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HSPPO COVID 19 FAQ updated 6/26/2020
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.