The ANNALS of the American Academy of Political and Social Science

Medical ethics are now in a period of great change. Some of the patterns, causes, agents, modes, resistance to, and costs of these changes are briefly described as a guide to the several detailed essays in this volume.

This essay discusses the growth of experimen tation on human subjects in the United States and Great Brit ain in the twentieth century and focuses on a linkage that developed in medicine between research and patient care. It examines circumstances that helped to forge this linkage: a notion that the uncertainty of outcome common to activi ties in medical research and practice basically joins the two; a concept of medical education that research training creates analytic skills essential in providing good patient care; gov ernment policies which fiscally link medical research to med ical education; and the view that patient care and research can be simultaneously and ethically pursued by a given doctor on a given patient.

Medicine, as a learned profession, has tradi tionally insisted that the conduct of physicians be governed by its own code of professional ethics. Increased government regulation of the practice of medicine, however, has largely substituted external, governmental regulation for earlier ethical constraints. Government regulations have been imposed both in response to greater risks in the practice of medicine and in consequence of ever greater government funding of health care. Though regulations reflect a contemporary consensus on ethical attitudes, their promulgation has narrowed the exercise of the physician's independent ethical judgment. While the physician is increasingly subject to legal require ments in his practice and in such areas as informed consent, the use of human subjects in clinical research, genetic and biological research, and the management of the dying pa tient, his ethical sensitivity in complying with such require ments is still essential for the protection of patients.

Informed consent has emerged as an issue both of great importance and substantial uncertainty and confusion. This paper examines some of the conceptual and practical complexities of informed consent and suggests some impli cations of our empirical knowledge about consent. Among the issues considered are the purposes of informed consent, ethical versus legal functions of informed consent, the dis tinction between informed consent and consent forms, and whether informed consent is an ideal that can never be achieved. It is argued that informed consent is presently not a reliable method of protecting subjects and patients from harm because of limited commitment of professionals to the concept of informed consent, the tendency for procedures to be substituted for substance, the dependence of the quality of consent on many factors, including the characteristics of the subjects or patients, and the tendency of human subjects review committees to confine their attention to consent forms rather than to the process by which consent is sought.

The study of medical ethics should properly include codes of ethics issued by Enlightenment philos ophers and modern medical associations. Official codes of ethics adopted by the medical profession in England and the United States have exhibited monopolistic tendencies which have strengthened over time. Examination of Thomas Percival's 1803 code of ethics reveals monopolistic rules in the areas of trust inducement, consultations, criticism, and fee setting. Another ethical code, written by John Gregory in 1770, provides evidence of antimonopolistic ethical atti tudes during the Enlightenment which were not subse quently adopted by official professional bodies. The series of ethical codes issued by the American Medical Association since its inception in 1847 exhibits even more monopolistic rules than had Percivalean ethics. In contrast to the mono polistic tendencies of official medical ethics, however, trends are currently emerging toward nonmonopolistic counter- ethics in the areas of restraint of competition, patient decision making, professional review mechanisms, and rational health care services planning.

Many prominent health experts now assert that major improvements in the health of the American people must come from individual efforts to alter unhealthy per sonal habits and lifestyles rather than through medical services and technology. But it does not necessarily follow that a more ethical and feasible national health policy would focus primarily on exhorting Americans to mobilize their indi vidual willpower to change to more healthful personal habits. In determining the nature of such policy, three main points are essential. First, the "health and individual responsi bility" argument may overestimate the health benefits which will accrue from personal habit changes. Second, that argu ment tends to overlook or misconstrue the nature of societal constraints on individual will. It fails to specify the socio logical conditions under which millions of individuals can change their lives significantly and the role social condi tions play in maintaining unhealthy behavior and attitudes. Finally, the focus on individual decisionmaking deempha sizes the role of collective efforts, of public policy, in securing higher health standards. In essence, then, we suggest that a health policy that promotes curbing unhealthy habits and encourages healthy ones through societal action is more ethical and feasible than one focusing on "health as individual responsibility."

As medical costs mount and as government as sumes increasing responsibility for financing, explicit forms of medical care rationing are likely to be introduced. This paper considers the benefits and costs of different approaches to rationing and their implications for a just medical care system. Rationing may be imposed through financial barriers for the patient in the form of coinsurance and deductibles or in limitations on the funds, facilities, and services made available to the population. It is argued that imposing barriers to access on the theory that consumers are in a good position to make necessary differentiations places the burden of ra tioning on the patient who is least able to make the decision rationally, and places the poor, who have the least medical knowledge and background, in particular jeopardy. Other al ternatives include either the introduction of fixed budgets that require professionals to establish priorities or adminis trative decisions that prescribe the facilities and types of serv ices made available to varying population groups. Rationing techniques have different behavioral and ethical implications, and existing research indicates that the consequences of some rationing approaches are inconsistent with theoretical as sumptions.

The author draws upon a number of studies to examine the multistaged process of selection and socializa tion—from medical school through internship and residency and into the research career—that pertains to the develop ment of research physicians with an ethically informed concern for human subjects. Recent changes relevant to this process are discussed, deficiencies are analyzed, brief recom mendations for remedies and improvements are made, and the need for supplementary controls is reaffirmed, all in the interest of more rational and better protection of sub jects' welfare and rights.

In response to the problems of coping with chronic disease, physicians are moving toward a social defini tion of life, that is, towards defining an individual as being alive if he is capable of performing his social roles, rather than if he simply meets physical criteria for life. A study of how physicians in four medical specialties say they would treat different types of critically ill patients shows that there is considerable consensus among physicians about the treatment of salvageable patients with physical damage and unsalvageable patients with mental damage but little consensus concerning those who are mentally damaged but salvageable or physically damaged and unsalvageable. Over 70 percent of the respondents in each specialty indicated that they would accept irreversible cessation of brain func tion as a criterion for death, permitting them to cease main taining the patient's respiratory functions. Examination of hospital records showed that physicians tend to overestimate on the questionnaires their likelihood of treating critically ill patients. In other words, there may be more consensus about not treating certain types of patients than the questionnaires suggest. The lack of consensus on these matters in other social institutions, such as law and religion, is also discussed.

The implications of the literal interpretation of established ethical codes versus the application of ad hoc moral principles are discussed and the concerns of minimiz ing risk, maximizing the scientific value of data, and provid ing adequate subject indemnification are examined. It is con cluded that the paramount ethical consideration in selecting subject populations is the diffusion of risk and the provision of adequate indemnification. Judicious selection of subject populations is essential and ad hoc moral principles should prevail at times over the use of established written codes.

Despite the Supreme Court decision in 1973, Roe v. Wade, making abortion legally available without impedi ment during the first two trimesters of pregnancy, neither the legal nor ethical problems of abortion have been solved. Congressional opposition to federal financial support of abor tion, as well as a wide disparity in availability of abortion, indicates the still unsettled state of public policy on the issue. In medical ethics, a number of problems have surfaced in the past few years, which together form a complex set of both moral and legal issues. Fetal research, on the one hand, and the prospect of in vitro fertilization, on the other, both point to issues which recent Supreme Court decisions have not clarified. The rapid development of amniocentesis as a major tool of prenatal diagnosis highlights some of the new dilem mas. If the Supreme Court decision is read literally, there would appear to be no grounds for a physician to refuse to perform an abortion except for a clear threat to a woman's health from the abortion itself. Yet many, and perhaps most, physicians appear morally opposed to using abortion for sex selection or in those cases where simple postnatal treatment is available to correct a genetic defect. What are the rights of physicians in such cases and what, if any, are the limits on the rights of women to have abortions? Lurking in the back ground is the growing power of medicine to push back the time of viability of an infant earlier and earlier. Both new legal and ethical problems are bound to result. Abortion re mains as deeply complex a moral issue as ever.

There is almost no step in the research process in epidemiology in which ethical issues do not exist. In this paper we follow the thread of our own experience in balancing values of scientific rigor against values concerning the interests of the people under study. Ethical issues in epidemiology are illustrated in the choice of research ques tions ; in the choice of study designs to explore the ques tions; in the maintenance of confidentiality; in obtaining the participation of populations; in experimental studies; and the giving or withdrawing of treatment.