Ethical challenges at the beginning of the millennium

• Published in: Statistics in medicine Vol. 20; no. 9-10; pp. 1415 - 1419
• Main Author: Steinberg, Karen K.
• Format: Journal Article Conference Proceeding
• Language: English
• Published: Chichester, UK John Wiley & Sons, Ltd 15-05-2001; Wiley
• Subjects: Bioethics; Biological and medical sciences; Biological Specimen Banks - standards; Centers for Disease Control and Prevention (U.S.); Ethics; Genetic Predisposition to Disease; Human Genome Project; Humans; Informed Consent; Medical sciences; Nutrition Surveys; United States; Prevention; Ethics; Perspective; Clinical management; DNA; Risk factor; Genetic character; Epidemiology; Recommendation; Genetics and Reproduction; Biomedical and Behavioral Research
• ISSN: 0277-6715; 1097-0258
• DOI: 10.1002/sim.678

In the mid‐1980s, the Centers for Disease Control and Prevention (CDC) recognized the need to study genetic risk factors for common diseases such as diabetes and heart disease. To take advantage of a rare opportunity to obtain a nationally representative, population‐based sample to study genetic risk factors, the CDC collected and stored DNA as part of the Third National Health and Nutrition Examination Survey (NHANES III). At the time, the methods for studying these risk factors in large epidemiologic studies were not available. However, in the midst of planning for NHANES III, a revolution was occurring in the field of genetics. The resulting changes would provide a means to realize the goal of explaining why some people are more susceptible than others to risks such as elevated cholesterol or exposure to carcinogens. During this period, ethicists were increasingly asking questions about the safety and risks for participants in genetic research. Was genetic research different from other research? Were new rules for obtaining informed consent for genetic research needed, or should our methods of obtaining informed consent be equally rigorous for all research? When collection of the NHANES III DNA bank was complete in 1994, the CDC and the National Institutes of Health (NIH) held a workshop to address these questions. The published recommendations of this workshop stimulated a national debate that resulted in a significant change in the way genetic epidemiologic research is done in the United States including not only stored biologic specimens but data collected for one purpose but used for another. In 1999, the National Bioethics Advisory Commission (NBAC) published recommendations for the ethical use of human biological materials. The recommendations of the NBAC and policies and practices of the CDC about informed consent for research on stored tissue samples will serve as models for future epidemiologic research. The problems that were recognized in the national debate that ensued and the solutions that followed will affect the way we gain access to biological specimens and data in the 21st century. Published in 2001 by John Wiley & Sons, Ltd.