Abstract
Clinical research continues to expand globally. Lower-income countries have become popular destinations for research institutions and pharmaceutical companies in which to conduct clinical trials (Ballantyne 2010; Emanuel et al. 2004; Glickman et al. 2009). To illustrate, Ghana, a country relatively new to clinical research (Ogutu et al. 2010; Ghana-Michigan Collaborative 2010), reported having thirteen registered clinical trials in operation in 2012, according to the government¡¦s Food and Drug Board that regulates this work (Food and Drug 2012). Of these trials, twelve were sponsored by non-African institutions, with the remaining one funded by a Tanzanian research institution (Food and Drug 2012).1 The pharmaceutical industry is aware that running trials in the lower-income countries is more cost effective than in higher-income countries (Petryna 2007; Schuklenk 2010). In lower-income countries like Ghana, participants are often targeted as preferable, ¡§treatment-naïve¡¨ trial candidates, meaning individuals who have not been exposed to drugs that could potentially interfere with clinical trial results (Frimpong-Mansoh 2008; Mbuagbaw et al. 2011; Petryna 2007).
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References
Angell, M. 1997. “The Ethics of Clinical Research in the Third World.” The New England Journal of Medicine 337 (12): 847–849.
Appelbaum, P. S., M. Anatchkova, K. Albert, L. B. Dunn, and C. W. Lidz. 2012. “Therapeutic Misconception in Research Subjects: Development and Validation of a Measure.” Clinical Trials (London, England) 9(6): 748–61. Accessed July 7, 2013. http://www.ncbi.nlm.nih.gov/pubmed/22942217.
Appelbaum, P. S., L. H. Roth, and C. Lidz. 1982. “The Therapeutic Misconception: Informed Consent in Psychiatric Research.” International Journal of Law and Psychiatry 5(3–4): 319–29. Accessed July 7, 2013. http://www.ncbi.nlm.nih.gov/pubmed/6135666.
Appelbaum, P. S., L. H. Roth, C. W. Lidz, P. Benson, and W. Winslade. 1987. “False Hopes and Best Data: Consent to Research and the Therapeutic Misconception.” Hastings Center Report 2: 20–24.
Ballantyne, A. J. 2010. “How to Do Research Fairly in an Unjust World.” The American Journal of Bioethics: 10(6): 26–35. Accessed July 7, 2013. http://www.ncbi. nlm.nih.gov/pubmed/20526966.
Beauchamp, T., and J. Childress. 2009. Principles of Biomedical Ethics. Sixth Edition. New York, New York: Oxford University Press.
Belmont Report. 1979. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, DC. Accessed June 12, 2013. hhs.gov/ohrp/humansubjects/guidance/belmont.html.
Benatar, S. R. 2002. “Reflections and Recommendations on Research Ethics in Developing Countries.” Social Science and Medicine (1982) 54(7): 1131–1141. Accessed July 7, 2013. http://www.ncbi.nlm.nih.gov/pubmed/11999507.
Brody, B. A. 2002. “Ethical Issues in Clinical Trials in Developing Countries.” Statistics in Medicine 21 (19): 2853–2858.
Buchanan, D., S. Sifunda, N. Naidoo, S. James, and P. Reddy. 2008. “Assuring Adequate Protections in International Health Research: A Principled Justification and Practical Recommendations for the Role of Community Oversight.” Public Health Ethics 1 (3): 1–12.
Chingono, A., T. Lane, A. Chitumba, M. Kulich, and S. Morin. 2008. “Balancing Science and Community Concerns in Resource-Limited Settings: Project Accept in Rural Zimbabwe.” Clinical Trials (London, England) 5(3): 273–6. Accessed July 7, 2013. http://www.ncbi.nlm.nih.gov/pubmed/18559417.
Corrigan, O. 2003. “Empty Ethics: The Problem with Informed Consent.” Sociology of Health and Illness 25 (3): 768–792.
Council for International Organizations of Medical Sciences (CIOMS). 2002. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva, Switzerland.
Dixon-Woods, M., S. J. Williams, C. J. Jackson, A. Akkad, S. Kenyon, and M. Habiba. 2006. “Why Do Women Consent to Surgery, Even When They Do Not Want To? An Interactionist and Bourdieusian Analysis.” Social Science and Medicine (1982) 62 (11): 2742–2753.
Dunn, M., M. Sheehan, T. Hope, and M. Parker. 2012. “Toward Methodological Innovation in Empirical Ethics Research.” Cambridge Quarterly of Healthcare Ethics 21 (4): 466–480. doi: 10.1017/S0963180112000242
Ehrich, K., C. Williams, B. Farsides, J. Sandall, and R. Scott. 2007. “Choosing Embryos: Ethical Complexity and Relational Autonomy in Staff Accounts of PGD.” Sociology of Health and Illness 29 (7): 1091–1106.
Ekouevi, D. K., R. Becquet, I. Viho, L. Bequet, C. Amani-Bosse, F. Dabis, and V. Leroy. 2004. “Obtaining Informed Consent from HIV-Infected Pregnant Women, Abidjan, Cote d’ Ivoire.” AIDS 18 (10): 1486–1488.
Ellis, R. D., I. Sagara, A. Durbin, A. Dicko, D. Shaffer, L. Miller, J. Millum, et al. (2010). “Comparing the Understanding of Subjects Receiving a Candidate Malaria Caccine in the United States and Mali.” The American Journal of Tropical Medicine and Hygiene 83 (4): 868–872.
Emanuel, E. J., D. Wendler, J. Killen, and C. Grady. 2004. “What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research.” The Journal of Infectious Diseases 189 (5): 930–937. doi: 10.1086/381709
Faden, R., T. Beauchamp, and N. King. 1986. A History and Theory of Informed Consent. Oxford: Oxford University Press.
Felt, U., M. D. Bister, M. Strassnig, and U. Wagner. 2009. “Refusing the Information Paradigm: Informed Consent, Medical Research, and Patient Participation.” Health (London, England: 1997) 13(1): 87–106. doi: 10. 1177/1363459308097362.
Fitzgerald, D. D. W. D., C. Marotte, R. R. I. Verdier, W. D. J. Johnson, and J. W. Pape. 2002. “Comprehension during Informed Consent in a Less-Developed Country.” Lancet 360(9342): 1301–1302. Accessed July 7, 2013. http://www.sciencedirect.com/science/article/pii/S0140673602113389.
Food and Drug. 2012. “Food and Drugs Board: Current On-Going Clinical Trials.” Food and Drugs Authority, Ghana. Accessed June 15, 2012. http://www.fdaghana.gov.gh/pdfs/Quick links/ON-GOING CLINICAL TRIALS1.pdf.
Frimpong-Mansoh, A. 2008. “Culture and Voluntary Informed Consent in African Health Care Systems.” Developing World Bioethics 8 (2): 104–114.
Gatter, R. 2006. “Conflicts of Interest in International Human Drug Research and the Insufficiency of International Protections.” Am. J.L. and Med. 32(2): 351–364. Accessed July 07 2013. http://heinonlinebackup.com/hol-cgibin/get_pdf. cgi?handle=hein. journals/amlmed32§ion=21.
Ghana-Michigan Collaborative. 2010. “The Ghana-Michigan Collaborative Health Alliance for Reshaping Training, Education, and Research (Charter).”
Glickman, S. W., J. G. McHutchison, E. D. Peterson, C. B. Cairns, R. A. Harrington, R. M. Califf, and K. A. Schulman. 2009. “Ethical and Scientific Implications of the Globalization of Clinical Research.” The New England Journal of Medicine 360(8): 816–823. Accessed July 7, 2013. http://www.ncbi.nlm.nih.gov/ pubmed/19228627.
Goldberg, D. S. 2011. “Eschewing Definitions of the Therapeutic Misconception: A Family Resemblance Analysis.” The Journal of Medicine and Philosophy 36 (3): 296–320.
Hill, Z., C. Tawiah-Agyemang, S. Odei-Danso, and B. Kirkwood. 2008. “Informed Consent in Ghana: What Do Participants Really Understand?” Journal of Medical Ethics 34 (1): 48–53.
Horng, S., and C. Grady. 2003. “Misunderstanding in Clinical Research: Distinguishing Therapeutic Misconception, Therapeutic Misestimation, and Therapeutic Optimism.” IRB: Ethics and Human Research 25 (1): 11–16.
Joffe, S., E. F. Cook, D. Cleary, J. W. Clark, and C. Jane. 2001. “Quality of Informed Consent: A New Measure of Research Subjects.” J Natl Cancer Inst 93 (2): 139–147.
Joubert, G., H. Steinberg, E. van der Ryst, and P. Chikobvu. 2003. “Consent for Participation in the Bloemfontein Vitamin A Trial: How Informed and Voluntary?” American Journal of Public Health 93 (4): 582–584.
Klitzman, R. L. 2012. “US IRBs Confronting Research in the Developing World.” Bioethics 12(2): 1471–8731. doi: 10. 1186/1472–6939–12–13.16.
Krogstad, D. J., S. Diop, A. Diallo, F. Mzayek, J. Keating, O. A. Koita, and Y. T. Touré. 2010. “Informed Consent in International Research: The Rationale for Different Approaches.” The American Journal of Tropical Medicine and Hygiene 83(4): 743–747. Accessed July 7, 2013. http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2946735&tool=pmcentrez&rendertype=abstract.
Krosin, M. T., R. Klitzman, B. Levin, J. Cheng, and M. L. Ranney. 2006. “Problems in Comprehension of Informed Consent in Rural and Peri-Urban Mali, West Africa.” Clinical Trials 3 (3): 306–313.
Kuczewski, M. G., and P. Marshall. 2002. “The Decision Dynamics of Clinical Research: The Context and Process of Informed Consent.” Medical Care 40 (9 Suppl): V45–54.
Leach, A., S. Hilton, B. M. Greenwood, E. Manneh, B. Dibba, A. Wilkins, and E. K. Mulholland. 1999. “An Evaluation of the Informed Consent Procedure Used during a Trial of a Haemophilus Inuenzae Type B Conjugate Vaccine undertaken in The Gambia, West Africa.” Social Science and Medicine 48: 139–148.
Levitt, M., and H. Zwart. 2009. “Bioethics: An Export Product? Reflections on Hands-On Involvement in Exploring the “External” Validity of International Bioethical Declarations.” Journal of Bioethical Inquiry 6 (3): 367–377.
Lock, M., and V. Nguyen. 2010. An Anthropology of Biomedicine. Oxford: Wiley-Blackwell.
London, L., A. Kagee, K. Moodley, and L. Swartz. 2012. “Ethics, Human Rights and HIV Vaccine Rrials in Low-Income Settings.” Journal of Medical Ethics 38 (5): 286–293. doi: 10.1136/medethics-2011–100227
Lorenzo, C., V. Garrafa, J. H. Solbakk, and S. Vidal. 2010. “Hidden Risks Associated with Clinical Trials in Developing Countries.” Journal of Medical Ethics 36 (2): 111–5.
Lynoe, N., Z. Hyder, M. Chowdhury, and L. Ekstrom. 2001. “Obtaining Informed Consent in Bangladesh.” New England Journal of Medicine 344 (6): 460–461.
Mansell, P. 2011. “Over 50% Growth to 2015 Seen in Global Trials Market.” Pharma–Times. Accessed August 5, 2012. http://www.pharmatimes.com/article/11–07–07/Over_50_growth_to_2015_seen_in_global_clinical_trials_market.aspx.
Marshall, P. A., C. A. Adebamowo, A. A. Adeyemo, T. O. Ogundiran, M. Vekich, T. Strenski, J. Zhou, T. E. Prewitt, R. S. Cooper and C. N. Rotimi 2006. “Voluntary Participation and Informed Consent to International Genetic Research.” American Journal of Public Health 96(11): 1989–1995.
Mbuagbaw, L., L. Thabane, P. Ongolo-Zogo, and T. Lang. 2011. “The Challenges and Opportunities of Conducting a Clinical Trial in a Low Resource Setting: The Case of the Cameroon Mobile Phone SMS (CAMPS) Trial, An Investigator Initiated Trial.” Trials 12 (1): 145.
Miller, T., and M. Boulton. 2007. “Changing Constructions of Informed Consent: Qualitative Research and Complex Social Worlds.” Social Science and Medicine 65: 2199–2211. Accessed July 7, 2013. http://www.sciencedirect.com/science/article/pii/S0277953607004340.
Moreno, J. D. 2007. “Goodbye to All That: The End to Moderate Protectionism in Human Subjects Research.” The Hastings Center Report 31 (3): 9–17.
Morris, N., and B. Bàlmer. 2006. “Volunteer Human Subjects’ Understandings of Their Participation in a Biomedical Research Experiment.” Social Science and Medicine (1982) 62 (4): 998–1008. doi: 10.1016/j.socscimed.2005.06.044
Moses, H., R. Dorsey, D. H. M. Matheson, and S. O. Thier. 2005. “Financial Anatomy of Biomedical Research.” JAMA 294 (11): 1333–1342.
Mystakidou, K., and I. Panagiotou. 2009. “Ethical and Practical Challenges in Implementing Informed Consent in HIV/AIDS Clinical Trials in Developing or Resource-Limited Countries.” Journal of Social Aspects of HIV/AIDS 6 (2): 37–41.
Nurgat, Z., W. Craig, N. Campbell, J. Bissett, J. Cassidy, and M. Nicolson. 2005. “Patient Motivations Surrounding Participation in Phase I and Phase II Clinical Trials of Cancer Chemotherapy.” British Journal of Cancer 92 (6): 1001–1005. doi: 10.1038/sj.bjc.6602423
Oduro, A. R., R. A. Aborigo, D. Amugsi, F. Anto, T. Anyorigiya, F. Atuguba, A. Hodgson and K. A. Koram, et al. 2008. “Understanding and Retention of the Informed Consent Process among Parents in Rural Northern Ghana.” BMC Medical Ethics 9(12): 12. Accessed August 7, 2013. http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2443367&tool=pmcentrez&rendertype=abstract.
Ogutu, B., R. Baiden, D. Diallo, P. Smith, and F. Binka. 2010. “Case Study Sustainable Development of a GCP-Compliant Clinical Trials Platform in Africa: The Malaria Clinical Trials Alliance Perspective.” Malaria Journal 9(103): 1–10. Accessed July 7, 2013. http://www.biomedcentral.com/content/pdf/1475–2875-9–103.pdf.
Pentz, R. D., M. White, R. D. Harvey, Z. L. Farmer, Y. Liu, C. Lewis, O. Dashevskaya, T. Owonikoko and F. R. Khuri. 2012. “Therapeutic Misconception, Misestimation, and Optimism in Participants Enrolled in Phase 1 Trials.” Cancer 118(18): 4571–4578. Accessed August 5, 2013. http://www.ncbi.nlm.nih.gov/pubmed/22294385.
Personal Communication. 2012.
Petryna, A. 2007. “Clinical Trials Offshored: On Private Sector Science and Public Health.” Bio Societies 2(1): 21–40. Accessed July 7, 2013. http://www.palgravejournals.com/doifinder/10.1017/S1745855207005030.
Petryna, A. 2009. When Experiments Travel: Clinical Trials and the Global Search for Human Subjects. Princeton: Princeton University Press.
Resnik, D. B. 2009. “The Clinical Investigator-Subject Relationship: a Contextual Approach.” Philosophy, Ethics, and Humanities in Medicine: 4: 16. Accessed July 7, 2013. http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2794289&tool=pmcentrez&rendertype=abstract.
Reynolds, W. W., and R. M. Nelson. 2007. “Risk Perception and Decision Processes Underlying Informed Consent to Research Participation.” Social Science and Medicine (1982) 65 (10): 2105–15. doi: 10.1016/j.socscimed.2007.06.021
Sariola, S., and B. Simpson. 2011. “Theorising the ‘Human Subject’ in Biomedical Research: International Clinical Trials and Bioethics Discourses in Contemporary Sri Lanka.” Social Science and Medicine 73 (4): 515–521.
Schuklenk, U. 2010. “For-Profit Clinical Trials in Developing Countries—Those Troublesome Patient Benefits.” The American Journal of Bioethics, 10 (6), 52–54.
Shamoo, A. E., and D. B. Resnik. 2006. “Strategies to Minimize Risks and Exploitation in Phase One Trials on Healthy Subjects.” The American Journal of Bioethics: 6 (3): W1–13.
Shapiro, H. T., and E. M. Meslin. 2001. “Ethical Issues In the Design and Conduct of Clinical Trials in Developing Countries.” N Engl J Med 345 (2): 139–142.
Silverman, H. 2011. “Protecting Vulnerable Research Subjects in Critical Care Rrials: Enhancing the Informed Consent Process and Recommendations for Safeguards.” Annals of Intensive Care 1 (1): 8. doi: 10.1186/2110–5820-1–8
Stoljar, N. 2011. “Informed Consent and Relational Conceptions of Autonomy.” The Journal of Medicine and Philosophy 36 (4): 375–384.
Sugarman, J., N. E. Kass, S. N. Goodman, P. Perentesis, R. R. Faden, and P. Fernandes. 2012. “What Patients Say about Medical Research.” Ethics 20 (4): 1–7.
Terranova, G., M. Ferro, C. Carpeggiani, V. Recchia, L. Braga, R. C. Semelka, and E. Picano. 2012. “Low Quality and Lack of Clarity of Current Informed Consent Forms in Cardiology: How to Improve Them.” JACC. Cardiovascular Imaging 5 (6): 649–655.
Tindana, P. O., N. Kass, and P. Akweongo. 2006. “The Informed Consent Process in a Rural African Setting: A Case Study of the Kassena-Nankana District of Northern Ghana.” IRB 28 (3): 1–6.
Van Loon, K., and G. Lindegger. 2009. “Informed Consent in Clinical Trials: Perceptions and Experiences of a Sample of South African Researchers.” Health SA Gesondheid 14 (1): 1–7.
Zvonareva, O., N. Engel, E. E. Ross, R. Berghmans, A. A. A. Dhai, and A. Krumeich. 2013. “Engaging Diverse Social and Cultural Worlds: Perspectives on Benefits in International Clinical Research From South African Communities.” Developing World Bioethics 8731. doi:10.1111/dewb.12030.
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Akrong, L., Horstman, K., Arhinful, D.K. (2014). Informed Consent and Clinical Trial Participation: Perspectives from a Ghanaian Community. In: Engel, N., Van Hoyweghen, I., Krumeich, A. (eds) Making Global Health Care Innovation Work. Palgrave Macmillan, New York. https://doi.org/10.1057/9781137456038_2
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