Drug Evaluation Committee 2021-07 Outside Members - Scope of "Persons having no vested interest in the Investigator Site" (Part 8)
Related classification: Clinical Trial Review Committee
Date of first publication: July 2021
Question
I have a question about the adequacy of IRB committee members.
In Article 28, Paragraph 1, Guidance 5 of the GCP, there is the following statement: "Employees, etc." means "persons who have no vested interest in the implementing medical institution.
- Employees, etc. of the Investigator Site do not fall under the category of "persons who do not have an interest in the Investigator Site.
Does this "employee, etc." include the spouse of a physician working at the Investigator Site?
The Guidance on the Management of Conflict of Interest under the Clinical Research Act defines a spouse and first-degree relatives (parents and children) who share the same livelihood as the person declaring a conflict of interest as "persons who declare a conflict of interest.
We would appreciate it if you could give us your opinion on the scope of "etc.".
JPMA's Opinion
The GCP Guidance does not strictly define the scope of "etc." for employees, etc. of Investigator Site. However, it states, "For example, a staff member of another department who has no business relationship with the Investigator Site is considered to be a "person who has no interest in the Investigator Site".
In the case of your question, if the spouse of a physician working at the Investigator Site has an employment relationship with the Investigator Site or receives money from the Investigator Site, he or she is not considered to be a "person who does not have an interest in the Investigator Site" as defined in Article 28, Paragraph 1, Item 4 of the GCP. On the other hand, if there is no employment relationship with the Investigator Site, or if there is no financial transaction with the Investigator Site, it cannot be concluded that the person is not a "person without an interest in the Investigator Site" only because he/she is a "physician's spouse," but it is possible that the person has some kind of business relationship with the Investigator Site, or that he/she is independent from the Investigator Site or the establisher of the Investigator Review Committee. However, if a person has some business relationship with the Investigator Site or cannot fulfill the role expected of him or her to provide impartial opinions regarding the implementation of a clinical trial from an independent standpoint from the Investigator Site and the investigational review committee, he or she is not considered to be a "person without an interest in the Investigator Site".
It is important that the appropriateness of an external committee member is ultimately determined by the establisher of the clinical trial review committee, with sufficient grounds to avoid suspicion from a third party. Please refer to the past opinion (Outside Committee Members - Scope of "Persons with No Conflict of Interest with Investigator Site" (Part 1-7)).