician tries to fill both roles.
It is unethical for a physician to disparage the professional competence, knowledge, qualifications, or services of another physician to a patient or a third party or to state or imply that a patient has been poorly managed or mistreated by a colleague without substantial evidence, especially when such behavior is used to recruit patients.
Of equal importance, a physician is ethically obligated to report fraud, professional misconduct, incompetence, or abandonment of patients by another physician. Professional peer review is critical in assuring fair assessment of physician performance for the benefit of patients. The trust that patients and the public invest in physicians requires disclosure to the appropriate authorities and to patients at risk for immediate harm.
All physicians have a duty to participate in peer review. Fears of retaliation, ostracism by colleagues, loss of referrals, or inconvenience are not adequate reasons for refusing to participate in peer review. Society looks to physicians to establish professional standards of practice, and this obligation can be met only when all physicians participate in the process. Federal law and most states provide legal protection for physicians who participate in peer review in good faith.
Conversely, in the absence of substantial evidence of professional misconduct, negligence, or incompetence, it is unethical to use the peer review process to exclude another physician from practice, to restrict clinical privileges, or to otherwise harm the physician's practice.
All health professionals share a commitment to work together to serve the patient's interests. The best patient care is often a team effort, and mutual respect, cooperation, and communication should govern this effort. Each member of the patient care team has equal moral status. When a health professional has major ethical objections to an attending physician's order, both should discuss the matter thoroughly. Mechanisms should be available in hospitals to resolve differences of opinion among members of the patient care team.
Medical progress and improved patient care depend on innovative and vigorous research. The basic principle of research is honesty, which must be assured by institutional protocols. Fraud in research must be condemned and punished. Honesty and integrity must govern all stages of research, from the initial grant application to publication of results. Reviewers of grant applications and journal articles must respect the confidentiality of new ideas and information; they must not use what they learn from the review process for their own purposes, and they should not misrepresent the ideas of others as their own.
Scientists have a responsibility to gather data meticulously; to keep impeccable records of work done; to interpret results objectively, not force them into preconceived molds or models; to submit their work to peer review; and to report new knowledge. Self-aggrandizement, public acclaim, recognition by professional peers, or financial gain should never be primary motivations in scientific research [61].
The medical profession must assume responsibility for assuring that research is potentially of significant value and ethically conducted. Benefits and risks of research must be distributed fairly, and particular care must be taken to avoid exploitation of vulnerable populations. Research participants must be instructed about the nature of the research; consent from the research participant or an authorized representative [62] must be truly informed and given freely; research must be planned thoughtfully, so that it has a high probability of yielding useful results; risks to patients must be minimized; and the benefit-to-risk ratio must be high enough to justify the research effort.
Each institution that receives federal support for research on humans is required to create an institutional review board. All proposed clinical research, regardless of the source of support, should be approved by the local institutional review board to assure that the research plans are reasonable and that research participants are adequately protected.
Although this formal system of review is designed to protect research participants, the premise on which all ethical research is based is mutual trust and respect between research participants and researchers. This premise requires that physician-investigators involved in designing or carrying out research have primary concern for the potential participants in these investigations.
Although the responsibility for assuring reasonable protection of human research participants resides with the investigators and the local institutional review board, the medical profession as a whole also has responsibilities. Clinical investigation is fraught with opportunities for conflicts to arise.
Physicians should avoid situations in which they are rewarded for particular outcomes. Physician-investigators may find themselves in dual roles with respect to patients who are also research participants. The health and welfare of the patient must always be the physician's primary consideration. Physicians who refer patients for participation in research protocols must be satisfied that the program follows established ethical guidelines, provides for realistic informed consent, gives reasonable assurances of safety, and has an acceptable benefit-to-risk ratio. If the risks of the research become too great or if continued participation cannot be justified, the physician must be willing to advise the patient to withdraw. Physicians-of-record should not abdicate overall responsibility for patients whom they have referred to a research project. Giving finder's fees to individual physicians for referring patients to a research project generates an unethical conflict of interest [63].
Research on delivery of health services raises issues about the protection of participants that have not yet been well examined. Researchers, physicians, and patients should thoughtfully balance the merits of innovation and the available means to monitor and protect research participants.
The use of innovative medical therapies falls along the continuum between established practice and research. Innovative therapies include the use of unconventional dosages of standard medications, previously untried applications of known procedures, and the use of approved drugs for nonapproved indications. The primary purpose of innovative medical therapies is to benefit the individual patient. Clinicians will confront the ethical issues of innovative practice more frequently than the ethical problems of medical research. Important medical advances have emerged from successful innovations, but innovation should always be approached carefully. Medical therapy should be treated as research whenever data are gathered to develop new medical information and for publication. When an innovative therapy has no precedent, consultation with peers, an institutional review board, or another expert group is necessary to assess the risks of the innovation, the probable outcomes of not using a standard therapy, and whether the innovation is in the patient's best interest [64]. Informed consent is particularly important; patients must understand that the therapy is not standard treatment [65].
Authors of research reports must be sufficiently acquainted with the work being reported that they can take public responsibility for the integrity of the study and the validity of the findings, and they must have substantially contributed to the research itself. Sources of funding for the research project must be disclosed to potential collaborators in the research and must be included in the manuscript for publication (see the section on conflicts of interest).
Scientists build on the published work of other researchers and can proceed with confidence only if they can assume that the previously reported facts on which their work is based have been reported accurately. All scientists have a professional responsibility to be honest in their publications. They must describe methods accurately and in sufficient detail, report only observations that were actually made, make clear in the manuscript which information derives from the author's work and which comes from others (and where it was published), assure readers that research has been carried out in accordance with ethical principles, and assign authorship only to persons who merit and accept authorship [66].
Plagiarism is unethical. Incorporating the words of others or one's own published words, either verbatim or by paraphrasing without appropriate attribution, is unethical and may have legal consequences.
In this era of rapid communication and intense media and public interest in medical news, it has become common for clinical investigators or their institutions to call press conferences and make public announcements of new research developments. Although it is desirable for the media to obtain accurate information about scientific developments, researchers should approach public pronouncements carefully and use language that does not invite misinterpretation or unjustified extrapolation.
In general, press releases should be issued and press conferences held only after the research has been published in a peer-reviewed journal or presented in a proper and complete abstract so that the details of the study are available to the scientific community. Statements of scientists receive great visibility. An announcement of preliminary results, even couched in the most careful terms, is frequently reported by the media as a "breakthrough." Care must be taken to avoid raising false public expectations and embarrassing the scientists involved, both of which reduce the credibility of the scientific community as a whole.
We hope that this Manual will help physicians, whether they are clinicians, educators, or research scientists, to address some of the challenging ethical dilemmas that confront them each day. The Manual is written for physicians by a physician organization as we attempt to find our way through difficult terrain. Our ultimate intent is to improve the quality of care provided to patients and to give an account of the conduct of the virtuous physician in whom patients and the public may justifiably place their trust.
1. Define the ethics problem as an "ought" or "should" question.
Example: "Should we withhold a respirator for this unconscious adult man with AIDS, as his partner requests, or use it, as his parents request?"
Not: "This man with AIDS is an ethics problem."
Not: "Is it better for terminally ill patients to die with or without a respirator?"
2. List significant facts and uncertainties that are relevant to the question. Include facts about the patient and caregivers (such as intimacy, emotional state, ethnic and cultural background, faith traditions, and legal standing).
Example: "This man and his partner have been living together for 10 years and purchased a house together. The partner has been a caregiver throughout the illness. The patient's parents have been unaccepting of his life-style and orientation and have been distant from him."
Include physiologic facts.
Example: "The patient is irreversibly unconscious and incapable of making decisions; thus, he cannot now be consulted about who should speak on his behalf about his preferences for treatment."
Include significant medical uncertainties (such as prognosis and outcomes with and without treatment).
Example: "Antibiotics can be given for the current lung infection, but we do not know whether the patient can be weaned from the respirator given the advanced disease. It seems more likely than not that he will eventually be weaned from the respirator. The patient has an estimated life span of 3 to 9 months, but it may be much shorter or somewhat longer."
Include the benefits and harms of the treatment options.
Example: "The respirator will prolong life, but it is a burdensome and invasive treatment and will confine the patient to a highly medicalized setting."
3. Identify a decision maker. If the patient is competent, the decision maker is the patient. If the patient is incompetent or lacks decision-making capacity, identify a proxy decision maker as specified by court appointment, state law, a durable power of attorney for health care, living will, or the persons who are best situated by virtue of their intimate, loving familiarity with the patient.
Example: "This is a 32-year-old adult who has lived away from home for 14 years and who has had only occasional contact with his parents, mainly on holidays. He does not have a living will or a durable power of attorney but has spoken often with his partner about his preferences for health care as his disease has advanced. His partner has accompanied the patient to clinic and cared for him as he has become increasingly debilitated."
4. Give understandable, relevant, desired information to the decision maker and dispel myths and misconceptions.
Example: "The respirator and antibiotics will prolong life and may allow for treatment of the lung infection, but they will not reverse the underlying severity of the patient's condition. No treatments exist at this time that can affect this patient's underlying condition. If the respirator is started, it can be discontinued if the patient does not respond to treatment. If the respirator is not used, medications can be given to assure that the patient is comfortable even if his lungs are failing."
5. Solicit values of the patient that are relevant to the question. These include the patient's values about life; place in the life cycle; relation to community, health care, and health care institutions; goals for health care (for example, palliation, enhancement of function or independence, prolongation of life, or palliation without prolongation of life) and conditions that would change goals; and specific preferences about health care or proxy decision makers that are relevant to this situation.
Example: "This patient made many statements to his partner about wanting exclusively palliative care at this time and specifically declined further anti-HIV therapies, as noted in the medical record. He stated that he wanted no life-prolonging treatments of any kind if he could not communicate with his partner, which his present unconscious state prevents him from doing."
6. Identify health professional values. Values include health-promoting goals (such as prolonging life, alleviating pain, promoting health, curing disease, rehabilitating an injury, preventing harm, providing comfort, empowering patients to make choices, and advocating for patient). Values that pertain to patient-physician communication (truth telling, confidentiality, nondiscrimination, requirement for informed consent, and tolerance of the diversity of values) are also included, as well as some values that extend outside of the patient-physician relationship (such as protection of third parties, promotion of public health, and respect for the law).
Example: "Although the physician may feel that a respirator is indicated for this person with respiratory failure, this patient has articulated different goals for health care. The physician is obliged to respect the diversity of values and the requirement for informed consent and respect the patient's goals and preferences."
7. Propose and critique solutions, including multiple options for treatment and alternative providers.
Example: "The physician could provide palliative care to a person who has respiratory therapy who elects not to receive a respirator or seek to expeditiously transfer the patient to someone who can provide such care (the latter course would disrupt a relationship between this physician and patient). The physician, in protecting the interests and values of this patient who cannot speak on his own behalf, must serve as the patient's advocate to the parents of the patient."
8. Identify and remove or address constraints on solutions (such as reimbursement, unavailability of services, laws, or legal myths).
Example: "The parents in this case asserted that the doctor had to obey them because they were family members. A check with the hospital attorney showed that this was not true in this state."
The Manual and a book of ethics case studies are available from the College. 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 800-523-1546, extension 2600, or 215-351-2600.
Acknowledgments: The American College of Physicians and the ACP Ethics and Human Rights Committee are solely responsible for the contents of the Manual. Both thank former Committee members who made contributions to the development of this Manual through their reviews of drafts: Elias Abrutyn, MD; Samuel Asper, MD; Jeremiah A. Barondess, MD; Michael Bernstein, MD; Stuart Bondurant, MD; John F. Burnum, MD; Christine K. Cassel, MD; Errol D. Crook, MD; Harriet P. Dustan, MD; Saul J. Farber, MD; Daniel Federman, MD; Arthur Feinberg, MD; Norton J. Greenberger, MD; Eugene A. Hildreth, MD; Edwin P. Maynard, MD; John A. Mitas II, MC USN; Robert H. Moser, MD; Warren Point, MD; William A. Reynolds, MD; Lawrence Scherr, MD; Gerald E. Thomson, MD; Susan W. Tolle, MD; Richard W. Vilter, MD; and Ralph Wallerstein, MD.
They also thank reviewers of the Manual: George Annas, JD, MPH; David Asch, MD; Stuart B. Baker, MD; William G. Baker Jr., MD; Helen Blumen, MD; James L. Borland Jr., MD; Dan W. Brock, PhD; James A. Bryan II, MD; Panagiota V. Caralis, MD; Clifton R. Cleaveland, MD; Linda Hawes Clever, MD; John A. Ellerton, MD; Robert L. Fine, MD; Joseph J. Fins, MD; John Fletcher, PhD; Howard K. Gogel, MD; Susan D. Goold, MD; Michael Grossman, MD; John M. Harris Jr., MD; Ida Hellander, MD; John J. Hoesing, MD; Charles L. Junkerman, MD; Mahendr S. Kochar, MD; Jonathan Moreno, PhD; Haavi Morreim, PhD; John Noble, MD; Robert Potter, MD; Timothy E. Quill, MD; Harold C. Sox Jr., MD; Brian L. Strom, MD; Steven B. Tucker, MD; Peter Ubel, MD; Robert Veatch, PhD; Sara E. Walker, MD; James R. Webster, MD; Stuart J. Youngner, MD; and Rowen K. Zetterman, MD.
Requests for Reprints: Lois Snyder, JD, American College of Physicians, Independence Mall West, Sixth Street at Race, Philadelphia, PA 19106.
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