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

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Prepare for the ACRP Certified Professional Exam with our comprehensive quiz. Elevate your clinical research skills with targeted flashcards and multiple-choice questions. Enhance your readiness with detailed explanations and insights for improved performance!

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Why is an impartial witness required during the consent process for illiterate subjects?

To serve as a backup signatory
To observe the consent process
To assist with translation
To verify the identity of the subject

The correct answer is: To observe the consent process

An impartial witness is required during the consent process for illiterate subjects primarily to observe the consent process. This ensures that the process is transparent and conducted ethically, allowing for the protection of the rights and welfare of the participant. The presence of an impartial witness helps ensure that the subject is adequately informed about the study and that the consent given is voluntary and genuine. The role of the witness is crucial as they can verify that the information was presented fairly and that the subject understood the elements of consent, despite their literacy constraints. This oversight adds an essential layer of protection against potential coercion or misunderstanding, which is particularly important in studies involving vulnerable populations such as illiterate individuals. Thus, the witness serves to maintain the integrity of the consent process while providing assurance to the researchers and ethical review boards that the subject's consent is ethically sound.