Current Opinions of the Council on Ethical and Judicial Affairs

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CURRENT OPINIONS OF THE COUNCIL ON ETHICAL AND JUDICIAL AFFAIRS

2002

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The 2002 revision of the Current Opinions of the Council on Ethical and Judicial Affairs, "reflects the application of the Principles of Medical Ethics to more than 175 specific ethical issues in medicine, including health care rationing, genetic testing, withdrawal of life-sustaining treatment, and family violence." A complete list of topics of the Current Opinions and the text of selected opinions follow; the annotations of court opinions and pertinent medical, ethical, and legal literature that follow many of the opinions are not included. (For full text opinions, go to www.ama-assn.org/ceja).

1.00 Introduction

1.01: Terminology
1.02: The Relation of Law and Ethics

E-2.01 Abortion

E-2.015: Mandatory Parental Consent to Abortion
E-2.02: Abuse of Spouses, Children, Elderly Persons, and Others at Risk
E-2.03: Allocation of Limited Medical Resources
E-2.035: Futile Care
E-2.037: Medical Futility in End-of-Life Care
E-2.04: Artificial Insemination by Known Donor
E-2.05: Artificial Insemination by Anonymous Donor
E-2.055: Ethical Conduct in Assisted Reproductive Technology
E-2.06: Capital Punishment
E-2.065: Court-Initiated Medical Treatments in Criminal Cases
E-2.067: Torture
E-2.07: Clinical Investigation
E-2.071: Subject Selection for Clinical Trials
E-2.075: The Use of Placebo Controls in Clinical Trials
E-2.076: Surgical "Placebo" Controls
E-2.077: Ethical Considerations in International Research
E-2.079: Safeguards in the Use of DNA Databanks in Genomic Research
E-2.08: Commercial Use of Human Tissue
E-2.09: Costs
E-2.095: The Provision of Adequate Health Care
E-2.10: Fetal Research Guidelines
E-2.105: Patenting Human Genes
E-2.11: Gene Therapy
E-2.12: Genetic Counseling
E-2.13: Genetic Engineering
E-2.132: Genetic Testing by Employers
E-2.135: Insurance Companies and Genetic Information
E-2.136: Genetic Information and the Criminal Justice System
E-2.137: Ethical Issues in Carrier Screening of Genetic Disorders
E-2.138: Genetic Testing of Children
E-2.139: Multiplex Genetic Testing
E-2.14: In Vitro Fertilization
E-2.141: Frozen Pre-Embryos
E-2.145: Pre-Embryo Splitting
E-2.147: Human Cloning
E-2.15: Financial Incentives for Organ Donation
E-2.155: Mandated Choice and Presumed Consent for Cadaveric Organ Donation
E-2.157: Organ Procurement Following Cardiac Death
E-2.16: Organ Transplantation Guidelines
E-2.161: Medical Applications of Fetal Tissue Transplantation
E-2.162: Anencephalic Neonates as Organ Donors
E-2.165: Fetal Umbilical Cord Blood
E-2.167: The Use of Minors as Organ and Tissue Donors
E-2.169: The Ethical Implications of Xenotransplantation
E-2.17: Quality of Life
E-2.18: Surrogate Mothers
E-2.19: Unnecessary Services
E-2.20: Withholding or Withdrawing Life-Sustaining Medical Treatment
E-2.21: Euthanasia
E-2.211: Physician-Assisted Suicide
E-2.215: Treatment Decisions for Seriously Ill Newborns
E-2.22: Do-Not-Resuscitate Orders
E-2.225: Optimal Use of Orders—Not—To—Intervene and Advance Directives
E-2.23: HIV Testing
E-2.24: Impaired Drivers and Their Physicians
E-2.30: Information from Unethical Experiments

3.00 Opinions on Interprofessional Relations

E-3.01: Nonscientific Practitioners
E-3.02: Nurses
E-3.03: Allied Health Professionals
E-3.04: Referral of Patients
E-3.041: Chiropractic
E-3.05: Specialists [deleted]
E-3.06: Sports Medicine
E-3.07: Teaching [deleted]
E-3.08: Sexual Harassment and Exploitation Between Medical Supervisors and Trainees
E-3.09: Medical Students Performing Procedures on Fellow Students

4.00 Opinions on Hospital Relations

4.01: Admission Fee
4.02: Assessments, Compulsory
4.03: Billing for Housestaff Services and Student Services
4.04: Economic Incentives and Levels of Care
4.05: Organized Medical Staff
4.06: Physician–Hospital Contractual Relations
4.07: Staff Privileges

5.00 Opinions on Confidentiality, Advertising And Communications Media Relations

E-5.01: Advertising and Managed Care Organizations
E-5.015: Direct-to-Consumer Advertisements of Prescription Drugs
E-5.02: Advertising and Publicity
E-5.025: Physician Advisory or Referral Services by Telecommunication
E-5.03: Communications Media: Press Relations
E-5.04: Communications Media: Standards of Professional Responsibility
E-5.045: Filming Patients in Health Care Settings
E-5.05: Confidentiality
E-5.051: Confidentiality of Medical Information Postmortem
E-5.055: Confidential Care for Minors
E-5.057: Confidentiality of HIV Status on Autopsy Reports
E-5.059: Privacy in the Context of Health Care
E-5.06: Confidentiality: Attorney-Physician Relation
E-5.07: Confidentiality: Computers
E-5.075: Confidentiality: Disclosure of Records to Data Collection Companies
E-5.08: Confidentiality: Insurance Company Representative
E-5.09: Confidentiality: Industry-Employed Physicians and Independent Medical Examiners

6.00 Opinions on Fees And Charges

6.01: Contingent Physician Fees
6.02: Fee Splitting
6.03: Fee Splitting: Referrals to Health Care Facilities
6.04: Fee Splitting: Drug or Device Prescription Rebates
6.05: Fees for Medical Services
6.06: Fees: Group Practice [deleted]
6.07: Insurance Form Completion Charges
6.08: Interest Charges and Finance Charges
6.09: Laboratory Bill
6.10: Services Provided by Multiple Physicians
6.11: Competition
6.12: Forgiveness or Waiver of Insurance Copayments
6.13: Professional Courtesy

7.00 Opinions on Physician Records

7.01: Records of Physicians: Availability of Information to Other Physicians
7.02: Records of Physicians: Information and Patients
E-7.025: Records of Physicians: Access by Non-Treating Medical Staff
7.03: Records of Physicians on Retirement or Departure from a Group
7.04: Sale of a Medical Practice
7.05: Retention of Medical Records

8.00 Opinions on Practice Matters

8.01: Appointment Charges
E-8.02: Ethical Guidelines for Physicians in Management Positions and Other Non-Clinical Roles
E-8.021: Ethical Obligations of Medical Directors
8.03: Conflicts of Interest: Guidelines
8.031: Conflicts of Interest: Biomedical Research
E-8.0315: Managing Conflicts of Interest in the Conduct of Clinical Trials
8.032: Conflicts of Interest: Health Facility Ownership by a Physician
8.035: Conflicts of Interest in Home Health Care
8.04: Consultation
8.041: Second Opinions
E-8.043: Ethical Implications of Surgical Co-Management
8.05: Contractual Relationships
E-8.051: Conflict of Interest Under Capitation
E-8.052: Negotiating Discounts for Specialty Care
E-8.053: Restrictions on Disclosure in Health Care Plan Contracts
E-8.054: Financial Incentives and the Practice of Medicine
E-8.06: Prescribing and Dispensing Drugs and Devices
8.061: Gifts to Physicians from Industry
E-8.062: Sale of Non-Health-Related Goods from Physicians' Offices
E-8.063: Sale of Health-Related Products from Physicians' Offices
8.07: Gifts to Physicians: Offers of Indemnity
8.08: Informed Consent
E-8.081: Surrogate Decision Making
E-8.085: Waiver of Informed Consent for Research in Emergency Situations
E-8.087: Medical Student Involvement in Patient Care
8.09: Laboratory Services
E-8.095: Reporting Clinical Test Results: General Guidelines
8.10: Lien Laws
8.11: Neglect of Patient
E-8.115: Termination of the Physician–Patient Relationship
8.12: Patient Information
E-8.13: Managed Care
E-8.132: Referral of Patients: Disclosure of Limitations
E-8.135: Cost Containment Involving Prescription Drugs in Health Care Plans
E-8.137: Restrictions on Disclosure in Managed Care Contracts
8.14: Sexual Misconduct in the Practice of Medicine
E-8.145: Sexual or Romantic Relations Between Physicians and Key Third Parties
8.15: Substance Abuse
8.16: Substitution of Surgeon Without Patient's Knowledge or Consent
8.17: Use of Restraints
8.18: Informing Families of a Patient's Death
E-8.181: Performing Procedures on the Newly Deceased for Training Purposes
8.19: Self-Treatment or Treatment of Immediate Family Members
E-8.20: Invalid Medical Treatment
E-8.21: Use of Chaperones During Physical Exams

9.00 Opinions on Professional Rights And Responsibilities

9.01: Accreditation
9.011: Continuing Medical Education
E-9.012: Physicians' Political Communications with Patients and Their Families
E-9.02: Restrictive Covenants and the Practice of Medicine
E-9.021: Covenants-Not-to-Compete for Physiciansin-Training
E-9.025: Collective Action and Patient Advocacy
9.03: Civil Rights and Professional Responsibility
9.031: Reporting Impaired, Incompetent or Unethical Colleagues
9.032: Reporting Adverse Drug or Device Events
9.035: Gender Discrimination in the Medical Profession
E-9.037: Signing Bonuses to Attract Graduates of U.S. Medical Schools
9.04: Discipline and Medicine
E-9.045: Physicians with Disruptive Behavior
9.05: Due Process
9.055: Disputes Between Medical Supervisors and Trainees
9.06: Free Choice
9.065: Caring for the Poor
9.07: Medical Testimony
9.08: New Medical Procedures
9.09: Patent for Surgical or Diagnostic Instrument
E-9.095: Patenting of Medical Procedures
9.10: Peer Review
9.11: Ethics Committees in Health Care Institutions
E-9.115: Ethics Consultations
9.12: Physician–Patient Relationship: Respect for Law and Human Rights
9.121: Racial Disparities in Health Care
9.122: Gender Disparities in Health Care
9.13: Physicians and Infectious Diseases
9.131: HIV Infected Patients and Physicians
E-9.132: Health Care Fraud and Abuse

E-10.00 Opinions on the Patient–Physician Relationship

E-10.01: Fundamental Elements of the Patient–Physician Relationship
E-10.015: The Patient–Physician Relationship
E-10.02: Patient Responsibilities
E-10.03: Patient–Physician Relationship in the Context of Work-Related and Independent Medical Examinations
E-10.05: Potential Patients

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2.00 • Opinions on Social Policy Issues

2.01 ABORTION. The Principles of Medical Ethics of the AMA do not prohibit a physician from performing an abortion in accordance with good medical practice and under circumstances that do not violate the law. (III, IV)

Issued prior to April 1977.

2.015 MANDATORY PARENTAL CONSENT TO ABORTION. Physicians should ascertain the law in their state on parental involvement to ensure that their procedures are consistent with their legal obligations.

Physicians should strongly encourage minors to discuss their pregnancy with their parents. Physicians should explain how parental involvement can be helpful and that parents are generally very understanding and supportive. If a minor expresses concerns about parental involvement, the physician should ensure that the minor's reluctance is not based on any misperceptions about the likely consequences of parental involvement.

Physicians should not feel or be compelled to require minors to involve their parents before deciding whether to undergo an abortion. The patient—even an adolescent—generally must decide whether, on balance, parental involvement is advisable. Accordingly, minors should ultimately be allowed to decide whether parental involvement is appropriate. Physicians should explain under what circumstances (e.g., life-threatening, emergency) the minor's confidentiality will need to be abrogated.

Physicians should try to ensure that minor patients have made an informed decision after giving careful consideration to the issues involved. They should encourage their minor patients to consult alternative sources if parents are not going to be involved in the abortion decision. Minors should be urged to seek the advice and counsel of those adults in whom they have confidence, including professional counselors, relatives, friends, teachers, or the clergy. (III, IV)

Issued June 1994 based on the report "Mandatory Parental Consent to Abortion," issued June 1992. (JAMA. 1993; 269: 82–86)

2.02 ABUSE OF CHILDREN, ELDERLY PERSONS, AND OTHERS AT RISK. The following are guidelines for detecting and treating family violence:

Due to the prevalence and medical consequences of family violence, physicians should routinely inquire about physical, sexual, and psychological abuse as part of the medical history. Physicians must also consider abuse in the differential diagnosis for a number of medical complaints, particularly when treating women.

Physicians who are likely to have the opportunity to detect abuse in the course of their work have an obligation to familiarize themselves with protocols for diagnosing and treating abuse and with community resources for battered women, children, and elderly persons.

Physicians also have a duty to be aware of societal misconceptions about abuse and prevent these from affecting the diagnosis and management of abuse. Such misconceptions include the belief that abuse is a rare occurrence; that abuse does not occur in "normal" families; that abuse is a private problem best resolved without outside interference; and that victims are responsible for the abuse.

In order to improve physician knowledge of family violence, physicians must be better trained to identify signs of abuse and to work cooperatively with the range of community services currently involved. Hospitals should require additional training for those physicians who are likely to see victims of abuse. Comprehensive training on family violence should be required in medical school curricula and in residency programs for specialties in which family violence is likely to be encountered.

The following are guidelines for the reporting of abuse:

Laws that require the reporting of cases of suspected abuse of children and elderly persons often create a difficult dilemma for the physician. The parties involved, both the suspected offenders and the victims, will often plead with the physician that the matter be kept confidential and not be disclosed or reported for investigation by public authorities.

Children who have been seriously injured, apparently by their parents, may nevertheless try to protect their parents by saying that the injuries were caused by an accident, such as a fall. The reason may stem from the natural parent-child relationship or fear of further punishment. Even institutionalized elderly patients who have been physically maltreated may be concerned that disclosure of what has occurred might lead to further and more drastic maltreatment by those responsible.

The physician should comply with the laws requiring reporting of suspected cases of abuse of spouses, children, elderly persons, and others.

Public officials concerned with the welfare of children and elderly persons have expressed the opinion that the incidence of physical violence to these persons is rapidly increasing and that a very substantial percentage of such cases is unreported by hospital personnel and physicians. A child or elderly person brought to a physician with a suspicious injury is the patient whose interests require the protection of law in a particular situation, even though the physician may also provide services from time to time to parents or other members of the family.

The obligation to comply with statutory requirements is clearly stated in the Principles of Medical Ethics. Absent such legal requirement, for mentally competent, adult victims of abuse, physicians should not report to state authorities without the consent of the patient. Physicians, however, do have an ethical obligation to intervene. Actions should include, but would not be limited to: suggesting the possibility of abuse with the adult patient, discussing the safety mechanisms available to the adult patient (e.g., reporting to the police or appropriate state authority), making available to the adult patient a list of community and legal resources, providing ongoing support, and documenting the situation for future reference. Physicians must discuss possible interventions and the problem of family violence with adult patients in privacy and safety. (I, III)

Issued December 1982.

Updated June 1994 based on the report "Physicians and Family Violence: Ethical Considerations," adopted December 1991 (JAMA. 1992; 267: 3190–93); updated June 1996; and updated June 2000 based on the report "Domestic Violence Intervention," adopted June 1998.

2.03 ALLOCATION OF LIMITED MEDICAL RESOURCES. A physician has a duty to do all that he or she can for the benefit of the individual patient. Policies for allocating limited resources have the potential to limit the ability of physicians to fulfill this obligation to patients. Physicians have a responsibility to participate and to contribute their professional expertise in order to safeguard the interests of patients in decisions made at the societal level regarding the allocation or rationing of health resources.

Decisions regarding the allocation of limited medical resources among patients should consider only ethically appropriate criteria relating to medical need. These criteria include likelihood of benefit, urgency of need, change in quality of life, duration of benefit, and, in some cases, the amount of resources required for successful treatment. In general, only very substantial differences among patients are ethically relevant; the greater the disparities, the more justified the use of these criteria becomes. In making quality of life judgments, patients should first be prioritized so that death or extremely poor outcomes are avoided; then, patients should be prioritized according to change in quality of life, but only when there are very substantial differences among patients

Nonmedical criteria, such as ability to pay, age, social worth, perceived obstacles to treatment, patient contribution to illness, or past use of resources should not be considered.

Allocation decisions should respect the individuality of patients and the particulars of individual cases as much as possible. When very substantial differences do not exist among potential recipients of treatment on the basis of the appropriate criteria defined above, a "first-come-first-served" approach or some other equal opportunity mechanism should be employed to make final allocation decisions. Though there are several ethically acceptable strategies for-implementing these criteria, no single strategy is ethically mandated. Acceptable approaches include a three-tiered system, a minimal threshold approach, and a weighted formula. Decision-making mechanisms should be objective, flexible, and consistent to ensure that all patients are treated equally.

The treating physician must remain a patient advocate and therefore should not make allocation decisions. Patients denied access to resources have the right to be informed of the reasoning behind the decision. The allocation procedures of institutions controlling scarce resources should be disclosed to the public as well as subject to regular peer review from the medical profession. (1, VII)

Issued March 1981.

Updated June 1994 based on the report "Ethical Considerations in the Allocation of Organs and Other Scarce Medical Resources Among Patients," issued June 1993. (Archive of Internal Medicine 1995; 155: 29–40).

2.035 FUTILE CARE. Physicians are not ethically obligated to deliver care that, in their best professional judgment, will not have a reasonable chance of benefiting their patients. Patients should not be given treatments simply because they demand them. Denial of treatment should be justified by reliance on openly stated ethical principles and acceptable standards of care, as defined in Opinion 2.03, "Allocation of Limited Medical Resources," and Opinion 2.095, "The Provision of Adequate Health Care," not on the concept of "futility," which cannot be meaningfully defined. (I, IV)

Issued June 1994.

2.06 CAPITAL PUNISHMENT. An individual's opinion on capital punishment is the personal moral decision of the individual. A physician, as a member of a profession dedicated to preserving life when there is hope of doing so, should not be a participant in a legally authorized execution. Physician participation in execution is defined generally as actions which would fall into one or more of the following categories: (1) an action which would directly cause the death of the condemned; (2) an action which would assist, supervise, or contribute to the ability of another individual to directly cause the death of the condemned; (3) an action which could automatically cause an execution to be carried out on a condemned prisoner.

Physician participation in an execution includes, but is not limited to, the following actions: prescribing or administering tranquilizers and other psychotropic agents and medications that are part of the execution procedure; monitoring vital signs on site or remotely (including monitoring electrocardiograms); attending or observing an execution as a physician; and rendering of technical advice regarding execution.

In the case where the method of execution is lethal injection, the following actions by the physician would also constitute physician participation in execution: selecting injection sites; starting intravenous lines as a port for a lethal injection device; prescribing, preparing, administering, or supervising injection drugs or their doses or types; inspecting, testing, or maintaining lethal injection devices; and consulting with or supervising lethal injection personnel.

The following actions do not constitute physician participation in execution: (1) testifying as to medical history and diagnoses or mental state as they relate to competence to stand trial, testifying as to relevant medical evidence during trial, testifying as to medical aspects of aggravating or mitigating circumstances during the penalty phase of a capital case, or testifying as to medical diagnoses as they relate to the legal assessment of competence for execution; (2) certifying death, provided that the condemned has been declared dead by another person; (3) witnessing an execution in a totally nonprofessional capacity; (4) witnessing an execution at the specific voluntary request of the condemned person, provided that the physician observes the execution in a nonprofessional capacity; and (5) relieving the acute suffering of a condemned person while awaiting execution, including providing tranquilizers at the specific voluntary request of the condemned person to help relieve pain or anxiety in anticipation of the execution.

Physicians should not determine legal competence to be executed. A physician's medical opinion should be merely one aspect of the information taken into account by a legal decision maker such as a judge or hearing officer. When a condemned prisoner has been declared incompetent to be executed, physicians should not treat the prisoner for the purpose of restoring competence unless a commutation order is issued before treatment begins. The task of re-evaluating the prisoner should be performed by an independent physician examiner. If the incompetent prisoner is undergoing extreme suffering as a result of psychosis or any other illness, medical intervention intended to mitigate the level of suffering is ethically permissible. No physician should be compelled to participate in the process of establishing a prisoner's competence or be involved with treatment of an incompetent, condemned prisoner if such activity is contrary to the physician's personal beliefs. Under those circumstances, physicians should be permitted to transfer care of the prisoner to another physician.

Organ donation by condemned prisoners is permissible only if (1) the decision to donate was made before the prisoner's conviction, (2) the donated tissue is harvested after the prisoner has been pronounced dead and the body removed from the death chamber, and (3) physicians do not provide advice on modifying the method of execution for any individual to facilitate donation. (I)

Issued July 1980.

Updated June 1994 based on the report "Physician Participation in Capital Punishment," adopted December 1992, (JAMA. 1993; 270: 365–368); updated June 1996 based on the report "Physician Participation in Capital Punishment: Evaluations of Prisoner Competence to be Executed; Treatment to Restore Competence to be Executed," adopted in June 1995; Updated December 1999; and Updated June 2000 based on the report "Defining Physician Participation in State Executions," adopted June 1998.

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2.077 ETHICAL CONSIDERATIONS IN INTERNATIONAL RESEARCH. Physicians, either in their role as investigators or as decision-makers involved in the deliberations related to the funding or the review of research, hold an ethical obligation to ensure the protection of research participants. When the research is to be conducted in countries with differing cultural traditions, health care systems, and ethical standards, and in particular in countries with developing economies and with limited health care resources, U.S. physicians should respect the following guidelines:

First and foremost, physicians involved in clinical research that will be carried out internationally should be satisfied that a proposed research design has been developed according to a sound scientific design. Therefore, investigators must ascertain that there is genuine uncertainty within the clinical community about the comparative merits of the experimental treatment and the one to be offered as a control in the population among which the study is to be undertaken. In some instances, a three-pronged protocol, which offers the standard treatment in use in the U.S., a treatment that meets a level of care that is attainable and sustainable by the host country, and a placebo (see Opinion 2.075, "Surgical 'Placebo' Controls"), may be the best method to evaluate the safety and efficacy of a treatment in a given population. When U.S. investigators participate in international research they must obtain approval for such protocols from U.S. Institutional Review Boards (IRBs).
IRBs, which are responsible for ensuring the protection of research participants, must determine that risks have been minimized and that the protocol's ratio of risks to benefits is favorable to participants. In evaluating the risks and benefits that a protocol presents to a population, IRBs should obtain relevant input from representatives from the host country and from the research population. It is also appropriate for IRBs to consider the harm that is likely to result from forgoing the research.
Also, IRBs are required to protect the welfare of individual participants. This can best be achieved by assuring that a suitable informed consent process is in place. Therefore, IRBs should ensure that individual potential participants will be informed of the nature of the research endeavor and that their voluntary consent will be sought. IRBs should recognize that, in some instances, information will be meaningful only if it is communicated in ways that are consistent with local customs.
Overall, to ensure that the research does not exploit the population from which participants are recruited, IRBs should ensure that the research corresponds to a medical need in the region where it is undertaken. Furthermore, they should foster research with the potential for lasting benefits, especially when it is undertaken among populations that are severely deficient in health care resources. This can be achieved by facilitating the development of a health care infrastructure that will be of use during and beyond the conduct of the research. Additionally, physicians conducting studies must encourage research sponsors to continue to provide beneficial study interventions to all study participants at the conclusion of the study. (I, IV, VII, VIII, IX)

Issued December 2001 based on the report "Ethical Considerations in International Research," adopted June 2001.

2.09 COSTS. While physicians should be conscious of costs and not provide or prescribe unnecessary services, concern for the quality of care the patient receives should be the physician's first consideration. This does not preclude the physician, individually or through medical or other organizations, from participating in policy-making with respect to social issues affecting health care. (I, VII)

Issued March 1981.

Updated June 1994 and June 1998.

2.095 THE PROVISION OF ADEQUATE HEALTH CARE.

Because society has an obligation to make access to an adequate level of health care available to all of its members regardless of ability to pay, physicians should contribute their expertise at a policy-making level to help achieve this goal. In determining whether particular procedures or treatments should be included in the adequate level of health care, the following ethical principles should be considered: (1) degree of benefit (the difference in outcome between treatment and no treatment), (2) likelihood of benefit, (3) duration of benefit, (4) cost, and (5) number of people who will benefit (referring to the fact that a treatment may benefit the patient and others who come into contact with the patient, as with a vaccination or antimicrobial drug).

Ethical principles require that the ethical criteria be combined with a fair process to determine the adequate level of health care. Among the many possible alternative processes, the Council recommends the following two:

Democratic decision making with broad public input at both the developmental and final approval stages can be used to develop the package of benefits. With this approach, enforcement of anti-discrimination laws will be necessary to ensure that the interests of minorities and historically disadvantaged groups are protected.
Equal opportunity mechanisms can also be used to determine the package of health care benefits. After applying the five ethical criteria listed above, it will be possible to designate some kinds of care as either clearly basic or clearly discretionary. However, for care that is not clearly basic or discretionary, a random selection or other equal consideration mechanism may be used to determine which kinds of care will be included in the basic benefits package.

The mechanism for providing an adequate level of health care should ensure that the health care benefits for the poor and disadvantaged will not be eroded over time. There should also be ongoing monitoring for variations in care that cannot be explained on medical grounds with special attention to evidence of discriminatory impact on historically disadvantaged groups. Finally, adjustment of the adequate level over time should be made to ensure continued and broad public acceptance.

Issued June 1994 based on the report "Ethical Issues in Health System Reform: The Provision of Adequate Health Care," issued December 1993. (JAMA. 1994; 272)

2.10 FETAL RESEARCH GUIDELINES. The following guidelines are offered as aids to physicians when they are engaged in fetal research:

(1) Physicians may participate in fetal research when their activities are part of a competently designed program, under accepted standards of scientific research, to produce data which are scientifically valid and significant.
(2) If appropriate, properly performed clinical studies on animals and nongravid humans should precede any particular fetal research project.
(3) In fetal research projects, the investigator should demonstrate the same care and concern for the fetus as a physician providing fetal care or treatment in a non-research setting.
(4) All valid federal or state legal requirements should be followed.
(5) There should be no monetary payment to obtain any fetal material for fetal research projects.
(6) Competent peer review committees, review boards, or advisory boards should be available, when appropriate, to protect against the possible abuses that could arise in such research.
(7) Research on the so called "dead fetus," macerated fetal material, fetal cells, fetal tissue, or fetal organs should be in accord with state laws on autopsy and state laws on organ transplantation or anatomical gifts.
(8) In fetal research primarily for treatment of the fetus:
A. Voluntary and informed consent, in writing, should be given by the gravid woman, acting in the best interest of the fetus.
B. Alternative treatment or methods of care, if any, should be carefully evaluated and fully explained. If simpler and safer treatment is available, it should be pursued.
(9) In research primarily for treatment of the gravid female:
A. Voluntary and informed consent, in writing, should be given by the patient.
B. Alternative treatment or methods of care should be carefully evaluated and fully explained to the patient. If simpler and safer treatment is available, it should be pursued.
C. If possible, the risk to the fetus should be the least possible, consistent with the gravid female's need for treatment.
(10) In fetal research involving a fetus in utero, primarily for the accumulation of scientific knowledge:
A. Voluntary and informed consent, in writing, should be given by the gravid woman under circumstances in which a prudent and informed adult would reasonably be expected to give such consent.
B. The risk to the fetus imposed by the research should be the least possible.
C. The purpose of research is the production of data and knowledge which are scientifically significant and which cannot otherwise be obtained.
D. In this area of research, it is especially important to emphasize that care and concern for the fetus should be demonstrated. (I, III, V)

Issued March 1980.

Updated June 1994.

2.11 GENE THERAPY. Gene therapy involves the replacement or modification of a genetic variant to restore or enhance cellular function or to improve the reaction of non-genetic therapies.

Two types of gene therapy have been identified:(1) somatic cell therapy, in which human cells other than germ cells are genetically altered, and (2) germ line therapy, in which a replacement gene is integrated into the genome of human gametes or their precursors, resulting in expression of the new gene in the patient's offspring and subsequent generations. The fundamental difference between germ line therapy and somatic cell therapy is that germ line therapy affects the welfare of subsequent generations and may be associated with increased risk and the potential for unpredictable and irreversible results. Because of the far-reaching implications of germ line therapy, it is appropriate to limit genetic intervention to somatic cells at this time.

The goal of both somatic cell and germ line therapy is to alleviate human suffering and disease by remedying disorders for which available therapies are not satisfactory. This goal should be pursued only within the ethical tradition of medicine, which gives primacy to the welfare of the patient whose safety and well-being must be vigorously protected. To the extent possible, experience with animal studies must be sufficient to assure the effectiveness and safety of the techniques used, and the predictability of the results.

Moreover, genetic manipulation generally should be utilized only for therapeutic purposes. Efforts to enhance "desirable" characteristics through the insertion of a modified or additional gene, or efforts to "improve" complex human traits"the eugenic development of offspring"are contrary not only to the ethical tradition of medicine, but also to the egalitarian values of our society. Because of the potential for abuse, genetic manipulation to affect non-disease traits may never be acceptable and perhaps should never be pursued. If it is ever allowed, at least three conditions would have to be met before it could be deemed ethically acceptable: (1) there would have to be a clear and meaningful benefit to the person, (2) there would have to be no trade-off with other characteristics or traits, and (3) all citizens would have to have equal access to the genetic technology, irrespective of income or other socioeconomic characteristics. These criteria should be viewed as a minimal, not an exhaustive, test of the ethical propriety of non-disease-related genetic intervention. As genetic technology and knowledge of the human genome develop further, additional guidelines may be required.

As gene therapy becomes feasible for a variety of human disorders, there are several practical factors to consider to ensure safe application of this technology in society. First, any gene therapy research should meet the Council's guidelines on clinical investigation (Opinion 2.07) and investigators must adhere to the standards of medical practice and professional responsibility. The proposed procedure must be fully discussed with the patient and the written informed consent of the patient or the patient's legal representative must be voluntary.

Investigators must be thorough in their attempts to eliminate any unwanted viral agents from the viral vector containing the corrective gene. The potential for adverse effects of the viral delivery system must be disclosed to the patient. The effectiveness of gene therapy must be evaluated fully, including the determination of the natural history of the disease and follow-up examination of subsequent generations. Gene therapy should be pursued only after the availablity or effectiveness of other possible therapies is found to be insufficient. These considerations should be reviewed, as appropriate, as procedures and scientific information develop. (I, V)

Issued December 1988.

Updated June 1994 based on the report "Prenatal Genetic Screening," adopted December 1992 (Arch Fam Med. 1994; 2: 633–642), and updated June 1996.

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2.147 HUMAN CLONING. "Somatic cell nuclear transfer" is the process in which the nucleus of a somatic cell of an organism is transferred into an enucleated oocyte. "Human cloning" is the application of somatic nuclear transfer technology to the creation of a human being that shares all of its nuclear genes with the person donating the implanted nucleus.

In order to clarify the many existing misconceptions about human cloning, physicians should help educate the public about the intrinsic limits of human cloning as well as the current ethical and legal protections that would prevent abuses of human cloning. These include the following: (1) using human cloning as an approach to terminal illness or mortality is a concept based on the mistaken notion that one's genotype largely determines one's individuality. A clone-child created via human cloning would not be identical to his or her clone-parent. (2) Current ethical and legal standards hold that under no circumstances should human cloning occur without an individual's permission. (3) Current ethical and legal standards hold that a human clone would be entitled to the same rights, freedoms, and protections as every other individual in society. The fact that a human clone's nuclear genes would derive from a single individual rather than two parents would not change his or her moral standing.

Physicians have an ethical obligation to consider the harms and benefits of new medical procedures and technologies. Physicians should not participate in human cloning at this time because further investigation and discussion regarding the harms and benefits of human cloning is required. Concerns include: (1) unknown physical harms introduced by cloning. Somatic cell nuclear transfer has not yet been refined and its long-term safety has not yet been proven. The risk of producing individuals with genetic anomalies gives rise to an obligation to seek better understanding of—and potential medical therapies for—the unforeseen medical consequences that could stem from human cloning.(2) Psychosocial harms introduced by cloning, including violations of privacy and autonomy. Human cloning risks limiting, at least psychologically, the seemingly unlimited potential of new human beings and thus creating enormous pressures on the clone-child to live up to expectations based on the life of the clone-parent.(3) The impact of human cloning on familial and societal relations. The family unit may be altered with the introduction of cloning, and more thought is required on a societal level regarding how to construct familial relations. (4) Potential effects on the gene pool.

Like other interventions that can change individuals' reproductive patterns and the resulting genetic characteristics of a population, human cloning has the potential to be used in a eugenic or discriminatory fashion—practices that are incompatible with the ethical norms of medical practice. Moreover, human cloning could alter irreversibly the gene pool and exacerbate genetic problems that arise from deleterious genetic mutations, resulting in harms to future generations.

Two potentially realistic and possibly appropriate medical uses of human cloning are for assisting individuals or couples to reproduce and for the generation of tissues when the donor is not harmed or sacrificed. Given the unresolved issues regarding cloning identified above, the medical profession should not undertake human cloning at this time and pursue alternative approaches that raise fewer ethical concerns.

Because cloning technology is not limited to the United States, physicians should help establish international guidelines governing human cloning. (V)

Issued December 1999 based of the report "The Ethics of Human Cloning," adopted June 1999.

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2.17 QUALITY OF LIFE. In the making of decisions for the treatment of seriously disabled newborns or of other persons who are severely disabled by injury or illness, the primary consideration should be what is best for the individual patient and not the avoidance of a burden to the family or to society. Quality of life, as defined by the patient's interests and values, is a factor to be considered in determining what is best for the individual. It is permissible to consider quality of life when deciding about life-sustaining treatment in accordance with opinions 2.20, 2.215, and 2.22 (I, III, IV)

Issued March 1981.

Updated June 1994.

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2.19 UNNECESSARY SERVICES. Physicians should not provide, prescribe, or seek compensation for services that are known to be unnecessary. (II, VII)

Issued prior to April 1977.

Updated June 1996.

2.20 WITHHOLDING OR WITHDRAWING LIFE-SUSTAINING MEDICAL TREATMENT. The social commitment of the physician is to sustain life and relieve suffering. Where the performance of one duty conflicts with the other, the preferences of the patient should prevail. The principle of patient autonomy requires that physicians respect the decision to forego life-sustaining treatment of a patient who possesses decision-making capacity. Life-sustaining treatment is any treatment that serves to prolong life without reversing the underlying medical condition. Life-sustaining treatment may include, but is not limited to, mechanical ventilation, renal dialysis, chemotherapy, antibiotics, and artificial nutrition and hydration.

There is no ethical distinction between withdrawing and withholding life-sustaining treatment.

A competent, adult patient may, in advance, formulate and provide a valid consent to the withholding or withdrawal of life-support systems in the event that injury or illness renders that individual incompetent to make such a decision. A patient may also appoint a surrogate decision maker in accordance with state law.

If the patient receiving life-sustaining treatment is incompetent, a surrogate decision maker should be identified. Without an advance directive that designates a proxy, the patient's family should become the surrogate decision maker. Family includes persons with whom the patient is closely associated. In the case when there is no person closely associated with the patient, but there are persons who both care about the patient and have sufficient relevant knowledge of the patient, such persons may be appropriate surrogates. Physicians should provide all relevant medical information and explain to surrogate decision makers that decisions regarding withholding or withdrawing life-sustaining treatment should be based on substituted judgment (what the patient would have decided) when there is evidence of the patient's preferences and values. In making a substituted judgment, decision makers may consider the patient's advance directive (if any); the patient's values about life and the way it should be lived; and the patient's attitudes towards sickness, suffering, medical procedures, and death. If there is not adequate evidence of the incompetent patient's preferences and values, the decision should be based on the best interests of the patient (what outcome would most likely promote the patient's well-being).

Though the surrogate's decision for the incompetent patient should almost always be accepted by the physician, there are four situations that may require either institutional or judicial review and/or intervention in the decision-making process: (1) there is no available family member willing to be the patient's surrogate decision maker, (2) there is a dispute among family members and there is no decision maker designated in an advance directive, (3) a health care provider believes that the family's decision is clearly not what the patient would have decided if competent, and (4) a health care provider believes that the decision is not a decision that could reasonably be judged to be in the patient's best interests. When there are disputes among family members or between family and health care providers, the use of ethics committees specifically designed to facilitate sound decision making is recommended before resorting to the courts.

When a permanently unconscious patient was never competent or had not left any evidence of previous preferences or values, since there is no objective way to ascertain the best interests of the patient, the surrogate's decision should not be challenged as long as the decision is based on the decision maker's true concern for what would be best for the patient.

Physicians have an obligation to relieve pain and suffering and to promote the dignity and autonomy of dying patients in their care. This includes providing effective palliative treatment even though it may foreseeably hasten death.

Even if the patient is not terminally ill or permanently unconscious, it is not unethical to discontinue all means of life-sustaining medical treatment in accordance with a proper substituted judgment or best interests analysis. (I, III, IV, V)

Issued December 1984 as Opinion 2.18, Withholding or Withdrawing Life-Prolonging Medical Treatment, and Opinion 2.19, Withholding or Withdrawing Life-Prolonging Medical Treatment—Patients' Preferences. In 1989, these Opinions were renumbered2.20 and 2.21, respectively.

Updated June 1994 based on the reports "Decisions Near the End of Life" and "Decisions to Forego Life-Sustaining Treatment for Incompetent Patients," both adopted June 1991 (Decisions Near the End of Life. JAMA. 1992; 267: 2229–2233), and updated June 1996. [In March 1981, the Council on Ethical and Judicial Affairs issued Opinion 2.11, Terminal Illness. The Opinion was renumbered 2.15 in 1984 and was deleted in 1986.]

2.21 EUTHANASIA. Euthanasia is the administration of a lethal agent by another person to a patient for the purpose of relieving the patient's intolerable and incurable suffering.

It is understandable, though tragic, that some patients in extreme duress—such as those suffering from a terminal, painful, debilitating illness—may come to decide that death is preferable to life. However, permitting physicians to engage in euthanasia would ultimately cause more harm than good. Euthanasia is fundamentally incompatible with the physician's role as healer, would be difficult or impossible to control, and would pose serious societal risks.

The involvement of physicians in euthanasia heightens the significance of its ethical prohibition. The physician who performs euthanasia assumes unique responsibility for the act of ending the patient's life. Euthanasia could also readily be extended to incompetent patients and other vulnerable populations.

Instead of engaging in euthanasia, physicians must aggressively respond to the needs of patients at the end of life. Patients should not be abandoned once it is determined that cure is impossible. Patients near the end of life must continue to receive emotional support, comfort care, adequate pain control, respect for patient autonomy, and good communication. (I, IV)

Issued June 1994 based on the report "Decisions Near the End of Life," adopted June 1991 (JAMA. 1992; 267: 2229–2233).

Updated June 1996.

2.211 PHYSICIAN ASSISTED SUICIDE. Physician-assisted suicide occurs when a physician facilitates a patient's death by providing the necessary means and/or information to enable the patient to perform the life-ending act (e.g., the physician provides sleeping pills and information about the lethal dose, while aware that the patient may commit suicide).

It is understandable, though tragic, that some patients in extreme duress—such as those suffering from a terminal, painful, debilitating illness—may come to decide that death is preferable to life. However, allowing physicians to participate in assisted suicide would cause more harm than good. Physician-assisted suicide is fundamentally incompatible with the physician's role as healer, would be difficult or impossible to control, and would pose serious societal risks.

Instead of participating in assisted suicide, physicians must aggressively respond to the needs of patients at the end of life. Patients should not be abandoned once it is determined that cure is impossible. Multidisciplinary interventions should be sought including specialty consultation, hospice care, pastoral support, family counseling, and other modalities. Patients near the end of life must continue to receive emotional support, comfort care, adequate pain control, respect for patient autonomy, and good communication. (I, IV)

Issued June 1994 based on the reports "Decisions Near the End of Life," adopted June 1991, and "Physician-Assisted Suicide," adopted December 1993 (JAMA. 1992; 267: 2229–33).

Updated June 1996.

2.215 TREATMENT DECISIONS FOR SERIOUSLY ILL

NEWBORNS. The primary consideration for decisions regarding life-sustaining treatment for seriously ill newborns should be what is best for the newborn. Factors that should be weighed are (1) the chance that therapy will succeed, (2) the risks involved with treatment and nontreatment, (3) the degree to which the therapy, if successful, will extend life, (4) the pain and discomfort associated with the therapy, and (5) the anticipated quality of life for the newborn with and without treatment.

Care must be taken to evaluate the newborn's expected quality of life from the child's perspective. Life-sustaining treatment may be withheld or withdrawn from a newborn when the pain and suffering expected to be endured by the child will overwhelm any potential for joy during his or her life. When an infant suffers extreme neurological damage, and is consequently not capable of experiencing either suffering or joy a decision may be made to withhold or withdraw life-sustaining treatment. When life-sustaining treatment is withheld or withdrawn, comfort care must not be discontinued.

When an infant's prognosis is largely uncertain, as is often the case with extremely premature newborns, all life-sustaining and life-enhancing treatment should be initiated. Decisions about life-sustaining treatment should be made once the prognosis becomes more certain. It is not necessary to attain absolute or near absolute prognostic certainty before life-sustaining treatment is withdrawn, since this goal is often unattainable and risks unnecessarily prolonging the infant's suffering.

Physicians must provide full information to parents of seriously ill newborns regarding the nature of treatments, therapeutic options and expected prognosis with and without therapy, so that parents can make informed decisions for their children about life-sustaining treatment. Counseling services and an opportunity to talk with persons who have had to make similar decisions should be available to parents. Ethics committees or infant review committees should also be utilized to facilitate parental decisionmaking. These committees should help mediate resolutions of conflicts that may arise among parents, physicians and others involved in the care of the infant. These committees should also be responsible for referring cases to the appropriate public agencies when it is concluded that the parents' decision is not a decision that could reasonably be judged to be in the best interests of the infant. (I, III, IV, V)

Issued June 1994 based on the report "Treatment Decisions for Seriously Ill Newborns," issued June 1992.

2.22 DO-NOT-RESUSCITATE ORDERS. Efforts should be made to resuscitate patients who suffer cardiac or respiratory arrest except when circumstances indicate that cardiopulmonary resuscitation (CPR) would be inappropriate or not in accord with the desires or best interests of the patient.

Patients at risk of cardiac or respiratory failure should be encouraged to express in advance their preferences regarding the use of CPR and this should be documented in the patient's medical record. These discussions should include a description of the procedures encompassed by CPR and, when possible, should occur in an outpatient setting when general treatment preferences are discussed, or as early as possible during hospitalization. The physician has an ethical obligation to honor the resuscitation preferences expressed by the patient. Physicians should not permit their personal value judgments about qualify of life to obstruct the implementation of a patient's preferences regarding the use of CPR.

If a patient is incapable of rendering a decision regarding the use of CPR, a decision may be made by a surrogate decisionmaker, based upon the previously expressed preferences of the patient or, if such preferences are unknown, in accordance with the patient's best interests.

If, in the judgment of the attending physician, it would be inappropriate to pursue CPR, the attending physician may enter a do-not-resuscitate order into the patient's record. Resuscitative efforts should be considered inappropriate by the attending physician only if they cannot be expected either to restore cardiac or respiratory function to the patient or to meet established ethical criteria, as defined in the Principles of Medical Ethics and Opinions 2.03 and 2.095. When there is adequate time to do so, the physician must first inform the patient, or the incompetent patient's surrogate, of the content of the DNR order, as well as the basis for its implementation. The physician also should be prepared to discuss appropriate alternatives, such as obtaining a second opinion (e.g., consulting a bioethics committee) or arranging for transfer of care to another physician.

Do-Not-Resuscitate orders, as well as the basis for their implementation, should be entered by the attending physician in the patient's medical record.

DNR orders only preclude resuscitative efforts in the event of cardiopulmonary arrest and should not influence other therapeutic interventions that may be appropriate for the patient. (I, IV)

Issued March 1992 based on the report "Guidelines for the Appropriate Use of Do-Not-Resuscitate Orders," issued December 1990. (JAMA. 1991; 265: 1868–1871)

Updated June 1994.

2.23 HIV TESTING. HIV testing is appropriate and should be encouraged for diagnosis and treatment of HIV infection or of medical conditions that may be affected by HIV. Treatment may prolong the lives of those with AIDS and prolong the symptom-free period in those with an asymptomatic HIV infection. Wider testing is imperative to ensure that individuals in need of treatment are identified and treated.

Physicians should ensure that HIV testing is conducted in a way that respects patient autonomy and assures patient confidentiality as much as possible.

The physician should secure the patient's informed consent specific for HIV testing before testing is performed. Because of the need for pretest counseling and the potential consequences of an HIV test on an individual's job, housing, insurability, and social relationships, the consent should be specific for HIV testing. Consent for HIV testing cannot be inferred from a general consent to treatment.

When a health care provider is at risk for HIV infection because of the occurrence of puncture injury or mucosal contact with potentially infected bodily fluids, it is acceptable to test the patient for HIV infection even if the patient refuses consent. When testing without consent is performed in accordance with the law, the patient should be given the customary pretest counseling.

The confidentiality of the results of HIV testing must be maintained as much as possible and the limits of a patient's confidentiality should be known to the patient before consent is given.

Exceptions to confidentiality are appropriate when necessary to protect the public health or when necessary to protect individuals, including health care workers, who are endangered by persons infected with HIV. If a physician knows that a seropositive individual is endangering a third party, the physician should, within the constraints of the law, (1) attempt to persuade the infected patient to cease endangering the third party;(2) if persuasion fails, notify authorities; and (3) if the authorities take no action, notify the endangered third party.

In order to limit the public spread of HIV infection, physicians should encourage voluntary testing of patients at risk for infection.

It is unethical to deny treatment to HIV-infected individuals because they are HIV seropositive or because they are unwilling to undergo HIV testing, except in the instance where knowledge of the patient's HIV status is vital to the appropriate treatment of the patient. When a patient refuses to be tested after being informed of the physician's medical opinion, the physician may transfer the patient to a second physician who is willing to manage the patient's care in accordance with the patient's preferences about testing. (I, IV)

Issued March 1992 based on the report "Ethical Issues Involved in the Growing AIDS Crisis," issued December 1987. (JAMA. 1988; 259: 1360–1361)

Updated June 1994.

3.00 • Opinions on Interprofessional Relations

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3.02 NURSES. The primary bond between the practices of medicine and nursing is mutual ethical concern for patients. One of the duties in providing reasonable care is fulfilled by a nurse who carries out the orders of the attending physician. Where orders appear to the nurse to be in error or contrary to customary medical and nursing practice, the physician has an ethical obligation to hear the nurse's concern and explain those orders to the nurse involved. The ethical physician should neither expect nor insist that nurses follow orders contrary to standards of good medical and nursing practice. In emergencies, when prompt action is necessary and the physician is not immediately available, a nurse may be justified in acting contrary to the physician's standing orders for the safety of the patient. Such occurrences should not be considered to be a breakdown in professional relations. (IV, V)

Issued June 1983

Updated June 1994.

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3.08 SEXUAL HARASSMENT AND EXPLOITATION BETWEEN MEDICAL SUPERVISORS AND TRAINEES. Sexual harassment may be defined as sexual advances, requests for sexual favors, and other verbal or physical conduct of a sexual nature when (1) such conduct interferes with an individual's work or academic performance or creates an intimidating, hostile, or offensive work or academic environment or (2) accepting or rejecting such conduct affects or may be perceived to affect employment decisions or academic evaluations concerning the individual. Sexual harassment is unethical.

Sexual relationships between medical supervisors and their medical trainees raise concerns because of inherent inequalities in the status and power that medical supervisors wield in relation to medical trainees and may adversely affect patient care. Sexual relationships between a medical trainee and a supervisor even when consensual are not acceptable regardless of the degree of supervision in any given situation. The supervisory role should be eliminated if the parties involved wish to pursue their relationship. (II, IV, VII)

Issued March 1992 based on the report "Sexual Harassment and Exploitation Between Medical Supervisors and Trainees," issued June 1989.

Updated June 1994

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5.00 • Opinions on Confidentiality, Advertising, and Communications Media Relations

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5.015 DIRECT-TO-CONSUMER ADVERTISEMENTS OF

PRESCRIPTION DRUGS. The medical profession needs to take an active role in ensuring that proper advertising guidelines are enforced and that the care patients receive is not compromised as a result of direct-to-consumer advertising. Since the Food and Drug Administration (FDA) has a critical role in determining future directions of direct-to-consumer advertising of prescription drugs, physicians should work to ensure that the FDA remains committed to advertising standards that protect patients' health and safety. Moreover, physicians should encourage and engage in studies regarding the effect of direct-to-consumer advertising on patient health and medical care. Such studies should examine whether direct-to-consumer advertising improves the communication of health information; enhances the patient–physician relationship; and contains accurate and reasonable information on risks, precautions, adverse reactions, and costs.

Physicians must maintain professional standards of informed consent when prescribing. When a patient comes to a physician with a request for a drug he or she has seen advertised, the physician and the patient should engage in a dialogue that would assess and enhance the patient's understanding of the treatment. Although physicians should not be biased against drugs that are advertised, physicians should resist commercially induced pressure to prescribe drugs that may not be indicated. Physicians should deny requests for inappropriate prescriptions and educate patients as to why certain advertised drugs may not be suitable treatment options, providing, when available, information on the cost effectiveness of different options.

Physicians must remain vigilant to assure that direct-to-consumer advertising does not promote false expectations. Physicians should be concerned about advertisements that do not enhance consumer education; do not convey a clear, accurate, and responsible health education message; do not refer patients to their physicians for more information; do not identify the target population at risk; and fail to discourage consumer self-diagnosis and self-treatment. Physicians may choose to report these concerns directly to the pharmaceutical company that sponsored the advertisement.

To assist the FDA in enforcing existing law and tracking the effects of direct-to-consumer advertising, physicians should, whenever reasonably possible, report to them advertisements that: (1) do not provide a fair and balanced discussion of the use of the drug product for the disease, disorder, or condition; (2) do not clearly explain warnings, precautions, and potential adverse reactions associated with the drug product; (3) do not present summary information in language that can be understood by the consumer; (4) do not comply with applicable FDA rules, regulations, policies, and guidelines as provided by the FDA; or (5) do not provide collateral materials to educate both physicians and consumers. (II, III)

Issued June 1999 based on the report "Direct-to-Consumer Advertisement of Prescription Drugs," adopted December 1998 (Food and Drug Law Journal. 2000; 55: 119–24).

5.045 FILMING PATIENTS IN HEALTH CARE SETTINGS. The use of any medium to film, videotape, or otherwise record (hereafter film) patient interactions with their health care providers requires the utmost respect for the privacy and confidentiality of the patient. The following guidelines are offered to assure that the rights of the patient are protected. These guidelines specifically address filming with the intent of broadcast for public viewing, and do not address other uses such as in medical education, forensic or diagnostic filming, or the use of security cameras. (1) Educating the public about the health care system should be encouraged, and filming of patients may be one way to accomplish this. This educational objective is not severely compromised by filming only patients who can consent; when patients cannot consent, dramatic reenactments utilizing actors should be considered instead of violating patient privacy. (2) Filming patients without consent is a violation of the patient's privacy. Consent is therefore an ethical requirement for both initial filming and subsequent broadcast for public viewing. Because filming cannot benefit a patient medically, and moreover has the potential of causing harm to the patient, it is appropriate to limit filming to instances where the party being filmed can explicitly consent. Consent by a surrogate decision-maker is not an ethically appropriate substitute for consent by the patient because the role of surrogates is to make medically necessary decisions in the best interest of the patient. A possible exception exists when the person in question is permanently or indefinitely incompetent (e.g., permanent vegetative state or minor child). In such circumstances, if a parent or legal guardian provides consent, filming may occur.(a) Patients should have the right to have filming stopped upon request at any time and the film crew removed from the area. Also, persons involved in the direct medical care of the patient who feel that the filming may jeopardize patient care should request that the film crew be removed from the patient care area. (b) The initial granting of consent does not preclude the patient from withdrawing consent at a later time. After filming has occurred, patients who have been filmed should have the opportunity to rescind their consent up until a reasonable time period before broadcast for public viewing. The consent process should include a full disclosure of whether the tape will be destroyed if consent is rescinded, and the degree to which the patient is allowed to view and edit the final footage before broadcast for public viewing. (c) Due to the potential conflict of interest, informed consent should be obtained by a disinterested third party, and not a member of the film crew or production team. (3) Information obtained in the course of filming medical encounters between patients and physicians is confidential. Persons who are not members of the health care team, but who may be present for filming purposes, must demonstrate that they understand the confidential nature of the information and are committed to respecting it. Where possible, it is desirable for stationary cameras or health care professionals to perform the filming.

Physicians, as advocates for their patients, should not allow financial or promotional benefit to the health care institution to influence their advice to patients regarding participation in filming. Because physician compensation for participation in filming may cause an undue influence to recruit patients, physicians should not be compensated directly. To protect the best interests of patients, physicians should participate in institutional review of requests to film. (I, IV, VII, VIII)

Issued December 2001 based on the report "Filming Patients in Health Care Settings," adopted June 2001.

5.05 CONFIDENTIALITY. The information disclosed to a physician during the course of the relationship between physician and patient is confidential to the greatest possible degree. The patient should feel free to make a full disclosure of information to the physician in order that the physician may most effectively provide needed services. The patient should be able to make this disclosure with the knowledge that the patient will respect the confidential nature of the communication. The physician should not reveal confidential communications or information without the express consent of the patient, unless required to do so by law.

The obligation to safeguard patient confidences is subject to 2certain exceptions which are ethically and legally justified because of overriding social considerations. Where a patient threatens to inflict serious bodily harm to another person or to him or herself and there is a reasonable probability that the patient may carry out the threat, the physician should take reasonable precautions for the protection of the intended victim, including notification of law enforcement authorities. Also, communicable diseases, gun shot and knife wounds should be reported as required by applicable statutes or ordinances. (IV)

Issued December 1983.

Updated June 1994.

5.055 CONFIDENTIAL CARE FOR MINORS. Physicians who treat minors have an ethical duty to promote the autonomy of minor patients by involving them in the medical decision-making process to a degree commensurate with their abilities.

When minors request confidential services, physicians should encourage them to involve their parents. This includes making efforts to obtain the minor's reasons for not involving their parents and correcting misconceptions that may be motivating their objections.

Where the law does not require otherwise, physicians should permit a competent minor to consent to medical care and should not notify parents without the patient's consent. Depending on the seriousness of the decision, competence may be evaluated by physicians for most minors. When necessary, experts in adolescent medicine or child psychological development should be consulted. Use of the courts for competence determinations should be made only as a last resort.

When an immature minor requests contraceptive services, pregnancy-related care (including pregnancy testing, prenatal and postnatal care, and delivery services), or treatment for sexually transmitted disease, drug and alcohol abuse, or mental illness, physicians must recognize that requiring parental involvement may be counterproductive to the health of the patient. Physicians should encourage parental involvement in these situations. However, if the minor continues to object, his or her wishes ordinarily should be respected. If the physician is uncomfortable with providing services without parental involvement, and alternative confidential services are available, the minor may be referred to those services. In cases when the physician believes that without parental involvement and guidance, the minor will face a serious health threat, and there is reason to believe that the parents will be helpful and understanding, disclosing the problem to the parents is ethically justified. When the physician does breach confidentiality to the parents, he or she must discuss the reasons for the breach with the minor prior to the disclosure.

For minors who are mature enough to be unaccompanied by their parents for their examination, confidentiality of information disclosed during an exam, interview, or in counseling should be maintained. Such information may be disclosed to parents when the patient consents to disclosure. Confidentiality may be justifiably breached in situations for which confidentiality for adults may be breached, according to Opinion 5.05, "Confidentiality." In addition, confidentiality for immature minors may be ethically breached when necessary to enable the parent to make an informed decision about treatment for the minor or when such a breach is necessary to avert serious harm to the minor. (IV)

Issued June 1994 based on the report "Confidential Care for Minors," adopted June 1992.

Updated June 1996.

5.07 CONFIDENTIALITY: COMPUTERS. The utmost effort and care must be taken to protect the confidentiality of all medical records, including computerized medical records.

The guidelines below are offered to assist physicians and computer service organizations in maintaining the confidentiality of information in medical records when that information is stored in computerized data bases:

(1) Confidential medical information should be entered into the computer-based patient record only by authorized personnel. Additions to the record should be time and date stamped, and the person making the additions should be identified in the record.
(2) The patient and physician should be advised about the existence of computerized data bases in which medical information concerning the patient is stored. Such information should be communicated to the physician and patient prior to the physician's release of the medical information to the entity or entities maintaining the computer data bases. All individuals and organizations with some form of access to the computerized data bases, and the level of access permitted, should be specifically identified in advance. Full disclosure of this information to the patient is necessary in obtaining informed consent to treatment. Patient data should be assigned a security level appropriate for the data's degree of sensitivity, which should be used to control who has access to the information.
(3) The physician and patient should be notified of the distribution of all reports reflecting identifiable patient data prior to distribution of the reports by the computer facility. There should be approval by the patient and notification of the physician prior to the release of patient–identifiable clinical and administrative data to individuals or organizations external to the medical care environment. Such information should not be released without the express permission of the patient.
(4) The dissemination of confidential medical data should be limited to only those individuals or agencies with a bona fide use for the data. Only the data necessary for the bona fide use should be released. Patient identifiers should be omitted when appropriate. Release of confidential medical information from the data base should be confined to the specific purpose for which the information is requested and limited to the specific time frame requested. All such organizations or individuals should be advised that authorized release of data to them does not authorize their further release of the data to additional individuals or organizations, or subsequent use of the data for other purposes.
(5) Procedures for adding to or changing data on the computerized data base should indicate individuals authorized to make changes, time periods in which changes take place, and those individuals who will be informed about changes in the data from the medical records.
(6) Procedures for purging the computerized data base of archaic or inaccurate data should be established and the patient and physician should be notified before and after the data has been purged. There should be no mixing of a physician's computerized patient records with those of other computer service bureau clients. In addition, procedures should be developed to protect against inadvertent mixing of individual reports or segments thereof.
(7) The computerized medical data base should be online to the computer terminal only when authorized computer programs requiring the medical data are being used. Individuals and organizations external to the clinical facility should not be provided on-line access to a computerized data base containing identifiable data from medical records concerning patients. Access to the computerized data base should be controlled through security measures such as passwords, encryption (encoding) of information, and scannable badges or other user identification.
(8) Back-up systems and other mechanisms should be in place to prevent data loss and downtime as a result of hardware or software failure.
(9) Security:
(a) Stringent security procedures should be in place to prevent unauthorized access to computerbased patient records. Personnel audit procedures should be developed to establish a record in the event of unauthorized disclosure of medical data. Terminated or former employees in the data processing environment should have no access to data from the medical records concerning patients.
(b) Upon termination of computer services for a physician, those computer files maintained for the physician should be physically turned over to the physician. They may be destroyed (erased) only if it is established that the physician has another copy (in some form). In the event of file erasure, the computer service bureau should verify in writing to the physician that the erasure has taken place. (IV) Issued prior to April 1977; Updated June 1994 and June 1998.

5.09 CONFIDENTIALITY: INDUSTRY-EMPLOYED PHYSICIANS AND INDEPENDENT MEDICAL EXAMINERS.

Where a physician's services are limited to performing an isolated assessment of an individual's health or disability for an employer, business, or insurer, the information obtained by the physician as a result of such examinations is confidential and should not be communicated to a third party without the individual's prior written consent, unless required by law. If the individual authorized the release of medical information to an employer or a potential employer, the physician should release only that information which is reasonably relevant to the employer's decision regarding that individual's ability to perform the work required by the job.

When a physician renders treatment to an employee with a work-related illness or injury, the release of medical information to the employer as to the treatment provided may be subject to the provisions of worker's compensation laws. The physician must comply with the requirements of such laws, if applicable. However, the physician may not otherwise discuss the employee's health condition with the employer without the employee's consent or, in the event of the employee's incapacity, the appropriate proxy's consent.

Whenever statistical information about employees' health is released, all employee identities should be deleted. (IV)

Issued July 1983.

Updated June 1994; updated June 1996; updated December 1999 based on the report "Patient–Physician Relationship in the Context of Work-Related and Independent Medical Examinations," adopted June 1999.

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6.00 • Opinions on Fees and Charges

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6.11 COMPETITION. Competition between and among physicians and other health care practitioners on the basis of competitive factors such as quality of services, skill, experience, miscellaneous conveniences offered to patients, credit terms, fees charged, etc., is not only ethical but is encouraged. Ethical medical practice thrives best under free market conditions when prospective patients have adequate information and opportunity to choose freely between and among competing physicians and alternate systems of medical care. (VII)

Issued July 1983.

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8.00 • Opinions on Practice Matters

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8.0315 MANAGING CONFLICTS OF INTEREST IN THE

CONDUCT OF CLINICAL TRIALS. As the biotechnology and pharmaceutical industries continue to expand research activities and funding of clinical trials, and as increasing numbers of physicians both within and outside academic health centers become involved in partnerships with industry to perform these activities, greater safeguards against conflicts of interest are needed to ensure the integrity of the research and to protect the welfare of human subjects. Physicians should be mindful of the conflicting roles of investigator and clinician and of the financial conflicts of interest that arise from incentives to conduct trials and to recruit subjects. In particular, physicians involved in clinical research should heed the following guidelines: (1) Physicians should agree to participate as investigators in clinical trials only when it relates to their scope of practice and area of medical expertise. They should have adequate training in the conduct of research and should participate only in protocols which they are satisfied are scientifically sound. (2) Physicians should be familiar with the ethics of research, and should agree to participate in trials only if they are satisfied that an Institutional Review Board has reviewed the protocol, that the research does not impose undue risks upon research subjects, and that the research conforms to government regulations. (3) When a physician has treated or continues to treat a patient who is eligible to enroll as a subject in a clinical trial that the physician is conducting, the informed consent process must differentiate between the physician's roles as clinician and investigator. This is best achieved when someone other than the treating physician obtains the participant's informed consent to participate in the trial. This individual should be protected from the pressures of financial incentives, as described in the following section. (4) Any financial compensation received from trial sponsors must be commensurate with the efforts of the physician performing the research. Financial compensation should be at fair market value and the rate of compensation per patient should not vary according to the volume of subjects enrolled by the physician, and should meet other existing legal requirements. Furthermore, according to Opinion 6.03, "Fee Splitting: Referral to Health Care Facilities," it is unethical for physicians to accept payment solely for referring patients to research studies. (5) Physicians should ensure that protocols include provisions for the funding of subjects' medical care in the event of complications associated with the research. Also, a physician should not bill a third-party payor when he or she has received funds from a sponsor to cover the additional expenses related to conducting the trial. (6) The nature and source of funding and financial incentives offered to the investigators must be disclosed to a potential participant as part of the informed consent process. Disclosure to participants also should include information on uncertainties that may exist regarding funding of treatment for possible complications that may arise during the course of the trial. Physicians should ensure that such disclosure is included in any written informed consent. (7) When entering into a contract to perform research, physicians should ensure themselves that the presentation or publication of results will not be unduly delayed or otherwise obstructed by the sponsoring company. (II, V)

Issued June 2001 based on the report "Managing Conflicts of Interest in the Conduct of Clinical Trials," adopted December 2000 (JAMA. 2002; 287: 78–84).

8.061 GIFTS TO INDUSTRY FROM PHYSICIANS. Many gifts given to physicians by companies in the pharmaceutical, device, and medical equipment industries serve an important and socially beneficial function. For example, companies have long provided funds for educational seminars and conferences. However, there has been growing concern about certain gifts from industry to physicians. Some gifts that reflect customary practices of industry may not be consistent with the Principles of Medical Ethics. To avoid the acceptance of inappropriate gifts, physicians should observe the following guidelines: (1) Any gifts accepted by physicians individually should primarily entail a benefit to patients and should not be of substantial value. Accordingly, textbooks, modest meals, and other gifts are appropriate if they serve a genuine educational function. Cash payments should not be accepted. The use of drug samples for personal or family use is permissible as long as these practices do not interfere with patient access to drug samples. It would not be acceptable for nonretired physicians to request free pharmaceuticals for personal use or use by family members. (2) Individual gifts of minimal value are permissible as long as the gifts are related to the physician's work (e.g., pens and notepads). (3) The Council on Ethical and Judicial Affairs defines a legitimate "conference" or "meeting" as any activity, held at an appropriate location, where(a) the gathering is primarily dedicated, in both time and effort, to promoting objective scientific and educational activities and discourse (one or more educational presentation(s) should be the highlight of the gathering), and (b) the main incentive for bringing attendees together is to further their knowledge on the topic(s) being presented. An appropriate disclosure of financial support or conflict of interest should be made. (4) Subsidies to underwrite the costs of continuing medical education conferences or professional meetings can contribute to the improvement of patient care and therefore are permissible. Since the giving of a subsidy directly to a physician by a company's representative may create a relationship that could influence the use of the company's products, any subsidy should be accepted by the conference's sponsor who in turn can use the money to reduce the conference's registration fee. Payments to defray the costs of a conference should not be accepted directly from the company by the physicians attending the conference. (5) Subsidies from industry should not be accepted directly or indirectly to pay for the costs of travel, lodging, or other personal expenses of physicians attending conferences or meetings, nor should subsidies be accepted to compensate for the physicians' time. Subsidies for hospitality should not be accepted outside of modest meals or social events held as a part of a conference or meeting. It is appropriate for faculty at conferences or meetings to accept reasonable honoraria and to accept reimbursement for reasonable travel, lodging, and meal expenses. It is also appropriate for consultants who provide genuine services to receive reasonable compensation and to accept reimbursement for reasonable travel, lodging, and meal expenses. Token consulting or advisory arrangements cannot be used to justify the compensation of physicians for their time or their travel, lodging, and other out-of-pocket expenses. (6) Scholarship or other special funds to permit medical students, residents, and fellows to attend carefully selected educational conferences may be permissible as long as the selection of students, residents, or fellows who will receive the funds is made by the academic or training institution. Carefully selected educational conferences are generally defined as the major educational, scientific or policy-making meetings of national, regional, or specialty medical associations. (7) No gifts should be accepted if there are strings attached. For example, physicians should not accept gifts if they are given in relation to the physician's prescribing practices. In addition, when companies underwrite medical conferences or lectures other than their own, responsibility for and control over the selection of content, faculty, educational methods, and materials should belong to the organizers of the conferences or lectures. (II)

Issued June 1992 based on the report "Gifts to Physicians from Industry," adopted December 1990 (JAMA. 1991; 265: 501)

Updated June 1996 and June 1998.

8.08 INFORMED CONSENT. The patient's right of self-decision can be effectively exercised only if the patient possesses enough information to enable an intelligent choice. The patient should make his or her own determination on treatment. The physician's obligation is to present the medical facts accurately to the patient or to the individual responsible for the patient's care and to make recommendations for management in accordance with good medical practice. The physician has an ethical obligation to help the patient make choices from among the therapeutic alternatives consistent with good medical practice. Informed consent is a basic social policy for which exceptions are permitted: (1) where the patient is unconscious or otherwise incapable of consenting and harm from failure to treat is imminent; or(2) when risk-disclosure poses such a serious psychological threat of detriment to the patient as to be medically contraindicated. Social policy does not accept the paternalistic view that the physician may remain silent because divulgence might prompt the patient to forego needed therapy. Rational, informed patients should not be expected to act uniformly, even under similar circumstances, in agreeing to or refusing treatment. (I, II, III, IV, V)

Issued March 1981.

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8.11 NEGLECT OF PATIENT. Physicians are free to choose whom they will serve. The physician should, however, respond to the best of his or her ability in cases of emergency where first aid treatment is essential. Once having undertaken a case, the physician should not neglect the patient. (I, VI)

Issued prior to April 1977.

Updated June 1996.

8.12 PATIENT INFORMATION. It is a fundamental ethical requirement that a physician should at all times deal honestly and openly with patients. Patients have a right to know their past and present medical status and to be free of any mistaken beliefs concerning their conditions. Situations occasionally occur in which a patient suffers significant medical complications that may have resulted from the physician's mistake or judgment. In these situations, the physician is ethically required to inform the patient of all the facts necessary to ensure understanding of what has occurred. Only through full disclosure is a patient able to make informed decisions regarding future medical care.

Ethical responsibility includes informing patients of changes in their diagnoses resulting from retrospective review of test results or any other information. This obligation holds even though the patient's medical treatment or therapeutic options may not be altered by the new information.

Concern regarding legal liability which might result following truthful disclosure should not affect the physician's honesty with a patient. (I, II, III, IV)

Issued March 1981.

Updated June 1994.

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8.14 SEXUAL MISCONDUCT IN THE PRACTICE OF MEDICINE. Sexual contact that occurs concurrent with the physician–patient relationship constitutes sexual misconduct. Sexual or romantic interactions between physicians and patients detract from the goals of the physician–patient relationship, may exploit the vulnerability of the patient, may obscure the physician's objective judgment concerning the patient's health care, and ultimately may be detrimental to the patient's well-being.

If a physician has reason to believe that non-sexual contact with a patient may be perceived as or may lead to sexual conduct, then he or she should avoid the non-sexual contact. At a minimum, a physician's ethical duties include terminating the physician–patient relationship before initiating a dating, romantic, or sexual relationship with a patient.

Sexual or romantic relationships between a physician and a former patient may be unduly influenced by the previous physician–patient relationship. Sexual or romantic relationships with former patients are unethical if the physician uses or exploits trust, knowledge, emotions, or influence derived from the previous professional relationship. (I, II, IV)

Issued December 1986.

Updated March 1992 based on the report "Sexual Misconduct in the Practice of Medicine," issued December 1990. (JAMA. 1991; 266: 2741–2745)

8.15 SUBSTANCE ABUSE. It is unethical for a physician to practice medicine while under the influence of a controlled substance, alcohol, or other chemical agents which impair the ability to practice medicine. (I)

Issued December 1986.

8.181 PERFORMING PROCEDURES ON THE NEWLY DE

CEASED FOR TRAINING PURPOSES. Physicians should work to develop institutional policies that address the practice of performing procedures on the newly deceased for purposes of training. Any such policy should ensure that the interests of all the parties involved are respected under established and clear ethical guidelines. Such policies should consider rights of patients and their families, benefits to trainees and society, as well as potential harm to the ethical sensitivities of trainees, and risks to staff, the institution, and the profession associated with performing procedures on the newly deceased without consent. The following considerations should be addressed before medical trainees perform procedures on the newly deceased:

The teaching of life-saving skills should be the culmination of a structured training sequence, rather than relying on random opportunities. Training should be performed under close supervision, in a manner and environment that takes into account the wishes and values of all involved parties.
Physicians should inquire whether the deceased individual had expressed preferences regarding handling of the body or procedures performed after death. In the absence of previously expressed preferences, physicians should obtain permission from the family before performing such procedures. When reasonable efforts to discover previously expressed preferences of the deceased or to find someone with authority to grant permission for the procedure have failed, physicians must not perform procedures for training purposes on the newly deceased patient.

In the event post-mortem procedures are undertaken on the newly deceased, they must be recorded in the medical record. (I, V)

Issued December 2001 based on the report "Performing Procedures on the Newly Deceased for Training Purposes," adopted June 2001.

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9.00 • Opinions on Professional Rights and Responsibilities

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9.031 REPORTING IMPAIRED, INCOMPETENT, OR UNETHICAL COLLEAGUES. Physicians have an ethical obligation to report impaired, incompetent, and unethical colleagues in accordance with the legal requirements in each state and assisted by the following guidelines:

Impairment. Impairment should be reported to the hospital's in-house impairment program, if available. Otherwise, either the chief of an appropriate clinical service or the chief of the hospital staff should be alerted. Reports may also be made directly to an external impaired physician program. Practicing physicians who do not have hospital privileges should be reported directly to an impaired physician program, such as those run by medical societies, when appropriate. If none of these steps would facilitate the entrance of the impaired physician into an impairment program, then the impaired physician should be reported directly to the state licensing board.

Incompetence. Initial reports of incompetence should be made to the appropriate clinical authority who would be empowered to assess the potential impact on patient welfare and to facilitate remedial action. The hospital peer review body should be notified where appropriate. Incompetence which poses an immediate threat to the health of patients should be reported directly to the state licensing board. Incompetence by physicians without a hospital affiliation should be reported to the local or state medical society and/or the state licensing or disciplinary board.

Unethical conduct. With the exception of incompetence or impairment, unethical behavior should be reported in accordance with the following guidelines:

Unethical conduct that threatens patient care or welfare should be reported to the appropriate authority for a particular clinical service. Unethical behavior which violates state licensing provisions should be reported to the state licensing board or impaired physician programs, when appropriate. Unethical conduct which violates criminal statutes must be reported to the appropriate law enforcement authorities. All other unethical conduct should be reported to the local or state medical society.

Where the inappropriate behavior of a physician continues despite the initial report(s), the reporting physician should report to a higher or additional authority. The person or body receiving the initial report should notify the reporting physician when appropriate action has been taken. Physicians who receive reports of inappropriate behavior have an ethical duty to critically and objectively evaluate the reported information and to assure that identified deficiencies are either remedied or further reported to a higher or additional authority. Anonymous reports should receive appropriate review and confidential investigation. Physicians who are under scrutiny or charge should be protected by the rules of confidentiality until such charges are proven or until the physician is exonerated. (II)

Issued March 1992 based on the report "Reporting Impaired, Incompetent, or Unethical Colleagues," adopted December 1991 (J Miss St Med Assoc. 1992; 33: 176–77).

Updated June 1994 and June 1996.

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9.035 GENDER DISCRIMINATION IN THE MEDICAL PROFESSION. Physician leaders in medical schools and other medical institutions should take immediate steps to increase the number of women in leadership positions as such positions become open. There is already a large enough pool of female physicians to provide strong candidates for such positions. Also, adjustments should be made to ensure that all physicians are equitably compensated for their work. Women and men in the same specialty with the same experience and doing the same work should be paid the same compensation.

Physicians in the workplace should actively develop the following: (1) Retraining or other programs which facilitate the reentry of physicians who take time away from their careers to have a family; (2) On-site child care services for dependent children; (3) Policies providing job security for physicians who are temporarily not in practice due to pregnancy or family obligations.

Physicians in the academic medical setting should strive to promote the following: (1) Extension of tenure decisions through "stop the clock" programs, relaxation of the seven year rule, or part-time appointments that would give faculty members longer to achieve standards for promotion and tenure; (2) More reasonable guidelines regarding the appropriate quantity and timing of published material needed for promotion or tenure that would emphasize quality over quantity and that would encourage the pursuit of careers based on individual talent rather than tenure standards that undervalue teaching ability and overvalue research; (3) Fair distribution of teaching, clinical, research, administrative responsibilities, and access to tenure tracks between men and women. Also, physicians in academic institutions should consider formally structuring the mentoring process, possibly matching students or faculty with advisors through a fair and visible system.

Where such policies do not exist or have not been followed, all medical workplaces and institutions should create strict policies to deal with sexual harassment. Grievance committees should have broad representation of both sexes and other groups. Such committees should have the power to enforce harassment policies and be accessible to those persons they are meant to serve.

Grantors of research funds and editors of scientific or medical journals should consider blind peer review of grant proposals and articles for publication to help prevent bias. However, grantors and editors will be able to consider the author's identity and give it appropriate weight. (II, VII)

Issued June 1994 based on the report "Gender Discrimination in the Medical Profession," issued June 1993. (Women's Health Issues. 1994; 4:1–11)

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9.045 PHYSICIANS WITH DISRUPTIVE BEHAVIOR. This Opinion is limited to the conduct of individual physicians and does not refer to physicians acting as a collective, which is considered separately in Opinion9.025, "Collective Action and Patient Advocacy." (1) Personal conduct, whether verbal or physical, that negatively affects or that potentially may negatively affect patient care constitutes disruptive behavior. (This includes but is not limited to conduct that interferes with one's ability to work with other members of the health care team.) However, criticism that is offered in good faith with the aim of improving patient care should not be construed as disruptive behavior. (2) Each medical staff should develop and adopt bylaw provisions or policies for intervening in situations where a physician's behavior is identified as disruptive. The medical staff bylaw provisions or policies should contain procedural safeguards that protect due process. Physicians exhibiting disruptive behavior should be referred to a medical staff wellness—or equivalent—committee. (3) In developing policies that address physicians with disruptive behavior, attention should be paid to the following elements: (a) Clearly stating principal objectives in terms that ensure high standards of patient care and promote a professional practice and work environment. (b) Describing the behavior or types of behavior that will prompt intervention. (c) Providing a channel through which disruptive behavior can be reported and appropriately recorded. A single incident may not be sufficient for action, but each individual report may help identify a pattern that requires intervention. (d) Establishing a process to review or verify reports of disruptive behavior. (e) Establishing a process to notify a physician whose behavior is disruptive that a report has been made, and providing the physician with an opportunity to respond to the report. (f) Including means of monitoring whether a physician's disruptive conduct improves after intervention. (g) Providing for evaluative and corrective actions that are commensurate with the behavior, such as self-correction and structured rehabilitation. Suspension of responsibilities or privileges should be a mechanism of final resort. Additionally, institutions should consider whether the reporting requirements of Opinion 9.031, "Reporting Impaired, Incompetent, or Unethical Colleagues," apply in particular cases. (h) Identifying which individuals will be involved in the various stages of the process, from reviewing reports to notifying physicians and monitoring conduct after intervention. (i) Providing clear guidelines for the protection of confidentiality. (j) Ensuring that individuals who report physicians with disruptive behavior are duly protected. (I, II, VIII)

Issued December 2000 based on the report "Physicians With Disruptive Behavior," adopted June 2000.

9.065 CARING FOR THE POOR. Each physician has an obligation to share in providing care to the indigent. The measure of what constitutes an appropriate contribution may vary with circumstances such as community characteristics, geographic location, the nature of the physician's practice and specialty, and other conditions. All physicians should work to ensure that the needs of the poor in their communities are met. Caring for the poor should be a regular part of the physician's practice schedule.

In the poorest communities, it may not be possible to meet the needs of the indigent for physicians' services by relying solely on local physicians. The local physicians should be able to turn for assistance to their colleagues in prosperous communities, particularly those in close proximity.

Physicians are meeting their obligation, and are encouraged to continue to do so, in a number of ways such as seeing indigent patients in their offices at no cost or at reduced cost, serving at freestanding or hospital clinics that treat the poor, and participating in government programs that provide health care to the poor. Physicians can also volunteer their services at weekend clinics for the poor and at shelters for battered women or the homeless.

In addition to meeting their obligations to care for the indigent, physicians can devote their energy, knowledge, and prestige to designing and lobbying at all levels for better programs to provide care for the poor. (I, VII)

Issued June 1994 based on the report "Caring for the Poor," issued December 1992. (JAMA. 1993; 269: 2533–2537)

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9.115 ETHICS CONSULTATIONS. Ethics consultations may be called to clarify ethical issues without reference to a particular case, facilitate discussion of an ethical dilemma in a particular case, or resolve an ethical dispute. The consultation mechanism may be through an ethics committee, a subset of the committee, individual consultants, or consultation teams. The following guidelines are offered with respect to these services: (1) All hospitals and other health care institutions should provide access to ethics consultation services. Health care facilities without ethics committees or consultation services should develop flexible, efficient mechanisms of ethics review that divide the burden of committee functioning among collaborating health care facilities.(2) Institutions offering ethics consultation services must appreciate the complexity of the task, recognizing the potential for harm as well as benefit, and act responsibly. This includes true institutional support for the service. (3) Ethics consultation services require a serious investment of time and effort by the individuals involved. Members should include either individuals with extensive formal training and experience in clinical ethics or individuals who have made a substantial commitment over several years to gain sufficient knowledge, skills, and understanding of the complexity of clinical ethics. A wide variety of background training is preferable, including such fields as philosophy, religion, medicine, and law. (4) Explicit structural standards should be developed and consistently followed. These should include developing a clear description of the consultation service's role and determining which types of cases will be addressed, how the cases will be referred to the service, whether the service will provide recommendations or simply function as a forum for discussion, and whether recommendations are binding or advisory. (5) Explicit procedural standards should be developed and consistently followed. These should include establishing who must be involved in the consultation process and how notification, informed consent, confidentiality and case write-ups will be handled. (6) In general, patient and staff informed consent may be presumed for ethics consultation. However, patients and families should be given the opportunity, not to participate in discussions either formally, through the institutional process, or informally. (7) In those cases where the patient or family has chosen not to participate in the consultation process, the final recommendations of the consultant(s) should be tempered.(8) In general, ethics consultation services, like social services, should be financed by the institution. (9) A consultation service should be careful not to take on more than it can handle, ie, the complexity of the role should correspond to the level of sophistication of the service and the resources it has available. As a result, some services may offer only information and education, others a forum for discussion but not advice, others might serve a mediation role, and some might handle even administrative or organizational ethics issues. (IV, V)

Issued June 1998 based on the report "Ethics Consultation," adopted December 1997.

9.121 RACIAL DISPARITIES IN HEALTH CARE. Disparities in medical care based on immutable characteristics such as race must be avoided. Whether such disparities in health care are caused by treatment decisions, differences in income and education, sociocultural factors, or failures by the medical profession, they are unjustifiable and must be eliminated. Physicians should examine their own practices to ensure that racial prejudice does not affect clinical judgment in medical care. (I, IV)

Issued March 1992 based on the report "Black-White Disparities in Health Care," issued December 1989. (JAMA. 1990; 263: 2344–2346)

Updated June 1994.

9.122 GENDER DISPARITIES IN HEALTH CARE. A patient's gender plays an appropriate role in medical decisionmaking when biological differences between the sexes are considered. However, some data suggest that gender bias may be playing a role in medical decisionmaking. Social attitudes, including stereotypes, prejudices and other evaluations based on gender role expectations may play themselves out in a variety of subtle ways. Physicians must ensure that gender is not used inappropriately as a consideration in clinical decisionmaking. Physicians should examine their practices and attitudes for influence of social or cultural biases which could be inadvertently affecting the delivery of medical care.

Research on health problems that affect both genders should include male and female subjects, and results of medical research done solely on males should not be generalized to females without evidence that results apply to both sexes. Medicine and society in general should ensure that resources for medical research should be distributed in a manner which promotes the health of both sexes to the greatest extent possible. (I, IV)

Issued March 1992 based on the report "Gender Disparities in Clinical Decisionmaking," issued December 1990. (JAMA. 1991; 266: 559–562)

Updated June 1994.

9.13 PHYSICIANS AND INFECTIOUS DISEASES. A physician who knows that he or she has an infectious disease, which if contracted by the patient would pose a significant risk to the patient, should not engage in any activity that creates a significant risk of transmission of that disease to the patient. The precautions taken to prevent the transmission of a contagious disease to a patient should be appropriate to the seriousness of the disease and must be particularly stringent in the case of a disease that is potentially fatal. (I, IV)

Issued August 1989.

Updated June 1996 and June 1999.

9.131 HIV-INFECTED PATIENTS AND PHYSICIANS. A physician may not ethically refuse to treat a patient whose condition is within the physician's current realm of competence solely because the patient is seropositive for HIV. Persons who are seropositive should not be subjected to discrimination based on fear or prejudice.

When physicians are unable to provide the services required by an HIV-infected patient, they should make appropriate referrals to those physicians or facilities equipped to provide such services.

A physician who knows that he or she is seropositive should not engage in any activity that creates a significant risk of transmission of the disease to others. A physician who has HIV disease or who is seropositive should consult colleagues as to which activities the physician can pursue without creating a risk to patients. (I, II, IV)

Issued March 1992 based on the report "Ethical Issues in the Growing AIDS Crisis," adopted December 1987 (JAMA. 1988; 259: 1360–1361).

Updated June 1996 and June 1998.

E-10.01 FUNDAMENTAL ELEMENTS OF THE PATIENT–

PHYSICIAN RELATIONSHIP. From ancient times, physicians have recognized that the health and well-being of patients depends upon a collaborative effort between physician and patient. Patients share with physicians the responsibility for their own health care. The patient–physician relationship is of greatest benefit to patients when they bring medical problems to the attention of their physicians in a timely fashion, provide information about their medical condition to the best of their ability, and work with their physicians in a mutually respectful alliance. Physicians can best contribute to this alliance by serving as their patients' advocate and by fostering these rights:

The patient has the right to receive information from physicians and to discuss the benefits, risks, and costs of appropriate treatment alternatives. Patients should receive guidance from their physicians as to the optimal course of action. Patients are also entitled to obtain copies or summaries of their medical records, to have their questions answered, to be advised of potential conflicts of interest that their physicians might have, and to receive independent professional opinions.
The patient has the right to make decisions regarding the health care that is recommended by his or her physician. Accordingly, patients may accept or refuse any recommended medical treatment.
The patient has the right to courtesy, respect, dignity, responsiveness, and timely attention to his or her needs.
The patient has the right to confidentiality. The physician should not reveal confidential communications or information without the consent of the patient, unless provided for by law or by the need to protect the welfare of the individual or the public interest.
The patient has the right to continuity of health care. The physician has an obligation to cooperate in the coordination of medically indicated care with other health care providers treating the patient. The physician may not discontinue treatment of a patient as long as further treatment is medically indicated, without giving the patient reasonable assistance and sufficient opportunity to make alternative arrangements for care.
The patient has a basic right to have available adequate health care. Physicians, along with the rest of society, should continue to work toward this goal. Fulfillment of this right is dependent on society providing resources so that no patient is deprived of necessary care because of an inability to pay for the care. Physicians should continue their traditional assumption of a part of the responsibility for the medical care of those who cannot afford essential health care. Physicians should advocate for patients in dealing with third parties when appropriate.

Issued June 1992 based on the report, "Fundamental Elements of the Patient-Physician Relationship," adopted June 1990; Updated 1993.

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E10.015 THE PATIENT–PHYSICIAN RELATIONSHIP. The practice of medicine, and its embodiment in the clinical encounter between a patient and a physician, is fundamentally a moral activity that arises from the imperative to care for patients and to alleviate suffering.

A patient–physician relationship exists when a physician serves a patient's medical needs, generally by mutual consent between physician and patient (or surrogate). In some instances the agreement is implied, such as in emergency care or when physicians provide services at the request of the treating physician. In rare instances, treatment without consent may be provided under court order (see Opinion 2.065). Nevertheless, the physician's obligations to the patient remain intact.

The relationship between patient and physician is based on trust and gives rise to physicians' ethical obligations to place patients' welfare above their own self-interest and above obligations to other groups, and to advocate for their patients' welfare.

Within the patient-physician relationship, a physician is ethically required to use sound medical judgment, holding the best interests of the patient as paramount.

Issued December 2001 based on the report "The Patient–Physician Relationship," adopted June 2001.

Encyclopedia of Bioethics