Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam 2025 - Free ACRP Practice Questions and Study Guide

The signed and dated informed consent form is a critical document in the clinical research process, especially when dealing with incapacitated subjects. In such cases, it is essential to ensure that the subject’s rights and welfare are protected. The legally acceptable representative, often a person designated by law to make decisions on behalf of the incapacitated individual, must receive a copy of the informed consent form. This representative is responsible for ensuring that the subject's interests are represented and protected throughout the research process.

Providing the legally acceptable representative with a copy of the consent form serves several purposes: it ensures they are fully informed about the study, aware of the potential risks and benefits involved, and can effectively advocate for the subject. This aligns with ethical practices that emphasize transparency and informed decision-making in research.

Other parties, such as the principal investigator or ethics committee, also play significant roles in the research process but do not have the same immediate need to hold a copy of the informed consent for incapacitated subjects as the legally acceptable representative. Family members might be involved in discussions but may not have the legal authority to provide consent unless they are identified as the representative. Thus, the emphasis on sharing the consent form with the legally acceptable representative is integral to maintaining ethical standards in clinical trials involving