According to ICH E6, what must IRBs obtain for the approval of the trial?

In the context of ICH E6, the primary responsibility of Institutional Review Boards (IRBs) is to ensure the protection of the rights, safety, and well-being of trial participants. To fulfill this role, an IRB must thoroughly review and provide approval or a favorable opinion on the trial protocol before the study can commence. This includes evaluating the study’s design, the informed consent process, and the risks versus benefits for participants.

The approval or favorable opinion of the protocol indicates that the IRB has determined that the proposed study has been designed in accordance with ethical guidelines and will adequately protect participants. This is a critical step in ensuring that the trial complies with applicable ethical standards and regulations, which is central to upholding the integrity of clinical research.

While informed consent from all subjects is also a crucial part of ethical research, it is a process that occurs after the IRB has provided its approval on the study protocol. Thus, the approval or favorable opinion of the trial protocol is what is explicitly mandated from the IRB to proceed with the study.