Biosafety, biosecurity and research misuse policy

We support responsible research of the highest quality, including ambitious and disruptive research, that has the potential to deliver transformative shifts in understanding health and wellbeing. 

As advances in the life sciences accelerate, so too do the risks of research being misused – both intentionally and unintentionally – in ways that could cause harm to people and animals. 

This policy applies to all Wellcome-funded research, including, but not limited to:

• in vitro, in vivo and in situ studies
• research involving modifying pathogens, toxins, engineering organisms, or gene synthesis (‘Gain of Function’, synthetic biology)
• research involving the study or development of ‘mirror molecules’ (‘Mirror Life’ organisms)
• research involving use of computational, AI or other emerging technologies that could pose risks to biosafety, biosecurity and research misuse
• research involving collection, storage and transport of biological samples
• dual-use implications of research findings, data, technologies or publications

Researchers are expected to understand the potential risks associated with their area of research. For the purposes of this policy, we consider the following definitions:

• Biological agent: A microorganism, virus, biological toxin, particle or otherwise infectious material, either naturally occurring or genetically modified, which may have the potential to cause infection, allergy, toxicity or otherwise create a hazard to humans and animals.
• Biosafety: containment principles, technologies and practices that are implemented to prevent unintentional exposure to biological agents or their accidental release.
• Biosecurity: principles, technologies and practices that are implemented for the protection of biological materials and their handling, with the aim to prevent their unauthorised access, loss, theft, misuse or release.
• Dual-use research: certain materials, information and technologies that are intended for societal benefit, but which might be misapplied to do harm.
• Emerging technologies: innovative and rapidly developing technologies (for example AI) that often involve new biological applications or innovative approaches to existing ones, which have the potential to disrupt traditional methods, and create new opportunities and risks.
• Gain of Function (GoF): research that changes the genome of an organism to enhance certain biological functions.
• Mirror Life: research that involves the development of organisms with biomolecular chirality reversed from their natural state.
• Pathogen: a biological agent capable of causing disease in humans and animals.
• Research misuse: any work that could enable, facilitate, or accelerate harmful application of biological knowledge or tools.
• Synthetic biology: research that involves the design and construction of novel artificial biological pathways, organisms and devices or the redesign of existing natural biological systems.

Organisations have a responsibility to mitigate and manage risks associated with their research activities. They must have policies and processes in place that comply with relevant local legislation and regulatory frameworks (or equivalent international standards), that promote the highest safety standards in research.

We will take into consideration the local context and organisational capacity, however, at a minimum, organisations must align with the following:

• Biological Weapons Convention (BWC)
• UN Security Council Resolution 1540 
• International Health Regulations (2005)
• WHO guidance on implementing regulatory requirements for biosafety and biosecurity in biomedical laboratories (2020)
• WHO Laboratory Biosecurity Guidance (2024)
• WHO Laboratory Biosafety Manual
• WHO Global Guidance Framework for the Responsible Use of the Life Sciences (2022)
• ISO 35001: Biorisk management for laboratories and other related organisations (2019)
• Cartagena Protocol on Biosafety (2000)

Organisations must:

• have robust and appropriate level of biosafety and biosecurity systems in place, including appropriate containment facilities that undergo regular inspection with continued oversight 
• require appropriate biosafety levels are used depending on the nature of the project (for example, the right level of BSL), including management of biological data and digital systems
• ensure all research activities comply with data protection, security and cyber security standards operating in the local context of the research, or with equivalent international regulations where these do not exist (for example, ISO/IEC 27701)
• have an ethical or biosafety individual or committee responsible for biorisk oversight throughout the life of the project. They can be at an organisational level or project-based level.
• have processes for reporting incidents, near misses or emerging risks to relevant parties
• demonstrate they have considered how to ensure the responsible use of emerging and converging technologies where these pose a biorisk, such as AI-enabled biological design tools
• enable training provision for researchers and visiting staff on biosafety and biosecurity who have access to labs and facilities and handle bioagents, including maintain records of training

Researchers have a responsibility to anticipate and mitigate risks associated with their work. This should include ethical considerations, unintended consequences, and the appropriateness of research methods. 

Research design

Researchers must:

• Be aware of the risks associated with their work and highlight these in their application form. For example, those working with synthetic nucleic acids should be aware of the risks of the generation and usage of sequences of concern, and follow relevant standards to minimise them (for example, ISO 20688-2:2024). 
• Address how they have factored using alternative lower-risk methods or locations for the research (for example, pseudoviruses, in silico models, attenuated systems) and justify when higher-risk approaches are scientifically necessary.
• Conduct project-specific risk assessments prior to commencing work and ensure active monitoring for new or additional risks that may arise.
• Seek independent expert advice on their risk management approach, for example through local biosafety committees or independent reviewers (in addition to complying with ethical approval processes).

Managing the research

Researchers must ensure regular assessment of project-specific risks and report to relevant oversight committee as well as Wellcome of any:

• significant changes in risk level 
• creation of unanticipated high-risk phenotypes
• incidents or near misses with biosafety or biosecurity implications

Biological samples

Collection, management and storing of samples (human and animal) must comply with all relevant regulatory and legislative standards and best practices. All researchers must tell us in their grant application how the tissue or data will be collected, stored and made available for access, subject to suitable safeguards.

In the UK, researchers must comply with the Human Tissue Act 2004 or the Human Tissue (Scotland) Act 2006. Researchers outside of the UK must comply with relevant local or national legislation and regulations, such as the European Tissues and Cells Directive.

Individuals who have concerns about potential intended misuse risks in ongoing or planned research are encouraged to raise their concerns through relevant organisational procedures. See our research misconduct policy for more information.

We will provide costs for:

• specific training, upskilling and professional development on biosafety, biosecurity protocols and lab management per staff working on the grant
• travel for training and capacity building, for example where specific training is not available in the location or country where the research is taking place
• dedicated staff with responsibility to manage biorisks per project and based on percentage provided no established institutional provision is available (ethics/safety committee; personnel)