Which governing body oversees the ethical treatment of subjects in clinical trials?

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The Food and Drug Administration (FDA) is the governing body that oversees the ethical treatment of subjects in clinical trials, as it has a specific mandate to protect public health by ensuring the safety and efficacy of medications and medical devices. The FDA establishes regulations and guidelines that clinical trials must follow, including the informed consent process to ensure participants are fully aware of the risks and benefits involved in the study. Additionally, the FDA requires that review boards, known as Institutional Review Boards (IRBs), assess the ethical aspects of a trial before it can proceed, ensuring that the rights and welfare of participants are prioritized.

Other organizations, such as the Centers for Disease Control and Prevention (CDC), the World Health Organization (WHO), and the National Institutes of Health (NIH), play important roles in public health and biomedical research. However, they do not have the same regulatory authority specifically focused on the ethical oversight of clinical trials as the FDA does. The CDC primarily works on disease control and prevention, the WHO focuses on global health standards and policies, and the NIH supports and conducts medical research and studies but relies on the FDA for the oversight of clinical trials.

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