I want to let the UTMB community know about a developing situation regarding our burn research program.
In late April 2018, UTMB received several allegations regarding possible research compliance issues with burn patients.
The allegations involved possible inappropriate treatment provided by UTMB faculty members and staff for burn patients enrolled in human subject research studies at Shriners Burns Hospital for Children-Galveston.
Based on these concerns, UTMB’s Institutional Review Board (IRB) immediately suspended research activities associated with three burn research protocols.
At that time, working with Shriners Hospitals, UTMB launched a comprehensive investigation spanning burn research at UTMB and Shriners Burns Hospital-Galveston. Based on the initial findings of this investigation, clinical burns research activities at UTMB and at the Shriners facility in Galveston were suspended.
Given the complexity of the situation, UTMB has engaged a specialized consulting firm to review identified areas of concern and to help develop a corrective action plan to ensure that, going forward, all research involving Shriners Burns Hospital-Galveston and UTMB consistently meets or exceeds all applicable standards. This work is in process. All burns research will remain suspended during this review.
As required, UTMB has notified federal agencies involved in oversight of human subject research and investigational new drugs and is working to schedule additional discussions with those agencies.
UTMB is committed to protecting the rights, safety and well-being of its participants in research studies and will continue to enhance safeguards to ensure this commitment is fulfilled.
An update for the UTMB community will be provided as we are able.
Thank you.
Dr. David L. Callender
President
CLARIFICATION: The statement, “All burns research will remain suspended during this review,” in this message refers only to clinical research (projects involving human subjects). Basic research projects related to burns have not been suspended.