Drug Evaluation Committee 2007-24 Relationship between the Opinions of the Clinical Trial Review Committee and the Decision of the Chairperson of the Medical Institution Conducting the Trial
Related classification: Clinical Trial Review Committee
First published: Jan. 2008
Revised publication date: Mar. 2012
Question
Please tell us about the role of IRBs.
- The IRB is not a decision-making body of a hospital.
- The hospital decides whether or not to conduct a clinical trial, and if it decides to conduct a clinical trial, the IRB's opinion is heard.
- If information on serious adverse drug reactions is obtained during a clinical trial, the responsible physician reviews it, decides whether or not to continue the clinical trial, and reports it to the hospital director (not specified in GCP).
- If the responsible physician's decision is that the clinical trial can continue, the hospital director asks for the opinion of the IRB → The IRB reviews the adverse event and makes a decision to approve (the responsible physician's decision), approve with conditions, reject, or revoke the approval already given.
- If the investigator's decision is to discontinue or suspend the trial, the hospital director notifies the IRB and the sponsor.
In short, the hospital first makes a decision and then listens to the IRB's opinion, not the hospital's decision based on the IRB's review results. First, please tell me if my understanding above is correct.
The only case in which the result of the IRB's deliberation differs from the hospital director's decision to direct the trial can be when the IRB approves the conduct or continuation of the trial and the hospital director denies it. This means that the IRB deliberation comes first, and then the hospital director decides whether to conduct or continue the clinical trial based on the IRB's deliberation.
What is your opinion on this?
JPMA's Opinion
Article 30, Paragraph 1, Guidance 1 of the GCP states that "The Chairperson of the implementing medical institution shall obtain the opinion of the Investigational Review Board (IRB) under Article 27, Paragraph 1 in advance regarding the appropriateness of conducting a clinical trial at that institution. The director of the site is required to obtain the opinion of the Investigational Review Board (IRB) on the suitability of the clinical trial before deciding to accept the clinical trial. Therefore, the procedure described in your question is not "the hospital must first make a decision and then hear the IRB's opinion, not the hospital's decision based on the IRB's review results," but rather "if there is a possibility that the hospital will accept the clinical trial, the head of the site must hear the IRB's opinion, The correct understanding is to "make the final decision based on the IRB's opinion.
Reason for revision
Explanation of GCP Article 30, Paragraph 1, Guidance 1 has been changed in accordance with the revision (October 24, 2011) of the "Implementation of Standards for Clinical Trials on Drugs".