Do I Need IRB Approval?

All research activities conducted by LSU faculty, staff or students that involve human participants must be submitted to the LSU IRB for review.  IRB approval must be obtained prior to beginning recruitment activities, data collection, etc. on any human subjects research.

Who Needs to Submit to LSU IRB?

If you are an LSU faculty member, staff member, undergraduate or graduate student, who is participating in or collaborating on a research project involving human participants and/or are utilizing LSU resources in any capacity to collaborate on a project involving human participants, you should submit an IRB protocol for review and approval, prior to commencing work with human subjects.  The LSU IRB reviews both non-exempt project and projects that may be exemptible from federal oversight. 

If you are collaborating on a project that is being led by another institution and LSU resources are being utilized in any way, you should submit a protocol focusing on your/LSU's role in the project.  A description of the overall project should be attached, as well, so that the IRB will know the purpose of the project and each entity's role in the project.  If it is a federally funded project, or if requested by the other institution, you may need to establish a single-IRB (sIRB) for Multi-Site or Cooperative Research for the study (also referred to as a "Reliance Agreement").

Does my project meet the definition of "Research"? 

"Research," as defined by the Office of Human Research Protections, is "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalized knowledge."


Are you intending to use this project to make inferences about the field beyond your data?  Will you generalize the results beyond your sample?  Will you publish or present your findings outside of the classroom setting? 

Some activities may not be considered research by this definition.  Activities such as oral histories, program evaluation, quality improvement, etc.  

Is it Human Subjects Research?

Human subject is defined as "a living individual about whom an investigator (whether professional or student) conducting research:

    1. Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens, including manipulation of the human’s environment.
    2. Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

If secondary data is being used and anyone affiliated with the research can reasonably access identifiable data, then it should be considered human subjects research.  If secondary data is not identifiable (i.e., commercially obtained samples), then it may not be considered human subjects research.

To view an HHS decision chart to determine if a project is considered human subjects research under 45 CFR 46, click here. 

What if I am still unsure if I need to submit? Or what if I need or would like a formal determination about whether or not my activity is human subjects research? 

If you are unsure, you can submit an IRB protocol for review, along with your project description/abstract and we can either provide feedback to guide you to approval, or provide you with a determination that IRB oversight is not required for your specific project.

 

Click here to proceed to Preparing Your IRB Protocol