Global Justice and Health Systems Research in Low- and Middle-Income Countries

Benatar S. R. Singer P. A. , “A New Look at International Research Ethics,” British Medical Journal 321, no. 7264 (2000): 824–826, at 826.

Benatar S. R. Shapiro K. , “HIV Prevention Research and Global Inequality: Steps towards Improved Standards of Care,” Journal of Medical Ethics 31, no. 1 (2005): 39–47.

Emanuel E. J. , “Global Justice and the ‘Standard of Care’ Debates,” in Millum J. Emanuel E. J. , eds., Global Justice and Bioethics (Oxford: Oxford University Press): At 181–212;.

London A. J. , “Justice and the Human Development Approach to International Research,” Hastings Center Report 35, no. 1 (2005): 24–37.

These theories take the position that the scope of justice is global. We recognize that, while there are strong arguments for this claim, it is not universally supported. Anti-cosmopolitan theorists assert that the scope of justice is national and that parties only have obligations of justice to other parties within their nation-states. See Ypi L. Goodin R. E. Barry C. , “Associative Duties, Global Justice, and the Colonies,” Philosophy and Public Affairs 37, no. 2 (2009): 103–135.

Pratt B. Zion D. Loff B. , “Evaluating the Capacity of Theories of Justice to Serve as a Justice Framework for International Clinical Research,” American Journal of Bioethics 12, no. 11 (2012): 30–41.

Pratt B. Loff B. , “A Framework to Link International Clinical Research to the Promotion of Justice in Global Health,” Bioethics 28, no. 8 (2014): 387–396.

See Pratt , supra note 4.

Id.

Ruger J. P. , Health and Social Justice (Oxford: Oxford University Press): At 94–95.

Ruger J. P. , “Health Capability: Conceptualization and Operationalization,” American Journal of Public Health 100, no. 1 (2010): 41–49.

See Ruger , supra note 8, at 81–83;. 88–95.

Since the health capability paradigm integrates health outcomes and health agency, both constructs provide guiding principles for the further definition of health capabilities. A broad range of health capability elements have been identified that include but are not limited to health status. Other elements include “the ability to acquire accurate health-related knowledge and obtain health-related resources and to use both to prevent the onset and exacerbation of morbidity…health-seeking skills, beliefs, and self-efficacy…self-governance and self-management to achieve health outcomes” (see Ruger , supra note 9, at 43). As a result, health status can be used as a rough measure of health capability, bearing in mind that it does not fully capture all the elements of health capability.

Ruger J. P. , “Global Health Justice,” Public Health Ethics 2, no. 3 (2009): 261–75, at 269.

In this paper, subsequent references to the worst-off refer to those who are worst-of in terms of their health.

Global actors are public or private entities from outside a particular state and include multilaterals, bilaterals, global health institutions, governments, nongovernmental organisations, businesses, foundations, families, and individuals. See Ruger , supra note 12.

Ruger J. P. , “Normative Foundations of Global Health Law,” Georgetown Law Journal 96, no. 2 (2008): 423–443.

See Ruger , supra note 12.

See Pratt Loff , supra note 5.

Although others have used the terms funder and sponsor interchangeably, we distinguish between the two in this article because, in international research, they are often not the same entity. The sponsoring institution is typically the employer of study investigators rather than the agency from whom funding is awarded. In the Mutuelles trial that we discuss later on, for example, the funder was the Doris Duke Charitable Foundation and the external sponsor was Harvard University.

See Pratt Loff , supra note 5.

See Ruger , supra note 12.

See Pratt Loff , supra note 5.

WHO Task Force on Health Systems Research, The Millennium Development Goals will not be Attained without New Research Addressing Health System Constraints to Delivering Effective Interventions (Geneva, Switzerland: WHO, 2005).

WHO Task Force on Research Priorities for Equity in Health and the WHO Equity Team, “Priorities for Research to Take Forward the Health Equity Policy Agenda,” Bulletin of the World Health Organization 83 (2005): 948–995.

Bamako Call to Action on Research for Health, November 17–19, 2008, the Global Ministerial Forum on Research for Health, Bamako, Mali.

The Mexico Statement on Health Research, November 16–20, 2004, the Ministerial Summit on Health Research, Mexico City, Mexico.

See Ruger , supra note 9.

See WHO Task Force on Health Systems Research, supra note 22.

Rudan I. El Arifeen S. Black R. E. , “Childhood Pneumonia and Diarrhoea: Setting our Priorities Right,” The Lancet Infectious Diseases 7, no. 1 (2007): 56–61.

See WHO Task Force on Health Systems Research, supra note 22;.

WHO Task Force on Research Priorities for Equity in Health and the WHO Equity Team, supra note 22;.

Bamako Call to Action, supra note 22;.

The Mexico Statement, supra note 22.

See Pratt , supra note 5.

See Emanuel , supra note 2;.

see London, supra note 2.

Bennett S. Adam T. Zarowsky C. , “From Mexico to Mali: Progress in Health Policy and Systems Research,” The Lancet 372, no. 9649 (2008): 1571–1578.

Hyder A. A. Rattani A. Krubiner C. , “Ethical Review of Health Systems Research in Low and Middle Income Countries: A Conceptual Exploration,” American Journal of Bioethics 14, no. 2 (2014): 28–37.

World Health Organization, Scaling up Research and Learning for Health Systems: Now Is the Time (Geneva, Switzerland: World Health Organization, 2009).

Gilson L. , Health Policy and Systems Research: A Methodology Reader (Geneva, Switzerland: Alliance for Health Policy and Systems Research, 2012).

Some public health research can be considered HSR. Hoffman (2012, 13) states that “[t]he overlap [of HSR] with population health research, however, is less clear, but likely includes research on the public health system and the delivery of non-personal public health programs and interventions. Excluded from health systems research would be population health research's focus on measuring or describing health, examining the determinants of health status and outcomes, and assessing the effects of specific health promotion interventions.” See Hoffman S. Røttingen J-A. Bennett S. , “Background Paper on Conceptual Issues Related to Health Systems Research to Inform a WHO Global Strategy on Health Systems Research,” 2012, available at <http://www.who.int/alliance-hpsr/alliancehpsr_backgroundpaperhsrstrat1.pdf> (last visited February 24, 2015).

Here, we acknowledge that it is possible to develop guidance on externally-funded HSR in LMICs from a global justice perspective using other theories of justice. However, as per the health capability paradigm, these theories would need to discuss just health systems and the requirements of global justice in-depth in order to facilitate the derivation of requirements for equity-oriented HSR. For example, Daniels' extension of Rawlsian justice does the former but does not do the latter in sufficient detail. See Pratt , supra note 4.

This is not to suggest that obligations of justice are not allocated to LMIC research actors. However, identifying the obligations of research actors in LMICs is beyond the scope of this paper. The nature of these obligations should be explored in future work to determine if host country research actors' obligations mirror, overlap, or are distinct from those of external research actors from high-income countries.

See Ruger , supra note 8, at 8–11;.

Ruger , supra note 12.

Alliance for Health Policy and Systems Research (AHPSR), Priority Setting for Health Policy and Systems Research (Geneva, Switzerland: WHO, 2009).

Council on Health Research for Development (COHRED) and Swedish International Development Cooperation Agency (SIDA), Cameroon: Alignment and Harmonization in Health Research (Geneva, Switzerland: Council on Health Research for Development, 2008).

Council on Health Research for Development (COHRED) and Swedish International Development Cooperation Agency (SIDA), Mozambique: Alignment and Harmonization in Health Research (Geneva, Switzerland: Council on Health Research for Development, 2008).

This was largely due to countries using disease-driven priority setting methods that devalue HSR and then failing to identify HSR priorities through a separate process. See Council on Health Research for Development (COHRED) and Swedish International Development Cooperation Agency (SIDA), Zambia: Alignment and Harmonization in Health Research (Geneva, Switzerland: Council on Health Research for Development, 2008).

Council on Health Research for Development (COHRED), Essential National Health Research in South Africa: Towards National Consensus Building in Health Research, 2001, available at <http://www.cohred.org/downloads/669.pdf> (last accessed February 24, 2015).

National Institute for Medical Research (NIMR), Tanzania Health Research Priorities, 2006–2010 (Dar es Salaam, Tanzania: National Institute for Medical Research, 2006).

This obligation will be discussed in the capacity-building section.

Ranson M. K. Bennett S. , “Priority Setting and Health Policy and Systems Research,” Health Research Policy and Systems 7 (2009): 27.

Ad Hoc Committee on Health Research Relating to Future Intervention Options, Investing in Health Research and Development (Geneva: World Health Organization, 1996).

See Ranson , supra note 40.

The malERA Consultative Group on Health Systems and Operational Research, “A Research Agenda for Malaria Eradication: Health Systems and Operational Research,” PLoS Medicine 8, no. 8 (2011): e1000397.

See Ruger , supra note 8, at 95–98.

See Ranson , supra note 40.

Mills A. , “Health Care Systems in Low- and Middle-Income Countries,” New England Journal of Medicine 370 (2014): 552–557.

Bennett S. Agyepong I. A. Sheikh K. , “Building the Field of Health Policy and Systems Research: An Agenda for Action,” PLoS Medicine 8, no. 8 (2011): e1001081.

Ruger J. P. , “Shared Health Governance,” American Journal of Bioethics 11, no. 7 (2011): 32–45, at 33.

Wachira C. Ruger J. P. , “National Poverty Reduction Strategies and HIV/AIDS Governance in Malawi: A Preliminary Study of Shared Health Governance,” Social Science and Medicine 72, no. 12 (2011): 1956–1964.

Id. See Ruger, supra note 8, at 6–8;.

Ruger , supra note 48. Here, we recognize that further work is needed to further define and operationalize the concepts of “inclusive decision making” and “consensus.” We are currently in the process of carrying it out.

Ranson K. Law T. J. Bennett S. , “Establishing Health Systems Financing Research Priorities in Developing Countries Using a Participatory Methodology,” Social Science and Medicine 70, no. 12 (2010): 1933–1942.

The exact package of health care that is owed to the population of a particular state is to be determined through a deliberative process at the national level. See Ruger , supra note 6, at 172–202.

See Ruger , supra note 8, at 8–11.

See Ruger , supra note 8, at 133–157.

Id.

Id.

The principle of equal access to high quality health care does not differ by the voluntary or involuntary nature of risk. Thus, smokers who continue to smoke against health advice are still owed equal access to health goods and services. Since it is extremely difficult to identify how much of choice is voluntary as opposed to due to genetic factors or social conditions, the health capability paradigm errs on the side of social responsibility. It also emphasizes developing people's health agency so that they become able to make good health decisions. See Ruger , supra note 8, at 153–155.

See Ruger , supra note 8, at 159–171.

Id.

Id.

Id.

World Health Organization, The World Health Report – Health Systems Financing: The Path to Universal Coverage (Geneva: World Health Organization, 2010).

Kutzin J. , “Health Financing for Universal Coverage and Health System Performance: Concepts and Implications for Policy,” Bulletin of the World Health Organization 91 (2013): 602–611.

Saghai Y. , “Internalized Public Moral Norms and Shared Sovereignty,” American Journal of Bioethics 11, no. 7 (2011): 49–51.

Sheikh K. Gilson L. Agyepong I.A. , “Building the Field of Health Policy and Systems Research: Framing the Questions,” PLoS Medicine 8, no. 8 (2011): e1001073.

Rockefeller Foundation, “Catalyzing Change: The System Reform Costs of Universal Health Coverage,” 2010, available at <http://www.rockefellerfoundation.org/uploads/files/ebafb89b-2d68–45c0–885e-74d40e8c55d9.pdf> (last accessed February 24, 2015).

Id.

By 2005, mutuelles infrastructure covered the entire country. Its impact between 2000 and 2008 was then assessed by a team comprised of researchers from Rwanda and the U.S. (Harvard University). See Rockefeller Foundation, supra note 66.

See Pratt , supra note 5.

Id;.

Mills A. , “Health Policy and Systems Research: Defining the Terrain; Identifying the Methods,” Health Policy and Planning 27, no. 1 (2012): 1–7.

Health care systems are composed of both hardware (human resources, health services, financing, governance, information technology) and software (norms, values) elements. See Sheikh , supra note 59.

See Gilson , supra note 31.

McIntyre D. Mills A. , “Research to Support Universal Coverage Reforms in Africa: The SHIELD Project,” Health Policy and Planning 27, Supp. 1 (2012): i1–i3.

Nguyen K. T. Khuat O. T. Ma S. , “Impact of Health Insurance on Health Care Treatment and Cost in Vietnam: A Health Capability Approach to Financial Protection,” American Journal of Public Health 102, no. 8 (2012): 1450–1461.

Ruger J. P. , “An Alternative Framework for Analyzing Financial Protection in Health,” PLoS Medicine 9, no. 8 (2012): e1001294.

See Ruger , supra note 74.

Lu C. Chin B. Lewandowski J. L. , “Towards Universal Health Coverage: An Evaluation of Rwanda Mutuelles in Its First Eight Years,” PLoS One 7, no. 6 (2012): e39282.

Id.

The precise indicators of financial protection proposed by Jennifer Ruger were not relied upon. They had not yet been devised/published.

Hyder A. A. Bloom G. Leach M. , “Exploring Health Systems Research and Its Influence on Policy Processes in Low Income Countries,” BMC Public Health 7 (2007): 309.

See AHPSR, supra note 36.

Global priorities do not necessarily reflect the specific national contexts, as some global priorities may not apply to certain countries (e.g., countries who have already met certain MDG health targets) and certain health problems at the national level may not be included on the list of global priorities.

See Pratt , supra note 4.

See Pratt Loff , supra note 5.

These requirements are discussed in Pratt and Loff (2012). See Pratt Loff , supra note 5.

See Gilson , supra note 31.

Hyder A. A. Corluka A. Winch P. J. , “National Policy-Makers Speak Out: Are Researchers Giving Them What They Need?” Health Policy and Planning 26, no. 1 (2011): 73–82.

Bennett S. Paina L. Kim C. , “What Must be Done to Enhance Capacity for Health Systems Research?” 2010, available at <http://www.rockefellerfoundation.org/uploads/files/c4ccb675–f6f8–47de-8552–e032d4c3fc20.pdf> (last accessed February 24, 2015).

See Bennett , supra note 29.

Hotez P. R. Cohen C. Mimura T. , Strengthening Mechanisms to Prioritize, Coordinate, Finance, and Execute R&D to Meet Health Needs in Developing Countries (Washington, D.C.: Institute of Medicine, 2013). This is not to say all development agencies view research and research capacity strengthening as falling outside their remit. A 2001 Overseas Development Institute report that mapped research capacity strengthening initiatives in LMICs identified funding streams available at the following agencies: The Danish International Development Agency (DANIDA), the Swedish International Development Cooperation Agency (SIDA)'s Department for Research Cooperation (SAREC), and Canada's International Development Research Centre (IDRC). The United Kingdom's Department for International Development also views research capacity strengthening as being part of its remit and funds both HSR and clinical research in LMICs.

See Young J. Kannemeyer N. , Building Capacity in Southern Research: A Study to Map Existing Initiatives (London, United Kingdom: Overseas Development Institute, 2001).

Department for International Development (DFID), Capacity Building in Research, 2010, available at <http://bsuhh.org/fileadmin/user_upload/bsu-ge/Other_Reports/How_To_Note_Research_Capacity_Building.pdf> (last accessed February 24, 2015).

Department for International Development (DFID), DFID Research Strategy 2008–2013 Working Paper Series: Capacity Building (London, United Kingdom: Department for International Development, 2008).

See Bennett , supra note 29.

Id.

See DFID, supra note 88.

Research funders that do not have a role in development and solely channel their resources to research also have an obligation to fund HSR capacity strengthening that occurs during research-related activities (i.e., institutional collaborations and research projects). They do not have an obligation to fund systems level strengthening.

See Ruger , supra note 9, at 44.

Basinga P. Gertler P. J. Binagwaho A. , “Effect on Maternal and Child Health Services in Rwanda of Payment to Primary Health-Care Providers for Performance: An Impact Evaluation,” The Lancet 377, no. 9775 (2011): 1421–1428.

During the research project, this responsibility is generally met by the research funder.

Koh H. H. Oppenheimer S. C. Massin-Short S. B. , “Translating Research Evidence into Practice to Reduce Health Disparities: A Social Determinants Approach,” American Journal of Public Health 100, Supp. 1 (2010): S72–S80.

Id.;.

Ssengooba F. Atuyambe L. Kiwanuka S. N. , “Research Translation to Inform National Health Policies: Learning from Multiple Perspectives in Uganda,” BMC International Health and Human Rights 11, Supp. 1 (2011): S13.

Ekirapa-Kiracho E. Waiswa P. Hafizur Rahman M. , “Increasing Access to Institutional Deliveries Using Demand and Supply Side Incentives: Early Results from a Quasi-Experimental Study,” BMC International Health and Human Rights, 11, Supp. 1 (2011): S11.

Pariyo G. Mayora C. Okui O. , “Exploring New Health Markets: Experiences from Informal Providers of Transport for Maternal Health Services in Eastern Uganda,” BMC International Health and Human Rights, 11, Supp. 1 (2011): S10.

Here, the framework calls for the handover of intervention implementation to local actors or international NGOs (working with local actors) that are involved in health programming and/or health system strengthening. Their delivery of interventions is supported by funding from aid agency, global health organisation, and/or philanthropic foundation donors (see Obligation-Bearers sub-section).

Hyder A. A. Bloom G. Leach M. , “Exploring Health Systems Research and Its Influence on Policy Processes in Low Income Countries,” BMC Public Health 7 (2007): 309.

Orem J. N. Mafigiri D. K. Marchal B. , “Research, Evidence and Policymaking: The Perspectives of Policy Actors on Improving Uptake of Evidence in Health Policy Development and Implementation in Uganda,” BMC Public Health 12 (2010): 109.

See Hyder , supra note 102;.

El-Jardali F. Lavis J. N. Ataya N. , “Use of Health Systems Evidence by Policymakers in Eastern Mediterranean Countries: Views, Practices, and Contextual Influences,” BMC Health Services Research 12 (2012): 200.

See Ssengooba , supra note 98;.

El Jardali , supra note 103;.

Jönsson K. Tomson G. Jönsson C. , “Health Systems Research in Lao PDR: Capacity Development for Getting Research into Policy and Practice,” Health Research and Policy Systems 5 (2007): 11.

These units would focus on getting successful systems-level interventions implemented, unlike technology transfer offices, which focus solely on the commercialisation of new medical technologies.

See Pratt , supra note 5.

HSR funders that only have a role in research have a narrower obligation to support the provision of post-study benefits. They should support grants for long-term programs of HSR that span system performance assessments to intervention development. Where applicants to funding schemes for HSR propose to evaluate an intervention, they should be required to design and execute an intervention implementation strategy during projects and be permitted to request budget allocations to support this.

Schmidt K. , “The Missing Link: The Global Fund and Financial Access to Health Care,” 2010, available at <http://www.rockefellerfoundation.org/uploads/files/6485982c-b708–4cc5-af99-ef411035a0f4-gfatm-support.pdf> (last visited February 24, 2015).

Id. Here, we are not suggesting that bilateral aid agencies, global health organizations, or philanthropic foundations take on the precise Global Fund model of funding for health system strengthening (HSS). It has proven quite difficult for LMICs to be awarded Global Fund HSS grants to support financial access to health services and few have been awarded.

See Schmidt , supra note 94.

The aforementioned global actors should also not restrict HSS grants on the basis of disease-focus or even require a disease-focus, as many systems-level interventions will be cross-cutting.

Pratt B. Loff B. , “Health Research Systems: Promoting Health Equity or Economic Competitiveness?” Bulletin of the World Health Organization 90 (2012): 55–62.

WHO Task Force on Health Systems Research, supra note 22;.

WHO Task Force on Research Priorities for Equity in Health and the WHO Equity Team, supra note 22;.

Bamako Call to Action, supra note 22;.

The Mexico Statement, supra note 22.

See Pratt Loff , supra note 5.

See Hyder , supra note 29.

Ruger J. P. , “Author Response to Letter to the Editor: Making Power Visible in Global Health Governance,” American Journal of Bioethics 12, no. 7 (2012): 65.

Mitra A. G. , “A Social Connection Model for International Clinical Research,” American Journal of Bioethics 13, no. 3 (2013): W1–W3.

See Saghai , supra note 64.