Regulations and guidelines on handling human materials obtained from medico-legal autopsy for use in research.

Human materials obtained from medico-legal autopsy have been used for research without consent from surviving relatives in majority of the cases in Japan. In recent years, however, informed consent has become a key principle in medical practice, and protection of privacy has been emphasized. We investigated the regulations and guidelines in Japan regarding handling of human materials obtained from medico-legal autopsy for use in research. The Autopsy Law, enforced in 1949, does not provide access of human materials for research, although preservation of such materials as specimens for medical education or research is legally approved. The Ethics Guidelines for Human Genome/Genetic Analysis Research, enforced in 2001, provide specific requirements: (1) the deceased had no intention of refusing organ donation during life; (2) consent of surviving relatives; (3) approval from the ethics review committee; and (4) Permission from the director of the institution. The guidelines officially announced in 2002 by the Ethics Committee of the Japanese Society of Legal Medicine provide that one of the fundamental ethical rules is to obtain consent from surviving relatives. However, if that is difficult, approval from the institutional or academic society's ethics committee is required. In conclusion, no domestic law exists for handling of human materials obtained from autopsy for use in research. New legislation on this issue should be enacted to protect human rights and dignity as well as to promote medical research as soon as possible.