What role does the Institutional Review Board (IRB) serve in clinical research?

The Institutional Review Board (IRB) plays a crucial role in clinical research by evaluating and approving research proposals to ensure they meet ethical standards. The primary function of the IRB is to protect the rights, welfare, and privacy of human subjects involved in research. They review study protocols to assess potential risks to participants and ensure that those risks are minimized and justified by the potential benefits of the research. By requiring informed consent and regular monitoring of ongoing studies, the IRB helps maintain high ethical standards in research practices.

This oversight is fundamental in ensuring that any clinical research conducted not only complies with regulations but also respects the dignity and autonomy of participants. The IRB’s focus on ethical considerations distinguishes it from other key activities in research, such as financial management, participant recruitment strategies, or data analysis, which are typically handled by different aspects of a research organization.