Developing the guidebook for the ethically sound clinical research

[背景]许多研究报告说。调查人员没有制定研究方案的方法技能，机构审查委员会(IRBs)在日本也不能正常运作。我们为研究人员、IRB成员和研究专业人员开发了一本实用指南，以支持协议的编写和审查。[结果]1)我们开发了指南的概念和内容如下：(1)应该如何进行研究？(2)概念分析是必要的(3)制定协议和知情同意文件(4)IRBs的角色和审查协议时应考虑的事项(5)进行研究的机构的角色。这本指南将由医学出版商出版。2)我们开发了手册、模板和样本文件，以帮助调查人员撰写协议和同意书。3)我们为IRB成员制定了检查表，以审查方案和知情同意文件。[未来研究]指南和材料的目的是提供关于研究设计、一些方法技能和IRB审查系统目的的基本背景信息。这些人将是辅助调查人员和IRB成员，然而，许多悬而未决的问题仍然需要进行科学和合乎道德的研究。应建立促进地方责任的教育和认证制度、规则和政策，以保护研究参与者。

[Background]A number of studies have reported that. investigators have no methodological skills to develop research protocol and institutional review boards (IRBs) do not function appropriately in Japan. We developed a practical guidebook for investigators, IRB members and research professionals to support writing and reviewing the protocol.[Results]1)We developed concept and contents of the guidebook as follows : (1)How should research be done? (2)Conceptual analysis is necessary (3)Developing protocol and informed consent documents (4)Role of IRBs and the points to consider when reviewing protocols (5)Role of institution that conducts research. This guidebook will be published by a medical publisher.2)We developed manuals, templates and sample documents to help investigators write protocols and consent forms. These will be released on internet homepages.3)We developed check lists for IRB members to review protocols and informed consent documents.[Future research]The purpose of the guidebook and materials is to provide a basic background information on research design, some of the methodological skills and purpose of the IRB review system. These will be support investigators and IRB members, however, many unsolved problems remain to conduct scientifically and ethically sound research. Education and certification systems, rules and policies to promote local responsibilities should be established to protect research participants.