1.0 Purpose

The purpose of this policy is to clearly articulate the position and expectations of Science for Africa Foundation (SFA Foundation) on biosafety and biosecurity in research involving biological samples, especially when high-risk pathogens are involved as categorised in the WHO Laboratory Biosafety Manual, 4th edition and the WHO Laboratory Biosafety Manual, 3rd edition. This policy is applicable for all research funded directly or indirectly by the SFA Foundation.

SFA Foundation recognises that advancing scientific understanding and improving public health through research requires careful handling of biological samples, particularly those that may contain high-risk pathogens. Research with such samples is crucial for understanding the mechanisms of diseases and developing effective interventions. When conducting research involving high-risk biological samples, the priority for researchers should always be the protection of public health, ensuring biosafety and biosecurity, and minimising any potential risks to researchers, research subjects, and the environment.

SFA Foundation acknowledges that certain biological research may pose dual-use risks, where legitimate science could be misused to cause harm, and encourages initiatives that strengthen oversight, risk assessment, and responsible research practices to ensure that beneficial scientific work is conducted safely.

SFA Foundation expects that research involving high-risk biological samples is undertaken with strict adherence to internationally recognised biosafety and biosecurity standards and principles, appropriately adapted to their local context. Research should comply with guidelines such as:

• World Health Organization (WHO) Laboratory Biosafety Manual: Providing global standards for safe practices in laboratory research.
• World Health Organisation (WHO) Laboratory Biosecurity Guidance: Providing guidance in preventing misuse or accidental release of high-risk biological materials.
• Africa Union's Regulatory and Certification Framework for Institutions Handling High-Risk Pathogens: offering specific regulatory guidance tailored to the African context.
• A Framework for Tomorrow’s Pathogen Research: Establishing forward-looking principles for biosafety in pathogen research.

These guidelines emphasise comprehensive requirements for the containment, handling, and disposal of high-risk biological samples, thus ensuring biosafety and biosecurity within the research environment.

Researchers funded by SFA Foundation are required to be aware of, and comply with, relevant local legislation and best practice guidance concerning biosafety and biosecurity in research involving biological samples. Researchers must implement rigorous risk management processes and ensure that emergency protocols are established to manage any incidents effectively.

All associated costs must be anticipated and included within the grantee’s proposed budget at the time of application. SFA Foundation will not provide supplementary or retrospective funding to cover these expenses.  

2.0 Scope

This policy applies to all SFA Foundation grantees undertaking research that involves biological samples including research involving high-risk pathogens.

3.0 Definitions

Biological material includes any sample that originated from living organisms, including human samples, animal samples, microbial, and other biological samples.

Biosafety refers to the measures and protocols that are implemented to ensure the safe handling, containment, and disposal of biological materials, particularly those that pose a risk to human health or the environment. It encompasses a range of practices and procedures, and facilities designed to mitigate risks associated with handling pathogens especially high-risk pathogens which have the potential to cause severe diseases and outbreaks. It focuses primarily on preventing accidental exposure, release, or spread of biological materials during research activities.

Biosecurity is the implementation of measures to prevent the unauthorized access, loss, theft, misuse, diversion, or intentional release of biological materials. It addresses concerns about deliberate misuse or malicious exploitation of biological agents and is focused on preventing intentional harm.  It includes physical security, personnel security, material control, transport security, and information security to guard against purposeful attempts to compromise biological containment.

Containment is the use of physical barriers, practices, and procedures to prevent the escape of biological agents from the laboratory environment ensuring the safety of laboratory personnel, the public, and the environment.

Dual use is research or technology with the potential for both beneficial and harmful applications.

High-risk pathogens are microorganisms classified in Risk groups 2, 3, and 4 according to the WHO’s classification system, that require stringent control measures due to their potential to cause severe disease or death.

• Risk Group 2: Pathogens that can cause disease but are unlikely to be a serious hazard.
• Risk Group 3: Pathogens that may cause serious or lethal disease via inhalation.
• Risk Group 4: Pathogens that pose a high risk of causing life-threatening diseases, often with no available vaccines or treatments.

Personal Protective Equipment (PPE) comprises specialised clothing or equipment worn by research personnel to minimise exposure to biological or other hazards.

Risk assessment is the systematic evaluation of potential hazards associated with conducting research involving high-risk pathogens. This process involves identifying risks, evaluating their impact, and implementing measures to mitigate them.

4.0 Policy Statement

The SFA Foundation expects all funded research to adhere to the highest standards of biorisk management. This policy emphasises adherence to global biosafety and biosecurity guidelines, recognising the importance in fostering a safe environment for researchers, the communities they serve and the environment.

5.0 Core Principles

• Commitment to Safety: Ensuring the health and safety of research personnel, the environment, and the public as a top priority.
• Adherence to Standards: All research involving high-risk pathogens and biological materials will comply with stringent international biosafety and biosecurity standards, appropriately adapted to the relevant context.
• Regional Consideration: Consideration of the unique challenges and regulatory contexts within Africa, incorporating tailored solutions to address these issues.

This policy outlines the minimum requirements that all grant awardees must meet to comply with SFA Foundation expectations and applicable regulations.

5.1 Biosafety Policy and Risk Management

The grant awardee shall establish, implement, and maintain a biosafety policy that includes provisions for:

1. The safe handling, containment, and disposal of biological materials, particularly those that pose a risk to human health or the environment.
2. Compliance with applicable local, regional, or international regulatory requirements, standards, and guidelines on biosafety.
3. Conducting biosafety risk assessments prior to initiating any research involving biological materials.
4. Ensuring that all personnel involved in research with biological materials receive appropriate and ongoing biosafety training.

5.2 Institutional Oversight

The grant awardee shall establish and maintain an Institutional Biosafety Committee (IBC) with appropriate expertise to:

1. Oversee and review biosafety procedures, research protocols, and institutional compliance.
2. Meet regularly to evaluate and monitor biosafety risks associated with ongoing and proposed research activities.

5.3 Record Keeping

The grant awardee shall maintain comprehensive records relevant to biosafety, including:

1. Biosafety training records and attendance logs.
2. Documentation of biosafety risk assessments, mitigation measures, and approvals.
3. Reports on biosafety incidents and accidents, with follow-up actions.
4. Maintenance and certification logs for biosafety equipment and infrastructure.

5.4 Laboratory and Facility Standards

The grant awardee shall ensure that laboratory and facility operations meet biosafety infrastructure requirements, including:

1. Maintenance of laboratories and facilities according to the designated biosafety level (BSL-1 to BSL-4) appropriate to the biological agents in use.
2. Proper maintenance, regular testing, and certification of biosafety cabinets, autoclaves, and personal protective equipment (PPE).
3. Implementation of engineering and administrative controls to reduce exposure to biological hazards.

6.0 Risk Assessment and Management

Effective biosafety and biosecurity begin with thorough risk assessment. Comprehensive risk assessments should be conducted before initiating research involving biological materials. These assessments should identify potential hazards, evaluate their likelihood and potential impact, and determine appropriate mitigation measures. Based on these assessments, researchers must implement containment measures appropriate to the risk level of the pathogens being studied.

Emergency preparedness is essential for responsible research. All research teams must establish clear emergency protocols for potential biorisk incidents and regularly practice these procedures to ensure readiness. Additionally, researchers must consider potential biosecurity implications of their work and implement controls to prevent unauthorized access, theft, or misuse of biological materials or research information.

7.0 Pathogen Classification and Controls

SFA Foundation recognises the WHO risk group classification system for pathogens and expects controls commensurate with risk levels.

Research involving Risk Group 2 pathogens, which can cause disease but are unlikely to be serious hazards, requires implementation of standard laboratory practices with particular emphasis on proper personal protective equipment and basic containment measures.

For work with Risk Group 3 pathogens, which may cause serious or lethal disease via inhalation, enhanced containment measures are mandatory. These include appropriate Biological Safety Cabinets and specialised facilities with controlled access and directional airflow.

Research proposals involving Risk Group 4 pathogens, which pose high risk of life-threatening diseases often without available treatments, must be conducted only in dedicated high-containment facilities with extensive safety protocols.

8.0 Biosecurity Requirements

SFA Foundation expects comprehensive biosecurity measures for all funded research involving biological materials. Physical security controls for laboratory spaces must restrict access to authorised personnel only, with particular attention to areas housing high-risk pathogens. Personnel reliability measures should include appropriate screening and ongoing training to ensure all team members understand and comply with security protocols.

Material control and accountability systems must be implemented to track all biological agents from acquisition through use, storage and disposal. Transport of biological materials must follow secure protocols to prevent loss, theft, or release during movement between facilities. Information security measures should protect sensitive research data from unauthorised access or disclosure, particularly for dual-use research of concern. All research proposals must undergo screening procedures for evaluating dual-use research concerns, with ongoing assessment throughout the project lifecycle.

9.0 Reporting and Accountability

Grantees must establish appropriate reporting mechanisms through their institutional biosafety and biosecurity committees, or other relevant local oversight bodies as required by institutional, national, and international standards. All biosafety and biosecurity incidents must be documented, reviewed with application of preventive and corrective actions and reported through these established channels within the required timeframe. Grantees are responsible for maintaining comprehensive records that demonstrate ongoing compliance with applicable standards and guidelines. See Annex 1: Biosafety and Biosecurity Compliance Records Checklist.

Periodic biosafety and biosecurity audits should be conducted by appropriate institutional or independent authorities in accordance with local or international regulations or guidance as applicable. These audits serve to identify and address potential vulnerabilities before incidents occur. Systematic reporting and analysis of near misses serve as early warning signs to help prevent future incidents.

10.0 Breach Response and Countermeasures

In the event of a biosafety or biosecurity breach, SFA Foundation grantees must implement immediate countermeasures to contain the incident and mitigate potential risks. All grantees are required to establish a Breach Response Plan before commencing research, which must be reviewed and approved by their Institutional Biosafety Committee or equivalent oversight body.

This plan should detail immediate containment procedures, decontamination protocols, exposure assessments, medical surveillance, and notification processes. Grantees should follow established guidelines such as the WHO's "Laboratory Biosafety Manual: Post-exposure Management" (4th edition, 2020), the Africa CDC's "Framework for Management of Laboratory Incidents and Emergencies" (2021), and the International Federation of Biosafety Associations' "Biosecurity Incident Response Guidelines" (2023).

For breaches involving Risk Group 3 or 4 pathogens, additional reporting to relevant national health authorities is mandatory, following country-specific regulations. As part of their responsibilities, grantees must conduct regular simulations of breach scenarios to ensure preparedness, maintain an emergency response kit accessible to all laboratory personnel, and implement a post-incident review process that identifies systemic vulnerabilities and necessary procedural modifications.

SFA Foundation may require independent assessment of serious breaches and reserves the right to suspend funding if significant non-compliance with biosafety or biosecurity protocols is determined to have contributed to the incident. Knowledge gained from breach incidents should be used for continuous improvement of safety protocols and, when appropriate, anonymised lessons learned should be shared with the broader scientific community to enhance biosafety and biosecurity practices across the continent.

11.0 Institutional Biosafety Committee Review

Research involving biological materials, particularly those with potential biosafety or biosecurity concerns, must undergo appropriate institutional oversight. Grantees should ensure that the safety of all research protocols are reviewed and approved by their Institutional Biosafety Committee (IBC) or equivalent local oversight body before commencing work. Where such committees do not exist, grantees are expected to work with their institutions to establish appropriate review mechanisms that align with international best safety practices while reflecting local contexts.

The review process should include thorough evaluation of research protocols, risk assessments, containment measures, emergency response plans, and potential dual-use implications. For research involving Risk Group 3 or 4 pathogens, genetic modification or similar emerging technologies, review by national regulatory authorities may be required. Grantees should maintain documentation of all approvals and address any stipulations or conditions imposed during the review process.

12.0 Expert Consultation

When working with high-risk pathogens or implementing novel procedures that may present biosafety or biosecurity challenges, grantees should seek consultation from appropriate subject matter experts. This may include biosafety professionals, infectious disease specialists, security experts, or other individuals with relevant expertise. For institutions with limited access to such expertise, collaboration with regional centres of excellence or international partners is encouraged to ensure appropriate guidance.

Expert consultation should be documented and recommendations incorporated into research protocols. SFA Foundation recognises that building networks of expertise across Africa is essential for advancing biosafety and biosecurity practices and encourages the sharing of knowledge and resources between institutions.

13.0 Training Requirements

All personnel involved in research with biological materials must receive appropriate biosafety and biosecurity training before beginning work. Training should be role-specific, comprehensive, and regularly updated to reflect evolving best practices. At minimum, training should cover:

• Risk assessment methodology and hazard identification
• Safe handling (including disposal and transport) procedures for biological materials
• Proper use of personal protective equipment and containment equipment
• Emergency response procedures for incidents and exposures
• Biosecurity awareness and responsibilities
• Ethical considerations including dual-use concerns

Biorisk management processes and procedures including risk assessments and control measures should be available to all applicable staff and they should be trained on these processes and procedures. Training should be provided in appropriate languages and formats to ensure comprehension by all staff members regardless of educational background or role. Refresher training should be conducted at least annually, with additional training provided when new procedures or equipment are introduced. Grantees should maintain records of all training activities, including content, attendance, and competency assessments.

Leadership within research institutions should promote a culture of safety and security by providing oversight, leading by example, ensuring good communication, participating in training activities and demonstrating commitment to biosafety and biosecurity principles. Peer-to-peer training and mentorship programs can complement formal training to build sustainable capacity within institutions.

DOWNLOAD Annex 1: Biosafety and Biosecurity Compliance Records Checklist

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For any queries on this policy, please contact [email protected]