Drug Evaluation Committee 2004-03 Appropriateness of Nominating Faculty Members of Medical Colleges as External Committee Members
Related classification: Clinical Trial Review Committee
Initial release date: June 2004
Revised publication date: March 2021
Question
I have a question regarding the members of the IRB. We have appointed a professor from the College of Liberal Arts and Sciences of a medical school as an external member who has no interest in our hospital, but is this a problem under GCP?
The IRB is established by the president of the medical school, and the actual operation of the IRB is entrusted to the dean of the medical school hospital. The IRB is held in response to requests for review from the respective hospital directors of the University's several affiliated hospitals.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
GCP Article 28, Paragraph 1, Guidance 5 states, "When the operating institution is an affiliated hospital of a medical school of a university with multiple faculties, faculty members of other faculties (e.g., law faculty) who have no business relationship with the operating institution are considered eligible for "persons who do not have an interest in the operating institution. However, in the case of a medical university, even a professor of a different department from the medical school may be indirectly involved in the management of the affiliated hospital through faculty meetings, etc., and it may be difficult to show that he/she has no vested interest in the affiliated hospital. Furthermore, since the president is the establisher of the IRB and the hospital director is responsible for its operation, it would be difficult to show that there is no conflict of interest even if the professor is from another department. In light of the above, we believe that it is essential to avoid any doubt when appointing "a member who has no interest in the implementing institution," which is one of the requirements for constituting an IRB, and that as many people outside the university as possible should be asked to serve on the IRB, but if a person within the university is to be appointed as a member, it is necessary to show that he/she has no interest (e.g., in the university's However, when appointing a person from within the university as a committee member, it is necessary to show that there is no conflict of interest (e.g., in the organization of meetings within the university or in business) with the implementing medical institution.
Reason for revision of opinion
With the issuance of the GCP Guidance (No. 0831-15 issued by the Pharmaceutical Affairs Agency on August 31, 2020), minor improvements have been made to the description.