Research Involving Human Biological Materials

Abstract

"Biomedical researchers have long studied human biological materials—such as cells collected in research projects, biopsy specimens obtained for diagnostic purposes, and organs and tissues removed during surgery—to increase knowledge about human diseases and to develop better means of preventing, diagnosing, and treating these diseases. Today, new technologies and advances in biology provide even more effective tools for using such resources to improve medicine’s diagnostic and therapeutic potential. Yet, the very power of these new technologies raises a number of important ethical issues. Is it appropriate to use stored biological materials in ways that originally were not contemplated either by the people from whom the materials came or by those who collected the materials? Does such use harm anyone’s interest? Does it matter whether the material is identified, or identifiable, as to its source, or is linked, or linkable, to other medical or personal data regarding the source? The extent to which a research sample can be linked with the identity of its source is a significant determination in assessing the risks and potential benefits that might occur to human subjects. For this reason, the National Bioethics Advisory Commission (NBAC) has developed a schema to describe the character of the personal information associated with particular samples of human biological materials as they exist in clinical facilities or other repositories and in the hands of researchers."