Which activities are deemed not to be research under the Common Rule?

The reasoning behind why all the listed activities are deemed not to constitute research under the Common Rule lies in the definitions and criteria established in the regulations. The Common Rule outlines what qualifies as research and sets forth guidelines to protect human subjects involved in such research activities.

Public health surveillance activities are considered not to be research because they often focus on the ongoing collection and analysis of data to inform public health decisions, rather than testing a hypothesis or generating generalizable knowledge. Their primary goal is to monitor and improve health outcomes, rather than to explore scientific questions typically associated with research.

Activities for criminal justice purposes are similarly excluded, as these may involve collecting and analyzing data for legal, law enforcement, or justice system functions. These activities serve specific operational or enforcement purposes and are not aimed at contributing to generalizable knowledge, which is the hallmark of research.

National security operational activities also fall outside the realm of research as defined by the Common Rule. These activities are typically focused on protecting national interests and gathering information that is sensitive and not subject to the same ethical considerations as research involving human subjects.

Together, these explanations affirm that all the listed activities — public health surveillance, criminal justice purposes, and national security operations — do not fit the criteria for research as articulated in the Common