Medical ethics and medical education.

Abstract

Medical ethics, at any rate in the West, has been traditionally based on the Hippocratic Oath, with its threefold principles of respect for human life, confidentiality in fiduciary relationships and beneficence (‘the duty to care and do no harm’). For many doctors and health professionals the Hippocratic Oath has been a sufficient basis for medical practice and they do not see the need for new codes or guidelines. However many developments in the modern world and contemporary health care have, in the view of others, made it imperative to clarify these general principles of medical ethics and consider in more detail their application in clinical practice and the larger areas of health care administration in both developed and developing countries. Public outrage at the discovery, during the Nuremberg War Crime Trials, of what had been done by Nazi doctors in the name of medicine and scientific research, gave major impetus to the review and elaboration of medical ethics. The Declaration of Geneva (1948 amended 1968) attempted to restate the Hippocratic Oath in modern terms, affirming the doctor's duty of respect for human life and service of humanity, the duty to care regardless of race, sex, religion or social class; and respect for the secrets of the patient. The Declaration of Helsinki (1964 revised 1975) sought to further clarify the ethical principles governing clinical research involving human subjects emphasizing informed consent and proper scientific research design; and the Declaration of Tokyo (1975) stressed that medical ethics precluded doctors from participating in torture and other cruel, inhuman or degrading treatment or punishment. Recent developments in bio-medical science and technology have made it possible to achieve successful organ transplants, safe abortions, resuscitation of, and artificial life support for, those who would previously have died. This in turn has produced pressure for further clarification of medical ethics: the Declaration of Sydney (1968) on the determination of death, the Declaration of Oslo (1970) on therapeutic abortion, and the Declaration of Hawaii (1977) on the responsibilities of psychiatrists particularly with reference to possible misuses of chemotherapy and invasive brain surgery. The World Health Organization and in particular the Council for International Organizations of Medical Science (CIOMS) have long been concerned about ethical issues in health care and the need for the integration of medical ethics in medical education. While in the past the concern has arisen within the medical profession and has been related either to the control of medical malpractice or the dilemmas of clinical medicine (particularly related to new developments) now the pressure is increasingly coming from the public and the media and relates to a series of new issues of growing importance. The first issue relates to the exponential growth in clinical research and particularly in the trial of new drugs, and public concern that there should be adequate control and protection of the rights of experimental subjects. This issue is particularly focussed in the developed countries on the role of Research Ethics Committees or Institutional Review Boards in providing ethical review of clinical research, and concern at the absence of adequate controls on pharmaceutical companies and medical entrepreneurs in developing countries. The second issue relates to the politics and economics of health care in a period of world recession, and the ethical issues to which economic scarcity has given prominence—namely questions concerning the ethics of resource allocation. These arise at several levels; in clinical practice (e.g. in deciding between patients for renal dialysis or intensive care when equipment and facilities are limited), in the management of personnel and resources within a health care system (e.g. in shifting resources from the acute high-technology hospital medicine to primary care or to care of the elderly and mentally ill), and in attempts to achieve justice in health-care at an international level (e.g. in providing for more adequate staff and resources for developing countries). Medical training tends to focus attention on the clinical relationship of doctor and patient, and much recent discussion of medical ethics tends to have concentrated on ethical dilemmas in one-to-one clinical relationships. The discussion of such issues tends to be couched in terms of personalist ethics and individualistic values. This tends to overlook the fact that doctors also frequently are involved in clinical research with groups of patients, exercise considerable power in the management of staff and allocation of resources within institutions, and may play a crucial role in determining policy at regional or national level in their respective countries. The fact is that personalist and individualistic ethics are in general inadequate to deal with ethical decision-making at this level. Understanding of institutional and political ethics with its more universalistic concerns with justice in health-care and the common good may be necessary, and these values may in fact conflict at times with more personal understanding of patients’rights and professional duties in a clinical situation. While there is a growing recognition that medical education should include medical ethics, the emphasis in existing courses tends to be either very traditional (concerned with forensic medicine and medical etiquette) or at best concerned with ethical dilemmas of clinical medicine. Little attention is given to the broader questions involved in medical research, public health policy and the national and international allocation of health resources, and yet it is obvious that most doctors have to address these questions at some time or other in their professional life. Medical Ethics and Medical Education, * a report of the proceedings of the XIVth Round Table Conference of CIOMS held in Mexico City from 1-3 December 1983, gives evidence that WHO and CIOMS are attempting to address themselves to these questions. The first two sessions of the Conference relate to the ethical review of clinical research, dealing both with general principles and considering local applications in several different countries in the Americas. The publication also includes the most helpful Provisional Guidelines for Ethical Review Procedures for Research Involving Human Subjects. The third session was devoted to discussion of both the theoretical importance of medical ethics in medical education and some interesting practical examples of courses where the attempt has been made to integrate medical ethics into the medical curriculum. The final session was concerned with the broader ethical and policy questions involved in the relationship of medical education and government. The introductory papers were particularly outstanding. John Ladd, a philosopher, in addressing ethical issues in human experimentation criticized Research Ethics Committees (or IRBs) for being unduly pre-occupied with questions of informed consent, pointing out that most committees are less concerned with the ethical issues of protecting patient dignity and autonomy than protecting themselves and the institution from legal action. Informed consent as a legal notion pre-supposes an adversarial relationship between doctor and patient which encourages defensive responses on the part of both. He pleads for a disentanglement of moral and legal aspects of the subject, greater awareness that‘bourgeois’ideals of freedom are largely inapplicable to patients who are highly dependent because of need, institutionalization or socio-economic circumstances, and that the real challenge of facilitating patient autonomy means getting away from legalistic interpretations of informed consent. On the subject of research he pleads for a greater awareness of the different value-conceptions or ideologies underlying those whom he calls‘enthusiasts’and‘restrictionists’. Both those who consider all scientific research invariably benefits mankind and those who are afraid of its Faustian pretentions tend to argue from absolutist premises. He argues very persuasively that both positions need to be qualified by human compassion and insistence on maintenance of the highest standards of scientific research. He concludes that there are three factors which must be taken into account in determining the moral quality of a medical experiment on a human subject: (a) the balance of risk and benefit for the subject; (b) the adequacy of the project and its potentiality for reducing suffering or benefitting future patients; and (c) the relationship between the experimental subject and those who stand to benefit from the experiment—that is, whether they are remote from him or people to whom he is related by some kind of community of interest. Robert J. Levine, in discussing the value and limitations of ethical review committees, makes some provocative comments as a clinician which must be of interest to those serving on such committees. He first points out that the limited research on such committees in the U.S.A. suggests both that they have contributed to better protection of the rights and welfare of human subjects, and also contributed to the improvement of the quality of research proposals submitted and the quality of the research done. The values which such committees attempt to uphold (in the light of the Declaration of Helsinki and other directives) are the following: (a) there should be informed consent; (b) there should be good research design; (c) there should be competent investigators; (d) there should be a favourable balance of harms and benefits; (e) there should be equitable selection of subjects; and (f) there should be compensation for research-induced injury. However, he suggests that ethical review committees are often limited in what they can do because they lack credibility. This lack of credibility is related to the fact that many spend too much time on unimportant details, that there is poor co-ordination between different committees where multi-centre trials are involved, there may be inconsistent criteria determining which projects require review and which do not, in the absence of standardized procedures committees will vary in the quality of review given, there is no provision for monitoring research approved, and some committees have difficulty in recruiting members who command the respect of the institution or community they serve. Francisco Vilardell gives an excellent analysis of ethical issues in gastroenterology and how these can be monitored effectively by laying down clear criteria. The paper is very specific and detailed and is a model of how ethical review can be developed in specific clinical areas. John F. Dunne gives a masterly overview of ethical review procedures for research involving human subjects, distinguishing three different kinds of research each with its own attendant ethical problems: (1) detailed studies of a physiological or pathological process in response to specific interventions, in one or more individuals; (2) prospective controlled trials of specific therapeutic regimens in larger groups of patients; and (3) field studies in which consequences of prophylactic or therapeutic measures are determined within comparable communities. In relation to these different kinds of research he draws attention to several kinds of ethical problems. First, whether in determining research policies countries will use public funds competently for the general benefit of society. Second, in developing countries there are specific problems which arise because of external sponsorship of research. These include research projects which are unrelated to the country's primary needs, make heavy demands on limited medical staff and resources, may be in conflict with local customs and mores, and do not involve long-term commitment to the country or accountability to its people. Third, developing countries lack the medical infrastructure in toxicology and pharmacology to support the regulatory apparatus for monitoring new drug developments. Fourth, there is a risk of exploitation of the underprivileged by sanctioning research in developing countries that would not be tolerated in countries with better general levels of education and health care. More generally his paper also contains some excellent observations on the limited usefulness of the notion of‘informed comment’when dealing with research involving children, pregnant women, the mentally ill and when public health measures (e.g. fluoridation) involve whole communities. These situations require other safeguards such as proxy consent, review tribunals, provision for compensation for personal injury and public accountability of individuals or institutions involved in research. The succeeding papers were of considerable interest in documenting the specific provisions for ethical review of clinical research in Argentina and Chile, specifically and more generally in the Latin-American Association of National Academies of Medicine. Two papers of particular interest deal with difficulties of doing paediatric research in Latin America with conservative attitudes of parents and established institutions (Kumate), and research related to fertility control in women (Stoltz) where the same difficulties apply compounded by the subordinate and oppressed condition of many women. Other papers deal with the teaching of mainly traditional forensic medicine and medical etiquette in Venezuela and Brazil, and reveal a debate internal to North American medical schools, namely between the teaching of‘bio-ethics’or‘clinical medical ethics’. The development of the Hastings Center and the Society for Health and Human Values focussed attention on the need to examine medical ethics in the wider context of ethical and value questions in the bio-medical sciences in general. The initiative in research had come from theologians and ethicists rather than doctors. Mark Siegier criticizes this development and argues for a restriction of medical ethics to what he calls‘clinical ethics’and preferably taught by ethically literate but clinically competent doctors. Edmund D. Pellegrino, doyen of bio-ethicists, defends the broader view and argues strongly for the injection of more training in the humanities into medical education. In part the debate is about method and content of medical ethics teaching: whether it should be theory based or case based, whether it should be given by philosophers or clinicians, or in a multi-disciplinary mode, whether it should be primarily medical or concerned with the bio-medical sciences in general. In part also the debate is about the scope of medical ethics: whether it should be restricted to clinical, doctor-patient relationships or whether it should take in the ethical responsibilities of doctor as researcher, hospital manager, public health planner, policy maker for health services generally, and international issues as well. The final closing addresses deal with some of these issues but less satisfactorily, perhaps because no one has really thought through these issues very carefully just yet. The two Latin-American contributions are mainly a plea for the independence of medical schools to be respected, for epidemiological rather than political criteria to be employed in defining priorities for developing health services at national and regional level, and for realistic partnership in striving to attain the WHO objective of Health for All by the Year 2000. Fitzhugh Mullan's paper is a rather smug defence of the U.S. National Health Service Corps as a means of dealing with the health problems of deprived areas by scholarships to medical students, requiring them to do compulsory service in deprived areas following qualification. Why those who can afford to finance their own medical training should not have to do so is not made clear. Howard H. Hiatt's paper is a most useful beginning to a discussion about the need for training of doctors in health policy and management and the ethical issues involved at that level. What this excellent publication lacks is a detailed discussion of the wider ethical issues of justice in health care between the developed and developing countries. What is needed is a WHO‘Brandt Report’which would deal with the ethical and educational challenges to doctors of the North-South polarization of wealth and poverty, health and disease, medical resources and the lack of them.