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Abstract

A code of conduct is a set of rules that guide the conduct of individuals who are members of a particular profession, institution or group. This entry focuses on codes of conduct that relate to professionals in the two main areas that deal with human life; healthcare and human health research. The entry discusses the development of codes of conduct in health and highlights present day codes that guide the conduct of professionals involved in health care and health research. Codes apply to three main parties namely professional associations or institutions, professionals who provide a service and the citizens. To each of these parties, the code of conduct holds a different meaning. Whilst there are numerous codes that have been issued by institutions and national authorities or professional associations involved in healthcare and health research, this entry mainly discusses codes that are international in scope including the World Medical Association (WMA) Declaration of Geneva, World Medical Association’s International Code of Medical Ethics, UNESCO Declaration on Bioethics and Human Rights, Nuremberg Code, Declaration of Helsinki, CIOMS Guidelines and the ICH Good Clinical Practice Guidelines. The majority of these codes relate mainly to professionals and hence fall under the category of professional ethics codes, while the Declaration on Bioethics and Human Rights relates to all persons and hence it is an applied ethics code.

Introduction

The serious abuses of human beings by fellow humans in the medical professions during the last century have played a signiﬁcant role in shaping present-day professional norms, standards and requirements. Previous abuses during the eighteenth and nineteenth centuries had resulted in the enactment of legislations aimed at protecting research participants. Such legislations included the Prussian Directive of 1900 and the Reich Health Council Regulations of 1931 (Vollmann and Winau 1996). Before the twentieth century examples given, legislation was almost non-existent during the eighteenth and nineteenth centuries. The unethical experiments that were conducted by Nazi scientists during the Second World War led to the Nuremberg Trials, which questioned the conduct of the Nazi scientists as both medical practitioners and researchers. At the end of the Nuremberg trials the judgement that was passed, included statements about how professional medical practitioners and researchers are supposed to conduct themselves in dealing with human research participants. The statements that are now commonly referred to as Nuremberg Code of 1947 have since then, inﬂuenced professions in the healthcare sector in various ways. Firstly, the Nuremberg code led to the inclusion of a statement on voluntary participation in research in the Human Rights Charter of 1948. The Nuremberg code has also led to the rise of other medical codes that address how professions in the healthcare and research arena should conduct themselves (Baker 2014).

The Hippocratic Code of Ethics which is taken to be one of the ﬁrst codes of medical ethics, was written by Hippocrates, a Greek physician during the fourth century. The oath has been modiﬁed and adapted by numerous training institutions and medical associations over the years. The Hippocratic Oath was based on personal trust and self-regulation. Formal codes of conduct that are issued by groups and institutions gained momentum after the second world war, out of the realization that self-regulation and reliance on trust were not enough as clients can be abused by unscrupulous professional members. The trials that were held at Nuremberg after Second World War, helped to demonstrate to the world the need for professions to regulate themselves by way of codes. Codes of conduct complement laws that guide professionals in executing their responsibilities. Codes of conduct are about professionals taking responsibility for their own actions. In the area of bioethics, there are several international codes that relate to medical care and research. These include the Declaration of Geneva that was pronounced by the World Medical Association (WMA) in 1948. This was followed by the WMA International Declaration on Medical Ethics in 1949. In the area of research that deals with humans, important codes include the Nuremberg Code of 1947, the Declaration of Helsinki which was pronounced by the World Medical Assembly in 1964, the CIOMS Guidelines of 1982 as well as the Good Clinical Practice Guidelines of 1996.

Besides the international codes listed above, numerous codes of conduct have been developed by institutions and professions in recent times. Globally, the 1990s witnessed a signiﬁcant increase in issuing of codes of conduct by both institutions and professional associations as well as an insistence on corporate and professional responsibility (Somers 2001; Jenkins, and Unies 2001). These codes were developed within a changing global environment that witnessed a major shift in the roles of the states from being regulators to facilitators of economic and social development.. The growth of codes of conduct during this time, represented efforts to complement government regulation of professions with self-regulation using professional codes. As new healthcare professions were being established, they, themselves, established their own codes of ethics (self-regulation), as standards of good practice.

In present day, codes range from vague and ﬂexible declarations of principles applicable to a speciﬁc group or profession, to more substantive and rigorous efforts aimed at self-regulation by particular groups or professions. Codes of conduct may be taken as aggregative response by professions or institutions to a ﬁeld’s historical experiences. Various codes of conduct have been converted into laws that are enforceable.

Conceptual Clarification/Definition

A code of conduct is a set of rules outlining the responsibilities of, or proper practices for, an individual, a group or organization. A code of conduct can also be said to be a set of principles and expectations that are considered binding on individuals who are members of a particular group. Alternatively a code of conduct may be termed a code of ethics or a code of practice. Ethical obligations are central to the professional’s responsibility, if the profession is to maintain its reputation. In the area of health there are numerous codes, which are international, national, professional as well as institutional in scope. While this entry discusses issues concerning codes of conduct, much of the focus is on professional codes for healthcare professionals involved in the various health-related disciplines including those involved in health research. The entry also discusses the UNESCO Declaration, a bioethical code that addresses all citizens. Both health care professionals and health researchers aim to improve human health and deal with human beings. Healthcare professionals rely on tools and methods already established to be effective through research and innovation while researchers seek to establish better ways of improving human health. For both groups, there are laws and institutional policies that guide professional conduct in the various countries. Codes of conduct complement the legislations and policies.

Ethical Dimension

Any professional, more so those who deal with humans in both an indirect as well as direct manner, has an obligation to demonstrate actions that reﬂect values, ethical principles, and ethical obligations. Codes of conduct are there to assist the professionals in attaining high levels of competent and ethical conduct in the delivery of their duties or provision of service. By so doing, codes of conduct can be said to serve various purposes. Codes promote high standards of practice. Codes of conduct also provide ethical principles by which the general public can hold the professionals or institutions accountable. They identify core values on which the professional groups or institution’s mandate and mission are based. Codes summarize broad ethical principles that reﬂect the profession’s or institutions’ core values. Codes also establish a set of ethical principles to be used to guide decision-making and actions by the professionals or individuals afﬁliated with the institution. They establish a framework for professional behavior and responsibilities when professional obligations conﬂict or ethical uncertainties arise. Codes assist in the mentoring of new practitioners into the new ﬁeld by providing the mission, values, and ethical principles.

A code of conduct may include principles and guidelines that are both enforceable and aspirational. The extent to which principle are enforceable is a matter of professional judgment to be exercised by professional or institutional authorities responsible for reviewing alleged violations of ethical principles. A code of conduct is intended to be a central guide and reference for users in support of day-to-day decision making. It is meant to clarify an organization’s mission, values and principles, linking them with standards of professional conduct. A code is an open disclosure of the way an organization operates. It provides visible guidelines for expected conduct.

A well-written and thoughtful code also serves as an important communication vehicle that reﬂects the oath that an organization would have made to uphold its most important values, dealing with such matters as its commitment to employees, its standards for doing business and its relationship with the community. A code is also a tool to encourage discussions of ethics and to improve how employees or members deal with the ethical dilemmas, prejudices and gray areas that are encountered in everyday work. A code is meant to complement, relevant national or institutional policies and rules, not to substitute for them.

Codes of conduct offer an invaluable opportunity for responsible organizations to create a positive public identity for themselves which can lead to a more supportive political and regulatory environment and an increased level of public conﬁdence and trust among important constituencies and stakeholders. It is expected at a minimum that members within a profession, commit themselves to some basic standards of conduct. Professionals are expected to constantly strive to improve their professional knowledge and skills and are obligated to share their knowledge with fellow colleagues in order to improve their colleagues’ skills as a way of strengthening the profession. They are expected to perform their occupational duties and responsibilities with diligence, loyalty and faithfulness, in an objective, ethical and fair manner with the best interest of the client or patient and community as the ultimate goal.

Professional members are also expected to further the mission, goals and objectives of the profession or the institution and to maintain the conﬁdentiality of privileged information entrusted or known to them by virtue of any role they have as a result of their positions and professions. Members of professional bodies are not expected to disparage the work or conduct of colleagues or other members of the profession and should exercise vigilance in uncovering illegal or unethical conduct of fellow members and in reporting such conduct to higher authorities. They are expected to respect the dignity of all, the rights and beliefs of others, and do not discriminate against others because of race, gender, age or creed and to act with dignity, courtesy and respect in all dealings with clients and with society. Professional groupings do not expect their members to use their positions, ofﬁce or professional membership for selﬁsh personal or ﬁnancial gain.

Examples Of International Codes Of Conduct For Healthcare Professionals

While there are numerous codes of conduct that are relevant to the ﬁeld of Bioethics, this entry discusses a few codes that are international in scope and appeal including the WMA Declaration of Geneva and the WMA International Code of Medical Ethics. The two codes of conduct were issued by an organisation that is international in scope.

Declaration of Geneva: The Declaration of Geneva, also referred to as the Physician’s Oath was adopted by the General Assembly of the World Medical Association at Geneva in 1948. It was subsequently amended in 1968, 1983, 1994 and editorially revised in 2005 and 2006. In 1946, the WMA appointed a committee tasked with the responsibility to prepare a “Charter of Medicine” which could be adopted as an oath or promise that every doctor in the world would make upon receiving his medical degree or diploma. After 2 years of intensive deliberations, the committee came up with a draft that was sent for consideration at the WMA’s second general assembly in Geneva in 1948. The medical vow was adopted and the assembly agreed to name it the “Declaration of Geneva” (Williams 2008). This document was adopted by the World Medical Association only 3 months before the United Nations General Assembly adopted the Universal Declaration of Human Rights (1948) which provides for the security of the person.

The Declaration of Geneva is a declaration of a physician’s dedication to the humanitarian goals of medicine, and is particularly important in view of the medical crimes which had just been committed in Nazi Germany during the second world war which had just ended. During the post World War II era and immediately after its foundation, the WMA showed concern over the state of medical ethics in general and all over the world, taking the responsibility for setting ethical guidelines for physicians throughout the world. The atrocities committed by the Nazi physicians during the Second World War clearly demonstrated the need for reform, and for a relevant set of guidelines regarding the conduct of physicians, particularly following the United Nations Universal Declaration of Human Rights in 1948. The Declaration of Geneva was an effort aimed at revising the Hippocratic Oath to ensure that it could be understood and relevant in present day medicine.

At the time of being admitted as a member of the medical profession, using the Declaration of Geneva, physicians solemnly pledge to consecrate their lives to the service of humanity, to respect their seniors, to practice the profession with conscience and dignity, to ensure that the health of their patients will be their ﬁrst consideration. They also pledge to respect the secrets that are conﬁded in them even after the patient has died. They also pledge not to discriminate on the basis of age, disease or disability, creed, ethnic origin, gender, nationality, political afﬁliation, race, sexual orientation, social standing or any other factors and to maintain the utmost respect for human life; not to use will not use their medical knowledge to violate human rights and civil liberties, even under threat;

The WMA international Code of Medical Ethics: The code was Adopted by the 3rd General Assembly of the World Medical Association, London, England, October 1949 and amended by the 22nd World Medical Assembly Sydney, Australia, August 1968 and the 35th World Medical Assembly Venice, Italy, October 1983 and the WMA General Assembly, Pilanesberg, South Africa, October 2006. The International Code of Medical Ethics highlight the duties of a physician including the following among other duties: exercising independent professional judgment and maintaining the highest standards of professional conduct; respecting a competent patient’s right to accept or refuse treatment; providing competent medical service in full professional and moral independence, with compassion and respect for human dignity; and dealing honestly with patients and colleagues; avoiding conﬂict of interest.

The declaration also requires the following of physicians; respecting the rights and preferences of patients, colleagues, and other health professionals; using health care resources in the best way to beneﬁt patients and their community; respecting the local and national codes of ethics; respecting human life; acting in the patient’s best interest when providing medical care; respecting a patient’s right to conﬁdentiality; giving emergency care as a humanitarian duty unless he/she is assured that others are willing and able to give such care; not entering into a sexual relationship with his/her current patient or into any other abusive or exploitative relationship and respecting colleagues and not to undermine the patient-physician relationship of colleagues in order to attract patients. The provisions of this code have been adopted by various national medical associations and continue to guide physicians and other health care professionals such as nurses in their day to day dealings with patients (World Medical Association 1995).

An Example Of An International Bioethics Code

A bioethics Code applies to all citizens while professional codes mainly apply to professionals within a speciﬁc profession.

UNESCO Universal Declaration on Bioethics and Human Rights: In 2005, UNESCO 2005 adopted the Universal Declaration on Bioethics and Human Rights (Andorno 2007). This Declaration addresses ethical issues related to medicine, life sciences and associated technologies as applied to human beings, taking into account their social, legal and environmental dimensions. The aims of the Declaration include amongst others, to promote respect for human dignity and protect human rights, to guide the actions of individuals, groups, communities institutions and corporations (public and private), to recognize the importance of freedom of scientiﬁc research and the beneﬁts derived from scientiﬁc and technological developments, and to provide a universal framework of principles and procedures to guide States in the formulation of their legislation, policies or other instruments in the ﬁeld of bioethics.

The UNESCO Declaration calls on Member States to adhere to the following principles, among others: human dignity and human rights; maximizing beneﬁts and minimizing any possible harm to patients, research participants and other affected individuals in applying and advancing scientiﬁc knowledge, medical practice and associated technologies; respect for autonomy and individual responsibility even for people who are not capable of exercising autonomy where for such people special measures are to be taken to protect their rights and interests; respect for privacy and conﬁdentiality; promoting equality, justice and equity; and promoting non-discrimination and non-stigmatization.

Examples Of International Codes Of Conduct In Research Involving Human Beings

The important codes that are available at present in the area of research ethics are a direct response to abuses of research participants by researchers. This section highlights the important codes and documents. The above incidences (and others that have not been described here) serve as important milestones in bioethics in as much as they have raised the awareness of the world to the bad that scientists can do to unsuspecting subjects in the name of science. During the past 50 years the main sources of guidance on the ethical conduct of research have been the Nuremberg Code of 1947, Declaration of Helsinki initially issued in 1964, CIOMS International Guidelines for Biomedical Research Involving Human Subjects initially issued in 1982, and the International Conference on Harmonisation Good Clinical Practice Guidelines initially issued in 1996. It is evident that most of these documents were written in direct response to speciﬁc issues or events in order to avoid future similar scandals. By focusing on the instigating issues, the guidelines have tended to emphasize different ethical requirements. It is however important to note that although the events highlighted above occurred in different countries, settings and times, they have all contributed signiﬁcantly in the development of different international, national and institutional codes and regulations as they are today.

Nuremberg Code: The Nuremberg Code served as the ﬁrst set of principles outlining professional ethics for medical researchers. It was a part of the judicial decision issued by the Nuremberg Tribunal in 1947 condemning the atrocities committed by the Nazi physician. The ten points decision included the statement that a “voluntary consent of the human subject is absolutely essential” and further established that animal experimentation should precede human experimentation; all unnecessary physical and mental suffering and injury should be avoided; the degree of risk to the participants should never exceed the “humanitarian importance of the problem” and should be minimized through “proper preparations”; and that the participants should always be at liberty to withdraw from the experiments (Annas and Grodin, 1995). This set of points established the basic principles that must be observed in order to satisfy moral, ethical, and legal concepts in the conduct of human participant research. While the Nuremberg Code is not a real code in the right sense of the word, it has been the model for many professional and governmental codes since the 1950s, and has, in effect, served as the ﬁrst international standard for the conduct of research.

Declaration of Helsinki: The Declaration of Helsinki is the code issued in 1964 by the World Medical Association for the medical community in response to Nuremberg Trials. The new declaration was supposed to deal with the shortcomings of the Nuremberg Code and especially the issue of physicians who conduct research using their patients. After the Nuremberg trials, the WMA saw it ﬁt to come out with a code to guide its own members as a way of avoiding the recurrence of the atrocities committed by the Nazi scientists some of whom were physicians. The Declaration made an important distinction between therapeutic and non-therapeutic research and, like the Nuremberg Code, it made informed consent a central requirement for ethical research, but allowing for surrogate consent when the research participant is incompetent, physically or mentally incapable of giving consent, or a minor. The Declaration states that research with these groups should only be conducted when the research is necessary to promote the health of the population represented, and when this research cannot be performed on legally competent persons. The Declaration of Helsinki has been revised several times including at the 29th WMA General Assembly in Tokyo in 1975, 35th WMA General Assembly in Venice in 1983, the 41st WMA General Assembly in Hong Kong in 1989, the 48th WMA General Assembly in South Africa in 1996, the 52nd WMA General Assembly in Edinburgh, Scotland in 2000 and the 59th WMA General Assembly, Seoul, October 2008.

CIOMS Guidelines: The Council for International Organizations of Medical Sciences (CIOMS) Guidelines which came out in 1982 were an attempt to adapt the Declaration of Helsinki to developing country situations especially in view of the rise in the number of researches conducted in developing countries and sponsored by developed countries and it includes a section on the compensation of subjects. The CIOMS Guidelines were revised in 1993 and 2002 so as to reﬂect the changing research landscape as well as to address controversies that have emerged since 1982 when the guidelines were developed. The Guidelines continue to reﬂect the conditions and the needs of low-resource countries, and the implications for multinational or transnational research in which they may be partners. The 2002 version speciﬁcally discusses the following issues from a justice point of view: research in populations and communities with limited resources; choice of control in clinical trials; equitable distribution of burdens and beneﬁts in the selection of groups of subjects in research; research involving vulnerable persons; research involving children; research involving individuals who by reason of mental or behavioral disorders are not capable of giving adequately informed consent; women as research participants; pregnant women as research participants; ethical obligation of external sponsors to provide health-care services as well as other issues.

Good Clinical Practice Guidelines: Good clinical practice guidelines have assumed great importance in clinical trials of medicines. While the title Good Clinical Practice suggests that these guidelines have something to do with clinical practice, GCP is about clinical trials and some have suggested that it should be renamed Good Research Practice or at least Good Clinical Trial Practice. GCP is an international quality standard that was issued in 1996 by the International Conference on Harmonisation (ICH), an international body that deﬁnes standards, which governments can transpose into regulations for clinical trials involving human subjects. The ICH started its work in the early 1990s; and was a joint effort to develop a single set of guidelines on Good Clinical Practice (GCP) to ensure that data generated from clinical trials are mutually acceptable to regulatory authorities in the US, European Union and Japan and thus enable more efﬁcient licensing of new drugs in all participating countries.

GCP is now accepted internationally as a standard for the protection of safety and welfare of research participants as well as assurance of the quality and credibility of data. Some countries have now issued their own GCP guidelines which are based on the ICH GCP Guidelines. Good Clinical Practice Guidelines include standards on how clinical trials should be conducted; deﬁne the roles and responsibilities of clinical trial sponsors, clinical research investigators, and study monitors. Some governments have since adopted GCP into their legislations as a way of ensuring that the requirements of GCP are binding on the researchers. There are also numerous other useful guidance documents such as Good Laboratory Practice (GLP) which guide the laboratory aspects of clinical trials. Other organisations including professional bodies have issued good practice guidelines aimed at ensuring that their members conduct themselves using the highest ethical and professional standards.

Conclusion

Codes of conduct appeals to two main entities in a direct manner, namely the profession or professional association; and the professional as an individual. Codes of conduct also appeal to clients or citizens in an indirect way. Codes of conduct serve these entities in different ways including providing guidance to those who act on behalf of a profession or institution, providing standards that can be used in judging performance and protecting the interests of the clients, public as well as the professions and institutions. Over the years, codes of conduct have proven to be useful tools in improving professional and institutional service due to their appeal. Various professions and institutions have issued codes of conduct that are aimed at improving the service they offer to their clients and such codes are ere enforced by way of institutional policies or in courts of laws. Professional associations involved in the healthcare and health research environment continue to rely on codes of conduct to guide the behaviours of individuals involved in these ﬁelds.

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