トランスレーショナルリサーチ・コーディネーター業務の経過と各職種における専門性および問題点の明確化

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Translational research refers to developmental research that establishes new therapy, based on findings obtained by basic studies, for patients with diseases for which there is no established therapy. The roles of translational research coordinators (TRCs) at the Research Hospital of the Institute of Medical Science of the University of Tokyo are to preserve the scientific nature of translational research and to confirm compliance to medical ethics. These coordinators support protocol compliance, manage data, perform the various duties related to informed consent, manage documents, and care for participants. TRCs are recruited from the following personnel: pharmacists, nurses, clinical psychologists, registered dieticians, and laboratory medical technologists. Almost three years have passed since the current TRC system was put into place, and the director for each job type was asked to look back over this period to clarify: 1) contents of their activities; 2) specialty of each job type; 3) current problems; and 4) means to resolve the problems and future tasks, so that the TRC system can function even more efficiently in the future. The present article deals mostly with the activities of clinical psychologists. The results indicated the following future tasks for clinical psychologists within the TRC system: 1) to establish means to judge psychological fit of subjects prior to their enrolment into translational research and define criteria related to this; 2) to systemize psychological intervention techniques that take into account progression in translational research and changes in subject symptoms; and 3) to establish concrete plans for higher ethical standards to improve participant quality of life. In addition, the following two problems, common to all job types, were identified: 1) lack of communication and collaboration with field personnel, and 2) lack of time to perform regular duties besides those required for translational research. Furthermore, several problems unique to each job type were identified. Hence, based on the results of the present study, it will be necessary to further improve the TRC system and enhance ethical compliance in translational research.
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トランスレーショナルリサーチ・コーディネーター業務の経過と各職種における専門性および問題点の明確化

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