Federal regulations define research as the systematic investigation, including development, testing and/or evaluation, designed to develop or contribute to generalizable knowledge. Federal regulations define a human subject as a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information. Investigators must seek IRB review and approval for research projects involving human subjects before the project commences.
However, investigators are not required to obtain IRB approval for other activities (e.g. clinical care, quality improvement, quality assurance, public health activities); unless the proposed activity also meet the definition of human subject research. If an investigator has any questions as to whether an activity also constitutes human subject research, it is strongly recommended that a Human Subject Research Determination Form be submitted to the IRB to obtain an official ruling as to whether IRB approval is required before the activity commences.
The Office for Human Research Protections (OHRP) has posted several Frequently Asked Questions regarding Quality Improvement activities.
Public Health Research: Surveillance, emergency responses, and program evaluations do not meet the definition of human subjects research. These activities constitute public health activities with the primary intent to prevent disease in a particular population, improve a public health program, or to provide emergency disaster relief. Therefore, these activities do not have to be reviewed by an IRB.