TY - JOUR KW - Ethical principles KW - One Health lens KW - projector model KW - regulatory context KW - risk decision-making AU - Yadvinder Bhuller AU - Marc Avey AU - Raywat Deonandan AU - Thomas Hartung AU - Gina M. Hilton AU - Robin J. Marles AU - Stefania Trombetti AU - Daniel Krewski AB - Risk assessors, managers, and decision-makers are responsible for evaluating diverse human, environmental, and animal health risks. Although the critical elements of risk assessment and management are well-described in national and international documents, the ethical issues involved in risk decision-making have received comparatively little attention to date. To address this aspect, this article elaborates fundamental ethical principles designed to support fair, balanced, and equitable risk-based decision-making practices. Experts and global thinkers in risk, health, regulatory, and animal sciences were convened to share their lived experiences in relation to the intersection between risk science and analysis, regulatory science, and public health. Through a participatory and knowledge translation approach, an integrated risk decision-making model, with ethical principles and considerations, was developed and applied using diverse, contemporary risk decision-making and regulatory contexts. The ten principles - autonomy, minimize harm, maintain respect and trust, adaptability, reduce disparities, holistic, fair and just, open and transparent, stakeholder engagement, and One Health lens - demonstrate how public sector values and moral norms (i.e., ethics) are relevant to risk decision-making. We also hope these principles and considerations stimulate further discussion, debate, and an increased awareness of the application of ethics in identifying, assessing, and managing health risks. BT - Regulatory Toxicology and Pharmacology DA - 2025-03-21 DO - 10.1016/j.yrtph.2025.105813 N2 - Risk assessors, managers, and decision-makers are responsible for evaluating diverse human, environmental, and animal health risks. Although the critical elements of risk assessment and management are well-described in national and international documents, the ethical issues involved in risk decision-making have received comparatively little attention to date. To address this aspect, this article elaborates fundamental ethical principles designed to support fair, balanced, and equitable risk-based decision-making practices. Experts and global thinkers in risk, health, regulatory, and animal sciences were convened to share their lived experiences in relation to the intersection between risk science and analysis, regulatory science, and public health. Through a participatory and knowledge translation approach, an integrated risk decision-making model, with ethical principles and considerations, was developed and applied using diverse, contemporary risk decision-making and regulatory contexts. The ten principles - autonomy, minimize harm, maintain respect and trust, adaptability, reduce disparities, holistic, fair and just, open and transparent, stakeholder engagement, and One Health lens - demonstrate how public sector values and moral norms (i.e., ethics) are relevant to risk decision-making. We also hope these principles and considerations stimulate further discussion, debate, and an increased awareness of the application of ethics in identifying, assessing, and managing health risks. PY - 2025 EP - 105813 T2 - Regulatory Toxicology and Pharmacology TI - Ethical principles for regulatory risk decision-making UR - https://www.sciencedirect.com/science/article/pii/S0273230025000431 Y2 - 2025-03-27 SN - 0273-2300 ER -