Drug Evaluation Committee 2009-10 Outside Members - Scope of "Persons with No Conflict of Interest with the Investigator Site" (Part 3)
Related classification: Clinical Trial Review Committee
First published: Jul 2009
Question
I have a question regarding the scope of "a person who has no vested interest in the Investigator Site" as an external member of a Clinical Trial Review Committee.
Due to the replacement of an external committee member, we are considering a replacement.
The candidate is a professor of pharmaceutical informatics at a nearby university's Faculty of Pharmacy.
Due to the proximity, there is a situation in which our university hospital's pharmacy department accepts many pharmacy students for internship.
When we asked the sponsors of clinical trials being conducted at our hospital about their views on the candidate's suitability, most of them answered that there was "no problem," but a few companies answered that there was a "gray area" or that the candidate was "inappropriate.
The reasons for "gray area" and "inappropriate" were that "the pharmacy school would be in the position of requesting the training," and "in the case of pharmacy student interns, money would be transferred between the organizations to cover the cost of the training. Even if no transfers occur between the candidates themselves, as long as there is a conflict of interest between their organizations, they should avoid serving as external committee members." This is the case.
In general, we believe that there are external committee members affiliated with pharmacy schools, and it is also normal for medical institutions to accept hospital training for pharmacy students. (Practice fees are incurred by all facilities.)
JPMA's Opinion
In response to GCP Article 28, Paragraph 1, Item 4 (Persons who do not have an interest in the Investigator Site), Guidance 5 of the GCP states that "Employees, etc. of the Investigator Site do not fall under the category of "persons who do not have an interest in the Investigator Site. However, for example, if the Investigator Site is a hospital affiliated with a medical school of a university with multiple faculties, faculty members of other faculties (e.g., law faculty) who have no business relationship with the Investigator Site are considered to be "persons who do not have an interest in the Investigator Site. This is stipulated as "a person who has no interest in the executing medical institution.
The case in question is a faculty member of another university corporation and is not working as an employee of the Investigator Site. In addition, the acceptance of the hospital training is a business based on a contract between the Investigator Site and the university corporation, and there is little direct interest between the candidate and the external committee member in question. In addition, it is considered that there is little influence from the interest relationship that accompanies general business transactions. Therefore, there should be no problem with their nomination as external committee members.
In addition, it is necessary for the establisher of the Investigator Site to make an individual judgment on the appointment of the external committee member, taking into consideration not only the relationship between the organization and the organization, but also the relationship between the Investigator Site and the candidate.