The ethics of health systems research in low- and middle-income countries: A call to action

Abstract

The increasing conduct of health systems research (HSR) in low- and middle-income countries (LMICs) has not been matched by concurrent work to clarify the field's ethical dimensions. To begin to address this gap, a two-day workshop on the ethics of HSR in LMICs was convened at Johns Hopkins University in June 2013. Participants included health systems researchers, philosophers, lawyers, bioethicists and institutional review board members from Botswana, Uganda, the UK, USA and Zambia. Based on discussions from the workshop, the paper affirms that, while HSR in LMICs raises ethical issues in relation to constructs (i.e. consent, risk, equipoise) common to international clinical research, the nature of the issues that arise often differ between the two fields. Three salient features of HSR and the ethical considerations associated with each of them in LMICs are described to demonstrate this point. Recommendations for institutional review boards’ oversight of HSR in LMICs are presented. Finally, a call is made for further action to develop thinking and guidance around the ethics of HSR in resource-poor settings.

Keywords:

• health systems research
• ethics
• IRB oversight
• developing countries

Acknowledgements

The authors would like to thank all the participants at the workshop on the ethics of HSR in LMICs convened at Johns Hopkins University in June 2013 for sharing their experiences and perspectives, which largely form the basis of the ideas presented in this article. The contents of this article are solely the responsibility of the authors and do not reflect the views of the NHMRC or the National Institutes of Health.

Funding

The workshop was supported by the Berman Institute of Bioethics, the Johns Hopkins School of Public Health, the National Institutes of Health Fogarty Africa Bioethics Training programme and Future Health Systems, a research partnership coordinated from the Johns Hopkins Bloomberg School of Public Health and funded by the UK Department for International Development. BP is supported by an Australian National Health and Medical Research Council (NHMRC) Early Career Sidney Sax Public Health Overseas Fellowship [Award No. 1052346]. AAH, JA and NK are partly supported by the Fogarty International Centre and National Institute of Allergy and Infectious Diseases of the National Institutes of Health under Award Number [R25 TW 001604].

Notes

1. Other health system building blocks include human resources, financing, governance and information technology (Gilson, 2012).

2. We recognise that health services research has long been conducted in high-income countries, though HSR, with its broader scope, is only starting to be.

3. In LMIC contexts, the choice of consent strategy must be informed not only by professional, institutional and environmental norms but also by social and political influences (negative and positive) and by the degree of trust in social/health systems and institutions. This is to reduce the potential for the consent strategy to further legitimise and entrench norms that relate to a lack of transparency in some contexts (Molyneux, Wassenaar, Peshu, & Marsh, 2005; Rosenthal, 2006; Upvall & Hashwani, 2001).

Additional information

Funding

Funding: The workshop was supported by the Berman Institute of Bioethics, the Johns Hopkins School of Public Health, the National Institutes of Health Fogarty Africa Bioethics Training programme and Future Health Systems, a research partnership coordinated from the Johns Hopkins Bloomberg School of Public Health and funded by the UK Department for International Development. BP is supported by an Australian National Health and Medical Research Council (NHMRC) Early Career Sidney Sax Public Health Overseas Fellowship [Award No. 1052346]. AAH, JA and NK are partly supported by the Fogarty International Centre and National Institute of Allergy and Infectious Diseases of the National Institutes of Health under Award Number [R25 TW 001604].