Development of a Harmonization Standard for Biosafety Risk Assessment of Infectious Disease Laboratories using Management Consulting Methodology

경영컨설팅 방법론을 이용한 감염병 실험실의 생물안전 위해성평가 조화기준 도출

  • Yu, Minsu (Division of Biosafety Evaluation & Control, NIH, KCDC Business Consulting Department, Graduate School of Hanyang University)
  • 유민수 (질병관리본부 국립보건연구원 생물안전평가과, 한양대학교 일반대학원 경영컨설팅학과)
  • Received : 2014.05.12
  • Accepted : 2014.06.16
  • Published : 2014.06.30


Objectives: As the demand to deal with pathogens in domestic research institutions has expanded and biological accidents have increased, the need for systematic biosafety management in infectious disease laboratories has grown. According to international standards, risk assessment (RA) is required for biosafety management. However, RA criteria have not been clearly established in Korea, so to this end I have attempted to determine RA criteria meeting international levels Methods: In order to provide RA criteria for application, I analyzed the RA criteria in use in the U.S., Europe and at international organizations. In order to ensure the public nature of the RA criteria, I constructed the research model through modified management consulting methodology reflecting the model of Radnor and O'Mahoney. Results: According to the results of the study, existing laboratory biosafety regulations were comparable to domestic laboratory safety laws. Existing laboratory biosafety standards that are designed around risk factors were found to be insufficient. An RA case to be carried out in infectious disease laboratories at the National Institute of Health of KCDC was identified. Conclusion: To establish a systematic risk management system meeting international standards, it was necessary first to harmonize the systems of national and international standards. In addition, in order to provide specific biosafety management on-site, I recognized a need for methodology and planning strategies to discover biosafety management so that it can be carried out as required through the RA of individual laboratories.


Biosafety;Management consulting methodology;Risk assessment;Risk management;Public policy consulting


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