Confidentiality: The Protection of Personal Data in Epidemiological and Clinical Research Trials

Abstract

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.