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

Published online by Cambridge University Press:  29 April 2021

Charles R. McCarthy  and
Joan P. Porter
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Extract

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.

Type
Article
Information
Law, Medicine and Healthcare , Volume 19 , Issue 3-4 , Fall Winter 1991 , pp. 238 - 241
Copyright
Copyright © American Society of Law, Medicine and Ethics 1991

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References

Lilienfeld, Abraham M. and Lilienfeld, David E. Foundations of Epidemiology, Second Edition. New York: Oxford University Press, 1980, p.4.Google Scholar
Ibid.Google Scholar
Council of International Organization of Medical Sciences Conference on “Development of International Ethical Guidelines for Epidemiological Research and Practice”, Geneva, Switzerland, November 7–9, 1990.Google Scholar
See also: U.S. Public Health Service (PHS) Consultation on International Collaborative Human Immuno-deficiency Virus (HIV) Research, Annapolis, Maryland, September 24–26, 1990, for a discussion of principles governing collaborative epidemiological or clinical research trials.Google Scholar
OPRR Reports, Protection of Human Subjects, Code of Federal Regulations, Title 45 Part 46, Subpart D, Additional Protections for Children Involved as Subjects in Research Revised as of March 8, 1983, pp. 15–18; revised June 18, 1991 (56FR20832).Google Scholar
McCarthy, Charles R., commentary on Carl-Gunnar Janson “Privacy and Informed Consent in Longitudinal Research”, paper presented at Ethical and Legal Issues in Longitudinal Studies of Individual Development Conference sponsored by the European Science Foundation, June 7–9, 1990.Google Scholar
OPRR, Title 45 CFR Part 46.Google Scholar
Council of International Organizations of Medical Sciences, Proposed International Guidelines for Biomedical Research Involving Human Subjects, Geneva, Switzerland, 1982.Google Scholar
Public Health Service Act, Section 301(d), 42 U.S.C. Section 241(d), as added by Publication L, No. 100-607, Section 163 (November, 1988).Google Scholar