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

What is the main goal of obtaining informed consent from trial subjects?

1. To ensure subjects understand the study procedures

2. To acquire legal protection for the sponsor

3. To make the trial run efficiently

4. To recruit more participants

The correct answer is: To ensure subjects understand the study procedures

The main goal of obtaining informed consent from trial subjects focuses primarily on ensuring that participants fully understand the study procedures, potential risks, and benefits involved in the clinical trial. This process is essential not only for ethical reasons but also for the integrity of the research. Informed consent is a way to respect the autonomy of the participants, allowing them to make knowledgeable decisions about their involvement in the study. By ensuring that subjects understand what participation entails, researchers can facilitate an environment of trust and transparency. This understanding is crucial for participants to feel comfortable and secure in their choices, which is especially important in clinical research that often involves risks to health or well-being. The other aspects, such as legal protection for the sponsor, trial efficiency, or recruitment strategies, can be secondary considerations or outcomes of the informed consent process, but they do not encompass the primary aim. Legal protection might result from obtaining consent, but the primary focus remains with the participants’ comprehension and voluntary agreement. Similarly, while informed consent can aid in recruitment by building trust, the fundamental goal is centered on the participants' understanding and rights.