Linking international clinical research with stateless populations to justice in global health

BMC Medical Ethics

Bebe Loff⁵  Francois Nosten⁶  Phaik Yeong Cheah⁴  Khin Maung Lwin¹  Deborah Zion³  Bridget Pratt² 

[1] Shoklo Malaria Research Unit, Mae Sot, Thailand;Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe St., Baltimore, MD 21205, USA;Victoria University, Melbourne, Australia;Ethox Centre, Oxford University, Oxford, UK;Michael Kirby Centre for Public Health and Human Rights, Monash University, Melbourne, Australia;Centre for Tropical Medicine, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK

关键词: Shoklo malaria research unit;    Health capability paradigm;    Research ethics;    Global justice;    International clinical research;   

Others  :  866222
DOI  :  10.1186/1472-6939-15-49

 received in 2013-12-21, accepted in 2014-06-20,  发布年份 2014

【 摘 要 】

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.

【 授权许可】

   
2014 Pratt et al.; licensee BioMed Central Ltd.

【 参考文献 】

• [1]Benatar SR, Singer PA: A new look at international research ethics. BMJ 2000, 321(7264):824-826.
• [2]Benatar SR, Singer PA: Responsibilities in international research: a new look revisited. J Med Ethics 2010, 36:194-197.
• [3]Luna F: Poverty and inequality: challenges for the IAB: IAB presidential address. Bioethics 2005, 19:451-459.
• [4]Ijsselmuiden CB, Kass NE, Sewankambo NK, Lavery JV: Evolving values in ethics and global health research. Global Publ Health 2010, 5:154-163.
• [5]Daniels N: Equity and population health: towards a broader bioethics agenda. Hastings Cent Rep 2006, 36:22-35.
• [6]Emanuel EJ: Global Justice and the Standard of Care Debates. In Global Justice and Bioethics. Edited by Millum J, Emanuel EJ. Oxford: Oxford University Press; 2012:181-212.
• [7]London AJ: Justice and the human development approach to international research. Hastings Cent Rep 2005, 35(1):24-37.
• [8]Macklin R: Global Justice, Human Rights, and Health. In Global Bioethics. Edited by Green RM, Donovan A, Jauss SA. Oxford: Oxford University Press; 2008:141-160.
• [9]Meslin E: Achieving Global Justice in Health Through Global Research Ethics: Supplementing Macklin’s Top-Down Approach with One from the Ground Up. In Global Bioethics. Edited by Green RM, Donovan A, Jauss SA. Oxford: Oxford University Press; 2008:163-177.
• [10]Pratt B, Loff B: A framework to link international clinical research to the promotion of justice in global health. Bioethics 2012. doi: 10.1111/bioe.12009
• [11]Ruger JP: Global health justice. Publ Health Ethics 2009, 2(3):261-275.
• [12]Pogge T: World Poverty and Human Rights: Cosmopolitan Responsibilities and Reforms. Cambridge: Polity Press; 2008.
• [13]Ruger JP: Health and Social Justice. Oxford: Oxford University Press; 2010.
• [14]Pratt B, Zion D, Loff B: Evaluating the capacity of theories of justice to serve as a justice framework for international clinical research. Am J Bioeth 2012, 12(11):30-41.
• [15]Wolitz R, Emanuel EJ, Shah S: Rethinking the responsiveness requirement for international research. Lancet 2009, 374:847-849.
• [16]Kass NE, Hyder AA: Attitudes and Experiences of U.S. and Developing Country Investigators Regarding U.S. Human Subjects Regulations. In Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries, Volume II. Bethesda, MD: National Bioethics Advisory Commission; 2001.
• [17]Heise L, Shapiro K, Slevin KW: Mapping the Standards of Care at Microbicide Clinical Trial Sites. Washington DC: Global Campaign for Microbicides; 2008.
• [18]Pratt B, Zion D, Lwin KM, Cheah PY, Nosten F, Loff B: Closing the translation gap for justice requirements in international research. J Med Ethics 2012. doi: 10.1136/medethics-2011-100301
• [19]Yin R: Case Study Research: Design and Methods. SAGE: Thousand Oaks, CA; 2009.
• [20]Ronat J-B: Migrant Population Assessment in Maesot District: Health Access Situational Analysis. Mae Sot: SMRU; 2005.
• [21]Braun V, Clarke V: Using thematic analysis in psychology. Qual Res Psychol 2006, 3(2):77-101.
• [22]McGready R, Boel M, Rijken MJ, Ashley EA, Cho T, Moo O, Paw MK, Pimanpanarak M, Hkirijareon L, Carrara VI, Lwin KM, Phyo AP, Turner C, Chu CS, van Vugt M, Price RN, Luxemburger C, ter Kuile FO, Tan SO, Proux S, Singhasivanon P, White NJ, Nosten FH: Effect of early detection and treatment on malaria related maternal mortality on the north-western border of Thailand 1986–2010. PLoS One 2012, 7:e40244.
• [23]Central Intelligence Agency (CIA): The World Factbook. [https://www.cia.gov/library/publications/the-world-factbook webcite]
• [24]Shoklo Malaria Research Unit (SMRU): SMRU: Shoklo Malaria Research Unit. [http://www.shoklounit.com/index.php/about-smru webcite]
• [25]Wellcome Trust: Research Involving People Living in Low and Middle Income Countries: Position Statement and Guidance Notes for Applicants. [http://www.wellcome.ac.uk/About-us/Policy/Policy-and-position-statements/WTD015295.htm webcite]
• [26]Moran M, Guzman J, Henderson K, Abela-Oversteegen L, Wu L, Omune B, Gouglas D, Chapman N, Zmudzki F: Neglected Disease Research and Development: Is the Global Financial Crisis Changing R&D?. Sydney: Policy Cures; 2011.
• [27]Moran M, Guzman J, Ropars A-L, McDonald A, Jameson N, Omune B, Ryan S, Wu L: Neglected disease research and development: how much are we really spending? PLoS Med 2009, 6(2):e1000030.
• [28]Jha A: Science Funding Cuts: We Won't Fill the Gaps, Say Firms and Charities. The Guardian[http://www.guardian.co.uk/science/2010/oct/07/science-funding-cuts-firms-charities webcite]
• [29]Gilbert N: Wellcome Trust makes it personal in funding revamp. Nature 2009, 462:145.
• [30]Pratt B, Lwin KM, Zion D, Nosten F, Loff B, Cheah PY: Exploitation and community engagement: Can CABs successfully assume a role minimising exploitation in international research? Developing World Bioethics 2013. doi: 10.1111/dewb.12031