Developing and testing an ethical framework to link international clinical research to justice in global health

Abstract

The thesis considers whether international research should contribute to the reduction of global health disparities and, if so, how the enterprise should do so. To answer these questions, I systematically analyse cosmopolitan and middle ground theories of justice in order to determine if they support the conduct of international health research. I then investigate which theory, if any, can provide the most comprehensive guidance about what is owed by external research actors from high-income countries to parties in low and middle-income countries and is, therefore, best-equipped to serve as the basis of a justice framework for international research. The analysis reveals that the human rights cosmopolitan theories of Thomas Pogge and Henry Shue, Peter Singer’s consequentialist cosmopolitan theory, and Jennifer Ruger’s health capability paradigm each provide grounds for the contention that international research should advance justice in global health. Of these theories, the health capability paradigm is selected to serve as the starting point of a justice framework for international clinical research. Relying on premises derived from the health capability paradigm, I develop the ‘research for health justice’ framework. The framework provides guidance on how four key aspects of international clinical research should be structured so that the enterprise most effectively reduces health disparities between and within countries. Those four aspects are: the research target, research capacity strengthening, ancillary care, and post-trial benefits. The framework identifies the obligations of multilaterals, governments, research funders, sponsors, and investigators towards putting this model of international clinical research into practice. The thesis then utilises empirical methods to test the theoretical concepts that it develops. To determine whether high-income country governments meet their obligations under the ‘research for health justice’ framework, I evaluate the alignment of research law and policy in the United States and United Kingdom against its requirements. Neither country is shown to have enacted research law and policy similar to that called for by the framework. Due to their sustained commitment to technology transfer legislation, both countries’ health research systems are organised to promote domestic economic ends rather than health equity. To establish whether and how research funders, sponsors, and investigators meet their obligations under the ‘research for health justice’ framework, case study research was performed on an ongoing equity-oriented international clinical trial—the Shoklo Malaria Research Unit’s vivax malaria treatment trial. Data were collected utilising a mix of qualitative research methods and analysed according to the principles of thematic analysis. The results demonstrate that international clinical research can meet ethical requirements linking it to justice in global health, even in difficult circumstances (i.e., where a research population largely cannot access its government health system). Framework requirements were largely upheld by Wellcome Trust (funder), Oxford University (sponsor), and investigators on the vivax malaria treatment trial. A number of factors facilitated adherence to the requirements, including chief investigators’ intentions and practices and the Shoklo Malaria Research Unit’s dual role as a research unit and health care provider.