CHEST Medical Writing Tips of the Month:010 治験審査委員会(IRB)に提出する治験申請書の書き方




Writing an Application for a Human Subjects Institutional Review Board*
(CHEST 2006; 130:1605-1607)

The formula for success through the IRB review and approval processes can be summarized as follows: simplify, use simplified language that is easy to understand; justify, provide rationale for the study, the design, the risk to subjects; protect, make clear the many ways that the protection of subjects is provided throughout the research experience; complete, provide complete detailed information in all areas of the required documents; and be consistent, achieve consistency of the information provided in each section and across study-related documents. In this way, investigators writing for an IRB are sure to explain in simple terms the reason for the research and its risks to human subjects, and to clearly demonstrate how those subjects will be protected from risk.

* 簡潔 - 理解しやすく簡潔な言葉を使用する
* 正当化 - 研究、デザイン、被験者のリスクの論理的根拠を述べる
* 保護 - 研究期間を通して被験者を保護するあらゆる方法を明確にする
* 完全性 - 必要な書類のすべての部分に詳細な情報を完全に含める
* 一貫性 - 各セクションおよび研究関連書類全体に記載する情報を統一させる


Human subjects institutional review boards (IRBs) were created as a direct result of ethical concerns about the preservation of autonomy, beneficence, nonmaleficence, and justice pertaining to research in human subjects. These concerns actually began during the Nuremberg trials during which medical experimentation on prisoners of war by Nazi doctors became apparent. Following the creation of the Nuremberg Code of 1945, an international code of ethics was formulated in the Declaration of Helsinki in 1964.


In the United States, rules and regulations of the Public Health Service led to the creation of IRBs in the 1970s. Further regulations, including the Code of Federal Regulations Protection of Human Subjects (45CFR Part 46), are the direct result of various abuses of patient rights, such as those that occurred during the 30-year government-sponsored Tuskegee syphilis study, during which 300 black men with syphilis were followed up longitudinally, yet were untreated, despite the recognized effectiveness of antibiotic treatment for this disease that had been discovered. In conjunction with the regulations under 45CFR46, are the US Food and Drug Administration (FDA) regulations under Title 21, which convey additional requirements and oversight for the protection of human subjects engaged in research that relates to food, drugs, biological agents, and devices.

 米国では、公衆衛生局(Public Health Service)の規定が1970年代IRB設置につながる。
 梅毒に羅患した黒人男性300人を長期にわたって治療をせずに経過観察をしたタスキギー梅毒研究Tuskegee syphilis studyなどから30年をかけて、「被験者の保護」(Code of Federal Regulations Protection of Human Subjects, 45CFR Part 46)などの規則が制定。
*45CFR46に定められた規則と併せて、第21編(Title 21)の元に成文化されたFDA規則集がある。