Drug Evaluation Committee 2007-12 Eligibility of Clinical Trial Review Committee Members
Related classification: Clinical Trial Review Committee
Date of first publication: Jan. 2008
Question
We would like to inquire about the composition of the Clinical Trial Review Committee when requesting a new clinical trial.
The medical institution (clinic) where we are planning to request a clinical trial has a Clinical Trial Review Committee, but the Chairperson of the committee is the wife of the head of the medical institution, so I have a question as to whether the committee can conduct an impartial review. The head of the medical institution, who is also a candidate for principal investigator, claims that there is no problem because he considers living together and deliberation of the clinical trial separately.
The Chairperson is the only physician on the committee, and if he/she decides not to participate in the voting, there will be no more physicians.
JPMA's Opinion
Your question is about a case in which the spouse of the investigator (i.e., the head of the institution) is appointed as a member (Chairperson) of the Clinical Trial Review Committee, but it does not fall under Article 29, Paragraph 1, Items 1-3 of the GCP, which stipulates that the spouse may not participate in the deliberations and voting. Furthermore, Article 29, Paragraph 1, Guidance 1 of the GCP states in a supplementary clause that "Members who are related to the investigator shall not participate in the deliberation and voting on matters related to the clinical trial at the investigational review committee. Explanation is not given as to whether or not the case in question falls under this "related" category.
Although it is not possible to determine that the Chairperson is an inappropriate committee member under the GCP solely because he/she is the spouse of the investigator, it would be necessary to determine individually whether or not the Chairperson is able to give his/her opinion to the Director from an independent standpoint.
In addition, Article 28, Paragraph 1 of the GCP stipulates that a clinical trial review committee must be "capable of fully discussing the clinical trial from ethical and scientific viewpoints," and Article 28, Paragraph 1, Guidance 10 of the GCP stipulates that "the clinical trial review committee may request the attendance and cooperation of experts in special fields who are not members of the committee. The GCP Article 28, Paragraph 1, Guidance 10 stipulates that "the clinical trial review committee may request the attendance and cooperation of experts in special fields other than the members. It may be important to confirm the opinion of the Chairperson of the site (the establisher of the clinical trial review committee) regarding the fact that only one member of the clinical trial review committee is qualified as a physician, and to take measures such as proposing the addition of a member or requesting the cooperation of an expert other than a member of the committee.
Reason for revision
Explanation of GCP Article 29, Paragraph 1, Guidance 1 has been changed in accordance with the revision (October 24, 2011) of "Implementation of the Standards for Clinical Trials on Pharmaceuticals".