Drug Evaluation Committee 2010-18 Division of Roles between Specialized Clinical Trial Review Committees and their own Institutional Review Boards (Part 1)
Related classification: Clinical Trial Review Committee
First published: August 2010
Question
As a result of a questionnaire survey of IRB members at several sites, the following comments were received regarding the review of safety information.
The following comments were made in response to the survey: "Only safety information provided by the sponsor should be reviewed by a separate review organization (IRB) such as Central IRB, and the results should be reported to the IRB of the investigational site to save time and effort. If the safety information has been properly reviewed by a specialized organization and that organization has determined that there is no problem with the continuation of the clinical trial, then there is no need to go to the trouble of having your own IRB review it."
I think it is true that there is no problem under GCP to hear opinions from multiple IRBs, but what about the fact that there is no need for review by one's own IRB because other IRBs have determined that there is no problem? Can this be addressed in the future?
JPMA's Opinion
As stipulated in Article 30, Paragraph 4 of the GCP, if the Chairperson of the site deems it necessary to have the IRB investigate and deliberate on a specific specialized matter that is a precondition for determining whether or not to conduct a clinical trial, the Chairperson of the site may, with the consent of the relevant investigational review committee, request the investigational review committee other than the relevant investigational review committee (a specialized investigational review committee) to provide its opinion on the said specialized matter. In such a case, the opinions of a committee other than the relevant Clinical Trial Review Committee (Specialized Clinical Trial Review Committee) may be heard. In this case, as stipulated in Paragraph 5 of the same Article, the Chairperson of the site must report the opinions of the expert investigational review committee to the investigational review committee that heard the opinions regarding the appropriateness of conducting the clinical trial at the site. Furthermore, the latter committee must state its opinion on the appropriateness of conducting the clinical trial, based on the opinion of the expert investigational review committee (GCP Article 32, Paragraph 5).
The request for review by the Specialized Investigational Review Committee is based on the assumption that there are no members of the Investigational Review Committee who can provide expert opinions on the trial to be reviewed. We believe that a clinical trial review committee that has a specialized organization review the safety information in question is not fulfilling its responsibilities as a clinical trial review committee, and we recommend that the review be outsourced to an external clinical trial review committee.