Drug Evaluation Committee 2005-03 Voting Criteria at the Investigational New Drug Review Board (IRB)
Related classification: Clinical Trial Review Committee
Date of first publication: May 2006
Question
This question is about the conditions for approval at an Investigational Research Board (IRB).
When preparing SOPs for the IRB, we prepared a proposal that "approval shall be based on the agreement of all committee members present who have the right to vote," but this was denied by the opinion of the implementing medical institution that "approval shall be based on a majority vote.
According to PMDA's comment, it is preferable to have a 2/3 majority or unanimous agreement.
Is there any official statement on this? Also, please let us know your opinion if there is any problem with approval by a majority.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 29, paragraph 2 of the GCP states that "Members who have not participated in the deliberations may not participate in the voting. However, it does not specify the criteria for voting, such as "a majority" or "2/3 or more". In addition, Article 28, Paragraph 2, Guidance 3 of the GCP states that the IRB must be established by "a majority of the committee members, but at least five or more members must be present. However, the requirement for the IRB to be established is "a majority of the committee members, but at least five members must be present. However, it does not specify the conditions for a vote.
It seems that there are cases where comments are made on the method of voting during GCP on-site inspections, but no such specific guidance seems to be provided in the official description or in the explanatory meetings organized by the regulatory authorities.
Considering the responsibility as an IRB, i.e., protection of human subjects, I think it is important to clarify the reasons for the committee members' disagreement, and if necessary, to request additional materials from the sponsor or other appropriate parties, or invite experts, etc., to hear their opinions and give sufficient consideration to the issue.
Even in cases where a provision is made to approve a decision by a majority vote, the reasons for the objection should be stated in the agenda, and the reasons for the objection should also be stated in the document describing the opinion of the Clinical Trial Review Committee to alert the sponsor and investigators when conducting the clinical trial.