IS YOUR ACTIVITY HUMAN SUBJECTS RESEARCH?
Any activity that meets either (a) the Department of Health and Human Services (DHHS) definitions of BOTH “research” and “human subjects”or (b) the Food and Drug Administration (FDA) definitions of BOTH “clinical investigation” and “human subjects” requires review and approval by the LSUHSC-NO IRB.
In many cases, identifying an an activity or investigation as human subjects research (HSR) is relatively straightforward. There are, however, several common types of activities 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 / Case Reports / Case Series
- Quality improvement projects
- Program evaluations
- Classroom activities
- Public health practice
Already Know Your Study is HSR?
If you are confident that your activity/investigation is indeed research involving human subjects, please submit your study for IRB review using one of the application forms found here.
Not Sure? ... Request an HSR Determination
If you are unsure whether your activity/investigation meets the regulatory definition of HSR requiring IRB review, request an HSR determination by clicking on the "Does My Study Require IRB Review?" link on your dashboard in IRBManager. Click here for details.
Using the xForm, you will submit basic information about your investigation so that the IRB Office can expeditiously determine whether the activity falls within its purview. After reviewing the information, and if the information provided is deemed sufficient to make a determination, the IRB Office will send you an e-mail notification of the final determination: Human Subjects Research or Non-Human Subjects Research.
If the determination is HSR, you will need to submit a standard application to the IRB for review. If the determination is non-HSR, IRB oversight is not required. Please save this notification; it can serve as documentation when so requested by journals, funding agencies, etc.
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