Drug Evaluation Committee 2009-55 Outside Committee Members - Scope of "Persons with No Conflict of Interest with the Investigator Site" (Part 4)
Related classification: Clinical Trial Review Committee
First published: April 2010
Question
Please indicate whether the following cases regarding external members of a clinical trial review committee fall under the category of members who have no vested interest with the investigator and the hospital.
Originally, the president of a university and an employee of the university were registered as external committee members, but recently the hospital and the university signed a memorandum of understanding (mutual cooperation with the university) to strengthen cooperative relations in various areas such as human resource development and joint research. In this case, will the president or staff of the university no longer be considered a disinterested member of the committee?
The establisher of the clinical trial review committee is the President of the hospital, and with regard to the signing of the MOU, it is the President of the university and the Chairperson of the hospital.
JPMA's Opinion
In response to GCP Article 28, Paragraph 1, Item 5 (Persons who do not have an interest in the establisher of the Investigator Site), Article 28, Paragraph 1, Guidance 5 of the GCP states that "Employees of the Investigator Site are not considered '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 (such as the Faculty of Law) who have no business relationship with the Investigator Site are considered to be "persons who do not have an interest in the Investigator Site". The provision stipulates that "a person who does not have an interest in the implementing medical institution" is considered to be eligible.
In the case of your question, there is a mutual cooperative relationship between the hospital and the university in terms of human resource development and joint research, but please determine whether university personnel are appropriate as "persons who do not have an interest in the Investigator Site" based on the nature of the cooperative relationship, especially in terms of joint research (whether there is any interest that involves commercial transactions, etc.). Please judge whether or not it is appropriate for a "person who has no interest in the institution" to be a "person who has no interest in the institution. It is also necessary to confirm that university-related persons are not involved in the development of the investigational drug in question.
Please note that the responsibility for explanation as to whether or not the relevant investigational review committee member has an interest in the current hospital rests with the director, who is the establisher of the investigational review committee.