What role does the Institutional Review Board (IRB) play in clinical trials?

What role does the Institutional Review Board (IRB) play in clinical trials?

• A. To ensure trial participants' financial compensation
• B. To approve and review the clinical trial protocol
• C. To conduct the actual trials
• D. To monitor post-trial product sales

Answer: (B)

The primary role of the Institutional Review Board (IRB) in clinical trials is to approve and review the clinical trial protocol. This responsibility is critical as the IRB is tasked with safeguarding the rights and welfare of human subjects participating in research. It evaluates the risk versus benefit of the trial, ensuring that ethical standards are upheld and that participants are adequately informed about the study through the informed consent process. An IRB reviews various components of the trial protocol, including the study design, participant selection criteria, and the informed consent documents. Its approval is necessary before any clinical trial can commence, reflecting the IRB's crucial role in regulatory compliance and ethical oversight within the research process. Through this evaluation, the IRB helps to ensure that research is conducted ethically and that participant safety is prioritized throughout the trial.

The primary role of the Institutional Review Board (IRB) in clinical trials is to approve and review the clinical trial protocol. This responsibility is critical as the IRB is tasked with safeguarding the rights and welfare of human subjects participating in research. It evaluates the risk versus benefit of the trial, ensuring that ethical standards are upheld and that participants are adequately informed about the study through the informed consent process.

An IRB reviews various components of the trial protocol, including the study design, participant selection criteria, and the informed consent documents. Its approval is necessary before any clinical trial can commence, reflecting the IRB's crucial role in regulatory compliance and ethical oversight within the research process. Through this evaluation, the IRB helps to ensure that research is conducted ethically and that participant safety is prioritized throughout the trial.