Human Subjects Research and Institutional Review Board (IRB)

Research personnel are directly involved in conducting the research with human participants through an interaction or intervention for research purposes, including participating in the consent process by either leading it or contributing to it; OR who are directly involved with recording or processing identifiable private information, including protected health information, related to those participants for the purpose of conducting the research study. All research personnel must be added to the research team in IRIS before they can begin working on the research. The IRB will not issue initial approval, continuation approval, or approve the addition of personnel if these items are not completed.

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.

iRIS profile:

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

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

• Instructions for uploading your CV
• CVs must have a version date entered in the specified field in iRIS.
• Be sure to hit "save" after uploading the document.

2. Complete the “Attestation and Disclosure Form”.

• Instructions for completing your ADF form
• The ADF form must be updated yearly (or sooner if necessary).

CITI Human Subjects/HIPAA Training:

Individuals are required to take "Human Subjects and HIPAA Research" training before they can be added to a study team. The Human Subjects training course is combined with the HIPAA-Research course. The certification period, upon successful training completion is 4 years.

The basic course has 5 required modules and 5 electives. Total of 10 courses with passing score of 75%.

The refresher course has 1 required module and 7 electives. Total of 8 courses with passing score of 75%.

If you are a VA researcher and have taken the VA human subjects training, it did not include the HIPAA Privacy modules required to do research at UofL. You will need to also complete the HIPAA Privacy-VA Researchers-Basic Course to be compliant with UofL training requirements.

Course Website: https://www.citiprogram.org

Course Registration: Video Tutorial

Register for CITI or update your account

If you need assistance, please consult our guides to registering and troubleshooting with the CITI program.

Checking CV/Training:

To verify if your research team has current Human Subjects and HIPAA Research training, login to use the Power BI reports.

If your submission was stopped in iRIS for "training validation," proof of training for the personnel in question must be submitted to the iRIS Service Desk at: https://servicedesk.louisville.edu/login. You will login with your UofL email. Once logged in, type "iRIS" in the search bar, at the top of the page click "Raise a Request", then choose "Get Support for iRIS/Cayuse."

Non-University of Louisville Research Team Members:

UofL Sponsored IT accounts can be requested for specific external individuals who need access to the iRIS system to conduct research activities reviewed by the UofL Institutional Review Board (IRB). Sponsorship is obtained through submitting a UofL IT Sponsored Account Request Form linked below. All requests will be reviewed by HSPP staff to ensure that there is a valid need for the account.

Please review the HSPPO UofL Sponsored IT Account Guidelines and complete the request form as indicated.

Please also note, the sponsored IT account does not give permission to work on a research project. If you are external to UofL (including volunteers, interns, or students that are minors), additional requirements may apply to be added to a UofL research team.

The University of Louisville IRB reviews projects led by students. A student is defined by of those in undergraduate, graduate, post-doctorate, fellowships, and resident programs. The UofL IRB requires student led research to go through the same review process as any other research project at the University that involves participants.

Student researchers are highly encouraged to review the IRB Submission Lesson.

Student led research must be overseen by someone with a UofL faculty or staff appointment. This person must serve as the principal investigator (PI). The student may serve as a co-investigator or sub-investigator. It is the PI’s responsibility to ensure that applicable research policies, processes, and regulations are being followed. The PI is also responsible for issuing sign off of the research plan. After the PI signs off on the initial IRB submission, the student can submit to the IRB and respond to any questions or changes that the IRB may have.