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

Bridget F Pratt, Deborah Ruth Zion, Khin Maung Lwin, Phaik Yeong Cheah, Francois H Nosten, Beatrice Loff

Research output: Contribution to journalArticleResearchpeer-review

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.
Original languageEnglish
Article number49
Pages (from-to)1 - 19
Number of pages19
JournalBMC Medical Ethics
Volume15
Issue number1
DOIs
Publication statusPublished - 2014

Cite this

Pratt, Bridget F ; Zion, Deborah Ruth ; Lwin, Khin Maung ; Cheah, Phaik Yeong ; Nosten, Francois H ; Loff, Beatrice. / Linking international clinical research with stateless populations to justice in global health. In: BMC Medical Ethics. 2014 ; Vol. 15, No. 1. pp. 1 - 19.
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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.",
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Linking international clinical research with stateless populations to justice in global health. / Pratt, Bridget F; Zion, Deborah Ruth; Lwin, Khin Maung; Cheah, Phaik Yeong; Nosten, Francois H; Loff, Beatrice.

In: BMC Medical Ethics, Vol. 15, No. 1, 49, 2014, p. 1 - 19.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Linking international clinical research with stateless populations to justice in global health

AU - Pratt, Bridget F

AU - Zion, Deborah Ruth

AU - Lwin, Khin Maung

AU - Cheah, Phaik Yeong

AU - Nosten, Francois H

AU - Loff, Beatrice

PY - 2014

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N2 - 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.

AB - 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.

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DO - 10.1186/1472-6939-15-49

M3 - Article

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JO - BMC Medical Ethics

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SN - 1472-6939

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