IS IT HUMAN SUBJECTS RESEARCH?
Federal regulations established by the Department of Health and Human Services (DHHS) and the Food and Drug Administration prohibit the conduct of research involving human subjects without prior Institutional Review Board (IRB) approval. In many cases, identifying an investigation as human subjects research (HSR) is relatively straightforward. There are, however, several common types of investigations involving human subjects, human specimens or identifiable data, that often do not meet the regulatory definition of HSR and, therefore, do not require IRB review. These include:
- Case studies
- Quality improvement projects
- Program evaluations
- Classroom activities
- Public health practice
If you think that your project is indeed research involving human subjects, please submit your study for IRB review using one of the application forms found here. Upon conducting its preliminary review the IRB Office will confirm that the study meets the HSR definition and the review will move forward.
Request an HSR Determination
If you are unsure whether your project requires IRB review, please complete and submit the HSR Determination Request Form. The form allows you to submit basic information about your project so that the IRB Office can expeditiously determine whether it falls within its scope. After reviewing the information, the IRB Office will email you a determination about whether your project should be submitted for formal review. When IRB oversight is not required, this determination letter can usually be used for journals requesting information about IRB status.
The following resources provide useful information about, and examples of, what does or does not constitute human subjects research.
Is Your Project Human Subjects Research, or Not?
; Office of Research, University of Southern California
HSR Decision Tree
; Office for Human Research Protections, DHHS
- Activities Deemed Not to Be Research: Public Health Surveillance 2018 Requirements ; OHRP, DHHS