Regulatory Affairs Certification (RAC) Practice Exam

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What is the role of the Institutional Review Board in clinical trials?

To approve drug efficacy.
To ensure ethical standards are met.
To oversee manufacturing processes.
To conduct safety assessments.

The correct answer is: To ensure ethical standards are met.

The role of the Institutional Review Board (IRB) in clinical trials is fundamentally to ensure that ethical standards are met throughout the research process. This includes reviewing study protocols, informed consent documents, and any materials that will be provided to participants to ensure their rights, welfare, and safety are prioritized. The IRB's primary function is to protect human subjects involved in clinical research by evaluating the ethical implications of proposed studies, assessing the potential risks versus benefits, and ensuring that participants are fully informed about the nature of the study. This oversight is critical in fostering trust in the research process and upholding regulatory standards designed to protect individuals from harm. The other roles mentioned, like approving drug efficacy, overseeing manufacturing processes, or conducting safety assessments, are typically handled by different agencies or committees, not the IRB. While these functions are essential to the overall development of a drug or treatment, they do not fall within the purview of the IRB's responsibilities.