The pathologist's role in the use of human tissues in research--legal, ethical, and other issues.

Because of their central role in examining and storing samples of human tissues obtained for diagnosis or therapy of diseases, pathologists frequently are involved in providing human tissues for a wide range of research. This is an important role for the pathologist that leads to increased understanding of disease, to potential methods of prevention, and to improved therapy. Recent conferences concerning uses of human tissues in research have indicated that there is confusion with respect to legal issues and requirements of pathologists who are involved in research with human tissues. This paper discusses current federal regulations concerning the use of human tissues and medical information in research as specified in Title 45, Part 46 of the Code of Federal Regulations (45 CFR 46) "Protection of Human Subjects." The authors also recommend approaches that pathologists can utilize to ensure that they are meeting all federal regulations with respect to the use of human tissues in research.