Research Involving Human Biological Materials: Ethical Issues and Policy Guidance. Executive Summary; Volume 1. The Report and Recommendations of the National Bioethics Advisory Commission; and Volume 2. Commissioned Papers.

摘要

On behalf of the National Bioethics Advisory Commission (NBAC), I am pleased to transmit our third report to you: Research Involving Human Biological Materials: Ethical Issues and Policy Guidance. This report addresses a topic that follows from the priorities established in Executive Order 12975-to consider the rights and welfare of human research subjects and the management and use of genetic information. In this report, NBAC addresses an issue at the confluence of two important developments. The first development is the remarkably enhanced ability of biomedical researchers to study human biological materials, such as biopsy specimens obtained for diagnostic purposes, organs and tissues removed during surgery, and biological materials collected in research projects; to increase knowledge about human diseases; and to develop better means to prevent, diagnose, and treat these diseases. NBAC has estimated that there are more than 282 million such specimens in the nation's laboratories, tissue repositories, and health care institutions. The ability to use these materials in research in striking new ways will provide even more effective tools for improving health. Yet, the very power of these new research tools raises a number of important ethical issues.