Biosecurity is based on the understanding that there is a “spectrum of biological risks”. The spectrum consists of three segments and represents biological risks that may occur naturally, accidentally, or intentionally. International scholars, researchers, and governmental officials have recognized that these risks span from naturally occurring pandemics such as influenza, to re-emerging infectious diseases such as Ebola; through unintentional laboratory accidents, failure to follow standard operating procedures or standard operating procedures (SOPs); and all the way to deliberate and intentional bioweapon manufacturing and release: bioterrorism.
Having biosecurity protocols in place helps to control, or at least minimize, accidental and intentional risks.
This courses covers all aspects of biosecurity, teaching participants how to minimize and manage exposure to biological risks. The course content is based on the requirements outlined in the International Federation of Biosafety Associations (IFBA) certification exam guidelines for biosecurity and the course can be used as a study aid for people wishing to take that exam.
Course Learning Objectives
- Define relevant terms used in internationally recognized conventions, treaties, codes, UN Security Council resolutions, guidelines, and standards relating to Biosecurity and recognize how these concepts relate to local laws and regulations
- Describe the fundamental elements of a biorisk management system and the steps and considerations required to implement such a system
- Describe how to measure, continually monitor performance, and improve the biosecurity program management system
- Describe the unique challenges for physically securing biological materials vs chemical or radiological materials
- Identify sensitive information and describe the relevant protection measures required to maximize biosecurity
- Identify the components of a biological material accountability program
- Describe the relationship between biosecurity and the integrity of individuals with access to biological materials
- Describe how to foster a culture of responsibility and accountability among individuals with access to biological materials
- Define the term “dual use” in relation to biological research and biosecurity
- Discern the concept of “bioethics” in relation to dual use and biosecurity.
Chapter 1 – Biosecurity Conventions, Guidelines, and Standards
A. Define biosecurity, biological weapons, and biological weapons‐related materials
B. Identify the major international biosecurity frameworks and conventions
C. Recognize how local laws, regulations, standards, and guidelines are used in conjunction with international biosecurity measures.
Chapter 2 – Elements of a Biorisk program
A. Describe the fundamental elements of a biosecurity program management system
B. Discern the importance of a multidisciplinary approach to biosecurity
C. Describe the jurisdictions, roles, and responsibilities of government health and security agencies involved in implementing and maintaining biosecurity
D. Describe the concept of “biosecurity” as applied in the laboratory setting and “beyond the laboratory” door
E. Describe the differences and similarities between biosafety and biosecurity
Chapter 3- Biosecurity Risk Assessment and Program Management
A. Describe how a biosecurity risk assessment is conducted and the stakeholders involved in the process
B. Describe the importance of designing biosecurity approaches based on a localized risk assessment
C. Identify at-risk biological materials and incorporate them in an accountability program
D. Identify, and describe the roles and responsibilities for individuals managing biosecurity risks within an organization
E. Describe how to measure, continually monitor performance and improve the biosecurity program management system
F. Develop emergency response plans for biosecurity incidents involving the theft or loss of biological materials
G. Describe the importance of early reporting and communication in the implementation of biosecurity response measures
H. Describe how to develop and implement biosecurity awareness and training programs
Chapter 4 – Physical Biosecurity Measures
A. Describe the unique challenges for physically securing biological materials vs chemical or radiological materials
B. Describe physical security approaches and options to detect intrusion and restrict access to biological materials
C. Discern the advantages, disadvantages and differences in approaches to physical security options
D. Describe how a system of graded protection relative to risk is used to secure biological materials
E. Describe the options for unauthorized intrusion alarm communication to, and response by, internal responders or external responders
F. Describe the importance of sensitive scientific information and the need for protection of the Information Technology infrastructure (cybersecurity)
G. Identify sensitive information and describe the protection measures to be applied
H. Describe how to control and maintain records, documents, and data relevant to the biosecurity management system.
Chapter 5 – Pathogen Accountability
A. Identify the components of a biological material accountability program
B. Describe how to maintain, document, and audit an inventory of biological materials
C. Describe regulations for in-country transfers and import/export rules for international transfers
D. Describe procedures for pathogen transfer within a facility and between different facilities to safeguard against loss, theft or diversion
Chapter 6 – Personnel Reliability
A. Describe the relationship between biosecurity and the integrity of individuals with access to biological materials
B. Describe how to identify individuals handling biological materials who require biosecurity training
C. Define an insider and outsider threat
D. Describe Personnel Reliability Programs, and explain their importance and value
E. Describe how to implement background checks in conjunction with regulatory and enforcement authorities and requirements
F. Describe how to foster a culture of responsibility and accountability among individuals with access to biological materials
G. Describe the importance of an employee wellness program relevant to promoting a culture of responsibility
Chapter 7 – Dual Use and Bioethics
A. Define the term “dual use” as related to biological research and biosecurity
B. Describe the concept of “bioethics” as related to dual use and biosecurity
C. Define the scope of social, ethical, and legal responsibilities incumbent upon life scientists with respect to biosecurity
D. Describe the role of life scientists in implementing biosecurity
E. Describe policies and practices that will prevent the misuse of biological research, including a code of conduct
F. Describe how to develop a mechanism to review biological research in order to minimize risks and vulnerabilities of employees and the facility.