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 researchers now have the ability to extract and amplify DNA from minuscule archived samples, virtually any human tissue sample can potentially become the template for a test that provides information that may relate to the inherited genes of an individual. Researchers using human biologic materials should follow the 3 basic principles that have been defined for all ethical human subjects research: respect for persons, beneficence, and justice. Institutional Review Boards are responsible for providing review of the risks and benefits of research proposals to safeguard the rights and welfare of human 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 have been anonymized or coded. In 1999, the National Bioethics Advisory Commission is expected to make recommendations to President Clinton and the National Science and Technology Council that are expected to clarify the balance between respect for personal autonomy and the societal need to pursue biomedical research to improve the health and welfare of all individuals.