Abstract
A growing proportion of clinical research funded by pharmaceutical companies, high-income country research agencies, and not-for-profit funders is conducted in low- and middle-income settings. Disparities in wealth and access to healthcare between the populations where new interventions are often tested and those where many of them are ultimately marketed raise concerns about exploitation. This chapter examines several ethical requirements frequently advanced as mechanisms for protecting research subjects in underserved communities from exploitation and evaluates the effectiveness of those mechanisms as responses to exploitation worries. It goes on to highlight where the conceptual frameworks relied upon by research ethicists must be improved if we are to fully understand the nature of the moral claims and obligations that arise in research conducted in underserved communities.
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Notes
- 1.
Adriana Petryna, When Experiments Travel: Clinical Trials and the Global Search for Human Subjects (Princeton: Princeton University Press, 2009), 13.
- 2.
Alan Wertheimer, Exploitation (Princeton: Princeton University Press, 1996); Ruth Sample, Exploitation: What It Is and Why It’s Wrong (New York: Rowman & Littlefield, 2003); Mikhail Valdman, “A Theory of Wrongful Exploitation,” Philosopher’s Imprint 9, no. 6 (2009); Robert E. Goodin, “Exploiting a Situation and Exploiting a Person,” in Modern Theories of Exploitation, ed. Andrew Reeve (Beverly Hills: SAGE Publications, 1987).
- 3.
For a canonical statement of these concerns, see Ezekiel J. Emanuel et al., “What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research,” Journal of Infectious Diseases 189 (2004).
- 4.
Liza Dawson, Karin Klingman, and Jeanne Marrazzo, “Addressing Standards of Care in Resource-Limited Settings,” Journal of Acquired Immune Deficiency Syndromes 65, no. 1 (2014).
- 5.
Robert J. Levine, “The‘Best Proven Therapeutic Method’ Standard in Clinical Trials in Technologically Developing Countries,” IRB: Ethics and Human Research 20, no. 1 (1998).
- 6.
Alex John London, “The Ambiguity and the Exigency: Clarifying ‘Standard of Care’ Arguments in International Research,” Journal of Medicine and Philosophy 25, no. 4 (2000).
- 7.
World Medical Association, “Declaration of Helsinki,” (2013).
- 8.
Alan Wertheimer, “The Ethics of Promulgating Principles of Research Ethics: The Problem of Diversion Effects,” JLBIOS 2, no. 1 (2015).
- 9.
David Wendler, Ezekiel J. Emanuel, and Reidar K. Lie, “The Standard of Care Debate: Can Research in Developing Countries Be Both Ethical and Responsive to Those Countries’ Health Needs?,” American Journal of Public Health 94, no. 6 (2004).
- 10.
Harold T. Shapiro and Eric M. Meslin, “Ethical Issues in the Design and Conduct of Clinical Trials in Developing Countries,” New England Journal of Medicine 345, no. 2 (2001).
- 11.
See, for example, Council for International Organizations of Medical Sciences (CIOMS), “International Ethical Guidelines for Health-Related Research Involving Humans,” (2016): Guideline 2; World Medical Association, “Declaration of Helsinki,” Guideline 20; National Bioethics Advisory Commission, “Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries,” (Bethesda, MD2001), Guideline 1.3.
- 12.
Christine Grady, “Ethics of International Research: What Does Responsiveness Mean?,” Virtual Mentor: Ethical Journal of the American Medical Association 8, no. 4 (2006); Alex John London, “Responsiveness to Host Community Health Needs,” in The Oxford Textbook of Clinical Research Ethics, ed. Ezekiel J. Emanuel, et al. (Oxford: Oxford University Press, 2008); Rebecca Wolitz, Ezekiel J. Emanuel, and Seema Shah, “Rethinking the Responsiveness Requirement for International Research,” Lancet 374 (2009); Seema Shah, Rebecca Wolitz, and Ezekiel J. Emanuel, “Refocusing the Responsiveness Requirement,” Bioethics 27, no. 3 (2013); Danielle M. Wenner, “The Social Value of Knowledge and the Responsiveness Requirement for International Research,” Bioethics 31, no. 2 (2017).
- 13.
CIOMS, “International Ethical Guidelines for Health-Related Research Involving Humans.”; National Bioethics Advisory Commission, “Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries.”
- 14.
Wertheimer, “The Ethics of Promulgating Principles of Research Ethics: The Problem of Diversion Effects.”
- 15.
George J. Annas and Michael A. Grodin, “Human Rights and Maternal-Fetal Hiv Transmission Prevention Trials in Africa,” American Journal of Public Health 88, no. 4 (1998).
- 16.
See, for example, World Medical Association, “Declaration of Helsinki.,” Guideline 34.
- 17.
Leonard H. Glantz et al., “Research in Developing Countries: Taking “Benefit” Seriously,” Hastings Center Report 28, no. 6 (1998).
- 18.
Shapiro and Meslin, “Ethical Issues in the Design and Conduct of Clinical Trials in Developing Countries,” 141.
- 19.
CIOMS, “International Ethical Guidelines for Health-Related Research Involving Humans.”
- 20.
National Bioethics Advisory Commission, “Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries.”
- 21.
Participants in the 2001 Conference on Ethical Aspects of Research in Developing Countries, “Moral Standards for Research in Developing Countries: From “Reasonable Availability” to “Fair Benefits”,” Hastings Center Report 34, no. 3 (2004).
- 22.
Ibid.
- 23.
Danielle M. Wenner, “The Social Value of Knowledge and International Clinical Research,” Developing World Bioethics 15, no. 2 (2015).
- 24.
Alex John London, “Justice and the Human Development Approach to International Research,” Hastings Center Report 35, no. 1 (2005).
- 25.
Jennifer S. Hawkins, “Research Ethics, Developing Countries, and Exploitation: A Primer,” in Exploitation and Developing Countries: The Ethics of Clinical Research, ed. Jennifer S. Hawkins and Ezekiel J. Emanuel (Princeton: Princeton University Press, 2008).
- 26.
Alan Wertheimer, “Is Payment a Benefit?,” Bioethics 27, no. 2 (2013).
- 27.
Participants in the 2001 Conference on Ethical Aspects of Research in Developing Countries, “Moral Standards for Research in Developing Countries: From “Reasonable Availability” to “Fair Benefits”.”; Wenner, “The Social Value of Knowledge and the Responsiveness Requirement for International Research.”
- 28.
London, “Justice and the Human Development Approach to International Research.”
- 29.
Wendler, Emanuel, and Lie, “The Standard of Care Debate: Can Research in Developing Countries Be Both Ethical and Responsive to Those Countries’ Health Needs?.”; London, “Justice and the Human Development Approach to International Research.”
- 30.
“Justice and the Human Development Approach to International Research.”; Thomas Pogge, “Testing Our Drugs on the Poor Abroad,” in Exploitation and Developing Countries: The Ethics of Clinical Research, ed. Jennifer S. Hawkins and Ezekiel J. Emanuel (Princeton: Princeton University Press, 2008).
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Wenner, D.M. (2018). Exploitation and International Clinical Research: The Disconnect Between Goals and Policy. In: Boonin, D. (eds) The Palgrave Handbook of Philosophy and Public Policy. Palgrave Macmillan, Cham. https://doi.org/10.1007/978-3-319-93907-0_43
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