Drug Evaluation Committee 2013-10 Attendance of Investigators at Clinical Trial Review Committee Meetings (Part 2)
Related classification: Clinical Trial Review Committee
First published: Jul 2013
Question
The vice chairperson of the Investigational Review Board (hereinafter referred to as "IRB") was presiding over the proceedings as acting IRB chairperson in accordance with the provisions of the SOP when the IRB chairperson was absent, and was also in charge of proceedings in the review of a clinical trial for which he was the investigator.
The IRB's response was, "I was only in charge of the proceedings and did not participate in the deliberations or voting. The IRB's response was, "I was only in charge of facilitating the proceedings and did not participate in the deliberations or voting. There are no plans to revise the SOP in the future. The IRB response was, "I was only in charge of facilitating the proceedings and did not participate in the deliberations or voting. I think this is inappropriate from the standpoint of independence of the review, but is the IRB's interpretation acceptable?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
GCP (Article 29, Paragraph 1) clearly states that investigators may not participate in deliberations and voting on their own clinical trials, but it does not state whether or not it is a problem for them to serve as facilitators of such deliberations and voting.
The purpose of Article 29, Paragraph 1 of the GCP, which prohibits the investigator's participation in deliberations and voting, is to allow the investigator to express his/her opinions from an independent standpoint, without being influenced by the party conducting the clinical trial. On the other hand, the facilitator plays an important role in the deliberation and voting by the Trial Review Committee. If the investigator, who is the party conducting the clinical trial, facilitates the deliberation and voting (or even if he/she only facilitates the deliberation before the voting), the free expression of opinions by other committee members may be prevented, and it would be very difficult to convince a third party that there was no such influence. It would be very difficult to convince a third party that there was no such influence.
Therefore, in such cases, it would be desirable to have another committee member serve as the facilitator. However, if it is unavoidable for operational reasons, it is necessary to clearly indicate in the minutes or other records that the facilitator did not participate in the deliberations and voting.