Human Subjects Protection Program

The IRB Submission Life Cycle – Choose the information you need for your current submission

Click for information before you begin IRB submissionClick for information before you begin IRB submission
Click to learn more about Initial SubmissionsClick to learn more about Initial Submissions
Click to learn more about Continual ReviewsClick to learn more about Continual Reviews
Click to learn more about amendmentsClick to learn more about amendments
Click to learn more about event reportingClick to learn more about event reporting
Click to learn more about study closureClick to learn more about study closure

REMOTE OFFICE NOTICE: All offices are OPEN. However, to prevent the spread of COVID-19, faculty and staff are working remotely. For assistance, please see our contact page.

News & Announcements

COVID 19 Human Subjects Research Resources

HSPPO COVID 19 FAQ updated 6/26/2020

COVID 19 Clinical/Lab Re-opening Guidelines

COVID 19 Social/Behavioral/Educational and Community Research Re-opening Guidelines

COVID 19 Additional Resources

7/1/2020 - New consent, assent, preamble, and HIPAA waiver templates available

The changes in the versions include new conflict of interest language, removing sites from the HIPAA waiver and minor administrative updates. Please pull templates from HSPPO website when starting a new initial submission to ensure the most recent templates is utilized. 

7/1/2020 Initial Submission tab updated on HSPPO website

The Initial Submission tab on the HSPPO homepage has been updated to include step by step instructions for submitting a new study to the IRB. The goal is to help researchers navigate the IRB submission process more efficiently.

5/1/2020- Summary of Changes Document Now Needed for Investigator Initiated Research 

UofL IRB will require researchers to include a “protocol summary of changes document” on protocol amendments for investigator initiated studies. This document will outline the changes made in the revised protocol that is being submitted for review. This document will continue to be updated as protocol amendments occur, making it easy to summarize the changes occurring over the life of the study. This does not replace the requirement to submit a “tracked copy" of the revised protocol.

Protocol Summary of Changes Template can be found at https://louisville.edu/research/humansubjects/qip/qip

02/21/2020- Study Location/Name Changes and the IRB: FAQs

During the course of a study, if the location or name of the study site changes, study documents must be revised and subjects must be notified. For further information and frequently asked questions please visit here.

News & Announcements Archive

Quick Links

iRIS Login Button

iRIS User Tutorial Button

Research Resources and Templates

 

Events

2020 IRB Meeting Calendar

Join the HSPPO/IRB Email listserv for updates, announcements, and educational information

 

 

 


Human Subjects Protection Program
Med Center One, Suite 200
University of Louisville
501 E. Broadway
Louisville, Kentucky 40202

Telephone number: 502-852-5188
Fax number: 502-852-2164

Full Accreditation Human Research Protection Program

You may also try the Advanced Search to refine your search.