Submit a New Study

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.

arrow downStep 1: Determine if your work meets the definition of human subjects research

IRB review is required when an activity meets the definition of research and includes human participants.

  • Research is defined as "a systematic investigation, including research development, testing and evaluation, designed to contribute to generalizeable knowledge."
  • Human subject is defined as a living individual about whom an investigator conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

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.

arrow downStep 2: Prepare your research protocol

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.

  • Login, then navigate to “Study Assistant”
  • Click “add a new study”
  • Click “IRB Application”
  • Follow the instructions in the IRB application form. The questions will branch based on your responses.

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.

arrow downStep 3: Determine the informed consent process to be used.
  • Signed informed consent – Required for research that is greater than minimal risk. Generally required for research with interventions.
  • Unsigned informed consent (aka preamble) - Used for minimal risk research that meets specific criteria outlined in the regulations. Generally used for survey, focus group, and interview research but can be used in other scenarios as deemed appropriate by the IRB.
  • Waiver/alteration of informed consent - Used for minimal risk research where it’s not practical to obtain consent and specific criteria in the regulations are met. Generally used for research using retrospective data and/or specimens. This request is made in the IRB application form. No additional templates or forms are needed.
  • Assent form - if the study involves participants between the ages of 7-17 an assent form is needed.
arrow downStep 4: Does the study involve viewing or collecting protected health information?

If your study involves viewing or collecting protected health information, you may need a signed consent form.

  • If you are using a signed consent form (discussed in Step 2) the IRB template consent form includes a HIPAA Research Authorization. This gives the researcher permission to utilize protected health information for the study as described in the document.
  • If you need to view or collect protected health information prior to obtaining informed consent/HIPAA Research Authorization from research participants, a HIPAA partial waiver is needed. This is generally used when you need to screen medical records to identify potential participants to approach for the study.
  • If you have requested a waiver of consent for minimal risk research utilizing PHI, a HIPAA complete waiver request is needed. This is used when it’s not practical to obtain consent and a signed HIPAA research authorization from participants. This is generally used for research using retrospective data and/or specimen.
arrow downStep 5: Submit your study and route for signoffs

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.