Drug Evaluation Committee 2020-22 Holding a Web-based Clinical Trial Review Committee Meeting
Related classification: Clinical Trial Review Committee
Date of first publication: September 2020
Question
We have been holding IRB meetings via the Internet since this fiscal year for the purpose of preventing coronavirus infection.
We have been handling the process of holding the IRB meetings via the Internet, confirming the identity of the IRB members, and collecting review materials from outside committee members. However, we have received a request from a company to record the location (home, doctor's office, etc.) from which the committee members participated via the Internet based on the opinion in Clinical Trial 119 No. 2011-58 (Holding of Clinical Trial Review Committee Meetings via Teleconference).
Our hospital does not believe that it is necessary to record information on where the member participated via the Web, as long as the member's identity is verified. Our IRB's SOP requires that the location of the meeting be included in the agenda summary, but in the case of a Web meeting, the Web system is the location of the meeting, not the location of the individual participants (home, office, etc.).
We would like to know your opinion on whether we should respond to this case or not.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
We understand that the case in question is a method of holding a Clinical Trial Review Committee meeting in which participants can participate at the meeting place or from individual locations using a web conferencing system, enabling deliberations to be conducted in a manner equivalent to a meeting in which all participants gather together (a face-to-face meeting).
However, when a Web conference system is used as a method of holding a clinical trial review committee meeting, the sponsor may request an explanation from the participants from a location where a third party may know the content of the deliberation from the viewpoint of confidentiality, regardless of whether it is recorded in the meeting record or not. Therefore, it is conceivable that the sponsor may ask for an explanation from the committee. Therefore, if the use of a web conferencing system is an option as a method of holding the meeting, it is desirable to establish procedures including the concept of the place of holding and participating in the meeting, and to manage and operate the system by clearly indicating the appropriate method of participating in the meeting.
Note that the background of 2011-58 is different from the case in question in that the method of holding a Clinical Trial Review Committee meeting is to connect meeting sites located in separate buildings within the same organization by videoconference, and the place of participation is limited to one of the meeting sites.