Cargando…
The Impact of Regulations, Safety Considerations and Physical Limitations on Research Progress at Maximum Biocontainment
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 numbe...
Autores principales: | , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2012
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3528297/ https://www.ncbi.nlm.nih.gov/pubmed/23342380 http://dx.doi.org/10.3390/v4123932 |
_version_ | 1782253811706888192 |
---|---|
author | Shurtleff, Amy C. Garza, Nicole Lackemeyer, Matthew Carrion, Ricardo Griffiths, Anthony Patterson, Jean Edwin, Samuel S. Bavari, Sina |
author_facet | Shurtleff, Amy C. Garza, Nicole Lackemeyer, Matthew Carrion, Ricardo Griffiths, Anthony Patterson, Jean Edwin, Samuel S. Bavari, Sina |
author_sort | Shurtleff, Amy C. |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-3528297 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2012 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-35282972013-01-02 The Impact of Regulations, Safety Considerations and Physical Limitations on Research Progress at Maximum Biocontainment Shurtleff, Amy C. Garza, Nicole Lackemeyer, Matthew Carrion, Ricardo Griffiths, Anthony Patterson, Jean Edwin, Samuel S. Bavari, Sina Viruses Review 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. MDPI 2012-12-19 /pmc/articles/PMC3528297/ /pubmed/23342380 http://dx.doi.org/10.3390/v4123932 Text en © 2012 by the authors; licensee MDPI, Basel, Switzerland. http://creativecommons.org/licenses/by/3.0/ This article is an open-access article distributed under the terms and conditions of the Creative Commons Attribution license (http://creativecommons.org/licenses/by/3.0/). |
spellingShingle | Review Shurtleff, Amy C. Garza, Nicole Lackemeyer, Matthew Carrion, Ricardo Griffiths, Anthony Patterson, Jean Edwin, Samuel S. Bavari, Sina The Impact of Regulations, Safety Considerations and Physical Limitations on Research Progress at Maximum Biocontainment |
title | The Impact of Regulations, Safety Considerations and Physical Limitations on Research Progress at Maximum Biocontainment |
title_full | The Impact of Regulations, Safety Considerations and Physical Limitations on Research Progress at Maximum Biocontainment |
title_fullStr | The Impact of Regulations, Safety Considerations and Physical Limitations on Research Progress at Maximum Biocontainment |
title_full_unstemmed | The Impact of Regulations, Safety Considerations and Physical Limitations on Research Progress at Maximum Biocontainment |
title_short | The Impact of Regulations, Safety Considerations and Physical Limitations on Research Progress at Maximum Biocontainment |
title_sort | impact of regulations, safety considerations and physical limitations on research progress at maximum biocontainment |
topic | Review |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3528297/ https://www.ncbi.nlm.nih.gov/pubmed/23342380 http://dx.doi.org/10.3390/v4123932 |
work_keys_str_mv | AT shurtleffamyc theimpactofregulationssafetyconsiderationsandphysicallimitationsonresearchprogressatmaximumbiocontainment AT garzanicole theimpactofregulationssafetyconsiderationsandphysicallimitationsonresearchprogressatmaximumbiocontainment AT lackemeyermatthew theimpactofregulationssafetyconsiderationsandphysicallimitationsonresearchprogressatmaximumbiocontainment AT carrionricardo theimpactofregulationssafetyconsiderationsandphysicallimitationsonresearchprogressatmaximumbiocontainment AT griffithsanthony theimpactofregulationssafetyconsiderationsandphysicallimitationsonresearchprogressatmaximumbiocontainment AT pattersonjean theimpactofregulationssafetyconsiderationsandphysicallimitationsonresearchprogressatmaximumbiocontainment AT edwinsamuels theimpactofregulationssafetyconsiderationsandphysicallimitationsonresearchprogressatmaximumbiocontainment AT bavarisina theimpactofregulationssafetyconsiderationsandphysicallimitationsonresearchprogressatmaximumbiocontainment AT shurtleffamyc impactofregulationssafetyconsiderationsandphysicallimitationsonresearchprogressatmaximumbiocontainment AT garzanicole impactofregulationssafetyconsiderationsandphysicallimitationsonresearchprogressatmaximumbiocontainment AT lackemeyermatthew impactofregulationssafetyconsiderationsandphysicallimitationsonresearchprogressatmaximumbiocontainment AT carrionricardo impactofregulationssafetyconsiderationsandphysicallimitationsonresearchprogressatmaximumbiocontainment AT griffithsanthony impactofregulationssafetyconsiderationsandphysicallimitationsonresearchprogressatmaximumbiocontainment AT pattersonjean impactofregulationssafetyconsiderationsandphysicallimitationsonresearchprogressatmaximumbiocontainment AT edwinsamuels impactofregulationssafetyconsiderationsandphysicallimitationsonresearchprogressatmaximumbiocontainment AT bavarisina impactofregulationssafetyconsiderationsandphysicallimitationsonresearchprogressatmaximumbiocontainment |