Clinical research and justice in global health

Linking international clinical research to justice in global health

In 1990, the Commission on Health Research for Development identified international health research partnerships as key to advancing health in low and middle-income countries (LMICs) and promoting global health equity. WHO reports and global ministerial summits have subsequently reiterated this idea. Yet the basis for this mandate and how it should be achieved has been left ill defined.

Theories of justice from political philosophy establish obligations for parties from high-income countries owed to parties from low and middle-income countries. This research has developed a new framework that is largely based on Jennifer Ruger’s health capability paradigm (the paradigm itself derived from the work of AmartyaSen and Martha Nussbaum) to strengthen the link between international clinical research and justice in global health. The ‘research for health justice’ framework provides direction on four features of international clinical research: selection of a research target, provision of ancillary care, research capacity strengthening, and the provision of post-trial benefits. It identifies the obligations of justice owed by external research actors from high-income countries (e.g., national governments, funders, sponsors, and researchers) to trial participants and host communities.

To establish whether and how funders, sponsors, and investigators meet their obligations under the ‘research for health justice’ framework, case study research was undertaken on an ongoing international clinical trial that was designed to promote health equity—the Shoklo Malaria Research Unit’s ongoing vivax malaria treatment (VHX) trial. Data were collected utilizing a mix of qualitative research methods, including in-depth interviews with VHX trial investigators, trial participants, community advisory board members, and funder representative from Wellcome Trust; direct observation over a five-week period at trial sites; and collecting trial-related documents. Data were analysed according to the principles of thematic analysis and showed that the ‘research for health justice’ framework’s requirements were largely upheld by the Wellcome Trust (funder), Oxford University (sponsor), and investigators on the VHX trial. This case study research shows that the ethical requirements identified by the ‘research for health justice’ framework can be achieved in practice.

Publications –

Bridget Pratt, Deborah Zion, Bebe Loff. Evaluating the Capacity of Theories of Justice to Serve as a Justice Framework for International Clinical Research. American Journal of Bioethics 2012; 12:30-41.

Bridget Pratt, Deborah Zion, Khin Maung Lwin, Phaik Yeong Cheah, Francois Nosten, Bebe Loff. Closing the translation gap for justice requirements in international research. Journal of Medical Ethics 2012; 38(9):552-558.

Bridget Pratt, Bebe Loff. Health research systems: Promoting health equity or economic competitiveness? Bulletin of the World Health Organization 2012; 90(1):55-62.
Bridget Pratt, Bebe Loff. US policy should not shape collaborations. Nature 2012; 486:191. (Letter)

Bridget Pratt, Bebe Loff. Justice in International Clinical Research. Developing World Bioethics 2011; 11 (2):75-81

Bridget Pratt, Bebe Loff. Linking international research to global health equity: The limited contribution of bioethics. Bioethics Article first published online: 13 Dec 2011; DOI: 10.1111/j.1467-8519.2011.01932.x