Drug Evaluation Committee 2023-22 Obtaining Consent for Handling Personal Information of IRB Members
Related classification: Others
Initial release date: Feb 2024
Question.
The Clinical Trial Office and IRB Office have been disclosing IRB member rosters and providing result notifications in accordance with GCP and related regulations. The IRB secretariat has received a request from the sponsor to explain and obtain consent from the IRB members in accordance with the Act on the Protection of Personal Information.As an IRB secretariat, we would like to avoid any contact, etc. from the sponsor to the IRB members in order to maintain the independence of the IRB, but on the other hand, if it is truly necessary, we must respond to the request.
We have not taken action at this time because the method of explanation and method of obtaining consent presented to us was not appropriate, and the response in the event that consent was not obtained was unclear, but what would be the appropriate action for the IRB secretariat to take?
Pharmaceutical Association's Opinion
Article 28, Paragraph 3 of the GCP stipulates the publication of a list of IRB members. In addition, if the IRB secretariat explains the possibility of cross-border transfer or provision to a third party to the IRB members when appointing them as IRB members, etc., and the IRB members agree that "the fact that they are members of the IRB will be announced" and "the scope of announcement is not limited to Japan," "implied consent" has been obtained, then the IRB members for each client are considered to be "implied" and the IRB members for each client are considered to be "implied" and the IRB members are considered to have agreed to the disclosure of information. If the IRB member has been informed of the possibility of cross-border transfer and provision to a third party and consent has been obtained, there is no need to obtain the consent of the IRB member for each client.Please also refer to the following documents published by the Pharmaceutical Manufacturers Association of Japan (PMAJ).
1) Points to keep in mind regarding the protection of personal information in drug development and secondary use of data (p28 5.1.1)
www.jpma.or.jp/information/evaluation/results/allotment/privacy_points_remember_202204.html
2) Introduction of "Points to keep in mind regarding the protection of personal information in drug development and secondary use of data" (p22: 5.1 Handling of personal information of clinical trial staff, etc.)
w ww.jpma.or.jp/i nformation/evaluation/symposium/2022_09_30.html