Drug Evaluation Committee 2016-24 External Members - Scope of "Persons with No Interest in the Implementing Medical Institution" (Part 7)
Related classification: Clinical Trial Review Committee
Date of first publication: August 2016
Question
I have heard that lawyers are special because of the principle of independence. Is it possible for our hospital's legal counsel to be an external member of our Clinical Trial Review Committee (a person who does not have an interest in the implementing medical institution)?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
With regard to the legal advisor in your question, if he/she receives consulting fees, etc. based on a consulting agreement with your hospital, he/she would not fall under the category of "a person who has no interest in the site" as defined in Article 28, Paragraph 1, Item 4 of the GCP. In addition, GCP does not specify the determination of "independence of duties" and "whether or not there is an interest with the implementing medical institution" for attorneys. Therefore, it would be inappropriate for the attorney to serve as an external committee member.
It is important that the appropriateness as an external committee member is ultimately determined by the establisher of the clinical trial review committee, with grounds that can be explained to a third party. Please also refer to our past opinion (Outside Committee Members - Scope of "Persons with No Interest in the Conducting Medical Institution" (No. 1-6)).