What is the primary purpose of IRB approval?

• A. approve and review the research to protect the rights of human participants
• B. ensure that the study will be profitable for sponsors
• C. monitor day-to-day clinical operations
• D. publish study results in journals

Answer: (A)

The primary purpose of IRB approval is to protect the rights and welfare of individuals who participate in research by reviewing the study to ensure ethical conduct. The IRB evaluates the study design to weigh risks against potential benefits, ensures informed consent is obtained and documented in a clear and voluntary way, and checks that privacy and confidentiality of participants’ data are safeguarded. It also considers fair participant selection and protections for vulnerable populations, and it oversees ongoing safety through continuing review and monitoring of adverse events.

This focus on ethical safeguards and participant protection is what sets IRB oversight apart from other functions. Profitability for sponsors, day-to-day clinical operations, and publication of results are outside the IRB’s primary role; those concerns pertain to financial management, operational management, and dissemination efforts, respectively.