What must be in place before initiating a trial?

• A. IRB/IEC approval for the protocol only.
• B. A documented and dated approval/favorable opinion from the IRB/IEC for the trial protocol, informed consent materials, and participant recruitment procedures.
• C. Sponsor approval with no IRB involvement.
• D. A signed contract with participants.

Answer: (B)

Before starting a trial, you need independent ethical review and documented approval of the study materials. An IRB/IEC must issue a favorable, dated approval for the trial protocol, the informed consent forms, and the participant recruitment procedures. This ensures the risks and benefits are weighed, participants are adequately informed about what participation involves, and the recruitment methods are ethical and non-coercive. Relying on sponsor approval alone doesn’t provide the required ethical oversight, and a contract with participants isn’t the precondition for initiating the study. No enrollment or data collection should begin until that IRB/IEC approval is in place, and any later changes to documents require new approval before implementation.