Skip to main content
SpringerLink
Log in

Ethical Considerations in Global Mental Health Research

  • Chapter
  • First Online:
Global Mental Health Ethics

  • 1040 Accesses

Abstract

The establishment of a successful global mental health research program requires first and foremost the development of trust, which necessarily rests on a foundation of ethics. This chapter provides an overview of the principles that underlie the ethical conduct of research involving human participants and the international ethics framework for such research. Particular attention is paid to informed consent processes and study design in conducting mental health research in the global context. Processes for monitoring the safety of study participants and ensuring their rights are also examined.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution
eBook
USD 16.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 16.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 129.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References

  1. C.F.R. §§ 46.101, 46.107, 46.116 (2018).

    Google Scholar 

  2. Fed. Reg. 7149-7272 (January 19, 2017).

    Google Scholar 

  3. Fed. Reg. 28497-28520 (June 19, 2018).

    Google Scholar 

  4. Abdullahi v. Pfizer, Inc. (“Abdullahi IV”), 562 F.3d 1163 (2d Cir. 2009).

    Google Scholar 

  5. Adams, V., Miler, S., Craig, S., Samen, A., et al. (2005). The challenge of cross-cultural clinical trial research: Case report from the Tibetan Autonomous Region, People’s Republic of China. Medical Anthropology Quarterly, 19(3), 267–289.

    Article  PubMed  Google Scholar 

  6. Addington, D. (1995). The use of placebos in clinical trials for acute schizophrenia. Canadian Journal of Psychiatry, 40, 171–175.

    Article  CAS  PubMed  Google Scholar 

  7. Adelekan, M. L., Makanjuola, A. B., & Ndom, R. J. (2001). Traditional mental health practitioners in Kwara State, Nigeria. East African Medical Journal, 78(4), 190–196.

    Article  CAS  PubMed  Google Scholar 

  8. Afolabi, M. O., Okebe, J. U., McGrath, N., Larson, H. J., Bojang, K., & Chandramohan, C. (2014). Informed consent comprehension in African settings. Tropical Medicine & International Health, 19(6), 625–642.

    Article  Google Scholar 

  9. Agarwal, M. (2003). Voluntariness in clinical research at the end of life. Journal of Pain and Symptom Management, 25(4), 25–32.

    Article  Google Scholar 

  10. Aghukwa, C. (2010). Medical students’ beliefs and attitudes towards people with mental illness in southwestern Nigeria. The Australian and New Zealand Journal of Psychiatry, 42(5), 389–395.

    Google Scholar 

  11. Alenichev, A., & Nguyen, V.-K. (2019). Precarity, clinical labour and graduation from Ebola clinical research in West Africa. Global Bioethics, 30(1), 1–18.

    Article  PubMed  PubMed Central  Google Scholar 

  12. Alexander, L. (2016). Deontological ethics. In: Stanford encyclopedia of philosophy. Available at https://plato.stanford.edu/entries/ethics-deontological/#DeoTheKan. Accessed 29 Feb 2020.

  13. Allbutt, H., & Masters, H. (2010). Ethnography and the ethics of undertaking research on different mental health care settings. Journal of Psychiatric and Mental Health Nursing, 17, 210–215.

    Article  CAS  PubMed  Google Scholar 

  14. Alphs, L., Benedetti, F., Flieschhacker, W. W., & Kane, J. M. (2012). Placebo-related effects in clinical trials in schizophrenia: What is driving this phenomenon and what can be done to minimize it? The International Journal of Neuropsychopharmacology, 15, 1003–1014.

    Article  PubMed  PubMed Central  Google Scholar 

  15. Annas, G. J., & Grodin, M. A. (Eds.). (1992). The Nazi doctors and the Nuremberg Code: Human rights in experimentation. London: Oxford University Press.

    Google Scholar 

  16. Anon. (2020). Bucharest early intervention project. Available at https://www.macbrain.org/beip.htm. Accessed 28 Feb 2020.

  17. Anon. (n.d.). Effects of early experience on brain-behavioral development. Available at http://www.macbrain.org/effects2.htm. Accessed 26 Jan 2004.

  18. Anon. (2008). The ethical neuroscientist. Nature Neuroscience, 11(3), 239. [editorial].

    Article  CAS  Google Scholar 

  19. Appelbaum, P. S., Grisso, T., Frank, E., O’Donnell, S., & Kupfer, D. J. (1999). Competence of depressed patients for consent to research. American Journal of Psychiatry, 156(9), 1380–1384.

    Article  CAS  Google Scholar 

  20. Appelbaum, P. S., Roth, L. H., & Lidz, C. (1982b). The therapeutic misconception: Informed consent in psychiatric research. International Journal of Law and Psychiatry, 5(3–4), 319–329.

    Article  CAS  PubMed  Google Scholar 

  21. Appelbaum, P. S., Roth, L. H., Lidz, C., Benson, P., & Winslade, W. (1982a). False hopes and best data: Consent to research and the therapeutic misconception. The Hastings Center Report, 17(2), 20–24.

    Article  Google Scholar 

  22. Beecher, H. K. (1970). Research and the individual: Human studies. Boston: Little, Brown and Company.

    Google Scholar 

  23. Benson, P. R., Roth, L. H., Appelbaum, P. S., Lidz, C. W., & Winslade, W. J. (1988). Information disclosure, subject understanding and informed consent in psychiatric research. Law and Human Behavior, 12, 455–475.

    Article  PubMed  Google Scholar 

  24. Bentham, J. (1962). An introduction to the principles of moral and legislation. In Utilitarianism and other writings. New York: New American Library.

    Google Scholar 

  25. Berk, M. (2007). The place of placebo? The ethics of placebo-controlled trials in bipolar disorder. Acta Neuropsychiatrica, 19, 74–75.

    Article  PubMed  Google Scholar 

  26. Brandt, A. M. (1985). Racism and research: The case of the Tuskegee study. In J. W. Leavitt & R. L. Numbers (Eds.), Sickness and health in America: Readings in the history of medicine and public health (pp. 331–343). Madison: University of Wisconsin Press.

    Google Scholar 

  27. Brown, W. A. (1988). Predictors of placebo response in depression. Pychopharmacology Bulletin, 24, 14–17.

    CAS  Google Scholar 

  28. Burgess, L. J., Gerber, B., Coetzee, K., Terblanche, M., Agar, G., & Kotze, T. J. W. (2019). An evaluation of informed consent comprehension by adult trial participants in South Africa at the time of providing consent for clinical trial participation and a review of the literature. Journal of Clinical Trials, 11, 19–35.

    Google Scholar 

  29. Burke, N. J. (2014). Rethinking the therapeutic misconception: Social justice, patient advocacy, and cancer clinical trial recruitment in the US safety net. BMC Medical Ethics, 15, 68. https:www.biomedcentral.com/1472-6939/15/68.

    Article  PubMed  PubMed Central  Google Scholar 

  30. Canadian Institutes of Health Research. (2014). Ethical conduct for research involving humans (TCPS2). Available at http://www.pre-ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/. Accessed 2 Aug 2018.

  31. Charney, D. S., Nemeroff, C. B., Lewis, L., Laden, S. K., Gorman, J. M., Laska, E. M., et al. (2002). National Depressive and Manic-Depressive Association consensus statement on the use of placebo in clinical trials of mood disorders. Archives of General Psychiatry, 59, 262–270.

    Article  PubMed  Google Scholar 

  32. Christakis, N. A., & Panner, M. J. (1991). Existing international guidelines for human subjects research: Some open questions. Law, Medicine & Health Care, 19, 214–221.

    Article  CAS  Google Scholar 

  33. Christopher, P. P., Appelbaum, P. S., Truong, D., Albert, K., Maranda, L., & Lidz, C. (2017). Reducing therapeutic misconception: A randomized intervention trial in hypothetical clinical trials. PLoS One, 12(9), e0184224. https://doi.org/10.1371/journal.pone.0184224.

    Article  PubMed  PubMed Central  Google Scholar 

  34. Council for International Organizations of Medical Sciences. (1993). International ethical guidelines for biomedical research involving human subjects. Geneva: Author.

    Google Scholar 

  35. Council for International Organizations of Medical Sciences. (2002). International ethical guidelines for biomedical research involving human subjects. Geneva: Author.

    Google Scholar 

  36. Council for International Organizations of Medical Sciences. (1991). International guidelines for ethical review of epidemiological studies. Geneva: Author.

    Google Scholar 

  37. Council for International Organizations of Medical Sciences. (2016). International ethical guidelines for health-related research involving humans. Geneva: Author.

    Google Scholar 

  38. Cox, A. C., Fallowfield, L. J., & Jenkins, V. A. (2006). Communication and informed consent in phase 1 trials: A review of the literature. Support Care Cancer, 14, 303–309.

    Article  CAS  PubMed  Google Scholar 

  39. Das, J., Do, Q. T., Friedman, J., McKenzie, D., & Scott, K. (2007). Mental health and poverty in developing countries: Revisiting the relationship. Social Science & Medicine, 65(3), 467–480.

    Article  Google Scholar 

  40. DCCT Research Group. (1989). Implementation in a multicomponent process to obtain informed consent in the Diabetes Control and Complications trial. Controlled Clinical Trials, 10, 83–96.

    Article  Google Scholar 

  41. Doak, L. G. A., & Doak, C. C. (1980). Patient comprehension profiles: Recent findings and strategies. Patient Counselling and Health Education, 2, 101–106.

    Article  CAS  PubMed  Google Scholar 

  42. Dunlop, B. W., & Banja, J. (2009). A renewed, ethical defense of placebo-controlled trials of new treatments for major depression and anxiety disorders. Journal of Medical Ethics, 45(6), 384–389.

    Article  Google Scholar 

  43. Emanuel, E. J., & Miller, F. G. (2001). The ethics of placebo-controlled trials—a middle ground. The New England Journal of Medicine, 345(12), 915–919.

    Article  CAS  PubMed  Google Scholar 

  44. Emeka, O. C. N. (2015). Migration of international medical graduates: Implications for the brain-drain. Open Medicine Journal, 2, 17–24.

    Article  Google Scholar 

  45. Emsley, R. (2017). On discontinuing treatment in schizophrenia: A clinical conundrum. NPJ Schizophrenia, 3, 4. https://doi.org/10.1038/s41537-016-0004-2.

    Article  PubMed  PubMed Central  Google Scholar 

  46. Emsley, R., Chiliza, B., & Asmal, L. (2013b). The evidence for illness progression after relapse in schizophrenia. Schizophrenia Research, 148, 117–121.

    Article  PubMed  Google Scholar 

  47. Emsley, R., Chiliza, B., Asmal, L., & Harvey, B. H. (2013a). The nature of relapse in schizophrenia. BMC Psychiatry, 13, 50. http://www.biomedcentral.com/1471-244X/13/50.

    Article  PubMed  PubMed Central  Google Scholar 

  48. Emsley, R., Fleischhacker, W. W., Galderisi, S., Halpern, L. J., McEvoy, J. P., & Schooler, N. R. (2016). Placebo control in clinical trials: Concerns about use in relapse prevention studies in schizophrenia. British Medical Journal, 354, i4728. https://doi.org/10.1136/bmj.i4728.

    Article  PubMed  Google Scholar 

  49. Etzioni, A. (1998). Introduction: A matter of balance, rights, and responsibilities. In A. Etzioni (Ed.), The essential communitarian reader (pp. ix–xxiv). Lanham: Rowman & Littlefield.

    Google Scholar 

  50. Fins, J. J. (2014). Orphans to history: A response to the Bucharest Early Intervention Project investigators. Bioethics Forum. Available at https://www.thehastingscenter.org/orphans-to-history-a-response-to-the-bucharest-early-intervention-project-investigators/. Accessed 29 Feb 2020.

  51. Fins, J. J. (2013). Romanian orphans: A reconsideration of the ethics of the Bucharest Early Intervention Project. Bioethics Forum. Available at https://www.thehastingscenter.org/romanian-orphans-a-reconsideration-of-the-ethics-of-the-bucharest-early-intervention-project/. Accessed 29 Feb 2020.

  52. Fitzgerald, D. W., Marotte, C., Verdier, R. I., Johnson, W. D., Jr., & Pape, J. W. (2002). Comprehension during informed consent in a less well-developed country. Lancet, 360, 1301–1302.

    Article  PubMed  Google Scholar 

  53. Freedman, B., Weijer, C., & Glass, J. K. C. (1996). Placebo orthodoxy in clinical research II: Ethical, legal, and regulatory myths. The Journal of Law, Medicine & Ethics, 24(3), 252–259.

    Article  CAS  Google Scholar 

  54. Gilligan, C. (1982). In a different voice: Psychological theory and women’s development. Cambridge, MA: Harvard University Press.

    Google Scholar 

  55. Goff, D. C., Falkai, P., Fleischhacker, W. W., Girgis, R. R., Kahn, R. M., Uchida, H., et al. (2019). The long-term effects of antipsychotic medication on clinical course in schizophrenia. American Journal of Psychiatry, 174(9), 840–849.

    Article  Google Scholar 

  56. Grisso, T., Appelbaum, P. S., Mulvey, E., & Fletcher, K. (1995). Measures of abilities related to competence to consent to treatment. Law and Human Behavior, 19, 127–148.

    Article  PubMed  Google Scholar 

  57. Grisso, T., Appelbaum, P. S., & Hill-Fatouhi, C. (1997). The MacCAT-T: A clinical tool to assess patients’ capacities to make treatment decisions. Psychiatric Services, 48, 1415–1419.

    Article  CAS  PubMed  Google Scholar 

  58. Henderson, G. E., Davis, A. M., King, N. M., Easter, M. M., Zimmer, C. R., Rothschild, B. B., et al. (2004). Uncertain benefit: Investigators’ views and communications in early phase gene transfer trials. Molecular Therapy, 10, 225–231.

    Article  CAS  PubMed  Google Scholar 

  59. Hilts, P. J. (1994). Agency faults a U.C.L.A. study for suffering of mental patients. New York Times.

    Google Scholar 

  60. Hirschfeld, R. M. A. (1996). Placebo response in the treatment of panic disorder. Bulletin of the Menninger Clinic, 60(Suppl A), A76–A86.

    CAS  PubMed  Google Scholar 

  61. Hornblum, A. M. (1998). Acres of skin: Human experiments in Holmesburg Prison. New York: Routledge.

    Google Scholar 

  62. Horng, S., & Grady, C. (2003). Misunderstanding in clinical research: Distinguishing therapeutic misconception, therapeutic misestimation, and therapeutic optimism. IRB, 25(5), 11–16.

    Article  PubMed  Google Scholar 

  63. Horowitz, J. (1994). For the sake of science: When Tony Lamadrid, a schizophrenic patient and research subject at UCLA, committed suicide, it set off a national debate: What is acceptable in human experimentation and who decides? New York Times.

    Google Scholar 

  64. Hughes, V. (2013). Detachment. Available at https://aeon.co/essays/romanian-orphans-a-human-tragedy-a-scientific-opportunity. Accessed 29 Feb 2020.

  65. Hyder, A. A., & Wali, S. A. (2006). Informed consent and collaborative research: Perspectives from the developing world. Developing World Bioethics, 6(1), 33–40.

    Article  PubMed  Google Scholar 

  66. International Conference on Harmonisation. (2001). Guidance E10: Choice of control group and related issues in clinical trials. Step 4 version. Author. Available at https://www.fda.gov/media/71349/download. Accessed 28 February 2020.

  67. James B. (2002). U.S. study of Romanian children face European challenge. New York Times. Available at https://www.nytimes.com/2002/06/06/news/us-study-of-romanian-children-faces-european-challenge.html?auth=login-email&login=email. Accessed 29 Feb 2020.

  68. Joffe, S., & Weeks, J. C. (2002). Views of American oncologists about the purposes of clinical trials. Journal of the National Cancer Institute, 94(24), 1847–1853.

    Article  PubMed  Google Scholar 

  69. Jonsen, A. R. (1995). Casuistry: An alternative or complement to principles? Kennedy Institute of Ethics Journal, 5, 237–251.

    Article  PubMed  Google Scholar 

  70. Kant, I. (1964 [1785]). Groundwork of the metaphysic of morals. (Trans. H.J. Paton). New York: Harper and Row.

    Google Scholar 

  71. Kass, N., & Hyder, A. (2001). Attitudes and experiences of U.S. and developing country investigators regarding U.S. human subjects regulations. In Ethical and policy issues in international research: Clinical trials in developing countries (Vol. II, p. B1–220). Bethesda: National Bioethics Advisory Commission.

    Google Scholar 

  72. Kass, N., Maman, S., & Atkinson, J. (2005). Motivations, understanding, and voluntariness in international randomized trials. IRB, 27(6), 1–8.

    Article  PubMed  PubMed Central  Google Scholar 

  73. Keck, P. E., Jr., Welge, J. A., McElroy, S. L., Arnold, L. M., & Strakowski, S. M. (2000). Placebo effect in randomized, controlled studies of acute bipolar mania and depression. Biological Psychiatry, 47, 748–755.

    Article  PubMed  Google Scholar 

  74. Kessler, R. C., McGonagle, K. A., Zhao, S., Nelson, C. B., Hughes, M., Eshleman, S., et al. (1994). Lifetime and 12-month prevalence of DSM-III-R psychiatric disorders in the United States, Results from the National Comorbidity Survey. Archives of General Psychiatry, 5(1), 8–19.

    Article  Google Scholar 

  75. Khan, A., Warner, H. A., & Brown, W. A. (2000). Symptom reduction and suicide risk in patients treated with placebo in antidepressant clinical trials: An analysis of the Food and Drug Administration database. Archives of General Psychiatry, 57, 311–317.

    Article  CAS  PubMed  Google Scholar 

  76. Kim, S. Y. H., Cox, C., & Caine, E. D. (2002). Impaired decision-making ability in subjects with Alzheimers disease & willingness to participate in research. American Journal of Psychiatry, 159(5), 797–802.

    Article  Google Scholar 

  77. King, N. M., Henderson, G. E., Churchill, L. R., Davis, A. M., Hull, S. C., Nelson, D. K., et al. (2005). Consent forms and the therapeutic misconception: The example of gene transfer research. IRB, 27, 1–8.

    Article  PubMed  Google Scholar 

  78. Kipnis, K. (2003). Seven vulnerabilities in the pediatric research subject. Theoretical Medicine, 24, 107–120.

    Google Scholar 

  79. Krugman, S. (1996). The Willowbrook hepatitis studies revisited: Ethical aspects. Reviews of Infectious Diseases, 8, 157–162.

    Article  Google Scholar 

  80. Levine, C., Faden, R., Grady, C., Hammerschhmidt, D., Eckenwiler, L., & Sugarman, J. (2004). The limitations of “vulnerability” as a protection for human research participants. The American Journal of Bioethics, 4(3), 44–49.

    Article  PubMed  Google Scholar 

  81. Levine, R. J. (1998). The ‘best proven therapeutic method’ standard in clinical trials in technologically developing countries. IRB, 20, 5–9.

    Article  PubMed  Google Scholar 

  82. Levine, R. J. (1985). The use of placebo in randomized controlled trials. IRB, 7(2), 1–4.

    Article  PubMed  Google Scholar 

  83. Lidz, C. W., Albert, K., Appelbaum, P., Dunn, L. B., Overton, E., & Pivovarova, E. (2015). Why is therapeutic misconception so prevalent? Cambridge Quarterly of Healthcare Ethics, 24(2), 231–241.

    Article  PubMed  Google Scholar 

  84. Loebel, A., Cucchairo, J., Siu, C., Daniel, D., & Kalali, A. (2010). Signal detection in clinical trials: A post-study survey of schizophrenia trial sites. Poster presentation, International Society for CNS Clinical Trials and Methodology 2010 Autumn Conference, October 13–14, Baltimore.

    Google Scholar 

  85. Loewy, E. H. (1996). Textbook of health care ethics. New York: Plenum Press.

    Google Scholar 

  86. Loue, S. (2004). Ethical issues in research: A Romanian case study. Rev Română de Bioetică, 2(1), 16–27.

    Google Scholar 

  87. Loue, S., & Loff, B. (2019). Teaching vulnerability in research: A study of approaches utilized by a sample of research ethics training programs. Journal of Empirical Research on Human Research Ethics, 14(4), 395–407.

    Article  PubMed  PubMed Central  Google Scholar 

  88. Loue, S., Okello, D., & Kawuma, M. (1996). Research bioethics in the Ugandan context: A program summary. The Journal of Law, Medicine & Ethics, 24, 47–53.

    Article  CAS  Google Scholar 

  89. LoVerde, M. E., Prochazka, A. V., & Byny, R. I. (1989). Research consent forms: Continued unreadability and increasing length. Journal of General Internal Medicine, 4, 410–412.

    Article  CAS  PubMed  Google Scholar 

  90. Luna, F. (2009). Bioethics and vulnerability: A Latin American view. Amsterdam and New York: Rodopi.

    Google Scholar 

  91. Macleod, C., Masilela, T. C., & Malomane, E. (1998). Feedback of research results: Reflections from a community-based health programme. South Africa Journal of Psychology, 28(4), 215–221.

    Article  Google Scholar 

  92. Marshall, P. A. (2004). The individual and the community in international genetic research. The Journal of Clinical Ethics, 15(1), 76–86.

    Article  PubMed  Google Scholar 

  93. Marshall, P. A. (2006). Informed consent in international health research. Journal of Empirical Research on Human Research Ethics, 1(1), 25–42.

    Article  PubMed  Google Scholar 

  94. Marshall, P. A. (2001). The relevance of culture for informed consent in U.S.-funded international health research. In Ethical and policy issues in international research: Clinical trials in developing countries (Vol. II, pp. C1–C38). Bethesda: National Bioethics Advisory Commission.

    Google Scholar 

  95. Marshall, P., Thomasma, D. C., & Bergsma, J. (1994). Intercultural reasoning: The challenge for international bioethics. Cambridge Quarterly of Healthcare Ethics, 3(3), 321–328.

    Article  CAS  PubMed  Google Scholar 

  96. Mathews, D. J. H., Fins, J. J., & Racine, E. (2018). The therapeutic “mis”conception: An examination of its normative assumptions and a call for its revision. Cambridge Quarterly of Healthcare Ethics, 27, 154–162.

    Article  PubMed  Google Scholar 

  97. McKay, T., & Timmermans, S. (2009). The bioethical misconception: A response to Lidz. Social Science & Medicine, 69, 1793–1796.

    Article  Google Scholar 

  98. McConville, P. (2017). Presuming patient autonomy in the face of therapeutic misconception. Bioethics, 31, 711–715.

    Article  PubMed  Google Scholar 

  99. McCormick, J. B. (2018). How should a research ethicist combat false beliefs and therapeutic misconception risk in biomedical research? AMA Journal of Ethics, 20(11), E1100–E1106.

    Article  PubMed  Google Scholar 

  100. McKay, T., & Timmermans, S. (2009a). The bioethical misconception: A response to Lidz. Social Science & Medicine, 69, 1793–1796.

    Article  Google Scholar 

  101. McKay, T., & Timmermans, S. (2009b). Clinical trials as treatment option: Bioethics and health care disparities in substance dependency. Social Science & Medicine, 69, 1784–1790.

    Article  Google Scholar 

  102. Michels, K. B., & Rothman, K. J. (2003). Update on unethical use of placebos in randomized trials. Bioethics, 17(2), 188–204.

    Article  PubMed  Google Scholar 

  103. Mill, J. S. (1998 [1863]). Utilitarianism. In J. P. Sterba (Ed.), Ethics: The big questions (pp. 119–132). Malden: Blackwell Publishers.

    Google Scholar 

  104. Miller, F. G. (2000). Placebo-controlled trials in psychiatric research: An ethical perspective. Biological Psychiatry, 47, 707–716.

    Article  CAS  PubMed  Google Scholar 

  105. Miller, F. G., & Brody, H. (2002). What makes placebo-controlled trials unethical? The American Journal of Bioethics, 2(2), 3–9.

    Article  PubMed  Google Scholar 

  106. Millum, J. (2013). Romanian orphans study: A bioethicist responds to ethical concerns. Bioethics Forum. https://www.thehastingscenter.org/romanian-orphans-study-a-bioethicist-responds-to-ethical-concerns/. Accessed 29 Feb 2020.

  107. Millum, J., & Emanuel, E. J. (2007). The ethics of international research with abandoned children. Science, 318(5858), 1874–1875.

    Article  PubMed  PubMed Central  Google Scholar 

  108. Molyneux, C. S., Peshu, N., & Marsh, K. (2004). Understanding of informed consent in a low-income setting: Three case studies from the Kenyan coast. Social Science & Medicine, 59(12), 2547–2559.

    Article  CAS  Google Scholar 

  109. Moncrieff, J. (2006). Does antipsychotic withdrawal provoke psychosis? Review of the literature on rapid onset psychosis (supersensitivity psychosis) and withdrawal-related relapse. Acta Psychiatrica Scandinavica, 2006, 1–11. https://doi.org/10.1111/j.1600-0447.2006.00787.x.

    Article  CAS  Google Scholar 

  110. Moser, D. J., Schulz, S. K., Arndt, S., Benjamin, M. L., Fleming, F. W., Berms, D. S., Appelbaum, P. S., & Andreason, N. C. (2002). Capacity to provide informed consent for participation in schizophrenia and HIV research. American Journal of Psychiatry, 159, 1201–1207.

    Article  Google Scholar 

  111. Murali, V., & Oyebode, F. (2004). Poverty, social inequality and mental health. Advances in Psychiatric Treatment, 10, 216–224.

    Article  Google Scholar 

  112. Mwangi, R., Ndebele, P., & Mongoven, A. (2017). Understanding therapeutic misconceptions and perceptions, and enrollment decision-making: A pediatric preventive malaria trial in rural Tanzania. IRB, 39(5), 8–18.

    PubMed  Google Scholar 

  113. National Commission for the Protection of Human Subjects of Research. (1979). The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research. Washington, D.C.: United States Department of Health, Education, and Welfare.

    Google Scholar 

  114. National Institute on Drug Abuse. (2018). Guidelines for establishing and operating a data and safety monitoring board. Available at https://www.drugabuse.gov/research/clinical-research/guidelines-establishing-data-safety-monitoring. Accessed 24 Feb 2020.

  115. National Institutes of Health. (1979). Clinical trial activity. NIH guide for grants and contracts. 8(8):29. Available at https://grants.nih.gov/grants/guide/historical/1979_06_05_Vol_08_No_08.pdf. Accessed 29 Feb 2020.

  116. National Institutes of Health. (1998). NIH guide: NIH policy for data and safety monitoring. Available at https://grants.nih.gov/grants/guide/notice-files/not98-084.html. Accessed 24 Feb 2020.

  117. National Institute of Mental Health. (2015). Data safety monitoring plan writing guidance: Guidance for developing a data and safety monitoring plan for clinical trials sponsored by NIMH. Available at https://www.nimh.nih.gov/funding/clinical-research/data-and-safety-monitoring-plan-writing-guidance.shtml. Accessed 24 Feb 2020.

  118. National Institute of Mental Health. (2015). Policy governing independent safety monitors and independent data and safety monitoring boards. Available at https://www.nimh.nih.gov/funding/clinical-research/policy-governing-independent-safety-monitors-and-independent-data-and-safety-monitoring-boards.shtml. Accessed 24 Feb 2020.

  119. Ndebele, P., Mwaluko, G., Kruger, M., Oukem-Boyer, O. O. M., & Zimba, M. (2014). History of research ethics review in Africa. In M. Kruger, P. Ndebele, & L. Horn (Eds.), Research ethics in Africa (pp. 3–10). Stellenbosch: SUN Press.

    Google Scholar 

  120. Nordling, L. (2018). African scientists call for more control of their continent’s genomic data. Nature. Available at https://www.nature.com/articles/d41586-018-04685-1. Accessed 29 Feb 2020.

  121. Onyut, L. P., Neuner, F., Ertl, V., Schauer, E., Odenwald, M., & Elbert, T. (2009). Trauma, poverty, and mental health among Somali and Rwandese refugees living in an African refugee settlement—an epidemiological study. Conflict and Health, 3, 6. https://doi.org/10.1186/1752-1505-1183-1186.

    Article  PubMed  PubMed Central  Google Scholar 

  122. Pailhez, G., Bulbena, A., López, C., & Balon, R. (2010). Views of psychiatry: A comparison between medical students from Barcelona and Medellín. Academic Psychiatry, 34, 61–66.

    Article  PubMed  Google Scholar 

  123. Perkins, D. O., Gu, H., Boteva, K., & Lieberman, J. A. (2005). Relationship between duration of untreated psychosis and outcome in first-episode schizophrenia: A critical review and meta-analysis. American Journal of Psychiatry, 162(10), 1785–1804.

    Article  Google Scholar 

  124. Peterson, B. T., Clancy, S. J., Champion, K., & McLarty, J. W. (1992). Improving readability of informed consent forms: What the computers may not tell you. IRB, 14, 6–8.

    Article  PubMed  Google Scholar 

  125. Preziosi, M. P., Yam, A., Nidaye, M., Simaga, A., Simondon, F., & Wassilak, S. (1997). Practical experiences in obtaining informed consent for a vaccine trial in rural Africa. The New England Journal of Medicine, 336(5), 370–373.

    Article  CAS  PubMed  Google Scholar 

  126. Proctor, R. N. (1988). Racial hygiene: Medicine under the Nazis. Cambridge, MA: Harvard University Press.

    Google Scholar 

  127. Purdy, L. M. (1992). A call to heal. In H. B. Holmes & L. M. Purdy (Eds.), Feminist perspectives in medical ethics (pp. 9–13). Bloomington: Indiana University Press.

    Google Scholar 

  128. Reich, W. (2005). The power of a single idea. In M. Patrão Neves & M. Lima (Eds.), Bioetica ou bioeticas na evolução das sociedades (pp. 380–382). Coimbra: Grafica de Coimbra.

    Google Scholar 

  129. Resnik, D. B. (1998). The ethics of HIV research in developing nations. Bioethics, 2(4), 286–306.

    Article  Google Scholar 

  130. Roberts, L. W., Laureillo, J., Geppert, C., & Keith, S. J. (2001). Placebos and paradoxes in psychiatric research: An ethics perspective. Biological Psychiatry, 49, 887–893.

    Article  CAS  PubMed  Google Scholar 

  131. Rothman, K. J., & Michels, K. B. (1994). The continued unethical use of placebo controls. The New England Journal of Medicine, 331, 394–398.

    Article  CAS  PubMed  Google Scholar 

  132. Saluja, S., Rudolfson, N., Massenburg, B. B., Meara, J. G., & Shrime, M. G. (2020). The impact of physician migration on mortality in low and middle-income countries: An economic modeling study. BMJ Global Health, 5, e001535.

    Article  PubMed  PubMed Central  Google Scholar 

  133. Sherwin, S. (1992a). Feminist and medical ethics: Two different approaches to contextual ethics. In H. B. Holmes & L. M. Purdy (Eds.), Feminist perspectives in medical ethics (pp. 17–31). Bloomington: Indiana University Press.

    Google Scholar 

  134. Sherwin, S. (1992b). No longer patient: Feminist ethics and health care. Philadelphia: Temple University Press.

    Google Scholar 

  135. Siriwardhana, C., Adikari, A., Jayaweera, K., & Sumathipala, A. (2013). Ethical challenges in mental health research among internally displaced people: Ethical theory and research implementation. BMC Medical Ethics, 14, 13. http://www.biomedcentral.com/1472-6939/14/13.

    Article  PubMed  PubMed Central  Google Scholar 

  136. Skiera, A.-S., & Michels, K. B. (2018). Ethical principles and placebo-controlled trials—interpretation and implementation of the Declaration of Helsinki’s placebo paragraph in medical research. BMC Medical Ethics, 19(1), 24. https://doi.org/10.1186/s12910-018-0262-9.

    Article  Google Scholar 

  137. Sorsdahl, K., Stein, D. J., Grimsrud, A., Seedat, S., Flisher, A. J., Williams, D. R., & Myer, L. (2009). Traditional healers in the treatment of common mental disorders in South Africa. The Journal of Nervous and Mental Disease, 197(6), 434–441.

    Article  PubMed  PubMed Central  Google Scholar 

  138. Ssenbunnya, J., Kigozi, F., Lund, C., Kizza, D., & Okello, E. (2009). Stakeholder perceptions of mental health stigma and poverty in Uganda. BMC International Health and Human Rights, 9(1), 1. https://doi.org/10.1186/1472-698X-9-5.

    Article  Google Scholar 

  139. Stewart, P. J., & Strathern, A. (2004). Witchcraft, sorcery, rumors, and gossip. Cambridge, MA: Cambridge University Press.

    Google Scholar 

  140. Sugarman, J., Popkin, B., Fortney, J., & Rivera, R. (2001). International perspectives on protecting human research subjects. In Ethical and policy issues in international research: Clinical trials in developing countries (Vol. II, pp. E1–E30). Bethesda: National Bioethics Advisory Commission.

    Google Scholar 

  141. Taub, H. A. (1986). Comprehension of informed consent for research: Issues and directions for future study. IRB, 8, 7–10.

    Article  PubMed  Google Scholar 

  142. Taylor, C. (1991). The harp that plays by itself. Medical Anthropology, 13, 99–129.

    Article  CAS  PubMed  Google Scholar 

  143. Taylor, K. M. (1992). Integrating conflicting professional roles: Physician participation in randomized clinical trials. Social Science & Medicine, 35(2), 217–224.

    Article  CAS  Google Scholar 

  144. Taylor, K. M., Feldstein, M. L., Skeel, R. T., Pandya, K. J., Ng, P., & Carbone, P. P. (1994). Fundamental dilemmas of the randomized clinical trial process: Results of the 1,737 Eastern Cooperative Oncology Group investigators. Journal of Clinical Oncology, 12(9), 1796–1805.

    Article  CAS  PubMed  Google Scholar 

  145. Taylor, K. M., & Kelner, M. (1987). Interpreting physician participation in randomized clinical trials: The Physician Orientation Profile. Journal of Health and Social Behavior, 28(4), 389–400.

    Article  CAS  PubMed  Google Scholar 

  146. Tee, S. R., & Lathlean, J. A. (2004). The ethics of conducting a co-operative inquiry with vulnerable people. Journal of Advanced Nursing, 47(5), 536–543.

    Article  PubMed  Google Scholar 

  147. Temple, R., & Ellenberg, S. S. (2000). Placebo-controlled trials and active-control trials in the evaluation of new treatments part 1: Ethical and scientific issues. Annals of Internal Medicine, 133(6), 455–463.

    Article  CAS  PubMed  Google Scholar 

  148. ten Have, H. (2015). Respect for human vulnerability: The emergence of a new principle in bioethics. Bioethical Inquiry, 12, 395–408.

    Article  PubMed  Google Scholar 

  149. Thomas, S. B., & Quinn, S. C. (1991). The Tuskegee syphilis study, 1932 to 1972: Implications for HIV education and AIDS risk education programs in the black community. American Journal of Public Health, 81, 1498–1504.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  150. Thong, I. S. K., Foo, M. Y., Sum, M. Y., Capps, B., Lee, T.-S., Ho, C., & Sim, K. (2016). Therapeutic misconception in psychiatry research: A systematic review. Clinical Psychopharmacology Neuroscience, 14(1), 17–25.

    Article  PubMed  Google Scholar 

  151. United Nations. International covenant on civil and political rights. United Nations treaty collection. Available at https://treaties.un.org/Pages/ViewDetails.aspx?src=TREATY&mtdsg_no=IV-4&chapter=4&clang=_en. Accessed 28 Feb 2020.

  152. United States Department of Health and Human Services, Office for Human Research Protections. (2016). Federal policy for the protection of human subjects (‘Common Rule’). https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html. Accessed 17 Feb 2020.

  153. United States Department of Health and Human Services, Office for Human Research Protections. (2017). Revised common rule. https://www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-common-rule/index.html. Accessed 22 Feb 2020.

  154. Voinescu, B., Szentagotai, A., & Coogan, A. (2010). Attitudes towards psychiatry—a survey of Romanian medical residents. Academic Psychiatry, 34, 75–78.

    Article  PubMed  Google Scholar 

  155. Wang, H., Erickson, J. D., Li, Z., & Berry, R. J. (2004). Evaluation of the informed consent process in a randomized controlled trial in China: The Sino-US NTD Project. The Journal of Clinical Ethics, 15(1), 61.

    Article  PubMed  Google Scholar 

  156. Wassenaar, D. R. (2006). Commentary: Ethical considerations in international research collaboration: The Bucharest Early Intervention Project. Infant Mental Health Journal, 27(6), 577–580.

    Article  PubMed  Google Scholar 

  157. Weijer, C. (1999). Placebo-controlled trials in schizophrenia: Are they ethical? Are they necessary? Schizophrenia Research, 35, 211–218.

    Article  CAS  PubMed  Google Scholar 

  158. Welsome, E. (1999). The plutonium files. New York: Dial Press.

    Google Scholar 

  159. Wolinsky, H. (2006). The battle of Helsinki. EMBO, 7(7), 670–672.

    Article  CAS  Google Scholar 

  160. World Health Organization. (2011). Mental health atlas 2011. Geneva: Author.

    Google Scholar 

  161. World Health Organization. (2005). Mental health resources in the world. Geneva: Author.

    Google Scholar 

  162. World Health Organization. (2007). Ten statistical highlights in global public health, Part 1: World health statistics. Geneva: Author.

    Google Scholar 

  163. World Medical Association. (2013). WMA Declaration of Helsinki—Ethical principles for medical research involving human subjects. https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/. Accessed 17 Feb 2020.

  164. Young, D. R., Hooker, D. T., & Freeberg, F. E. (1990). Informed consent document: Increasing comprehension by reducing reading level. IRB, 12, 1–5.

    Article  PubMed  Google Scholar 

  165. MacQueen, K., Shapiro, K., Karim, Q., & Sugarman, J. (2004). Ethical challenges in international HIV prevention research. Accountability in Research: Policies and Quality Assurance, 11(1), 49–61.

    Google Scholar 

  166. Eckenwiler, L., Ellis, C., Feinholz, D., & Schonfeld, T. (2008). Hopes for Helsinki: Reconsidering “vulnerability.” Journal of Medical Ethics, 34(10), 765–766.

    Google Scholar 

  167. Kahn, K., & Bryant, J.H. (1994). The vulnerable in developed and developing countries–A conceptual approach. In Poverty, vulnerbility, the value of human life, and the emergence of bioethics (pp. 57–63). Geneva: Council for International Organizations of Medical Sciences.

    Google Scholar 

  168. United Nations Development Program. (1999). Human development report 1999. New York: Oxford University Press.

    Google Scholar 

  169. Taylor, T. (1946). Opening statement of the prosecution, Dece,ber 9, 1946. In G.J. Annas, M.A. Gordon (Eds.). [1992]. The Nazi doctors and the Nuremberg Code (pp. 67–93). New York: Oxford University Press.

    Google Scholar 

  170. Vennell, V.A.M. (1995). Medical research and treatment: Ethical standards in the international context. Medical Law International, 2, 1–21.

    Google Scholar 

  171. Rosenthal, E. (1997). The International Covenant on Civil and Political Rights and the rights of research subjects. In A.E. Shamoo (Ed.). Ethics in neurobiological research with human subjects: The Baltimore conference on bioethics (pp. 265–272). Amsterdam: Overseas Publishers Association.

    Google Scholar 

  172. Stewart, D.P. (1993). United States ratification of the Covenant on Civil and Political Rights: The significance of the reservations, understandings, and declarations. DePaul Law Review, 42, 1183–1207.

    Google Scholar 

  173. Muss, H.B., White, D.R., Michielutte, R., Richards, F., Cooper, M..R., Williams, S., …& Spurr, C.L. (1979). Written informed consent in patients with breast cancer. Cancer, 43, 1549–1556.

    Google Scholar 

  174. Lavelle-Jones, C., Byrne, D.J., Rice, P., & Cuschieri, A. (1993). Factors affecting quality of informed consent. British Medical Journal, 306(6882), 885–890.

    Google Scholar 

  175. Morrow, G., Gootnick, J., & Schmale, A. (1978). A simple technique for increasing cancer patients’ knowledge of informed consent to treatment. Cancer, 42(2), 793–799.

    Google Scholar 

  176. de Melo-Martin, I., & Ho, A. (2008). Beyond informed consent: The therapeutic misconception and trust. Journal of Medical Ethics, 34(3), 202–205.

    Google Scholar 

  177. Taneja, V., Sriram, S., Beri, R.S., Sreenivas, V. Aggarwal, R., & Kaur, R. (2002). “Not by bread alone”: The impact of a structured 90-minute play session on development of children in an orphanage. Child Care, Health and Development, 28(1), 95–100.

    Google Scholar 

  178. United Nations Children’s Fund, Innocenti Research Centre. (2001). A decade of transition. Regional monitoring report no. 8. Florence, Italy: Author. https://www.unicef-irc.org/publicationspdf/monee8/eng5.pdf. Accessed 14 February 2021.

  179. Groza, V., Ileana, D., & Irwin, I. (1999). A peacock or a crow: Stories, interviews and commentaries on Romanian adoptions. Lakeshore Communications.

    Google Scholar 

  180. Loue, S., Groza, V., & ARAS Working Group. (1998). HIV knowledge and attitudes in Iasi, Romania: A pilot study. Journal of Health Management and Public Health, 3(2).

    Google Scholar 

  181. Zeanah, C.H., Fox, N.A., & Nelson, C.A. (2012). Case study in ethics of research: The Bucharest early intervention project. Journal of Nervous and Mental Disease, 200(3), 243–247.

    Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Case Western Reserve University, Department of Bioethics, Cleveland, OH, USA

    Sana Loue

Authors
  1. Sana Loue
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Sana Loue .

Editor information

Editors and Affiliations

  1. Department of Psychiatry and Behavioral Sciences, The George Washington University, Washington, DC, USA

    Allen R. Dyer

  2. Division of Global Mental Health, George Washington University, Washington, DC, USA

    Brandon A. Kohrt

  3. Department of Behavioral Health, Saint Elizabeths Hospital, Washington, DC, USA

    Philip J. Candilis

Rights and permissions

Reprints and permissions

Copyright information

© 2021 Springer Nature Switzerland AG

About this chapter

Check for updates. Verify currency and authenticity via CrossMark

Cite this chapter

Loue, S. (2021). Ethical Considerations in Global Mental Health Research. In: Dyer, A.R., Kohrt, B.A., Candilis, P.J. (eds) Global Mental Health Ethics. Springer, Cham. https://doi.org/10.1007/978-3-030-66296-7_4

Download citation

  • DOI: https://doi.org/10.1007/978-3-030-66296-7_4

  • Published:

  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-030-66295-0

  • Online ISBN: 978-3-030-66296-7

  • eBook Packages: MedicineMedicine (R0)

Publish with us

Policies and ethics

Search

Navigation