ゲノム・遺伝子解析が付随した治験の倫理審査における課題  ―セントラルIRBの審査体制確立のために―

抄録

Osaka University Hospital has recently received many applications for clinical trials that involve genome analysis. Prior to review by the Institutional Review Board (IRB) of the hospital, these genome analyses are classified into groups A, B, or C, as defined by the Japan Pharmaceutical Manufacturers Association (JPMA), in accordance with the study purpose, target gene, and analysis schedule within the research. The IRB reviews the protocols and written informed consent forms in accordance with the GCP Ordinance and Ethical Guidelines for Human Genome and Genetic Analysis Research. At Osaka University Hospital, disagreements sometimes occur regarding the A, B, and C classification between the sponsors and the IRB. In the present study, we found that 24 applications that include genome analyses were judged as C by the IRB of our hospital, while they were judged as A, B, or even as a no genome analysis by the sponsors. We also conducted a questionnaire survey among other IRBs in Japan to find out their review policies for genome analyses. The questionnaire survey results revealed wide differences among IRBs in their review policies. Centralization of the IRB is currently being promoted to improve the efficiency and quality of ethical review of clinical trials. However, the establishment of a central IRB system requires standardization of the classification of genome analysis and review policies. In addition, sponsors should prepare protocols that clearly state the purpose and procedure of the planned genome analysis, and the hospitals where clinical trials are performed should consider an appropriate review system.