Why might an IRB not review certain studies?

An Institutional Review Board (IRB) is tasked with ensuring the protection of the rights and welfare of human research subjects. One of the main reasons an IRB might not review certain studies is that those studies do not meet the definition of research. According to federal regulations, research is typically defined as a systematic investigation designed to develop or contribute to generalizable knowledge. If a study does not fit this definition—such as quality assurance activities, some public benefit or service programs, or research that solely focuses on internal evaluations—it falls outside the IRB's jurisdiction. Therefore, studies that do not generate new knowledge, do not employ systematic investigation, or are not intended to inform broader contexts will not be subjected to IRB review.

This understanding is crucial as it clarifies the scope of what the IRB oversees and highlights the significance of the research definition in determining the necessity of an IRB review.