Drug Evaluation Committee 2021-07 External Members - Scope of "Persons with No Interests in the Performing Medical Institutions" (Part 8)
Related classification: Clinical Trial Review Committee
Date of first publication: Jul. 2021
Question
I have a question about the appropriateness of IRB members.
GCP Article 28, Paragraph 1, Guidance 5 states the following.
- Employees, etc. of the implementing medical institution do not fall under the category of "persons who do not have an interest in the implementing medical institution.
Does this "employees, etc." include the spouses of physicians working at the implementing medical institution?
The Guidance on the Management of Conflict of Interest under the Clinical Research Act defines "employees, etc." as spouses and their first-degree relatives (parents and children) who share the same living arrangements as the person declaring a conflict of interest.
We would appreciate it if you could give us your opinion on the scope of "etc.".
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The GCP Guidance does not strictly define the scope of "etc." for employees, etc. of the implementing medical institution. However, we believe that this can be used as a basis for judgment, as it states, "For example, staff members of other faculties who have no business relationship with the executing medical institution are considered to be covered by the term 'persons who do not have an interest in the executing medical institution.
In the case of your question, if the spouse of a physician working at the implementing medical institution has an employment relationship with the medical institution or receives money from it, he or she is not considered to be a "person who does not have an interest in the implementing medical institution" as defined in Article 28, Paragraph 1, Item 4 of the GCP. On the other hand, if there is no employment relationship or financial transaction with the medical institution in question, it cannot be ruled that the person does not fall under the category of "a person who does not have an interest in the medical institution in question" merely because he/she is a "physician's spouse," but it is possible that the person has some kind of business relationship with the medical institution in question, or that he/she is independent from the medical institution in question or the establisher of the medical institution in question. However, if a person has some business relationship with the medical institution in question 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 medical institution in question and the investigational review committee, he or she is considered not to be a "person without an interest in the medical institution in question.
It is important that the appropriateness of an external committee member is ultimately determined by the establisher of the clinical trial review committee, based on sufficient evidence so as not to arouse suspicion from a third party. Please refer to the past opinion (Scope of Outside Members - "Persons with No Interest in the Host Medical Institution" (Part 1-7)).