The Role of the Translational Research Coordinator and Trials to Maintain Medical Ethics in Translational Research: Focus on Activities Related to Informed Consent

Abstract

Translational research is the development of new treatments for currently incurable illnesses, based on cutting edge findings in scientific research. The main purpose of translational research for cancer is the evaluation of safety and pharmacokinetics of current phase I trials. In order to conduct translational research and to maintain the highest medical ethics and scientific methods, Translational Research Coordinators (TRCs) at the Research Hospital of the Institute of Medical Science of the University of Tokyo objectively monitor intra-institutional research from the third party perspective. The present paper describes: 1) the role of TRCs in translational research; 2) activities related to informed consent; and 3) aspects related to advanced ethical problems. TRCs comprise pharmacists, research nurses, certified clinical psychologists, registered dieticians, and medical technologists. TRCs monitor and oversee ethical and scientific compliance in their specialized field. Activities related to informed consent are as follows: 1) indicate inappropriate descriptions in informed consent documents, and propose alternative descriptions to physicians; 2) arrange schedules for the interview of informed consent; 3) provide physicians for exercises on the explanation of informed consent; 4) explain the content of protocols to participants before informed consent is obtained; 5) when informed consent is obtained, confirm and evaluate the adequacy of explanations given by physicians, and check the understanding and mental condition of participants. The role of TRCs is nearly established, however, such a careful monitoring system will be necessary in the future to achieve a higher level of medical ethics.