花岡 英紀

The University Hospital Clinical Trial Alliance (UHCT Alliance) was established in 2006 with the goal to conduct global studies in Japan, and is presently organized by 7 national university hospitals in the Kanto and Shin-Etsu area To promote more efficient and safer clinical trials, we have been considering the possibility of a centralized IRB (CIRB) system in the Alliance. The outline of our plan is as follows: One of the university hospitals selected for a clinical trial is responsible for both Cooperative Hearing and CIRB, resulting in a shift of the site in charge of member hospitals in the Alliance. The CIRB should review not only "ethical and scientific issues" but also "local issues" such as qualifications of the investigators and the institutions. The CIRB should conduct continuing review of each ongoing trial. In the case of occurrence of significant adverse events in a member hospital, the site voluntarily offers opinions to the CIRB. Low efficiency caused by a small number of member hospitals and the CIRB shifting system seems to be the most serious problem in our plan. A CIRB for three Alliance members, similar to the Alliance system, has been working in an investigator-initiated clinical trial since July 2010. This ongoing system will provide more information about the advantages and disadvantages of our CIRB plan. When the number of member hospitals increases markedly, the methods of reviewing "local issues" should be reconsidered in order to safeguard the rights, safety, and well-being of trial subjects.