Good Clinical Practice (GCP) Practice Exam

What is the role of the IRB in clinical trials?

1. To manage trial funds

2. To oversee the ethical conduct of research

3. To recruit participants

4. To analyze data

The correct answer is: To oversee the ethical conduct of research

The role of the Institutional Review Board (IRB) in clinical trials is primarily to oversee the ethical conduct of research. The IRB is established to protect the rights, welfare, and well-being of human participants involved in research studies. This board reviews research protocols to ensure that studies are designed with the utmost consideration for the ethical implications of the research and the protection of participants. During the review process, the IRB assesses how informed consent will be obtained, evaluates any potential risks to participants, and ensures that the potential benefits of the research outweigh those risks. The IRB also monitors ongoing studies to ensure compliance with established ethical standards. Their mandate is to safeguard the integrity of the research process while ensuring that the rights of participants are upheld throughout the trial. Other roles mentioned, such as managing trial funds, recruiting participants, or analyzing data, do not fall under the IRB’s responsibilities. These activities are typically managed by the sponsors or research teams, while the IRB focuses specifically on ethical oversight. This differentiation emphasizes the unique and crucial role that the IRB plays in maintaining ethical standards in clinical research.