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08.08.2025

ELSI Mapping: guidelines for infectious diseases

International legal and regulatory framework

Research on epidemic- and pandemic-prone pathogens is governed by a variety of international laws and regulations aimed at ensuring safety and public health. Navigating the international laws and regulatory frameworks for research on epidemic- and pandemic-prone pathogens requires a comprehensive understanding of these diverse guidelines. Adhering to these frameworks is crucial for ensuring ethical research practices, protecting public health, and fostering international collaboration in addressing global health threats.

ISIDORe Deliverable 4.2 established a quality and regulatory framework across ISIDORe service provider partners. Additionally, these are relevant to consider:

World Health Organization (WHO) Frameworks

  • Laboratory biosafety manual, 4th edition: Recommendations for safe handling of pathogens in laboratories, including biosafety levels and practices. The WHO Laboratory Biosafety Manual (LBM) has been in broad use at all levels of clinical and public health laboratories, and other biomedical sectors globally, serving as a de facto global standard that presents best practices and sets trends in biosafety.
  • Laboratory biosecurity guidance: The document shares global best practice and covers the biosecurity part of the biological risk management lifecycle, starting from collection, transportation, storage and experiment, and in specific context such as every type of biomedical laboratory, research activities, repository and biobank.
  • Strengthening laboratory biological risk management: The resolution urges Member States to adopt comprehensive, risk-based national strategies—backed by WHO guidance and support—to strengthen laboratory biosafety and biosecurity and prevent accidental or deliberate release of dangerous pathogens.
  • Global guidance framework for the responsible use of the life-sciences: mitigating biorisks and governing dual-use research: This framework aims to provide values and principles, tools and mechanisms to support Member States and key stakeholders to mitigate and prevent biorisks and govern dual-use research. The framework is primarily intended for those who have responsibilities in the governance of the biorisks, such as policy makers and regulators in charge of developing national policies to harness the potential benefits of the life sciences while constraining their risks.

Other bioethics Frameworks

  • Declaration of Helsinki. The Declaration of Helsinki establishes ethical principles for medical research involving human subjects, significantly contributing to pandemic preparedness. It emphasizes informed consent, ensuring participant safety and trust, while requiring a thorough risk-benefit analysis to balance urgency with ethical considerations. By promoting scientific validity and international collaboration, the Declaration facilitates reliable research on epidemic- and pandemic-prone pathogens, ultimately enhancing public health responses and protecting vulnerable populations during health crises.
  • Belmont Report. The Belmont Report outlines ethical principles for research involving human subjects, focusing on respect for persons, beneficence, and justice. Its contributions to pandemic preparedness include emphasizing informed consent to foster trust, guiding ethical decision-making to maximize benefits and minimize harm, and advocating for equitable treatment of vulnerable populations. By providing a robust ethical framework, the Belmont Report enhances the integrity of research on epidemic-prone pathogens, supporting effective public health responses during health crises.
  • Terrestrial Animal Health Code. The World Organization for Animal Health provides these standards for the improvement of animal health, animal welfare, and veterinary public health worldwide. These standards should be used by Members to set up measures for the prevention, early detection, reporting, and control of pathogenic agents in terrestrial animals (mammals, reptiles, birds, and bees), including zoonotic agents. Implementation of the recommendations in the Terrestrial Code ensures the safety of international trade in animals and animal products while avoiding unjustified sanitary barriers.
  • Russell and Burch’s Principles of Humane Experimental Techniques. These guidelines articulate the Three Rs (Replacement, Reduction, and Refinement) as a framework that requires researchers to avoid animal use where possible, minimize the number of animals when use is unavoidable, and design procedures that alleviate pain and distress. By embedding these principles into every stage of experimental planning and regulation, they aim to raise ethical standards while also improving the scientific quality and relevance of research involving animals.
  • The Global Health Security Agenda (GHSA) is an international initiative aimed at enhancing global health security by strengthening countries’ capacities to prevent, detect, and respond to infectious disease threats. A partnership of countries and international organizations aimed at strengthening global capacity to prevent, detect, and respond to infectious disease threats. It emphasizes collaboration and research on high-threat pathogens.
  • The Convention on Biological Diversity: Signed by 150 government leaders at the 1992 Rio Earth Summit, the Convention on Biological Diversity is dedicated to promoting sustainable development. Conceived as a practical tool for translating the principles of Agenda 21 into reality, the Convention recognizes that biological diversity is about more than plants, animals and micro-organisms and their ecosystems – it is about people and our need for food security, medicines, fresh air and water, shelter, and a clean and healthy environment in which to live.
  • Dual-use research of concern guidelines. European Archive Virus Global prepared this document to provide support and guidance in identifying and assessing dual-use risks in their research projects. It is not intended to be prescriptive. Researchers and their institutions are still responsible for their own actions and to ensure that the implementation of their research complies with international frameworks and national regulations.

European Union Regulations

National Regulations

Many countries have specific laws governing research on infectious diseases, including biosafety laws, ethical review processes, and regulations on the use of human and animal subjects in research. ISIDORe Deliverable D4.2 has provided a framework for national laws relevant to the Consortium. See: https://isidore-project.eu/wp-content/uploads/quality-criteria-for-isidores-services-national-laws.pdf

The recommendation is to always refer to legal national authorities for guidelines.

Societal aspects

Pandemic preparedness lives or dies by public trust. That means plain-language, transparent risk communication plans must accompany every scientific milestone. Dedicated science communication teams that partner with local journalists have proven effective in defusing misinformation during recent outbreaks, safeguarding both research continuity and uptake of countermeasures. Communication science offers promising public health messaging strategies for combating COVID-19 and future pandemics.[1]

[1] See: https://www.tandfonline.com/doi/abs/10.1080/10410236.2021.1994910