Before You Begin

Before submitting to the IRB there are steps to be taken to establish a profile in iRIS and to complete required training. iRIS is the IRB electronic submission system.

If your submission was stopped, proof of training for the personnel in question must be submitted to the iRIS Service Desk at: https://iris.support.louisville.edu/jira/servicedesk/customer/portal/6. Submissions will not be routed to the IRB until the training has been updated in the iRIS system.

Additional information on how to check study personnel training prior to submission and how to submit tickets to the service desk can be found on pages 27-32 in the IRIS Submission manual: http://louisville.edu/research/humansubjects/iRISSubmissionManual.pdf.

iRIS profile

All research personnel must:

  • Upload a CV in the iRIS system.
  • Complete the required annual Attestation and Disclosure Form in the iRIS system.
  • Complete the required combined Human Subjects and HIPAA Research basic course through the CITI website.

Login to iRIS using an ULINK/Outlook user name and password: http://iris.louisville.edu

To complete a profile in the iRIS system:
1. Upload your CV

2. Complete the “Attestation and Disclosure Form”.

Non-University of Louisville Research Team Members
If you are a non-UofL employee, you will need to obtain a sponsored account in order to set up access to the iRIS system. Please complete the “Sponsored Account Request Form.”

CITI Human Subjects/HIPAA Training:

All individuals involved in human subjects research are required to take Human Subjects and HIPAA Research training. The Human Subjects training course is combined with the HIPAA-Research course. The University of Louisville has chosen to utilize the CITI Program which is a collaborative institutional training initiative located at the University of Miami. The certification period, upon successful training completion is 4 years.  Results from CITI will be transferred to iRIS.
Previous HIPAA-Research training expiration dates will be extended to match your Human Subject’s Protection expiration date. Upon expiration, you will be required to take the new combined course.

If you are a VA researcher and has taken the VA human subjects training, you must complete the HIPAA Privacy -VA Researchers - Basic Course.  Completion of the course is required if you will submit any projects for IRB review.

    Course Registration: http://www.citiprogram.org

    Course Instructions:

    I am a researcher who:

    If you do not see your current CITI training in iRIS, please follow these trouble shooting tips

    Checking CV/Training:

    All research team members are required to have a CV in iRIS and current CITI Human Subjects & HIPAA training. To verify if your research team is in compliance, follow the instructions outlined in the iRIS Submission Manual on page 29. The IRB will not issue initial approval, continuation approval, or approve the addition of personnel if these items are not completed.

    Find your IRB Analyst:

    Each department is assigned to a specific IRB Analyst. The IRB Analysts are the first members of the IRB team to review your study upon submission. They are a great resource to reach out to at any time for questions or training. The assignments are based on the PI’s primary department.