Introduction

These Guidelines are intended for investigators, health policy-makers, members of ethical review committees, and others who have to deal with ethical issues that arise in epidemiology. They may also assist in the establishment of standards for ethical review of epidemiological studies.

The Guidelines are an expression of concern to ensure that epidemiological studies observe ethical standards. These standards apply to all who under take any of the types of activity covered by the Guidelines. Investigators must always be held responsible for the ethical integrity of their studies.

Epidemiology is defined as 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.

Epidemiology has greatly improved the human condition in the present century. It has clarified our understanding of many physical, biological and behavioural dangers to health. Some of the knowledge obtained has been applied to the control of environmental and biological threats to health, such as diseases due to drinking polluted water. Other epidemiological knowledge has become part of popular culture, leading to changed values and behaviour, and thus has led to improved health: examplesinclude attitudes towards personal hygiene, tobacco smoking, diet and exercise in relation to heart disease, and the use of seat-belts to reduce the risk of traffic injury and death.

Epidemiological practice and research are based mostly on observation, and require no intervention more invasive than asking questions and carrying out routine medical examinations. Practice and research may overlap, as, for example, when both routine surveillance of cancer and original research on cancer are conducted by professional staff of a population-based cancer registry.