Human and Animal Subject Protection, Biorepositories, Biosafety Considerations, and Professional Ethics

This chapter presents the concepts of biorepositories, biosafety, and professional ethics. A biorepository is a collection of human specimens and associated data for research purposes, the physical structure where the collection is stored, and all relevant processes and policies. Biorepositories pose specific ethical issues. The participant donating a specimen, be it blood, urine, or tissue, expects that the specimen will be valued, that it will be handled and stored appropriately, and distributed as needed so it will contribute to scientific knowledge. Further, the participant expects that the users of the donated specimens will respect his or her privacy, and that the specimen(s) will be used only in ways consistent with the consent granted. Biological safety means using infectious and other hazardous materials safely in the laboratory, and reducing or eliminating the exposure of laboratory personnel, other personnel, and the outside environment. The primary principle is that of containment. Professional ethics for epidemiology and public health are not regulated. However, there is a code of ethics for the practice of epidemiology that has been adopted by several epidemiology societies and for public health professionals, which has been approved by the American Public Health Association. These general principles are summarized in the chapter, with particular examples relating to molecular epidemiologic studies.