Ethical principles for regulatory risk decision-making

Abstract

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.