In clinical trial operations, what is the main purpose of an IRB?

• A. To approve marketing materials
• B. To monitor site compliance
• C. To protect the rights, safety, and well-being of human research participants
• D. To assess data quality

Answer: (C)

Protecting the rights, safety, and well-being of human research participants is the central purpose of the IRB. They review study protocols and informed consent documents before a study starts to ensure risks are minimized and reasonable in relation to potential benefits, and that participant privacy and understanding are protected. The IRB also conducts continuing reviews to monitor safety and compliance as the study proceeds and to address any adverse events. Marketing materials aren’t within the IRB’s typical remit, and monitoring site compliance or solely assessing data quality are tasks handled by sponsors, monitors, and QA processes rather than by the IRB. This focus on participant protection is what makes this the best answer.