Drug Evaluation Committee 2009-25 Publication of Affiliations of Members of Clinical Trial Review Boards
Related classification: Clinical Trial Review Committee
First published: January 2010
Question
Question 1
We changed the affiliation of the IRB external member (pharmacist) who worked at a hospital to "None", but it was pointed out that the affiliation should be written as "Formerly worked at XX hospital" because we cannot judge his eligibility as a member by writing "None". However, it was pointed out that the term "None" should be replaced with "Formerly employed at XX Hospital" because it is impossible to determine eligibility as a committee member.
We believe that only the current affiliation should be listed in the list of committee members, and that a verbal explanation of the past background, etc., should be sufficient to determine eligibility.
Question 2
An external committee member refused to disclose the name of his/her employer to protect his/her privacy, and the IRB office has published the list of committee members for public inspection.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
We believe that it is acceptable to list the affiliations of external committee members who are not currently working as "None" (it is not necessary to list their previous employers or affiliations).
The affiliation of outside committee members is important information to determine whether or not there are any conflicts of interest with the site or the investigational review committee. Therefore, it is undesirable to mask the work or affiliation of the external committee member so that it is impossible to determine whether or not there is a conflict of interest. We recommend that you obtain the understanding of the committee members or devise a way to describe "occupation, qualifications, and affiliations" to the extent that it is possible to determine the existence of an interest (e.g., "securities company employee").