What organization holds the main oversight responsibility for ethical aspects of clinical trials?

What organization holds the main oversight responsibility for ethical aspects of clinical trials?

• A. World Health Organization (WHO)
• B. Food and Drug Administration (FDA)
• C. Institutional Review Board (IRB)
• D. International Conference on Harmonisation (ICH)

Answer: (C)

The Institutional Review Board (IRB) holds the primary responsibility for overseeing the ethical aspects of clinical trials. The IRB's main function is to protect the rights and welfare of human subjects involved in any research study. This includes reviewing research proposals to ensure that the study is designed ethically, that informed consent is obtained appropriately, and that risks to participants are minimized. The IRB's oversight is crucial in maintaining ethical standards and ensuring that the research aligns with the principles set forth by regulations and guidelines. While other organizations, such as the World Health Organization, Food and Drug Administration, and International Conference on Harmonisation, play important roles in the regulation and guidance of clinical trials, their focus is broader and often includes regulatory compliance, public health concerns, and facilitating international collaboration. However, it is the IRB that specifically and directly addresses the ethical considerations of each individual study, making it the central body responsible for ensuring ethical practices in clinical research.

The Institutional Review Board (IRB) holds the primary responsibility for overseeing the ethical aspects of clinical trials. The IRB's main function is to protect the rights and welfare of human subjects involved in any research study. This includes reviewing research proposals to ensure that the study is designed ethically, that informed consent is obtained appropriately, and that risks to participants are minimized. The IRB's oversight is crucial in maintaining ethical standards and ensuring that the research aligns with the principles set forth by regulations and guidelines.

While other organizations, such as the World Health Organization, Food and Drug Administration, and International Conference on Harmonisation, play important roles in the regulation and guidance of clinical trials, their focus is broader and often includes regulatory compliance, public health concerns, and facilitating international collaboration. However, it is the IRB that specifically and directly addresses the ethical considerations of each individual study, making it the central body responsible for ensuring ethical practices in clinical research.