title: Description and Evaluation of the Research Ethics Review Process in Japan: Proposed Measures for Improvement.
abstract: Research Ethics Committees (RECs) are designed to protect human subjects in research. It is essential to recognize whether the RECs are achieving this goal. Several studies have reported on RECs; however, detailed data regarding the quality of research protocols and the review process of RECs have not been reported in Japan. We examine research protocols reviewed by RECs and the review processes at three institutions using a novel checklist we developed. The data show that approximately half of all examined protocols lacked a clearly written "Background" section that defines the study rationale and design. These results reiterate suggestions made in previous research regarding educational programs and support departments that could enhance responsible conduct in clinical research to protect human subjects in Japan.
authors.affiliation: Kyoto University, Japan msuzuki@cira.kyoto-u.ac.jp.
authors.forename: Mika
authors.initials: M
authors.lastname: Suzuki
authors.affiliation: Kyoto University Hospital, Japan.
authors.forename: Keiko
authors.initials: K
authors.lastname: Sato
mesh_terms: D035843:Biomedical Research / Q000941:ethics* / Q000592:standards; D057189:Checklist; D026724:Ethical Review; D028744:Ethics Committees, Research; D032984:Ethics, Research; D006801:Humans; D007564:Japan; D058996:Quality Improvement
keywords: Japan; document review; education of research methodology and ethics; research ethics; research ethics committee; research support; review process