AUSTIN, Texas—As a result of an inquiry from the National Institutes of Health (NIH) in spring 2007 The University of Texas at Austin began a systematic review of all reported laboratory incidents and adverse events from January 2000 to the present.
The review found 13 incidents that occurred in University laboratories, including five in a laboratory conducting research on Shigella bacteria in 2002-2007. Shigella is infectious and can cause diarrhea, fever and stomach cramps. At the time of each incident an inspection of the lab and a review of safety and training were conducted in conjunction with the faculty member supervising the lab. In four cases laboratory workers required medical treatment for symptoms that developed subsequent to exposure to Shigella. All workers have recovered fully without incident. In each case different laboratory workers and different laboratory events were deemed to have been the cause of the exposure. The incidents did not extend beyond the specific individual involved in the lab at the time of the incident and was not at any time a threat to the general University population or the public.
In April 2007, as a result of the NIH inquiry noted above, the University revisited the events noted above, plus other reported incidents, and requests from the public for information about some of these laboratory incidents. As a result of that review, the University undertook a thorough revision of laboratory policies and procedures with an emphasis on surveillance, inspection, training, incident reporting and incident response.
The University’s standard for research conducted in the almost 1,000 laboratories on the campus is to ensure the safety of all involved, including the University community and the public. The University is determined to take all steps necessary to ensure that the standard is met and is undertaking a number of changes as outlined below.
The University believes every effort must be made to ensure, consistent with applicable laws and regulations, that high levels of transparency and accountability are maintained by all involved in research. The University and sponsoring entities, such as NIH, and the public must be assured that safe laboratory research, training and education are being conducted at and by the University.
Some of the specific changes made to date include:
- Development and implementation of additional training—The development and implementation of additional safety and laboratory procedure training for all laboratory investigators and workers, with special emphasis on the NIH Guidelines for those who work with bio-hazardous materials and recombinant DNA. The University is also re-emphasizing personal accountability of all laboratory workers for adherence to the University standard. The successful completion of the new training plus acknowledgment of the personal responsibility of all laboratory workers to conduct safe research that adheres to all applicable rules and regulations is now a condition of research at the University.
- Implementation of a Rapid Response Team—In order to respond to any laboratory incident and ensure appropriate response and reporting, a University Rapid Response Team (RRT) headed by senior University officials, must respond immediately to any reported incident. This will help ensure transparency and accountability by improving reporting, review and the identification of corrective actions for all laboratory incidents and adverse events.
- Provision of Additional Resources to the Institutional Biosafety Committee (IBC)—The IBC, which oversees most bio-hazardous research at the University, has its policies and procedures clarified and the University has reaffirmed that the IBC has first line responsibility for ensuring that bio-hazardous research is conducted safely pursuant to both the NIH Guidelines, and University policies. A full-time IBC coordinator has been hired to support the IBC and the hiring of additional employee is being considered.
- Review of Research Management Structure and Research Data—The University has begun a complete review of the research management and support databases and has begun a system-wide upgrade of these important surveillance tools.
These measures are just the start of additional oversight and support measures the University plans to ensure safe and transparent research. Other planned measures include:
- A new laboratory safety manual that incorporates lessons learned from throughout the academic world;
- Stepped up on-site inspections; and
- Electronic inspections that incorporate advances in inspection and health technologies to enhance traditional inspection and oversight methods.
The University of Texas at Austin is implementing a host of changes in the University’s oversight of laboratory research. These changes will ensure that safety remains paramount in the conduct of all University research and that if any incident does occur that affects the safety of anyone in the University community or the public, all required measures will be taken immediately to minimize any adverse effects. These changes will also ensure that the important information concerning such incidents are promptly made available to the appropriate officials, sponsoring or other required entities, and the public.
For more information contact: Tim Green, Office of the Vice President for Research, 512-475-6596.