Who should vote during the IRB/IEC review and discussion process?

During the IRB/IEC review process, only members who actively participated in the review and discussion are eligible to vote. This ensures that votes are cast by those who are adequately informed about the study and can make an educated decision. Non-member experts may participate in discussions but do not have voting rights.

GCP guidelines state that voting rights in IRB/IEC meetings are limited to members who have thoroughly reviewed and discussed the study, maintaining unbiased and informed decision-making.

"Only IRB/IEC members who were involved in the review and discussion should participate in the voting process."

Objectives:

Ensure informed voting in ethical review processes.

Maintain integrity and objectivity in IRB/IEC decisions.