New studies involving human subjects research will require an initial submission to the IRB for approval. Please use the information under “Researcher Resources” and in the steps below to prepare your submission.
Human subjects research may fall under three different categories: Exempt Review, Expedited Review, or Full Committee review if the project does not fit under an exempt or expedited review category. If you are unsure which category your work falls into, please contact the HSPPO staff for guidance.
The following examples may be activities that are not considered human subjects research.
- If you believe your project is NOT human subjects research and would like an official determination from the IRB office, you can prepare a written protocol/project description and submit it. Select “Non-Human Subjects Research Application” in iRIS. The IRB will review the protocol and send a letter indicating whether or not the project meets the definition of human subjects research. Examples of this would be:
- Quality improvement or program evaluation
- research with de-identified data/specimens when there is no way to link the data/specimen to a person
- Case reports by University of Louisville definition are medical information collected and presented on up to five patients to highlight an interesting treatment, presentation, or outcome. They generally result from retrospective review of the medical record. In this regard, case reports differ from research in which data are collected with intent to evaluate a specific hypothesis. Case reports must be submitted to the IRB for acknowledgement based on local policy. Case Reports are covered on page 85 of the HSPPO Policy Manual. The written case report must be attached to the submission in iRIS.
If your project does indeed meet the definition of human subjects research, the next step in an IRB approval is preparing your research protocol. If your study involves collecting existing data/specimen or creating a database for future research, review the following guidance documents:
- 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.
- 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.
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.
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.
For full board, expedited, and exempt 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 here.
The IRB has minimum submission standards that must be met in order for your study to be assigned to a reviewer.
Data Use/Sharing Agreements: Contact the Office of Sponsored Programs Administration (OSPA@louisville.edu) for instructions on submitting these agreements for contract review.