Drug Evaluation Committee 2010-29 Establishment of an Institutional Review Board by a Medical Practitioner Affiliated with a Corporation that Owns a Clinical Trial Review Committee
Related classification: Clinical Trial Review Committee
First published: October 2010
Question
Our hospital is one of the hospitals affiliated with a certain corporation. Currently, a joint IRB has been established with the heads of all affiliated hospitals of this corporation as the establishers, but there is a plan to change this IRB to an IRB established by the corporation (corporate IRB) instead of a joint IRB of all affiliated hospitals in the future.
Since our hospital has been in existence for a shorter period of time than the other affiliated hospitals, and since we are located far from each other, and even though we are affiliated to one corporation, we consider ourselves separate as a medical institution, we had wanted to establish our own IRB from the very beginning of our establishment. However, the corporation has stated that all affiliated hospitals must be represented on the corporate IRB (thus, the establishment of our own IRB would not be allowed), and the reason for this is that all affiliated hospitals of a single corporation must have one unified view on the same matter, and the international joint IRB will be established in the future. In addition, the above-mentioned unified corporate view is very important as the number of global clinical trials increases in the future.
As for our hospital, as mentioned above, even if two hospitals are affiliated with the same corporation, they are different medical institutions, so there is no need to select the same IRB only because they are affiliated with the same corporation. Therefore, it is possible that different medical institutions may have different deliberation results even for the same case.
Also, even in the case of global clinical trials, if they are conducted only at our affiliated hospitals, but other institutions also participate, we do not think it is significant to unify the views of only our organization.
So here is my question. （Please tell us your opinion on GCP in general, without considering the policy of the corporation.)
- Even if an organization (corporation) affiliated with a certain hospital establishes a "corporate IRB," is there any problem with the hospital establishing its own IRB and submitting its deliberations to that IRB? Also, is it possible to select either a corporate IRB or a medical institution-established IRB depending on the case?
- Do you think it is important to have a unified view on global clinical trials by a corporation or other group organization, separately from other clinical trials?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Answer 1
Under GCP, even if a school corporation, etc., to which an investigational institution belongs, establishes a clinical trial review committee, it does not preclude an investigational institution from establishing its own clinical trial review committee.
Article 27, Paragraph 1, Guidance 2 of the GCP states, "The head of the implementing medical institution shall establish the procedures necessary for selecting an appropriate clinical trial review committee, and shall select a clinical trial review committee that has sufficient personnel to conduct investigations and deliberations, and is capable of deliberating and evaluating from ethical, scientific, and medical/pharmacological perspectives, for each clinical trial. The regulations stipulate that "an appropriate committee shall be selected for each clinical trial, and a request for investigation and deliberation shall be made to the committee. The following is stipulated in the regulation. Therefore, there is no problem in selecting a different Investigational Review Committee for each clinical trial and requesting them to conduct investigation and deliberation in accordance with the procedure.
However, the original GCP stipulated that only the site of the implementing medical institution was to establish a clinical trial review committee and that only that committee was to be requested to conduct deliberations. The head of the medical institution can select an appropriate committee and request its deliberation. This is intended to facilitate the smooth implementation of clinical trials in Japan, and the Central IRB is considered to be a part of this. Therefore, when setting up a Clinical Trial Review Committee at individual medical institutions, please make your decision in consideration of the purpose of the GCP revision, which aims to improve the efficiency of clinical trials and reduce the burden on the sponsor and the medical institution (the Clinical Trial Review Committee).
Answer 2
The position and the way of being of a clinical trial review committee does not change just because it is an international joint clinical trial.