For a non-therapeutic trial conducted with consent of the subject's legally acceptable representative, what must the IRB/IEC determine?

• A. The sponsor approves the protocol
• B. The proposed protocol and/or other documents adequately addresses relevant ethical concerns and meets applicable regulatory requirements for such trials
• C. Consent is not required
• D. The trial has potential therapeutic benefit

Answer: (B)

If a study is non-therapeutic and involves a subject who cannot consent, with consent provided by a legally acceptable representative, the IRB/IEC must verify that the proposed protocol and related documents adequately address ethical concerns and comply with applicable regulatory requirements for such trials. This means the IRB checks that the study design minimizes risks, protects the subject’s welfare and privacy, and that the consent process through the legally acceptable representative is appropriate and properly documented, all in line with GCP and local regulations. The sponsor’s approval of the protocol alone does not fulfill the IRB’s duty, and non-therapeutic nature does not remove the need to meet ethical and regulatory standards. Therapeutic benefit is not a prerequisite for approval in these cases, but appropriate consent and protections are.