If a trial involves emergency situations where prior consent is not possible, what is the IRB/IEC responsible for?

• A. The IRB/IEC must ensure that the protocol meets ethical and regulatory standards.
• B. The researcher may proceed after obtaining consent from a legal guardian.
• C. Consent is unnecessary in emergency trials.
• D. The sponsor may approve the protocol without IRB/IEC review.

Answer: (A)

In emergency research where prior consent isn’t possible, the IRB/IEC’s role is to make sure the study is designed and planned in an ethically and legally sound way, including how consent will be handled in that context. This means the board reviews whether a waiver of consent or deferred consent is appropriate under regulatory criteria, ensures that risks are minimized and potential benefits justify the research, and checks that safeguards are in place. They also verify plans to inform participants or their legally authorized representatives and to obtain consent as soon as feasible. This oversight helps protect participants and ensure regulatory compliance before the study proceeds.