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Sector - Biosecurity

Cybersecurity

Data Security

User Access & Privileging

Health and Safety

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Process Governance

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Getting Started

Biosecurity - Management Oversight

An organization that works with pathogens or valuable biological materials needs a strong management oversight governance program to develop a comprehensive biosecurity plan, ensuring that risk assessments, physical and information security controls, pathogen accountability, transportation security, personnel reliability, DURC oversight, training requirements, incident response plans, safeguarding sensitive data, ethical research standards, SOPs, and long-term strategic impacts are clearly defined and resourced. Without executive-level governance, institutions risk regulatory violations, resource gaps, insider threats, data breaches, uncontrolled transfers or theft of pathogens, ethical lapses, emergency confusion, and potentially catastrophic impacts from high-consequence pathogens.

Biosecurity - Risk Assessment

An organization that works with biological agents needs a risk assessment governance program to systematically identify, prioritize, and mitigate vulnerabilities before they lead to theft, misuse, accidental release, or operational disruption. A structured program evaluates agent characteristics, insider and external threats, facility and information security controls, and assigns mitigation measures, significantly reducing high-consequence biosecurity risks. Without this governance, assessments can become outdated or inconsistent, leaving gaps in access control, transportation security, and emergency preparedness, exposing the institution to regulatory violations, financial losses, or serious public health consequences.

Biosecurity - Physical Security

An organization that handles pathogens or other valuable biological materials needs a physical security governance program to ensure that access to sensitive areas is strictly limited, monitored, and documented. The organization should have policies in place; access controls should be graded; architectural features (doors, locks, fences, barriers) should be secured; electronic systems (card access, alarms), CCTV surveillance, tamper-evident measures, and defined employee responsibilities should be in place. This is critical in facilities that work with high-consequence pathogens. Without structured oversight, weaknesses in perimeter security, access controls, or staff awareness can lead to theft, insider misuse, unauthorized entry, regulatory violations, or serious public health consequences.

Biosecurity - Personnel Reliability

An organization that handles dangerous biological agents needs a personnel reliability governance program to ensure that individuals with access to high-consequence materials are trustworthy, qualified, and ethically aligned. This includes rigorous pre-employment screening, background checks, security risk assessments, ongoing medical and psychological evaluations, least-privilege access, insider-threat monitoring, visitor controls, clear role definitions, immediate access revocation upon termination, and a culture of responsibility and compliance. Without such governance, an organization risks theft, sabotage, regulatory violations, or catastrophic misuse.

Biosecurity - Transport

An organization handling biological agents needs a transportation governance program to ensure materials are securely authorized, documented, tracked, and received without breach. A program establishes formal approval processes, chain-of-custody records, trained and screened personnel, compliant packaging (such as triple packaging), vetted carriers, secure internal and external transfers, clear accountability from first use to final disposal, emergency-response readiness during shipment, and adherence to national and international transport regulations. Without such governance, materials are most vulnerable during transport - creating risks of loss, theft, tampering, regulatory violations, financial penalties, or catastrophic misuse.

Biosecurity - Information Security

An organization handling biological agents needs an information security governance program to protect sensitive data, including security plans, pathogen inventories, storage locations, and personnel reliability records. Clear responsibility must be assigned, data sensitivity levels must be role-based, and access must be enforced. Strong passwords, encryption, network segmentation, and secure backups must be required. Controls should be regularly reviewed, and strict rules should be applied for labeling, transmitting, and destroying information. Without strong governance, data breaches, insider misuse, poor access management, or improper disposal can expose critical vulnerabilities, enable theft or sabotage, trigger regulatory violations, and damage public trust.

Biosecurity - Pathogen Accountability

An organization that handles pathogens or other valuable biological materials needs a pathogen accountability governance program to ensure that all materials are properly recorded, tracked, stored, transferred, audited, and securely destroyed. A structured program includes administrative oversight, clear role definitions, detailed inventories, chain-of-custody controls, regular physical counts, routine audits and inspections, and compliance reviews aligned with standards such as ISO 35001. Without strong accountability, gaps in tracking or documentation can lead to loss, misuse, regulatory violations, environmental release, or serious public health consequences.

Biosecurity - Dual Use

An organization that conducts life sciences research needs a dual-use governance program to ensure that research with legitimate benefits is not misapplied to cause harm. Because most research can be Dual Use - and some may qualify as Dual Use Research of Concern (DURC) - a structured program requires mandatory training, early project screening, Institutional Review Committee oversight, risk assessments and mitigation strategies, balancing transparency with security, reporting protocols, and controlled communication plans. Without it, harmful findings could be misused, regulatory obligations overlooked, or threats to public health and national security created.