[Japanese guidelines on research use of human materials and disease information].

Demand on the use of human materials and personal disease information for research and development comes on the stage of action. International competition in biomedical and pharmaceutical research pushed the government and related societies about to release guidelines on the issue to ensure the protection of direct and indirect research participants. To work on human materials and information now requires ethical and scientific review by the research ethical committee and the guidelines set the stage of reviewing process. We should aware of the overall view of situation around and of the guidelines before planning the experiments and analyses on human materials and personal information. In this review we summarized the related guidelines and put comments on them to help researchers to understand the situation.