Before starting a trial, which statement about IRB approval is correct?

Before starting a trial, which statement about IRB approval is correct?

• A. IRB approval is optional.
• B. IRB approval or favorable opinion must be obtained prior to initiating the trial.
• C. IRB approval is required only for multicenter trials.
• D. IRB approval can be substituted with sponsor approval.

Answer: (B)

The key idea is that protecting people in research requires IRB review before any study begins. An IRB approval, or at least a favorable opinion, must be in place prior to starting the trial, including before enrolling the first participant. This ensures the study has been reviewed for risks, benefits, informed consent, and protections for subjects, and it establishes ongoing oversight. Sponsor authorization or sponsorship approval does not substitute for IRB review; IRB approval is a regulatory and ethical requirement, not something that can be bypassed by the sponsor. In multicenter studies, each site generally needs IRB approval or an approved reliance arrangement, so that every location involved is properly reviewed before it starts. Therefore, the statement that IRB approval or favorable opinion must be obtained prior to initiating the trial is the correct one.

The key idea is that protecting people in research requires IRB review before any study begins. An IRB approval, or at least a favorable opinion, must be in place prior to starting the trial, including before enrolling the first participant. This ensures the study has been reviewed for risks, benefits, informed consent, and protections for subjects, and it establishes ongoing oversight.

Sponsor authorization or sponsorship approval does not substitute for IRB review; IRB approval is a regulatory and ethical requirement, not something that can be bypassed by the sponsor. In multicenter studies, each site generally needs IRB approval or an approved reliance arrangement, so that every location involved is properly reviewed before it starts.

Therefore, the statement that IRB approval or favorable opinion must be obtained prior to initiating the trial is the correct one.