If prior consent of the trial subject or the subject's legally acceptable representative is not possible, what must the IRB/IEC determine?

• A. The proposed protocol and/or other documents adequately addresses relevant ethical concerns and meets applicable regulatory requirements for such trials
• B. The trial should be halted
• C. Ethical concerns are irrelevant
• D. The subject should be enrolled without consent

Answer: (A)

When consent cannot be obtained in advance, the IRB/IEC must confirm that the study is designed in a way that ethically protects participants and complies with regulatory requirements for situations where consent may be waived or deferred. This means reviewing the protocol and related documents to ensure they address risks, potential benefits, safeguards, and the specific regulatory criteria for enrolling without prior informed consent (or obtaining consent post hoc) are met. If these elements are not adequately addressed, the study cannot proceed under a waiver. This is why the correct choice is that the protocol and other documents adequately address relevant ethical concerns and regulatory requirements for such trials. Enrolling without consent is not automatically permissible, and ethical concerns are central to the approval decision; halting the trial would only be the outcome if the criteria aren’t met.