Secretariat, Alumni Association, IDAC
Date Thursday, December 15, 2016 (18:30 – onwards)
Room 7th Floor, Seminar Room 1, IDAC Center for Basic Aging Research
Title Introduction for Clinical Research: Basic Concept of the Rule and Guidelines for
Approval
Speaker Takano Tadao, MD
Affiliation Clinical Research, Innovation and Education Center, Tohoku University Hospital
Organizer Yoshinori Okada (Department of Thoracic Surgery・ext 8520)
Organizer Tetsu Sado (Department of Thoracic Surgery・ext 8526)
Abstract The purpose of a clinical trial is to ensure that human dignity and rights are to be protected, and that medical and health research involving human subjects are promoted appropriately through rules and procedures. To all those concerned with this type of research must do so in accordance with new guidelines, such as “Ensuring scientific validity”, “Comprehensive assessment of the burdens on research subjects and predicted risks and benefits”, “Adequate prior explanation and voluntary informed consent” and “Protection of personal information”. In this seminar, I would like to discuss both the basic concept of the new guidelines and the important points in terms of the approval standards by the ethics committee.