title: Linking international clinical research with stateless populations to justice in global health.
abstract: BACKGROUND
  In response to calls to expand the scope of research ethics to address justice in global health, recent scholarship has sought to clarify how external research actors from high-income countries might discharge their obligation to reduce health disparities between and within countries. An ethical framework-'research for health justice'-was derived from a theory of justice (the health capability paradigm) and specifies how international clinical research might contribute to improved health and research capacity in host communities. This paper examines whether and how external funders, sponsors, and researchers can fulfill their obligations under the framework.
  
  
  METHODS
  Case study research was undertaken on the Shoklo Malaria Research Unit's (SMRU) vivax malaria treatment trial, which was performed on the Thai-Myanmar border with Karen and Myanmar refugees and migrants. We conducted nineteen in-depth interviews with trial stakeholders, including investigators, trial participants, community advisory board members, and funder representatives; directly observed at trial sites over a five-week period; and collected trial-related documents for analysis.
  
  
  RESULTS
  The vivax malaria treatment trial drew attention to contextual features that, when present, rendered the 'research for health justice' framework's guidance partially incomplete. These insights allowed us to extend the framework to consider external research actors' obligations to stateless populations. Data analysis then showed that framework requirements are largely fulfilled in relation to the vivax malaria treatment trial by Wellcome Trust (funder), Oxford University (sponsor), and investigators. At the same time, this study demonstrates that it may be difficult for long-term collaborations to shift the focus of their research agendas in accordance with the changing burden of illness in their host communities and to build the independent research capacity of host populations when working with refugees and migrants. Obstructive factors included the research funding environment and staff turnover due to resettlement or migration.
  
  
  CONCLUSIONS
  Our findings show that obligations for selecting research targets, research capacity strengthening, and post-trial benefits that link clinical trials to justice in global health can be upheld by external research actors from high-income countries when working with stateless populations in LMICs. However, meeting certain framework requirements for long-term collaborations may not be entirely feasible.
authors: Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe St,, Baltimore, MD 21205, USA. bpratt2@jhu.edu.
authors: Bridget
authors: B
authors: Pratt
authors: Deborah
authors: D
authors: Zion
authors: Khin Maung
authors: KM
authors: Lwin
authors: Phaik Yeong
authors: PY
authors: Cheah
authors: Francois
authors: F
authors: Nosten
authors: Bebe
authors: B
authors: Loff
mesh_terms: D035843:Biomedical Research / Q000941:ethics*; D032984:Ethics, Research; D005260:Female; D014943:Global Health / Q000941:ethics*; D017408:Guidelines as Topic; D006801:Humans; D007391:International Cooperation; D008288:Malaria; D008297:Male; D028681:Moral Obligations; D012108:Research Personnel / Q000941:ethics*; D012935:Social Justice; D012941:Social Responsibility