About the IRB

 

ICH GCP Compliance Statement: The University of Louisville Institutional Review Boards and the Human Subjects Protection Program were accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) in 2005. The University of Louisville IRBs operate in compliance with Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) Guidelines insofar as those guidelines are consistent with the U.S. Food and Drug Administration regulations (21 CFR Parts 50 and 56) and the Department of Health and Human Services regulations (45 CFR 46) pertaining to the protection of human subjects in research.