Not Human Subjects Research

IRB oversight is limited to human subjects research. Therefore, activities that are not considered research, as well as research that does not involve human subjects, are not within the scope of IRB review. Research that clearly falls outside the scope of IRB oversight does not have to be submitted to the IRB. In less clear circumstances, it is highly recommended to submit to the IRB for a formal determination prior to beginning research.

To obtain a formal determination, you will have to submit the IRB. The submission should follow standard procedures and does not have to be modified to seek a Not Human Subjects Research (NHSR) determination. The IRB will make the appropriate determination and request additional materials if your submission is deemed as human subjects research. For guidance on submitting to the GU IRB.

Please note that formal IRB determinations and NHSR letters will only be provided through the review process in the Georgetown-MedStar IRB system. Formal determinations cannot be provided through email or Virtual Office Hours. 

Research is defined as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” (45 CFR 46.102(l))

Activities that fall outside the definition of research may not be under the oversight of the IRB. Protocols that do not develop or contribute to generalizable knowledge may be considered “not research.” 

The following activities are not considered research (45 CFR 46.102(l)):

• (1) Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
• (2) Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
• (3) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
• (4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

The following activities may be considered not research, though can be very fact dependent and it is recommended to submit the IRB for a formal determination. 

• Case studies involving three or less subjects
• Quality Improvement projects

Human subjects research is defined by the Common Rule as meaning “research involving a living individual about whom an investigator (whether professional or student) conducting research: 

• Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
• Obtains, uses studies, analyzes, or generates identifiable private information or identifiable bio specimens.  (45 CFR 102(e)(1))

Research that does not involve human subjects as defined by the common rule as not under the oversight of the IRB. 

As it can be difficult to determine if research involves human subjects, it is highly recommended to formally submit to the IRB.

Please reach out to IRBoard@georgetown.edu