In emergency enrollment where prior consent is not possible, which statement is NOT correct?

• A. Enrollment may proceed with measures described in the protocol and IRB approval
• B. The subject or LAR should be informed about the trial as soon as possible and consent to continue requested
• C. Enrollment must comply with applicable regulatory requirements
• D. Enrollment should be delayed until consent can be obtained from the subject or LAR if possible

Answer: (D)

In emergencies, enrollment without prior consent is allowed under the protocol with IRB-approved provisions when delaying would harm the patient. The important point is that treatment can begin promptly, and after enrollment you must inform the subject or legally authorized representative as soon as feasible and seek consent to continue. Enrollment must also comply with applicable regulatory requirements. Delaying enrollment to obtain consent contradicts the practice in emergency situations, where timely intervention is the priority and consent to continue is sought after the fact.