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 (ICF)?

1. The investigator conducting the trial

2. The subject's legally acceptable representative

3. The hospital administration

4. The ethics committee

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

The focus on providing a signed and dated Informed Consent Form (ICF) to the subject's legally acceptable representative is crucial in clinical research, especially when dealing with incapacitated individuals. When a subject is unable to provide informed consent due to incapacity (for reasons such as age, mental state, or medical condition), the responsibility shifts to the legally acceptable representative, often a family member or a legal guardian, who can make informed decisions on behalf of the subject. This ensures that the representative is fully aware of the details of the study, including its risks, benefits, and purpose, which allows them to advocate for the best interests of the incapacitated subject. By receiving the ICF, they are formally recognized as the person who has the authority to make decisions impacting the subject's participation in the clinical trial. Distributing the ICF to other parties, such as the investigator, hospital administration, or ethics committee, while also important for regulatory and compliance reasons, does not replace the vital role of ensuring that the legally acceptable representative is well-informed and able to support the subject's rights and well-being.