Akabayashi Akira, Slingsby Brian T, Nagao Noriko, Kai Ichiro, Sato Hajime
Department of Biomedical Ethics, Graduate School of Medicine University of Tokyo University of Tokyo 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan.
BMC Med Ethics. 2007 Jun 29;8:8. doi: 10.1186/1472-6939-8-8.
Ethics committees and their system of research protocol peer-review are currently used worldwide. To ensure an international standard for research ethics and safety, however, data is needed on the quality and function of each nation's ethics committees. The purpose of this study was to describe the characteristics and developments of ethics committees established at medical schools and general hospitals in Japan.
This study consisted of four national surveys sent twice over a period of eight years to two separate samples. The first target was the ethics committees of all 80 medical schools and the second target was all general hospitals with over 300 beds in Japan (n = 1457 in 1996 and n = 1491 in 2002). Instruments contained four sections: (1) committee structure, (2) frequency of annual meetings, (3) committee function, and (4) existence of a set of guidelines for the refusal of blood transfusion by Jehovah's Witnesses.
Committee structure was overall interdisciplinary. Frequency of annual meetings increased significantly for both medical school and hospital ethics committees over the eight years. The primary activities for medical school and hospital ethics committees were research protocol reviews and policy making. Results also showed a significant increase in the use of ethical guidelines, particularly those related to the refusal of blood transfusion by Jehovah's Witnesses, among both medical school and hospital ethics committees.
Overall findings indicated a greater recognized degree of responsibilities and an increase in workload for Japanese ethics committees.
伦理委员会及其研究方案同行评审系统目前在全球范围内使用。然而,为确保研究伦理和安全的国际标准,需要有关各国伦理委员会质量和功能的数据。本研究的目的是描述日本医学院校和综合医院设立的伦理委员会的特征和发展情况。
本研究包括在八年时间内分两次向两个不同样本进行的四项全国性调查。第一个目标是所有80所医学院校的伦理委员会,第二个目标是日本所有床位超过300张的综合医院(1996年为1457家,2002年为1491家)。调查工具包含四个部分:(1)委员会结构,(2)年度会议频率,(3)委员会功能,以及(4)是否存在针对耶和华见证人教派拒绝输血的一套指导方针。
委员会结构总体上是跨学科的。在这八年中,医学院校和医院伦理委员会的年度会议频率均显著增加。医学院校和医院伦理委员会的主要活动是研究方案评审和政策制定。结果还显示,伦理准则的使用显著增加,尤其是在医学院校和医院伦理委员会中与耶和华见证人教派拒绝输血相关的准则。
总体研究结果表明,日本伦理委员会的责任认可度更高,工作量增加。