Epidemiology is the study of the distribution and determinants of health-related states or events in specified populations, and the application of this study to control of health problems.

Several terms used in this definition require discussion. “Study” encompasses (a) observations in public health practice, e.g. to investigate outbreaks of food poisoning, identify the source of an epidemic, trace contacts of sexually transmitted diseases; (b) hypothesis-testing observational studies using cross-sectional, cohort and casecontrol methods; and (c) experiments such as randomized controlled trials, in which there is intervention as well as observation, usually with the aim of evaluating a preventive, diagnostic or therapeutic regimen or procedure. “Distribution” refers to time sequences, places of occurrence, and persons affected. “Determinants” are all the physical, biological and behavioral factors that can influence health. “Health-related states or events” include diseases, injuries, deaths, behaviors such as tobacco addiction, and reactions to preventive, diagnostic or therapeutic regimens or procedures.

The Nuremberg Code of 1947 is often taken to mark the beginning of the modern age of ethical codes for medical and health-related research with human subjects. The 1947 Code was fashioned in response to inhumane medical experimentation revealed at the Nuremberg War Crimes Tribunal. The fact that, prior to 1939, Germany had an ethical code for human research in medicine that appears sensitive and sophisticated even by current standards indicates that codes in themselves do not assure ethical conduct. Nevertheless, calls continue for the preparation of codes of conduct to guide the exercise of ethical judgment in health-related research.

Medical research concerned with individual subjects as such now possesses codes or guidelines at many levels, including funding agency, research institutional, national and international levels. The World Medical Association's Helsinki Code is now in its fourth version, and the Guidelines proposed in 1982 by the World Health Organization affiliate, the Council for International Organizations of Medical Sciences (CIOMS) is about to be revised to take account of a decade of significant developments.

Imagine, if you will, a place where health, hospitalization, education, military, employment, law enforcement, housing, tax and financial records, as well as disease registries and the data sources for the census, vital statistics, and all aspects of people's private activities, are meticulously kept, fully linked together, and easily accessible to qualified researchers. What is that place? Epidemiologists’ heaven.

Of course, formidable problems face epidemiologists trying to reach heaven. The data sources on many aspects of our lives are incomplete and the means of linking them are typically nonexistent or partial at best. But even if the data all existed, there would be a further “catch”: epidemiologists would probably find themselves facing great obstacles in gaining access to the data.

Epidemiologists sometimes think of “ethics” as the source of those obstacles, which are believed to be embodied in the federal rules for the protection of research subjects—colloquially called 45 CFR Part 46—especially as they are interpreted by some institutional review boards (IRBs).

Ethical principles for the protection of human subjects in clinical research are now well recognized, and rooted in the inherent worth and dignity of the individual.

Respect for persons recognizes people as autonomous agents and requires that their choices be observed. For persons who are not fully autonomous, the principle of respect for persons requires that they are protected from risks and adverse consequences of research, even sometimes excluded from research.

Beneficence (do good) and non-maleficence (do no harm) are complementary ethical principles that impose affirmative duties on researchers to maximize any benefits for subjects and minimize any risks. Thus, researchers must go beyond mere respect for a person's choices. The researcher must be vigilant to ensure that the subject receives all possible benefits and avoids all possible harms from participating in the research.

To a Western audience the terms “people” and “people's perspective” could appear somewhat perplexing. Technically, every person belongs to the class of “people”; hence, to talk of “people's perspective” seems to make an artificial division within one monolithic group. This ostensibly artificial division reflects a reality that necessitates it. In a Third World context, the term “people” has a fairly distinct connotation. It is not just a majority which is governed by a system that gives all people a minimal quality of life and allows them a meaningful participation in the political process. In a Third World context “people” are a “mass”—a faceless body of massive energy to be manipulated and kept domesticated in the interest of the powerelite. It is a power-bloc that is threatening as well as inescapable.

This paper presents first an account of informed consent as it is envisioned and ethically grounded in the Western world. Next there is a discussion of why the Western model is unsuitable in much of the remainder of the world where the concept of “person” differs substantially from that of Western societies. This is followed by some comments on the current controversy on whether ethical standards should be regarded as universally applicable or, rather, whether some degree of ethical and cultural relativism is to be regarded as legitimate. After providing preliminary responses to some questions posed by the Conference Programme Committee, the paper concludes with a proposal for a procedural approach to the resolution of problems with informed consent.

International guidelines regarding ethics, and in particular the ethics of clinical research, are problematic on two broad levels. First, by asserting their universality, “international” guidelines obscure real and legitimate crosscultural differences in ethical expectations. International guidelines seek to make homogeneous something which is not necessarily so. Second, existing guidelines are ambiguous about their objectives and purposes. On the one hand, guidelines are structured as a set of goals, largely aspirational in language and content. But on the other hand, such guidelines also suggest a normative function, providing a set of standards by which to judge and, if appropriate, sanction investigators’ conduct.

These criticisms are not intended to argue that international guidelines are useless. Nor are they intended to question the good faith under which such guidelines are developed. Rather, we wish to suggest that the role of present international guidelines is somewhat more limited than is ordinarily appreciated.

With the identification of HIV as the etiological agent responsible for AIDS in 1984, it became clear that an understanding of the dimensions of the epidemic would require more than a careful detailing of the incidence and prevalence of overt symptoms of AIDS. To enable public health authorities to target and evaluate preventative interventions and plan for the health care services that would be required in the future as the infected progressed to symptomatic conditions, knowledge of the incidence and prevalence of HIV infection was critically needed.

“All things considered, I chose what was best for my children, or what I thought was best…” confessed Jean- Jacques Rousseau in 1782. What more can one expect from a parent or a professional entrusted with decisions about children? What Rousseau thought was “best” for each of his five infants, however, was to dispatch them to foundling homes in Paris, without even keeping a record of their birthdates, thus leaving them to an unknown but probably dismal fate.

Acting from moral and often legal obligations to protect vulnerable persons from harm and to enhance their welfare, adults daily make decisions about and for children. Professionals and policy makers fulfill their social responsibilities by creating and implementing policies and practices that enable children's caregivers to fulfill these same goals.

Lilienfeld and Lilienfeld have defined epidemiology as “the study of the distribution of a disease or physiological condition in human populations and of the factors that influence this distribution.” Epidemiology is an eclectic discipline, utilizing statistics, sociology, and biology of the study of disease populations. Epidemiological studies can help explain the etiology of a specific disease; they can evaluate the consistency of epidemiologic data with etiological hypotheses and provide a basis for developing or evaluating preventive procedures and public health practices.

The consultation for the Development of International Guidelines for Epidemiological Research and Ethical Review Procedures assembled in Geneva in November 1990 offered basic principles that should apply to epidemiological and clinical research. The principles provide the basis for discussion here.

Providing protection for the rights and welfare of two categories of research subjects in epidemiologic research must be a matter of serious concern to those who design, conduct and disseminate findings of epidemiological research.

The HIV epidemic has led to a reassessment of attitudes regarding public access to new therapeutic agents for the treatment of life-threatening and severely debilitating diseases. People with AIDS and their advocates have relentlessly attacked the process by which new drugs are developed and approved for marketing in this country, a process characterized as overly conservative, risk-averse, and paternalistic. In response to growing pressure to accelerate access to important new therapeutic agents, the Food and Drug Administration (FDA) has issued several bold initiatives designed to facilitate the development of experimental drugs used in the treatment of serious or immediately life-threatening diseases.

The clinical testing and regulatory review of new therapeutic agents in the United States are lengthy processes. A recent analysis of new chemical entities (NCE) approved by the FDA in 1987,1988, and 1989 has revealed that, on average, the clinical development phase for new drugs exceeds five years (63 months).

This is the first in a projected series of periodic reports on international legal developments relating to reproductive health. It follows an introductory essay on abortion law developments in the industrialized world, which appeared in the Winter 1990 issue of Law, Medicine & Health Care. The major focus of this report is again abortion, the reproductive health issue with the highest international legal profile. Like its predecessor, it discusses the consequences of the withering away of Communism in Eastern Europe—in this case Czechoslovakia, the German Democratic Republic, and Poland—as well as the effects of major liberalization of abortion law in Belgium and Canada and the approval by France of use of the abortion-inducing drug RU-486.