What action can an IRB take regarding research that does not fit the federal definition of research?

An Institutional Review Board (IRB) can decline to review a study that does not fit the federal definition of research because such studies fall outside the scope of IRB authority. The federal definition of research typically encompasses systematic investigations designed to develop or contribute to generalizable knowledge, while certain activities may not meet this threshold, such as quality improvement projects, public service programs, or other similar initiatives.

In these instances, an IRB assesses whether the study meets the criteria that warrant oversight. If it is determined that the activity does not involve research as defined by federal regulations, the IRB has the option to decline to review it altogether. This aligns with the IRB's primary responsibility to ensure ethical evaluation of research studies and protect the rights and welfare of human participants in research contexts that qualify under the regulatory framework.