Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

What must investigators ensure after enrolling a subject without consent in a life-threatening situation?

1. They must conduct an immediate follow-up with the patient’s family.

2. They must ensure the LAR is informed as soon as possible.

3. They need to wait until the next committee meeting.

4. They only need to inform the sponsor later.

The correct answer is: They must ensure the LAR is informed as soon as possible.

When investigators enroll a subject into a study without consent due to a life-threatening situation, it is imperative for them to ensure that the legally authorized representative (LAR) is informed as soon as possible. This obligation stems from the ethical principles governing clinical research, which emphasize the protection of individuals’ rights and well-being. Informing the LAR promptly allows for the appropriate discussion about the subject's participation and any related health considerations, ensuring that the subject's rights are upheld even when direct consent cannot be obtained in a timely manner. In cases where consent cannot be secured immediately due to the urgency of the situation, it is essential to maintain transparency with families or representatives. The LAR serves as the individual's advocate and can make informed decisions regarding their continued participation in the study once they are fully aware of the circumstances and potential risks. The other options do not align with the critical ethical and regulatory requirements following an emergency enrollment. Immediate follow-up with the patient's family, while important, may not be feasible or relevant in every acute scenario. Waiting until the next committee meeting would hinder the prompt communication that is necessary in such urgent circumstances. Simply informing the sponsor later disregards the immediate obligation to the subject and their representative, making it an insufficient response. Thus, ensuring