Certified Clinical Research Coordinator (CCRC) Practice Exam

What is the function of an Independent Ethics Committee?

1. To monitor the financial aspects of the trial

2. To ensure participant safety and rights through protocol review

3. To oversee the consent process conducted by investigators

4. To provide legal advice to sponsors

The correct answer is: To ensure participant safety and rights through protocol review

The function of an Independent Ethics Committee (IEC) is primarily to ensure the safety and rights of trial participants through the review of study protocols. This committee plays a critical role in evaluating clinical research proposals, ensuring that the proposed studies are ethically sound and that participants are adequately informed and consented. By reviewing protocols, the IEC aims to identify any potential risks to participants and ensure that appropriate measures are in place to mitigate these risks. They assess the scientific validity of the study and ensure that the design protects the well-being of subjects involved in the trial, making sure that ethical standards are upheld throughout the research process. This oversight is fundamental to maintaining the integrity of clinical research and protecting participants. In contrast, the other options focus on roles that do not encapsulate the core responsibility of the IEC. For instance, monitoring financial aspects, overseeing consent processes, or providing legal advice to sponsors are not primary functions of the IEC. These roles belong to different entities within the clinical research framework.