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 it acceptable to nominate the Chairperson of a medical institution, who is also a physician, as a member of an investigational new drug review committee (IRB) established by the implementing medical institution? Although Article 29 of the GCP stipulates that the head of the site cannot participate in the deliberations and voting of the IRB, it does not stipulate that the chairman of the board of directors, who is the manager of the medical institution, can participate.
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 a medical institution may attend a clinical trial review committee established by the institution, but may not be a member of the committee or participate in its deliberations or voting. The reason for this is that the person who requests the Investigational Review Committee 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 Investigational Review Committee (the Chairperson of the implementing medical institution), will 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 Chairperson and the head of the site are not the same, we believe that there are concerns about the Chairperson's participation as a member of the Clinical Trial Review Committee as well as the head of the site. Although GCP does not mention the participation of the Chairperson as a member of the Clinical Trial Review Committee, we believe it is important for the Chairperson to make an appropriate decision based on the purpose of the fact that the head of the implementing institution cannot participate as a member.