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Introduction: The SARS-CoV-2 virus emerged as a novel virus and is the causative agent of the COVID-19 pandemic. It spreads readily human-to-human through droplets and aerosols. The Biosafety Research Roadmap aims to support the application of laboratory biological risk management by providing an evidence base for biosafety measures. This involves assessing the current biorisk management evidence base, identifying research and capability gaps, and providing recommendations on how an evidence-based approach can support biosafety and biosecurity, including in low-resource settings. Methods: A literature search was conducted to identify potential gaps in biosafety and focused on five main sections, including the route of inoculation/modes of transmission, infectious dose, laboratory-acquired infections, containment releases, and disinfection and decontamination strategies. Results: There are many knowledge gaps related to biosafety and biosecurity due to the SARS-CoV-2 virus's novelty, including infectious dose between variants, personal protective equipment for personnel handling samples while performing rapid diagnostic tests, and laboratory-acquired infections. Detecting vulnerabilities in the biorisk assessment for each agent is essential to contribute to the improvement and development of laboratory biosafety in local and national systems.

Laboratory biosafety is essential for the protection of laboratory personnel and the wider community against exposure to and inadvertent release of biological agents. Personal protective equipment (PPE) is often used to protect laboratory personnel from exposure to biological and other hazards such as chemicals that may be present in the laboratory. The types of PPE worn in laboratories where biological agents are being handled are designed to protect the body, eyes and face, feet, hands and the respiratory system and hearing. The type(s) of PPE required and specifics on when this equipment should be used are determined as part of the risk assessment for the work being carried out in the laboratory. This monograph provides information on the types, selection and use of PPE for personnel carrying out risk assessments, such as biosafety officers or laboratory managers, and laboratory personnel or scientists who use PPE for laboratory activities.The information in this monograph on PPE is designed to accompany and support the fourth edition of the WHO Laboratory biosafety manual (core document) and the other associated monographs. The manual and the monographs adopt a risk- and evidence-based approach to biosafety, rather than a prescriptive approach, in order to ensure that laboratory facilities, safety equipment and work practices are locally relevant, proportionate to needs and sustainable. Emphasis is placed on the importance of a “safety culture” that incorporates risk assessment, good microbiological practice and procedure and standard operating procedures, relevant introductory, refresher and mentoring training of personnel, and prompt reporting of incidents and accidents followed by appropriate investigation and corrective actions. This new approach aims to facilitate laboratory design and ways of operating that ensure greater sustainability of laboratory work while maintaining adequate and appropriate control of biosafety.The associated monographs provide detailed information and help implement systems and strategies on the following specialized topics: risk assessment, laboratory design and maintenance, biological safety cabinets and other primary containment devices, decontamination and waste management, biosafety programme management, and outbreak preparedness and resilience. This monograph covers the factors to be considered when selecting PPE, including a risk assessment of the work being done and regulations. The different types of PPE available are described, which include, but are not limited to, laboratory coats, gowns, full-body suits, gloves, protective footwear, safety glasses, safety goggles, face shields, masks and respirators. In addition, the correct way to put on and remove and test certain PPE is explained, and the PPE needed for implementation of core requirements, heightened control and maximum containment measures is described. Hand hygiene methods, and cleaning, maintenance, storage and disposal of PPE are also discussed, as well as national and international standards and regulations on PPE.

Risk assessment is a systematic process of gathering information and evaluating risks to support a risk management strategy that is informed by the likelihood and consequences of an inadvertent release of and/or exposure to a biological agent. Risk assessment is essential to guide the selection of risk control measures and ensure biosafety within the laboratory when working with biological agents. This assessment requires consideration of many factors including: route(s) of transmission of the biological agent(s), pathogenicity and infectious dose, availability of prophylactic treatment or a vaccine, disease severity and mortality, contagiousness, endemicity, high-risk laboratory procedures (such as work with aerosols, high titres or volumes of the biological agent(s) being produced/handled, sharps, animals), competency of laboratory personnel, susceptibility of individual personnel and biosecurity (potential for misuse of biological agents/use as a weapon for harm). This monograph describes the process of carrying out a risk assessment of work with a biological agent(s) so that an informed decision can be made by a laboratory facility about the risk control measures needed for the work to be safely conducted. The targeted readership for this monograph is biosafety officers, laboratory personnel, laboratory managers and scientists who are doing the risk assessment.The information in this monograph on risk assessment is designed to accompany and support the fourth edition of the WHO Laboratory biosafety manual (core document) and other associated monographs. The manual and the monographs adopt a risk- and evidence-based approach to biosafety rather than a prescriptive approach in order to ensure that laboratory facilities, safety equipment and work practices are locally relevant, proportionate to needs and sustainable. Emphasis is placed on the importance of a “safety culture” that incorporates risk assessment, good microbiological practice and procedure and standard operating procedures, relevant introductory, refresher and mentoring training of personnel, and prompt reporting of incidents and accidents followed by appropriate investigation and corrective actions. This new approach aims to facilitate laboratory design and ways of operating that ensure greater sustainability while maintaining adequate and appropriate control of biosafety.The other associated monographs provide detailed information and help implement systems and strategies on the following specialized topics: laboratory design and maintenance, biological safety cabinets and other primary containment devices, personal protective equipment, decontamination and waste management, biosafety programme management and outbreak preparedness and resilience.This monograph describes selecting a risk assessment team and completing a risk assessment as well as implementation strategies and lessons learnt. Two risk assessment templates, a short and long one, are provided that personnel can use as guides when carrying out a risk assessment. In addition, four examples of completed risk assessments with different scenarios are included

Disinfection, sterilization and waste management are key to safe handling of biological agents. It is therefore important to understand the basic mechanisms of the different methods of disinfection, sterilization and waste management that can be used in a laboratory. The specific decontamination requirements depend on the nature of the biological agents being handled. This monograph describes the methods for the management and final disposal of laboratory waste that is considered a biological hazard. The information can be used to develop standardized and more specific procedures on decontamination and waste management for a particular laboratory. The targeted readership for this monograph is personnel who perform the risk assessment, for example, laboratory managers or biosafety officers, as well as laboratory personnel and scientists who decontaminate laboratory items and workers who handle laboratory waste.The information in this monograph on decontamination and waste management is designed to accompany and support the fourth edition of the WHO Laboratory biosafety manual (core document) and other associated monographs. The manual and the monographs adopt a risk- and evidence-based approach to biosafety, rather than a prescriptive approach, in order to ensure that laboratory facilities, safety equipment and work practices are locally relevant, proportionate to needs and sustainable. Emphasis is placed on the importance of a “safety culture” that incorporates risk assessment, good microbiological practice and procedure and standard operating procedures, relevant introductory, refresher and mentoring training of personnel, and prompt reporting of incidents and accidents followed by appropriate investigation and corrective actions. This new approach aims to facilitate laboratory design and ways of operating that ensure greater sustainability while maintaining adequate and appropriate control of biosafety.The other associated monographs provide detailed information and help implement systems and strategies on the following specialized topics: risk assessment, laboratory design and maintenance, biological safety cabinets and other primary containment devices, personal protective equipment, biosafety programme management and outbreak preparedness and resilience. The monograph includes a description of the methods of decontamination used in a microbiology laboratory including handwashing, and chemical, gaseous and heat disinfection. The different classes of chemical disinfectants and their constituents, their mechanisms of action and their advantages and disadvantages are discussed. Factors that can influence the effectiveness of disinfectants are also listed. The monograph includes an overview of fumigation methods, heat inactivation and how verification of the effectiveness of these treatments is carried out by means of indicators. The monograph also covers aspects of waste management as well as documentation and record-keeping which are an integral part of waste management. Considerations for removal of both liquid and solid waste products from the laboratory and their safe disposal are described. Methods for inactivation of specimens are also discussed.