Ethical issues in molecular pathology - Paradigms in flux

Recent advances in molecular pathology and molecular genetics have created new concerns about the use of human biologic materials in research. Since r esearchers now have the ability to extract and amplify DNA from minuscule a rchived samples, virtually any human tissue sample can potentially become t he template for a test that provides information that may relate to the inh erited genes of an individual. Researchers using human biologic materials s hould follow the 3 basic principles that have been defined for all ethical human subjects research: respect for persons, beneficence, and justice. Ins titutional Review Boards are responsible for providing review of the risks and benefits of research proposals to safeguard the rights and welfare of h uman subjects. Currently, there is considerable debate concerning the role of informed consent procedures and the Institutional Review Board oversight process in situations when researchers use human biologic materials that h ave been anonymized or coded. In 1999, the National Bioethics Advisory Comm ission is expected to make recommendations to President Clinton and the Nat ional Science and Technology Council that are expected to clarify the balan ce between respect for personal autonomy and the societal need to pursue bi omedical research to improve the health and welfare of all individuals.