Certified Clinical Research Coordinator (CCRC) Practice Exam

Which signature is required by regulation on the consent form?

1. The investigator

2. The subject

3. The study sponsor

4. The research coordinator

The correct answer is: The subject

The requirement for the subject's signature on the consent form is a fundamental aspect of the informed consent process in clinical research. This signature indicates that the participant has been adequately informed about the study, including its purpose, procedures, risks, benefits, and their rights, and that they voluntarily agree to participate. Obtaining the subject's signature is crucial because it demonstrates that the individual has understood the information provided and is giving their explicit consent, which is a cornerstone of ethical research practice. Regulatory bodies, such as the FDA and the ICH-GCP guidelines, emphasize the necessity of obtaining informed consent from research subjects to ensure their autonomy and protect their rights throughout the study. In contrast, while the investigator, study sponsor, and research coordinator may play crucial roles in the consent process, their signatures are not mandated by regulation for the consent form itself. The focus is placed on the subject's voluntary agreement to participate, making their signature the primary regulatory requirement on the consent document.