Office of Research and Innovation
University of Louisville
Louisville, Ky. 40202
502.852.6512, 502.852.8361 (Fax)
Looking for a unit within the Office of Research and Innovation? Contact information here.
Approval by the IRB is required by regulation before research with participants can take place. Research can involve interacting with participants or with their identifiable data and/or specimens. Interaction with participants can also include remote and/or virtual interactions (e.g., online survey research). IRB review of a research study can fall under different categories: Exempt Review, Expedited Review, or Full Committee review.
It is important to note that study participants are partners in the research process. The UofL IRB is charged with reviewing research studies to ensure the rights, safety, and welfare of research participants are protected. Please use the information below to prepare your IRB submission.
IRB review is required when an activity meets the definition of research and includes human participants.
The following examples may be activities that are not considered human subjects research.
Researchers unsure of whether or not their project meets either definition should submit their project details to the IRB on a non-human subjects research form. Projects involving elements of human subjects research must be reviewed by the IRB prior to beginning any research activities.
If your project meets the definition of human subjects research, the next step is preparing your research protocol.
Next, ensure your research team members have completed all of the requirements under Getting Started: Personnel Requirements. Then, prepare your IRB submission in iRIS.
When you complete the iRIS IRB application you will be able to upload your consent forms and other study documents.
If your study involves collecting existing data/specimen or creating a database for future research, review the following guidance documents:
Data Use/Sharing Agreements: Contact the Office of Sponsored Programs Administration (OSPA@louisville.edu) for instructions on submitting these agreements for contract review.
If your study involves viewing or collecting protected health information, you may need a signed consent form.
All initial submissions must be signed off by the principal investigator. You do not need to include sub-investigators or co-investigators in the final signoff. Future submissions on the study can be submitted the IRB by anyone on the study team.
Beginning July 1, 2023, for only full board research the department assigned Scientific and Scholarly Merit Reviewer and Department Chair must sign off on the study in iRIS. This information is entered in the IRIS application, section 3.4. If your departmental signoff is responsible for signing off in both roles then enter their name and from the drop down box choose “Scientific Reviewer/Department chair”. If you have two departmental signoffs, please first enter the “Scientific Reviewer” and then the “Department Chair”. Specific instructions for routing your application to the appropriate individuals can be found on the Templates and Resources page.