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

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In a life-threatening situation requiring the test article and no consent can be provided, what must the Principal Investigator (PI) do?

  1. Enroll the subject immediately without consent.

  2. Obtain prior documented approval from the IRB/IEC and inform the subject's legally authorized representative (LAR).

  3. Wait for the LAR to approve before enrollment.

  4. Inform the sponsor and wait for instructions.

The correct answer is: Obtain prior documented approval from the IRB/IEC and inform the subject's legally authorized representative (LAR).

In a life-threatening situation where immediate intervention is necessary and informed consent cannot be obtained, the Principal Investigator (PI) must take specific actions to ensure compliance with ethical and regulatory standards. Obtaining prior documented approval from the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) is crucial, as these bodies are responsible for overseeing the protection of participants in research. This approach ensures that the research adheres to ethical guidelines while still prioritizing the urgent health needs of the patient. Additionally, informing the subject's legally authorized representative (LAR) is vital because, although consent cannot be obtained at the moment, the LAR should be made aware of the circumstances and the nature of the treatment being provided. This safeguards the rights of the patient and maintains transparency in the research process. In contrast, enrolling a subject immediately without consent does not align with ethical standards and can lead to severe consequences for both the patient and the research team. Waiting for the LAR's approval before enrollment is impractical in life-threatening situations where swift action is needed. Informing the sponsor and waiting for further instructions may delay critical treatment that the subject requires in that instant. Consequently, obtaining prior approval from the IRB/IEC while also notifying the LAR represents the most

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