Drug Evaluation Committee 2010-21 Public Access to Information System and Clinical Trial Review Committee Meeting Agenda
Related classification: Clinical Trial Review Committee
Initial release date: August 2010
Revised release date: Mar. 2021
Question
The city in which the municipal hospital is located has an information disclosure system (a system under which administrative documents held by the mayor and other organizations are made public upon request by citizens). The hospital business administrator is included in the organizations that implement this system. The information that is not disclosed includes 1) information on individuals and 2) information on corporations.
Since the minutes of ethics committee meetings and other meetings are subject to disclosure at hospitals, we assume that the minutes of clinical trial review board (IRB) meetings are also subject to disclosure. Therefore, we have been instructed not to include the names of the committee members during the question-and-answer sessions in the minutes. They do not want to keep which committee members asked what kind of questions. (The list of committee members, the IRB-SOP, and a summary of the meeting record are published on our website.)
In addition, if the information is disclosed, questions about the content of the clinical trial in the Q&A session would be considered an infringement of confidentiality and the sponsor's intellectual property. Therefore, it is expected that many of the contents will no longer be kept in the meeting minutes.
The proposal to prepare a separate summary of the minutes for publication has been rejected by the hospital. It has been pointed out that treating the summary of the meeting record as the minutes is insufficient in terms of content. We believe that contents that cannot be disclosed to the public (those that violate confidentiality) or those that are inconvenient for the hospital should not be included.
If the minutes are written in accordance with the hospital's view, it is possible that the content of the deliberations will not be preserved and the minutes will lose their meaning.
There is no description in the hospital SOP or IRB SOP regarding the content of the minutes.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
GCP Article 28, Paragraph 2, Guidance 8 stipulates that the "record of the meeting" (minutes) should include not only the conclusions of the deliberations (approval, disapproval, etc.), but also the names of the committee members who participated in the deliberations and voting, as well as a summary of the proceedings. This is stipulated in the "Minutes of the Meeting". Although there is no mention of how much detail should be included in the summary of the proceedings, it is desirable to include the background to the results of deliberations, what opinions were expressed by the committee members, what discussions took place, and any other details that are considered particularly important. If it would hinder active deliberation by the committee members, it is acceptable not to specify which questions were asked by which committee members.
In disclosing information, it is acceptable to follow the city's information disclosure system, and if necessary, ask the sponsor to confirm the information, and take measures such as masking personal information and intellectual property rights that are considered to be undisclosed.
Reason for revision of opinion
The content has been changed in accordance with the revision of the GCP Guidance (August 31, 2020, Pharmaceutical Affairs Bureau of Japan, No. 0831-15).