[Research Ethics on Handling of Clinical Samples].

Abstract

Medical research that has utilized the residual parts of clinical samples after routine laboratory examination has yielded numerous findings and contributed to the progress in clinical medicine as well as the detailed elucidation of pathological states of various diseases. However, ethics guidelines on human medical research have recently been established by the Japanese Government, and the Personal Information Protection Law has now imposed stricter rules. Therefore, the enactment of a new guideline became necessary for the secondary utilization of the residual parts of clinical samples. Basic concepts are proposed as follows: (1) research utilizing the residual parts of clinical samples can be performed using an opt-out form that guarantees the right to refuse'8eing enrolled in a study; and (2) the importance and significance of such studies using residual samples should be disseminated in society. To support the promotion of laboratory medical research and avoid the unnecessary or excessive suppres- sion of research, the Japanese Society of Laboratory Medicine is aiming to devise and disseminate appropriate ethics guidelines. [Review].