Good Clinical Practice (GCP) Practice Exam

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What is the main purpose of an Independent Ethics Committee (IEC)?

To develop trial protocols
To ensure the protection of rights, safety, and well-being of human subjects
To approve marketing authorizations
To analyze clinical trial results

The correct answer is: To ensure the protection of rights, safety, and well-being of human subjects

The main purpose of an Independent Ethics Committee (IEC) is to ensure the protection of the rights, safety, and well-being of human subjects participating in clinical trials. This is a fundamental aspect of conducting ethical research, as the IEC reviews trial protocols, informed consent documents, and other relevant materials to assess potential risks to participants and their rights. Their role is crucial in safeguarding participants and ensuring that any clinical research adheres to ethical principles, regulations, and guidelines. The protection of participants is prioritized to maintain the integrity of the research process and public trust in clinical investigations. The other options, while related to the broader context of clinical trials, do not accurately represent the primary focus of an IEC. Developing trial protocols and analyzing results are responsibilities typically handled by researchers and sponsors. Approving marketing authorizations pertains to regulatory agencies rather than ethics committees. Thus, the IEC’s primary focus remains firmly on the ethical and protective measures for human subjects involved in research.