Drug Evaluation Committee 2005-09 Concept of "Majority" in the Requirements for Formation of a Clinical Trial Review Committee
Related classification: Clinical Trial Review Committee
First published: Mar 2007
Revised publication date: Mar. 2021
Question
The requirement for the establishment of an IRB at a medical institution is defined as a majority of the number of committee members (members), When we suggested that a majority means more than half of the committee members, and that if there are 12 committee members, 7 members are needed, they said that only your company would make such a request.
In Hospital B, the number of committee members was 11 (including one investigator), and since the investigator was excluded from the deliberation, the committee deliberated with 5 members, which is considered a majority, and since the investigator was excluded from the denominator of the number of committee members, the number of committee members was 10, and the deliberation was approved with 5 members.
I would like to ask for your opinion on whether it is acceptable to calculate the number of committee members by excluding the investigator's assistant from the denominator when the investigator is included in the committee.
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What is a majority in the case of an even number of members?
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Whether or not to subtract the denominator when a clinical investigator is included in the committee members.
Thank you in advance.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
（Regarding (1)
According to the Kojien (Japanese dictionary), a majority means a number exceeding half of the total number of members, and the Dictionary of Legal Terms (Gakuyo Shobo) says, "In the case of a majority vote, a majority, or one-half plus one, is sufficient for passage. Therefore, unless otherwise specified, the condition for satisfying GCP is seven members, not six members, which is half of the twelve members present at Hospital A, the hospital you inquired about.
(2) Regarding (2)
As stated in Article 28, Paragraph 2, Guidance 3 of the GCP, not only is the attendance of so-called non-expert committee members and external committee members essential for a meeting to be successful, but it is also necessary to be able to sufficiently deliberate from ethical and scientific perspectives (to satisfy the requirements of Article 28, Paragraph 1 of the GCP) with only the committee members who deliberate and vote. The requirements of Article 28, Paragraph 1 of the GCP must be fulfilled. Although it is a prerequisite that this requirement is satisfied, if the SOP of the investigational review committee stipulates in advance how to calculate the "majority of the members on the roster," which is a requirement for the establishment of a meeting, in cases where the members of the committee are investigators, subinvestigators, or collaborators, such members may be considered as "members of the roster" from the members of the investigational review committee when calculating the "majority of the members on the roster. If there is a provision in the SOP of a clinical trial review committee in advance as to how to calculate the "majority of the list of members" required for a meeting, then it is acceptable to subtract such members from the denominator of the "majority of the list of members.
Reason for revision of opinion
This opinion was partially changed due to the revision of the GCP Guidance on August 31, 2020.