Drug Evaluation Committee 2014-58 External Members - Scope of "Persons with No Conflict of Interest with the Executing Medical Institution" (Part 6)
Related classification: Clinical Trial Review Committee
First published: July 2015
Question
Is there any problem with appointing an attorney who belongs to a law firm that has an advisory contract with our hospital, other than the attorney in charge of our hospital, as an external member of the Clinical Trial Review Committee?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
We believe that the role of an external member of a clinical trial review committee (a person who has no vested interest in the site) is to provide impartial opinions regarding the implementation of the clinical trial from a standpoint independent of the site and the establisher of the clinical trial review committee.
The lawyer in question has no direct employment relationship with the medical institution in question and can be an external committee member. However, whether or not a colleague of the legal counsel can fulfill the above role must ultimately be determined by the establisher of the clinical trial review committee with a rationale that can be explained to a third party. We hope you will also refer to our previous opinions (2004-03, 2004-18, 2005-04, 2008-17, 2009-10, 2009-55, 2010-19, 2013-17).