OF SERVICES [?or Community I hing DC. 2030] March 18, 2016 William M. Pierce, Jr., Executive Vice President for Research and Innovation Of?ce of the Executive Vice President for Research and Innovation ouett Hall, Suite 202 University of Louisville Louisville, KY 40292?0001 Email: wmpier01@louisville.edu Subject: University of Louisville?s SCIMS study entitled ?Baclofen With Locomotor Training: The Effect on Function and Neuroplasticity in Chronic Incomplete Spinal Cord Injury.? Dear Dr. Pierce: NIDILRR has carefully reviewed the University of Louisville?s detailed response to the HHS Of?ce of Human Research Protections? inquiry into the study entitled ?Baclofen With Locomotor Training: The Effect on Function and Neuroplasticity in Chronic Incomplete Spinal Cord Injury.? This study was being conducted by University of Louisville under a Spinal Cord Injury Model Systems (SCIMS) grant from NIDILRR. This grant was initiated while NIDILRR was part of the Department of Education (grant number H133N110007) and continued following transfer to the Department of Health and Human Services (grant number 90815004). NIDILRR has decided that we will discontinue funding for this particular study, effective immediately. NIDILRR will issue an amended Notice of Award to state that from the date of this amendment, no NIDILRR ?inds may be used for the Baclofen study. The University may continue to use their NIDILRR funds from this award to continue participation in the SCIMS longitudinal database, and to continue to work with other members of the SCIMS network on. collaborative module research projects. We base our decision to discontinue this study on a number of factors. The primary basis for our decision is the University?s report documenting numerous instances of non-compliance and serious non?compliance with the study protocol as it was reviewed and approved by NIDILRR and the University of Louisville IRB. A number of these ?ndings of non-compliance, including one ?nding of serious non-compliance related to lack of oversight and documentation of medication compliance (Finding 6), have not been resolved. The particular ?nding of serious non-compliance related to medication compliance raises critical questions about the investigators? ability to reliably measure one of the study?s two primary independent variables (use of baclofen), while another unresolved ?nding raises serious questions about the availability and utility of follow?up records (Finding 5). Another factor in our decision is the small number of study participants who have been enrolled into this study to date, combined with the fact that the study is scheduled to end on September 30, 2016. If this study were to proceed, NIDILRR would require the implementation of an independent data safety monitoring board to oversee the remaining work. There simply is not enough time to create and implement such an independent monitoring board, resolve remaining ?ndings of protocol non?compliance, and carry out the large number of data collection and analysis tasks that remain on this study. We understand from the University of Louisville?s response to the HHS Of?ce of Human Research Protections? inquiry that the University of Louisville will comply with this amendment to the Notice of Award. If you should have any questions about this notice please contact me at 202-795-7459, or Ruth Brannon, Director, Of?ce of Research Sciences at 202-795-7308. 1 John Tschida, lrec National Institute on Disability, Independent Living, and Rehabilitation Research Administration for Community Living U. S. Department for Health and Human Services Washington, DC 20201 CC: Rebecca H. Higgins, BS, CIP, Director Human Subjects Protection Program University of Louisville MedCenter One Suite 200 501 E. Broadway Louisville, KY 40202-1798 Email: l'cbcwalligginsm Kristina Borror, Director Division of Compliance Oversight Of?ce of Human Research Protections 1 101 Wootton Parkway, Suite 100 The Tower Building Rockville, MD 20852 Email: Kristina.Borrorm hhsuov