The use of human samples obtained during medicolegal autopsies in research: An introduction to current conditions and initiatives in Japan.

Background Leftover samples obtained during autopsies are extremely important basic materials for forensic research. However, there are no established practices for research-related use of obtained samples. Objective This study discusses good practice for the secondary use of samples collected during medicolegal autopsies. Methods A questionnaire was posted to all 76 departments of forensic medicine performing medicolegal autopsies in Japan, and 48 responses were received (response rate: 63.2%). As a secondary analysis, we surveyed information provided on department websites. Results Ethical reviews conducted when samples were to be used for research varied greatly among departments, with 21 (43.8%) departments reporting 'fundamentally, all cases are subject to review', eight (16.7%) reporting 'only some are subject to review' and 17 (39.6%) reporting 'none are subject to review'. Information made available on websites indicated that 11 departments had a statement of some type to bereaved families about the potential research use of human samples obtained during autopsies. Nine of these included a notice stating that bereaved families may revoke their consent for use. Several departments used an opt-out system. Conclusion There is no common practice in the field of legal medicine on the ethical use for medical research of leftover samples from medicolegal autopsies. The trust of not only bereaved families but also society in general is required for the scientific validity and social benefits of medical studies using leftover samples from medicolegal autopsies through the use of opt-out consenting and offline and online dissemination and public-relations activities.