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

In the case of an incapacitated subject, who should receive a copy of the signed and dated informed consent form?

1. The subject's legally acceptable representative

2. The principal investigator

3. The ethics committee

4. The subject's family member

The correct answer is: The subject's legally acceptable representative

The signed and dated informed consent form is a crucial document that acknowledges a subject's understanding and agreement to participate in a study. In instances where a subject is incapacitated, it is essential that a legally acceptable representative steps in to provide consent on their behalf. This representative is typically someone who is authorized by law or designated by the subject, and their role is to protect the interests of the incapacitated individual. Providing a copy of the informed consent form to this representative serves several important functions. It ensures that the representative is fully informed about the study's details, risks, and benefits, allowing them to make an educated decision that aligns with the best interests of the subject. Additionally, documenting this process contributes to ethical compliance and accountability in research practices. The involvement of a legally acceptable representative is especially significant in the context of safeguarding the rights and welfare of individuals who are unable to advocate for themselves, as it helps ensure informed participation even in their absence.