Pandemic Ethics

Pandemic Ethics is a multi-country, interdisciplinary research initiative aimed at addressing the ethical imperative of post-trial arrangements (PTA) in low- and middle-income countries (LMICs) during public health emergencies such as epidemics and pandemics. The project seeks to develop national and global agendas for a just, practical, and solidarity-based PTA system that ensures equitable access to the benefits of clinical research, including new therapies and knowledge. Purpose and Rationale: The COVID-19 pandemic exposed stark inequities in access to life-saving therapies between high-income countries (HICs) and LMICs, despite the latter’s significant participation in clinical trials. PTA—defined as the obligation to provide continued access to interventions and knowledge generated in trials—is often inconsistently applied, poorly regulated, and narrowly interpreted. This project aims to realign PTA with its original ethical intent: to promote health equity, reduce global health disparities, and advance social justice. Theoretical Framework: The project is grounded in Alex John London’s Human Development Approach to International Research (HDAIR), which views research as a form of social cooperation that must contribute to the development priorities of host communities. PTA is conceptualized as a complex intervention within a dynamic socio-ecological system, requiring a multi-stakeholder, systemic approach rather than a narrow, contractual one. Research Objectives: Map the PTA landscape in six LMICs (Brazil, India, Kenya, Nepal, Philippines, Tanzania) and one HIC (Norway) during epidemics/pandemics. Investigate stakeholder experiences and perceptions of PTA, including regulators, ethics committees, researchers, sponsors, and patient groups. Analyze clinical trial protocols and ethics committee deliberations to assess the presence and nature of PTA provisions. Develop national and global agendas for a just and practicable PTA system. Propose a bioethical framework for PTA grounded in human development and solidarity. Methodology: The project employs a mixed-methods approach across five work packages: WP1: Scoping reviews of literature, laws, and media content on PTA. WP2: In-depth interviews and focus group discussions with stakeholders and beneficiaries. WP3: Review of clinical trial dossiers and ethics committee minutes. WP4: Development of national and global PTA agendas through stakeholder consultations. WP5: Communication, dissemination, and a train-the-trainer workshop on PTA. Expected Outcomes: A comprehensive understanding of the PTA socio-ecological landscape in LMICs. Evidence-based national and global PTA agendas. A human development-based ethical framework for PTA. Policy briefs, scientific publications, and training materials. Enhanced stakeholder capacity and public awareness on PTA. Impact: Pandemic Ethics directly contributes to the Sustainable Development Goals (SDGs): SDG 3: Good Health and Well-Being SDG 10: Reduced Inequalities SDG 5: Gender Equality By addressing systemic barriers to equitable access in clinical research, the project aims to transform PTA from an exception to a norm, especially in LMICs, and to strengthen global health solidarity during future public health emergencies.