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The Impact of Regulations, Safety Considerations and Physical Limitations on Research Progress at Maximum Biocontainment
Integrated Toxicology Division, United States Army Medical Research Institute of Infectious Diseases, 1425 Porter Street, Fort Detrick, MD 21702, USA
Integrated Research Facility Frederick, Division of Clinical Research, National Institute of Allergy and Immunology, National Institute of Health, Frederick, MD 21702, USA
Department of Virology and Immunology, Texas Biomedical Research Institute, San Antonio, TX 78245, USA
Select Agent Management Division, United States Army Medical Research Institute of Infectious Diseases, 1425 Porter Street, Fort Detrick, MD 21702, USA
* Author to whom correspondence should be addressed.
Received: 22 November 2012; in revised form: 14 December 2012 / Accepted: 14 December 2012 / Published: 19 December 2012
Abstract: We describe herein, limitations on research at biosafety level 4 (BSL-4) containment laboratories, with regard to biosecurity regulations, safety considerations, research space limitations, and physical constraints in executing experimental procedures. These limitations can severely impact the number of collaborations and size of research projects investigating microbial pathogens of biodefense concern. Acquisition, use, storage, and transfer of biological select agents and toxins (BSAT) are highly regulated due to their potential to pose a severe threat to public health and safety. All federal, state, city, and local regulations must be followed to obtain and maintain registration for the institution to conduct research involving BSAT. These include initial screening and continuous monitoring of personnel, controlled access to containment laboratories, accurate and current BSAT inventory records. Safety considerations are paramount in BSL-4 containment laboratories while considering the types of research tools, workflow and time required for conducting both in vivo and in vitro experiments in limited space. Required use of a positive-pressure encapsulating suit imposes tremendous physical limitations on the researcher. Successful mitigation of these constraints requires additional time, effort, good communication, and creative solutions. Test and evaluation of novel vaccines and therapeutics conducted under good laboratory practice (GLP) conditions for FDA approval are prioritized and frequently share the same physical space with important ongoing basic research studies. The possibilities and limitations of biomedical research involving microbial pathogens of biodefense concern in BSL-4 containment laboratories are explored in this review.
Keywords: biocontainment; biosafety level 4 (BSL-4); biological select agents and toxins (BSAT); positive pressure suit; biodefense; biosecurity; ebola virus; highly pathogenic viruses; limitations; collaboration
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Shurtleff, A.C.; Garza, N.; Lackemeyer, M.; Carrion, R.J.; Griffiths, A.; Patterson, J.; Edwin, S.S.; Bavari, S. The Impact of Regulations, Safety Considerations and Physical Limitations on Research Progress at Maximum Biocontainment . Viruses 2012, 4, 3932-3951.
Shurtleff AC, Garza N, Lackemeyer M, Carrion RJ, Griffiths A, Patterson J, Edwin SS, Bavari S. The Impact of Regulations, Safety Considerations and Physical Limitations on Research Progress at Maximum Biocontainment . Viruses. 2012; 4(12):3932-3951.
Shurtleff, Amy C.; Garza, Nicole; Lackemeyer, Matthew; Carrion, Ricardo J.; Griffiths, Anthony; Patterson, Jean; Edwin, Samuel S.; Bavari, Sina. 2012. "The Impact of Regulations, Safety Considerations and Physical Limitations on Research Progress at Maximum Biocontainment ." Viruses 4, no. 12: 3932-3951.