Drug Evaluation Committee 2005-04 Participation in Deliberations and Voting by Members of a Clinical Trial Review Committee Who May Be Subjects of the Study
Related classification: Clinical Trial Review Committee
Date of first publication: May 2006
Question
If an external member of an investigational review board (IRB) is attending the institution as a patient or is scheduled to be a subject of the trial, is there any problem under GCP for this external member to participate in the deliberations and voting of the IRB?
JPMA's Opinion
Regarding external committee members, Article 28 of the GCP states that they are "persons who do not have an interest in the Investigator Site," and Article 28, Paragraph 1, Guidance 5 of the GCP describes examples regarding the existence or non-existence of business relationships. However, interest is not limited to business relationships, and a case such as the one in question is considered to be a case of interest, and in the case in question, it is judged that there is a problem under GCP. In addition, even if the patient is not attending the hospital, if the patient is scheduled to be a subject of the clinical trial, the committee member's judgment may be arbitrary, and the requirements for IRB members as third parties (independent of both the sponsor and Investigator Site) as well as external committee members may be questioned.
In order to avoid such a situation, we think it is necessary to take measures such as having multiple external committee members and not allowing committee members who fall under the situation described in your question to participate in deliberations and voting.