HUMAN SUBJECT RESEARCH DETERMINATIONS
The IRB is responsible for reviewing human subject research (HSR). Any activity that meets the regulatory definitions of Research/Clinical Investigation AND Human Subjects as defined by the Department of Health and Human Services and Food and Drug Administration requires review and approval by the LSUHSC-NO IRB prior to implementation.
Many activities fail to meet the definition of HSR and, therefore, don't require IRB review and approval. LSUHSC-NO institutional policy grants only the IRB Office, and not individual researchers or other entities, the authority to make this determination. 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
A comprehensive list of activities that are not human subjects research (NHSR), and the conditions under which they are deemed to be NHSR, are outlined in this document.
How to Request a NHSR Determination
All research applications for IRB review are submitted through the Kuali Research (KR) electronic submission platform. If you are confident that your activity/investigation is indeed HSR, select one of several protocol types available in the system.
If you are unsure whether your activity/investigation meets the regulatory definition of HSR, select the protocol type of Not Human Subjects Research and follow the instructions provided in the form. Depending on the activity under consideration, a HSR determination may be made as you are entering information in the form. In this case, you will be instructed to select a different research protocol type and complete the application for review by the IRB.
If an HSR determination is not made during data entry, complete and submit the form for review by IRB Office staff. If the staff determination is NHSR, IRB oversight is not required. You will receive a system-generated notification to this effect, which can serve as documentation of review and determination if and when requested by journals, funding agencies, or other entities.
Additional instructions for completing and submitting specific protocols are provided in Kuali Quickguides.
Resources
The following resources provide useful information about, and examples of, what does or does not constitute human subjects research and how to submit protocols for review.
- 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
- Activities That are Not Human Subjects Research
- HRP-2810: Not Human Subjects Research Determination on the Kuali Quickguides Webpage
