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Operationalizing the Ethical Review of Global Health Policy and Systems Research: A Proposed Checklist

Published online by Cambridge University Press:  21 April 2021

Abbas Rattani  and
Adnan A. Hyder
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Abstract

There has been growing consensus to develop relevant guidance to improve the ethical review of global health policy and systems research (HPSR) and address the current absence of formal ethics guidance.

Keywords

Health Systems ResearchGlobal HealthHealth PolicyEthical ReviewChecklist
Type
Independent Articles
Information
Journal of Law, Medicine & Ethics , Volume 49 , Issue 1: Public Sector and Non-Profit Contributions to Drug Development: Historical Scope, Opportunities, and Challenges , Spring 2021 , pp. 92 - 122
Copyright
© 2021 The Author(s)

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References

Gilson, L., Hanson, K., Sheikh, K., Agyepong, I. A., Ssengooba, F., and Bennett, S.. “Building the Field of Health Policy and Systems Research: Social Science Matters,” PLoS Medicine 8, no. 8 (2011); L. Gilson, Health Policy and Systems Research: A Methodology Reader (Geneva: World Health Organization, 2012); S. J. Hoffman, J. Røttingen, S. Bennett, J. N. Lavis, J. S. Edge, and J. Frenk. “Background Paper on Conceptual Issues Related to Health Systems Research to Inform A WHO Global Strategy on Health Systems Research,” Health Systems Alliance, revised February 29, 2012, available at <https://www.who.int/alliance-hpsr/alliancehpsr_backgroundpaperh-srstrat1.pdf> (last visited February 18, 2021); A. A. Hyder, B. Pratt, J. Ali, N. Kass, and N. Sewankambo, “The Ethics of Health Systems Research in Low-and Middle-Income Countries: A Call to Action,” Global Public Health 9, no. 9 (2014): 1008-1022; A. A. Luyckx, N. Biller-Andorno, A. Saxena, and N. T. Tran, “Health Policy and Systems Research: Towards a Better Understanding and Review of Ethical Issues,” BMJ Global Health 2, no. 2 (2017):e000314; J. H. Remme, F., T. Adam, F. Becerra-Posada, C. DArcangues, M. Devlin, C. Gardner, A. Ghaffar, J. Hombach, J.F.K. Kengeya, and A. Mbewu, “Defining Research to Improve Health Systems,” PLoS medicine 7, no. 11 (2012); Ethical Considerations for Health Policy and Systems Research (Geneva: World Health Organization; 2019) WHO: Alliance for Health Policy and Systems Research, “What is Health Policy and Systems Research?” (Geneva: World Health Organization, 2018), available at <https://www.who.int/alliance-hpsr/about/hpsr/en/> (last visited January 25, 2021.)CrossRefGoogle Scholar
See Hyder, supra note 1; A. A. Hyder, A. Rattani, C. Krubiner, A. M. Bachani, and N. T Tran, “Ethical Review of Health Systems Research in Low-and Middle-Income Countries: A Conceptual Exploration,” The American Journal of Bioethics 14, no. 2 (2014): 28-37; A. A. Hyder and A. Rattani. “Changing the Discourse on Health Systems Research: Response to Open Peer Commentaries on ‘Ethical Review of Health Systems Research in Low-and Middle-Income Countries: A Conceptual Exploration,” The American Journal of Bioethics 14, no. 2 (2014): W1-W2; See Luyckx, supra note 1; B. Pratt, A. Paul, A. A. Hyder, and J. Ali, “Ethics of Health Policy and Systems Research: A Scoping Review of the Literature,” Health Policy and Planning 32, no. 6 (2017): 890-910; See World Health Organization, supra note 1.CrossRefGoogle Scholar
Bachani, A. M., Rattani, A., and Hyder, A.A., “A Scoping Study on the Ethics of Health Systems Research,” Developing World Bioethics 16, no. 3 (2016): 124–132; V. Gopichandran, V. A. Luyckx, N. Biller-Andorno, A. Fairchild, J. Singh, N. Tran, A. Saxena, P. Launois, A. Reis, and D. Maher, “ Developing the Ethics of Implementation Research in Health,” Implementation Science 1, no. 1 (2016):161; See Hyder, supra note 1; See Hyder, supra note 2; See Luyckx, supra note 1; See Pratt, supra note 2; A. Rattani and A. A. Hyder. “Developing an Islamic Research Ethics Framework,” Journal of Religion and Health 58, no. 1 (2019): 74-86; See World Health Organization, supra note 1.CrossRefGoogle Scholar
See Bachani, supra note 3; See Gopichandran, supra note 3; See Hyder, supra note 1; See Hyder, supra note 2; See Luyckx, supra note 1; See Pratt, supra note 2; See Remme, supra note 1; See World Health Organization, supra note 1.Google Scholar
See Bachani, supra note 3; See Hyder, supra note 1.Google Scholar
Bamford, R., “Ethical Review of Health Systems Research: Vulnerability and the Need for Philosophy in Research Ethics,” American Journal of Bioethics 14, no. 2 (2014): 38–39; See Hyder, supra note 2; See Hyder, Rattani, supra note 2; M. M. Lange, “Vulnerability as a Concept for Health Systems Research,” The American Journal of Bioethics 14, no. 2 (2014): 41-43; See Luyckx, supra note 1; See Pratt, supra note 2; See World Health Organization, supra note 1.CrossRefGoogle Scholar
See Gopichandran, supra note 3; See Hyder, supra note 1; See Luyckx, supra note 1; See Pratt, supra note 2; See World Health Organization, supra note 1.Google Scholar
See Luyckx, supra note 1.Google Scholar
See Pratt, supra note 2.Google Scholar
See Luyckx, supra note 1.Google Scholar
See Hyder, supra note 1; See Hyder, supra note 2; See Luyckx, supra note 1; See World Health Organization, supra note 1.Google Scholar
See Hyder, supra note 2.Google Scholar
Pratt, B., Cheah, P. Y., and Marsh, V., “Solidarity and Community Engagement in Global Health Research,” American Journal of Bioethics 20, no. 5 (2020): 43–56; B. Pratt and J. de Vries, “Community Engagement in Global Health Research that Advances Health Equity,” Bioethics 32, no. 7 (2018): 454-463; A. Rattani, “Is Solidarity Possible in Global HPSR?” American Journal of Bioethics 20, no. 5 (2020): 67-69.CrossRefGoogle Scholar
See Hyder, supra note 1; Pratt, B. and Hyder, A. A., “Applying a Global Justice Lens to Health Systems Research Ethics: An Initial Exploration,” Kennedy Institute of Ethics Journal 25, no. 1 (2015): 35-66; B. Pratt and A. A. Hyder, “Global Justice and Health Systems Research in Low and Middle Income Countries,” Journal of Law, Medicine & Ethics 43, no. 1 (2015): 143-161.CrossRefGoogle Scholar
See Pratt, supra note 11; See Rattani, supra note 11.Google Scholar
See Hyder, supra note 1; See Pratt, 2015a, supra note 12; See Pratt, 2015b, supra note 12; Wassenaar, D. and Rattani, A., “What Makes Health Systems Research in Developing Countries Ethical? Application of the Emanuel Framework for Clinical Research to Health Systems Research,” Developing World Bioethics 16, no. 3 (2016): 133-139.CrossRefGoogle Scholar
See Luyckx, supra note 1.Google Scholar
See Pratt, 2015a, supra note 12; See Pratt, 2015b, supra note 12; See Wassenaar, supra note 14.Google Scholar
See Hyder, supra note 2.Google Scholar
Hutton, J. L., “Are Distinctive Ethical Principles Required for Cluster Randomized Controlled Trials?” Statistics in Medicine 20, no. 3 (2001): 473–488; See Hyder, supra note 2; A. D. McRae, C. Weijer, A. Binik, A. White, J. M. Grimshaw, R. Boruch, J. C. Brehaut, A. Donner, M. P. Eccles, and R. Saginur, “Who is the Research Subject in Cluster Randomized Trials in Health Research?” Trials 12, no. 1 (2001): 183.3.0.CO;2-D>CrossRefGoogle ScholarPubMed
Weijer, C., Grimshaw, J. M., Eccles, M. P., et al., “The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials,” PLoS Medicine 9 (2012): e1001346.CrossRefGoogle Scholar
See Hyder, supra note 1.Google Scholar
See Pratt, 2015a, supra note 12; See Rattani, supra note 11.Google Scholar
See Pratt, 2015a, supra note 12; See Rattani, supra note 11.Google Scholar
See Bamford, supra note 6; See Lange, supra note 6.Google Scholar
Pratt, B. and Hyder, A. A., “How Can Health Systems Research Reach the Worst-Off? A Conceptual Exploration,” BMC Health Services Research 16, no. 7 (2016): 619.CrossRefGoogle Scholar
See Hyder, supra note 1.Google Scholar
See Pratt, 2015a, supra note 12.Google Scholar
See Gopichandran, supra note 3.Google Scholar
See Hyder, supra note 1.Google Scholar
Emanuel, E.J., Wendler, D., Killen, J., and Grady, C., “What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research,” The Journal of Infectious Diseases 189, no. 5 (2004): 930–937; See Hyder, supra note 1; See Luyckx, supra note 1; See Pratt, supra note 2; See Pratt, de Vries, supra note 11; See Rattani, supra note 11; E. Wallwork, “Ethical Analysis of Research Partnerships with Communities,” Kennedy Institute of Ethics Journal 18, no. 1 (2008):57-85; See Wassenaar, supra note 14.CrossRefGoogle Scholar
See Pratt, supra note 11.Google Scholar
See Wallwork, supra note 29.Google Scholar
See Wassenaar, supra note 14.Google Scholar
See Pratt, 2015a, supra note 12; See Pratt, 2015b, supra note 12.Google Scholar
See Gopichandran, supra note 3; Hyder, A. A., Rattani, A., and Pratt, B., “Research Capacity Strengthening in Low-and Middle-Income Countries: Ethical Explorations,” Journal of Law, Medicine & Ethics 45, no. 1 (2017): 129-137; See Wassenaar, supra note 14.CrossRefGoogle Scholar
See Pratt, 2015a, supra note 12.Google Scholar
See Pratt, 2015a, supra note 12; See Pratt, 2015b, supra note 12; Pratt, B. and Hyder, A. A., “Reinterpreting Responsiveness for Health Systems Research in Low and Middle Income Countries, Bioethics 29, no. 6 (2015): 379-388; See Pratt, supra note 11; See Rattani, supra note 11; See Wassenaar, supra note 14.CrossRefGoogle Scholar
See Hyder, supra note 2; Lairumbi, G. M., Michael, P., Fitzpatrick, R., and English, M. C., “Ethics in Practice: The State of the Debate on Promoting the Social Value of Global Health Research in Resource Poor Settings Particularly Africa.” BMC Medical Ethics 12, no. 1 (2011): 22.CrossRefGoogle Scholar
See Rattani, Hyder, supra note 3.Google Scholar
Wild, V. and Pratt, B., “Health Incentive Research and Social Justice: Does the Risk of Long-Term Harms to Systematically Disadvantaged Groups Bear Consideration? Journal of Medical Ethics 43, no. 3 (2017): 150–156.CrossRefGoogle Scholar
See Hyder, supra note 1.Google Scholar
See Hyder, supra note 1.Google Scholar
See Pratt, 2015a, supra note 12; See Pratt, 2015c, supra note 36.Google Scholar
See Hyder, supra note 1.Google Scholar
See Gopichandran, supra note 3.Google Scholar
See Pratt, 2015b, supra note 12.Google Scholar
See Pratt, supra note 2; See Pratt, 2015a, supra note 12; See Pratt, 2015b, supra note 12.Google Scholar
See Gopichandran, supra note 3; See Hyder, supra note 1; See Pratt, 2015a, supra note 12; Pratt, B. and Loff, B., “A Framework to Link International Clinical Research to the Promotion of Justice in Global Health,” Bioethics 28, no. 8 (2014): 387-396.CrossRefGoogle Scholar
Morris, S. S., Flores, R., Olinto, P., and Medina, J. M., “Monetary Incentives in Primary Health Care and Effects on Use and Coverage of Preventive Health Care Interventions in Rural Honduras: Cluster Randomised Trial,” The Lancet 364, no. 9450 (2004): 2030–2037.CrossRefGoogle Scholar
See Pratt, supra note 11; See Rattani, supra note 11.Google Scholar
See Hyder, supra note 1; See Hyder, supra note 2; See Luyckx, supra note 1; See Pratt, supra note 2.Google Scholar
Chodos, A. H. and Lee, S. J., “Journalists, District Attorneys and Researchers: Why IRBs Should Get in the Middle,” BMC Medical Ethics 16, no. 1 (2015): 19; R. Clay-Williams, N. Taylor, and J. Braithwaite, “Potential Solutions to Improve the Governance of Multicentre Health Services Research,” The Medical Journal of Australia 208, no. 4 (2018): 152-154; See Luyckx, supra note 1.CrossRefGoogle Scholar
See Luyckx, supra note 1.Google Scholar
See Bachani, supra note 3; See Pratt, supra note 2; See Hyder, supra note 2; See Hyder, Rattani, supra note 2; See Pratt, 2015a, supra note 12; See Pratt, 2015b, supra note 12; See Pratt, supra note 24; See Rattani, supra note 11.Google Scholar
See World Health Organization, supra note 1.Google Scholar
See Luyckx, supra note 1.Google Scholar
See Hyder, supra note 1; See Hyder, supra note 2; See Luyckx, supra note 1; See World Health Organization, supra note 1.Google Scholar
See Luyckx, supra note 1.Google Scholar
Morgan, R., Ayiasi, R. M., Barman, D., Buzuzi, S., Ssemugabo, C., Ezumah, N., George, A. S., Hawkins, K., Hao, X., and King, R., “Gendered Health Systems: Evidence from Low-and Middle-Income Countries,” Health Research Policy and Systems 16, no. 1 (2018): 58; S. Theobald, R. Morgan, K. Hawkins, S. Ssali, A. George, and S. Molyneux, “The Importance of Gender Analysis in Research for Health Systems Strengthening,” Health Policy Planning 32, Suppl. 5 (2017): v1-v3.CrossRefGoogle Scholar
See Gopichandran, supra note 3.Google Scholar
See Hyder, supra note 1; See Hyder, supra note 2; See Luyckx, supra note 1; MacGregor, H. and Bloom, G., “Health Systems Research in a Complex and Rapidly Changing Context: Ethical Implications of Major Health Systems Change at Scale,” Developing World Bioethics 16, no. 3 (2016): 158-167.CrossRefGoogle Scholar
See World Health Organization, supra note 1.Google Scholar
See Hyder, supra note 1; See Hyder, supra note 2; See Pratt, supra note 2.Google Scholar
See Luyckx, supra note 1; Molyneux, S. B., Tsofa, B., Barasa, E., Nyikuri, M. M., Waweru, E. W., Goodman, C., and Gilson, L., “Research Involving Health Providers and Managers: Ethical Issues Faced by Researchers Conducting Diverse Health Policy and Systems Research in Kenya,” Developing World Bioethics 16, no. 3 (2016): 168-177.CrossRefGoogle Scholar
See World Health Organization, supra note 1.Google Scholar
See Bachani, supra note 3; See Gopichandran, supra note 3; See Hyder, supra note 2; See Pratt, supra note 2; See Pratt, supra note 47.Google Scholar
See Pratt, supra note 2.Google Scholar
See Hyder, supra note 1.Google Scholar
Ndebele, P. and Hyder, A. A., “Ethical Issues in Health Systems Research in Low and Middle-Income Countries,” Developing World Bioethics 3 (2016): 122–123.CrossRefGoogle Scholar
See Bachani, supra note 3.Google Scholar
See World Health Organization, supra note 1.Google Scholar