Developing the guidebook for the ethically sound clinical research

[研究背景]已有多项研究报道。在日本，研究者没有方法学技能来制定研究方案，机构审查委员会（IRB）也没有适当地发挥作用。我们为研究者、IRB成员和研究专业人员编写了一本实用指南，以支持撰写和审查方案。[结果]（1）初步形成了指导手册的概念和内容：（1）如何进行研究;（2）概念分析是必要的（3）制定方案和知情同意文件（4）IRB的作用和审查方案时要考虑的要点（5）开展研究的机构的作用。这本指南将由一位医学专家出版。2）我们开发了手册、模板和样本文件，以帮助研究者撰写方案和同意书。这些将在互联网主页上发布。3）我们为IRB成员制定了检查列表，以审查方案和知情同意文件。[未来的研究]指南和材料的目的是提供研究设计的基本背景信息，一些方法技巧和IRB审查系统的目的。这些将是支持研究者和IRB成员，然而，许多未解决的问题仍然存在，以进行科学和道德上合理的研究。应建立教育和认证制度、规则和政策，促进地方承担责任，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.