The impact of regulations, safety considerations and physical limitations on research progress at maximum biocontainment

Amy C. Shurtleff, Nicole Garza, Matthew Lackemeyer, Ricardo Carrion, Anthony Griffiths, Jean Patterson, Samuel S. Edwin, Sina Bavari

Research output: Contribution to journalReview articlepeer-review

15 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)3932-3951
Number of pages20
Issue number12
StatePublished - 2012
Externally publishedYes


  • Biocontainment
  • Biodefense
  • Biological select agents and toxins (BSAT)
  • Biosafety level 4 (BSL-4)
  • Biosecurity
  • Collaboration
  • Ebola virus
  • Highly pathogenic viruses
  • Limitations
  • Positive pressure suit

ASJC Scopus subject areas

  • Infectious Diseases
  • Virology


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