Chiba Shigeru
Department of Hematology, Faculty of Medicine, University of Tsukuba.
Rinsho Ketsueki. 2019;60(9):1366-1371. doi: 10.11406/rinketsu.60.1366.
A conflict of interest (COI) is a conflict between private interests and one's official responsibilities. COI is unavoidable and thus needs to be managed. Debates about COI in medical research area began in the United States in the 1980s. COI clause was added to the Helsinki Declaration in the year of 2000 after the Gelsinger affair. Discussions in Japan subsequently followed, and COI management guidelines have been sequentially presented by different organizations, particularly after the Diovan incident in 2013. Guidelines presented by the Japan Medical Association (JMA) in 2017 are currently regarded as standard. COI disclosure is required at research presentations and medical practice guideline announcements, among others, and should be carefully managed in the latter. In 2018, the Japanese Society of Hematology announced revision of the Japanese Society of Internal Medicine common guidance, presenting it in accordance with the JMA's guidelines. In the "Specific Clinical Research" section defined in the "Clinical Research Method Enforcement Rule", people who should not take a representative position or who should pay special attention when taking it are defined.
利益冲突(COI)是个人私利与官方职责之间的冲突。利益冲突不可避免,因此需要加以管理。医学研究领域中关于利益冲突的讨论始于20世纪80年代的美国。在盖辛格事件之后,2000年《赫尔辛基宣言》增加了利益冲突条款。日本随后也展开了讨论,不同组织相继出台了利益冲突管理指南,尤其是在2013年缬沙坦事件之后。日本医学协会(JMA)在2017年出台的指南目前被视为标准。在研究报告和医学实践指南发布等场合需要披露利益冲突,在后者的情况下应谨慎管理。2018年,日本血液学会宣布修订日本内科医学会通用指南,并按照日本医学协会的指南予以发布。在《临床研究方法实施规则》所定义的“特定临床研究”部分,明确了不应担任代表职务或担任该职务时应特别注意的人员。