Good Clinical Practice (GCP) Practice Exam

An Independent Ethics Committee (IEC), also known as an Institutional Review Board (IRB) in some regions, plays a crucial role in the clinical trial process, particularly in safeguarding the rights and welfare of participants. One of its essential functions is to review and evaluate the ethical implications of trial protocols before they are enacted. This includes assessing the design of the study, the risks and benefits to participants, and ensuring that informed consent processes are adequate and uphold the participants' rights. By approving trial protocols, the IEC ensures that the study adheres to ethical standards and regulations, which are foundational for maintaining public trust in the clinical research process. Their role is not involved in the operational aspects of the trial, such as conducting procedures or participant recruitment, which are typically handled by the research team and trial sponsors. Additionally, since the IEC's mandate is focused on ethics, providing marketing strategies does not fall within their purview. This protective function is critical for promoting ethical conduct in clinical research and ensuring that participant safety and well-being are prioritized.