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

• A. Enrollment may proceed only after obtaining written consent from the subject.
• B. Enrollment may proceed only with prior consent of the subject's LAR, even if unavailable.
• C. Enrollment is prohibited in emergencies.
• D. Enrollment should occur with measures described in the protocol and IRB/IEC approval, and the subject or LAR should be informed as soon as possible and consent to continue requested.

Answer: (D)

In emergencies where you can’t obtain consent beforehand, research can proceed under a pre-approved plan that allows exception from informed consent. The study protocol must specify the emergency enrollment procedures and the IRB/IEC must approve them. After enrollment, the subject or their legally authorized representative should be informed as soon as feasible, and consent to continue participation should be sought. This option reflects both the regulatory allowance for emergency enrollment with IRB-approved safeguards and the obligation to inform and obtain consent to continue when possible.

The other statements don’t fit because they require prior consent that isn’t feasible in an emergency, or state that enrollment is prohibited, which isn’t correct under the approved exception-from-informed-consent approach.