Drug Evaluation Committee 2012-08 Pros and Cons of Nominating the Chairperson of a Medical Institution as a Member of a Clinical Trial Review Committee
Related classification: Clinical Trial Review Committee
First published: Jun. 2012
Question
Is there any problem with appointing the Chairperson of the Investigator Site as a member of the Investigational Review Board (IRB), who is also a physician? Although Article 29 of the GCP stipulates that the head of the Investigator Site may not participate in the deliberations and voting of the IRB, there is no provision for the chairman of the board of directors, who is the manager of the Investigator Site.
Under GCP, the head of a medical institution cannot participate in an IRB established by himself/herself, and the opinion of the Chairperson of the IRB, who is the manager of that medical institution, may have an impact on the clinical trial in question, and we believe that he/she is inappropriate as an IRB member. I have seen many IRBs in the past, but this is the first case in which the Chairperson is an IRB member. Also, please tell us why the head of a medical institution cannot participate in an IRB established by himself/herself.
JPMA's Opinion
As stipulated in Article 28, Paragraph 1, Guidance 4 of the GCP, the Chairperson of an Investigator Site may attend the Investigational Review Committee established by the Investigator Site, but may not be a member or participate in deliberations or voting. The reason for this is that a person who requests the Investigator Site to investigate and deliberate on the appropriateness of conducting a clinical trial, and who is in a position to give instructions and make decisions based on the opinions of the Investigator Site (Chairperson), may participate in deliberations and voting on the appropriateness of the said clinical trial on his/her own, which may bias the review and opinions at the investigational review committee. One reason for this may be the possibility of bias in the review and opinions of the Clinical Trial Review Committee.
Although the authority and roles of the Chairman of the Board of Directors and the Chairperson of Investigator Site are not the same, we believe that there are concerns about the participation of the Chairman of the Board of Directors as a member of the Clinical Trial Review Committee, as well as the Chairperson of Investigator Site. Although GCP does not mention the participation of the Chairperson as a member of the Clinical Trial Review Committee, we believe that it is important for the Chairperson to make an appropriate decision based on the purpose of the fact that the head of the Investigator Site cannot participate as a member of the Committee.