Codes of Conduct and Ethics Guidelines
CODES OF CONDUCT AND ETHICS GUIDELINES
Rules of conduct or ethical codes are often considered to be characteristic of professions, as opposed to craft and trade associations. They are particularly common within health care professions, where they set guidelines for how professionals should act in dealings with their patients and with each other in clinical care, in public health or epidemiological studies, and in experimental studies involving animals, humans, and social or population groups.
PURPOSES OF CODES AND GUIDELINES
Rules of conduct are enforced through ethics or professional conduct committees, which can impose sanctions such as withdrawal or suspension of professional group membership or of licenses to practice. They can also require practitioners to make reparations to those they have treated in breach of a code or to undertake instruction in professional ethics. Codes of conduct or ethics are becoming more widely adopted as various organizations seek to assure the public that their members are required to adhere to ethical practices. Health care professions, however, can also invoke the legacy of the physicians' historic Hippocratic Oath to show that ethical conduct is the very foundation of their practice. Professionals and their interest groups have an incentive to develop ethical codes or guidelines to dissuade legislators from enacting more rigid, legally enforceable, and punitive laws.
The ethical principles that underlie codes of conduct and ethics guidelines are beneficence, or the duty to do good; nonmaleficence, or the duty to do no harm; and the principle of justice. The principle of justice is popularly seen to be based on punitive or corrective justice, demonstrated in the liability of offenders against an institution's code to forfeit their membership or professional status and to make good the wrongs they have done. Another aspect of justice requires that like cases be treated alike, demonstrated in the expectation that those bound by the same code will observe the same standards of conduct and integrity.
Codes may also be prepared in order to require and facilitate adherence to a religious, spiritual, or philosophical tradition. For instance, membership in the Catholic Hospital Association, which is affiliated with the Roman Catholic Church, requires hospital administrations to adhere to Church teaching on such matters as nonperformance of abortions and sterilization procedures. The association may also limit the recruitment or promotion of divorced applicants to certain offices, based on the Church's views on divorce and local laws on hospital discrimination on the basis of marital status.
CODES, GUIDELINES, AND
Codes of conduct and ethics guidelines that are prepared in order to standardize behavior within a profession or among practitioners of an occupation may relate to preexisting practice in various ways. Some guidelines may codify longstanding and approved practices, which are formally established to guard against dangers of laxity and changes in practice. For instance, it is a common rule that professionals not practice in collaboration with related commercial product manufacturers or service suppliers. Thus, physicians cannot participate in the profits of pharmacists who fill the prescriptions they write for their patients. This prevents vertical integration of business interests that might otherwise occur, and also protects patients against physicians having a conflict of interest that may lead them to over prescribe medications or prescribe unnecessary or unduly costly medications.
The celebrated Nuremberg Code, which addresses medical experimentation with human subjects, was adopted by the International War Crimes Tribunal in 1947, after the Second World War. Its function was to restore the standards of research integrity in studies of human subjects, which had been grossly violated by physicians tried and condemned by the tribunal, and to protect vulnerable persons in such studies. The code incorporates the most basic ethical standards of conduct, which were drawn from the research guidelines of many countries, including prewar Germany.
Sometimes codes and guidelines are established to change preexisting practices, either to remedy faults or to keep practices or earlier codes up-to-date. For instance, in 1964 the World Medical Association adopted its Declaration of Helsinki, which deals with biomedical research involving human subjects. The purpose was to update and expand the Nuremberg Code, which addressed only the medical research outrages and inhumanities committed against powerless detainees of concentration camps under the Nazi administration. As such, the Nuremberg Code was so narrowly directed that it would have made much necessary, humanely conducted, and ethically conducted research impossible. For instance, the 1947 code provides only that "the voluntary consent of the human subject is absolutely essential," and that "the person involved should have legal capacity to give consent." These provisions omit and might seem to preclude research to advance health care for children, mentally impaired persons or unconscious head-injury patients. Research of this nature satisfies scientific standards only when such persons themselves are studied. The Helsinki Declaration proposed ethical guidelines under which such studies could be scientifically conducted. Further, the 1964 Declaration was amended in 1975, 1983, 1989 and 1996, and remains under continuing review.
Some codes and guidelines aim not to change preexisting practices, but to codify them in accessible, comprehensible language, or to reform those that have become antiquated in light of conceptual or technological developments. A conceptual reform has occurred, for instance, because research guidelines used to exclude women of reproductive age from pharmaceutical and other studies of unproven products, on the ground that these studies might cause harm to embryos or fetuses such women had conceived. This exclusion has resulted in many women of reproductive age, including some who are pregnant, taking products that have never been tested for safety and efficacy on women who might be pregnant. In order to test products for safety and effectiveness in pregnancy, research guidelines now often require that women of reproductive age be included in studies, unless human experience or animal studies have shown that a product is likely to be harmful to pregnant women or their unborn children.
An earlier reconceptualization occurred in 1973 when the International Council of Nurses amended its Code for Nurses, originally adopted in 1953. The original code required a nurse's loyalty and obedience to the physician the nurse served, reflecting a culture of nursing dating to the time of Florence Nightingale, the founder of modern nursing. The code was amended in 1973, however, deleting this requirement and replacing it with a requirement of loyalty to the patient. Physicians, however, did not necessarily note any change in nurses' ethical priorities, including when physicians were members of nursing councils considering cases of nursing misconduct. This raised the unresolved issue of divided loyalties between physicians and patients, and whether the new concept should displace the earlier concept or coexist with it.
Codes that reflect a newer concept may also retain provisions that were part of earlier codes, and may not distinguish items that change earlier practice from items designed to maintain former practice. In this case a code may be understood only by exploring records of committee meetings or other discussions conducted while the code was being prepared, or by considering subsequent requests for clarification before tribunals such as institutional ethics review boards.
CODES, GUIDELINES, DECLARATIONS, AND PRINCIPLES
Documents designed to affect conduct have various names, which may indicate different purposes. A code may consolidate and systematize preexisting practices without changing them, or may prescribe new practices that differ from or supplement those in earlier codes. International documents tend not to be described as codes because in the legal tradition of continental Europe, which now extends into Central and South America and Africa, a code, such as the Code Napoléon, is a legally binding document. Similarly, in the United States, the code of Federal Regulations, Title 45, Part 46 of which governs protection of human subjects of research, is legally enacted under authority of the Public Health Service Act. Documents called "guidelines" are usually understood to guide rather than to strictly govern practice. It is expected, however, that a deliberate departure from a guideline will have to be explained, and ethics review committees may say within what limits a departure is justifiable. For instance, many guidelines on ethical professional practice require that practitioners have no conflict of interests and serve patients with uncompromised loyalty. A conflict may arise, for instance, when a physician has a financial interest in a clinical laboratory to which a patient may be referred for testing. An alternative response to the prohibition of any conflict of interests, however, is that it be disclosed in advance to those seeking services. They may then decide for themselves whether or not to receive services. A client's knowing consent thus neutralizes an appearance of conflict.
Like a code, a "declaration" may articulate existing expectations, as was the case with the United Nations' Universal Declaration of Human Rights (1948). The Declaration of Helsinki, on the other hand, outlined principles intended for future application. It is, in fact, subtitled "Recommendations Guiding Physicians in Biomedical Research." It is, however, often applied quite strictly, and in some countries committees created according to its provisions are called "Helsinki committees." Inadequacies in the declaration are remedied by formal amendments, which may be the subject of intense reflection and debate.
Intergovernmental organizations whose agreements have no legally binding force in member countries may acknowledge this by naming their agreements "recommendations." The Council of Europe followed this practice, for instance, in its Recommendation Concerning Medical Research on Human Beings (1990), and in its Recommendation on Xenotransplantation (1997). The World Health Organization (WHO), however, whose conclusions on ethical practice are similarly unenforceable in member countries, usually describes its documents as guidelines, as in its Guidelines for Good Clinical Practice for Trials on Pharmaceutical Products (1999) and the Guidelines for the Promotion of Human Rights of Persons with Mental Disorders (1996). Similarly described are conclusions of the Council for International Organizations of Medical Sciences, jointly constituted by WHO and UNESCO, including its International Guidelines for Ethical Review of Epidemiological Studies (1991).
Documents intended to influence conduct are also classified as "principles," an example being the Council of Europe's Ad Hoc Committee of Experts on Bioethics' Principles in the Field of Human Artificial Procreation (1989); and "resolutions," which include the United Nations Commission on Human Rights' Resolution on Human Rights and Bioethics (1993 and 1997). These and other documents provide texts and concepts that are used in many ways: legislatures may embody them in law; funding agencies, universities, and hospitals may incorporate them into contracts for the funding of recipients, faculty members, and investigators; and ethics and discipline committees of professional and licensing authorities may refer to them in determining professional misconduct.
MINIMUM STANDARDS AND HIGHEST EXPECTATIONS
Codes and guidelines are used to establish common minimal standards of conduct that those bound by them must invariably observe. They also serve to improve standards to the highest attainable level and to demonstrate a profession's most worthy aspirations. A code used to determine professional misconduct will set a minimum acceptable standard, or a floor, and condemn any practice that falls short. In contrast, a code that sets an aspirational target, or ceiling, is meant to inspire people to aim high, while recognizing that achievements will usually be at a lower level.
Some associations that perceive the dual roles of codes and guidelines may clearly separate standards that serve different functions. For instance, the Australian Nursing Council has both a Code of Ethics, and a Code of Professional Conduct. The Code of Ethics serves the purposes of identifying the moral commitments of the profession, providing nurses with an elevated basis for professional reflection and a guide to ethical practice, and indicating to nurses and the community the values that inspire nursing practice. In contrast, the Code of Professional Conduct informs the profession and the public of the minimum standards of acceptable conduct and provides licensing, disciplinary, and other bodies with a basis for decisions regarding nursing misconduct.
Bernard M. Dickens
(see also: Adherence or Compliance Behavior; Ethics of Public Health; Hippocrates of Cos; Legal Liability of Public Health Officials; Legislation and Regulation; World Health Organization )
Bankowski, Z.; Bryant, J. H.; and Last, J. M., eds. (1991). Ethics and Epidemiology: International Guidelines. Geneva: CIOMS.
Bergel, S. D. (1997). "UNESCO Declaration on the Protection of the Human Genome." Law and the Human Genome Review 7:31–57.
Fluss, S. S. (1999). "International Guidelines on Bioethics." The EFGCP (European Forum for Good Clinical Practice) News December Supplement.
Fluss, S. S.; Simon, F.; and Gutteridge, F. (1991). "Development of International Ethical Guidelines for Epidemiological Research and Practice." Ethics and Epidemiology: International Guidelines, eds. Z. Bankowski, J. H. Bryant, and J. M. Last. Geneva: CIOMS.
Glantz, L. H. (1992). "The Influence of the Numbering Code on U.S. Statutes and Regulations." The Nazi Doctors and the Nuremberg Code, eds. G. J. Annas and M. A. Grodin. New York and Oxford: Oxford University Press.
Redman, B. K. (1994). "Clinical Practice Guidelines as Tools of Public Policy: Conflicts of Purpose, Issues of Autonomy, and Justice." Journal of Clinical Ethics 5:303–309.
Sutherland, H. J.; Meslin, M.; and Till, J. E. (1994). "What's Missing from Current Clinical Trial Guidelines? A Framework for Integrating Science Ethics, and the Community Context." Journal of Clinical Ethics 5:297–302.
The World Medical Association, Handbook of Declarations (1996). France: Ferney-Voltaire.
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