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GLOBVAC-Global helse- og vaksin.forskn

Developing national and global agendas for the ethics of post-trial arrangements in LMICs during pandemics/epidemics

Alternative title: Utvikle nasjonale og globale strategier for etikk for post-trial-ordninger i LMICs under pandemier / epidemier

Awarded: NOK 12.0 mill.

Many drug clinical trials and other health interventions studies happened during the pandemic because we needed the vaccines and the health care as soon as possible, but the world was not ready for an emergency like this. The pandemic has shown that during emergency situations, low- and middle-income countries take the brunt. In addition to vaccine nationalism, there was a lack of global and national governance during the pandemic. We need governance and procedures based on equity to assure that the most vulnerable receive health care on time. Pandemic Ethics will bring together the voices of stakeholders from the different countries and continents. First to understand their needs, perspectives and desires about how the global order should be. Second to develop national and global governance agendas on post-trial responsibilities during emergency situations. The goal of Pandemic Ethics is to develop country-based and global agendas for a just and practicable post-trial arrangements (PTA) for low and middle income countries (LMICs) during epidemic/pandemic situations. During, and even before the COVID-19 pandemic, the world was scrambling to provide the necessary health care to its citizens. There was a lack of an agenda and a system, both on national and international levels. The project will be ongoing for four years, starting July 2023 and continuing until 2027. The research consortium consists of partners from four continents: Africa, Asia, Europe, and Latin America, with partners from Norway (University of Oslo [coordinator], University of South-Eastern Norway), the Philippines (University of the Philippines, Department of Health, and the Philippine Alliance of Patient Organizations), Nepal (Nepal Health Research Council, Tribhuvan University), India (King Edward Memorial Hospital), Kenya (University of Nairobi), Tanzania (National Institute for Medical Research) and Brazil (Universidade Federal de Santa Catarina).

Post-trial arrangement (PTA), otherwise known as post-trial access, is an ethical intervention designed to address inequity in terms of access to new therapies and knowledge after clinical trials. Immediately, it addresses the needs of patient participants to access not only the new knowledge gained but also the studied therapy post-trial. However, as an intervention to address health inequities, it also refers to access to both knowledge and new therapy by the community/host country, especially in regions suffering from health inequalities. However, the application of PTA has been patchy and more an exception than the rule as enabling legislations have also been wanting. The deeper reason for this is the bilateral, inconsistent, and contractual interpretation of PTA, i.e., PTA interpretations suffer from myopia and so will its application. Pandemic Ethics will refocus PTA discussions to bring it back to its original intent by FIRST, describing, investigating and making explicit the complex pandemic/epidemic PTA socio-ecological landscape in 6 LMICs from a legal/regulatory, stakeholder-based, and popular perspective. THEN, formulating research ethics foundations and proposing country-based and global agendas on a just and practicable PTA system during epidemics/pandemics. The project will use document review, qualitative methodology, and ethical reflection to address these objectives. Pandemic Ethics has 6 WPs, the first three will map the socio-ecological landscape through scoping reviews (WP1); investigation of stakeholders' experiences, roles, responsibilities, and perceptions (WP2); and document reviews of research ethics committee dossiers and minutes (WP3). WP4 will consolidate the findings of WPs 1-3 and provide a research ethics framework as well as propose country-based and global agendas for PTA for LMICs during epidemics/pandemics. WP5 will communicate, disseminate, and exploit results and WP6 is project management.

Funding scheme:

GLOBVAC-Global helse- og vaksin.forskn