Abstract
Increasingly, pharmaceutical phase III clinical trials are coordinated across multiple centers and clinical research organizations worldwide (Annas 2009). In line with this global development, international cooperation has universalized global health standards and has standardized medical bioethics. For the sake of patient protection worldwide, the Declaration of Helsinki was formulated by the World Medical Association during the 1960s. It upholds internationally-recognized principles, guidelines, and norms of medical ethics that serve to protect human subjects during medical research; it also stipulates the three linchpins of high-quality informed consent: the forbidding of coercion, the mandate that patients who volunteer fully comprehend the risks associated with the research in question, and the stipulation that consent must be formally documented and witnessed (Lee 2010).
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
Similar content being viewed by others
References
Annas, G. J. 2009. “Globalized Clinical Trials and Informed Consent.” New England Journal of Medicine 360 (20): 2050–2053.
Byk, C. 2009. “Chapter 9: The UniversalDeclaration on Bioethics and Human Rights: Bioethics, a Civilizing Utopia in the Age of Globalization? Bioethics: Between Universalism and Globalization.” Accessed March 3, 2012 http://www.ashgate.com/pdf/SamplePages/Nexus_of_Law_and_Biology_Pref.pdf.
Department of Health. 2005. Drugs and Cosmetics (2nd Amendment) Rules. New Delhi: Ministry of Health and Family Welfare.
Fitzgerald D., C. Marotte, R. Verdier, W. Johnson, and J. Pape. 2002. “Comprehension during Informed Consent in a Less-Developed Country.” The Lancet 360: 1301–1302.
Kumar, R. 2008. “Evolving Clinical Trials, Pharmaceutical Executive.” Accessed March 20, 2014. http://www.pharmexec.com/pharmexec/R%26D/Evolving-Clinical-Trials/ArticleStandard/Article/detail/557676.
LaFraniere, S., M. Flaherty, and J. Stephens. 2000. “The Dilemma: Submit or Suffer, Article 3 of The Body Hunters.” Washington Post.
Laughton, A. H. 2007. “Somewhere to Run, Somewhere to Hide?: International Regulations of Human Subject Experimentation.” Duke Journal of Comparative and International Law 18 (181): 181–212.
Lee, B. 2010. “Informed Consent: Enforcing Pharmaceutical Companies’ Obligations Abroad.” Health and Human Rights 12 (1): 15–27.
Maiti, R., M., R. 2007 “Clinical trials in India”, Pharmacological Research 56(1) 1–10.
Miller, F. G, and Shorr, A. F. 2002 “Ethical assessment of industry-sponsored clinical trials: a case analysis.” Chest, 121 (4): 1337–1342.
Rachid, A. 2006. “Global Clinical Trials in Bangladesh: A Call for Action.” BAPA Journal. http://www.bapainfo.org/html/html/documents/1526.pdf.
Rajaraman et al. 2011. “How Participatory Is Parental Consent in Low Literacy Rural Settings in Low Income Countries? Lessons Learned from a Community Based Study of Infants in South India.” BMC Medical Ethics 12(3). Accessed March 20, 2014. http://www.biomedcentral.com/1472–6939/12/3.
RNCOS. 2007. “Booming Clinical Trials Market in India.” Accessed March 20, 2014. http://www.canbiotech.com/CommonData/NewsFiles/Booming%20Clinical%20Trials%20Market%20in%20India.pdf.
Sengupta, S., B. Lo, R. Strauss, J. Eron, and A. L. Gifford. 2011. “Pilot Study Demonstrating Effectiveness of Targeted Education to Improve Informed Consent Understanding in AIDS Clinical Trials.” AIDS Care 23 (11): 1382–1391.
Shah, S. 2006. The Body Hunters, Testing New Drugs on the World’s Poorest Patients. New York: The New Press.
Silverman, E. 2011. “Clinical Trials Death and Compensation in India.” Pharmalot. Accessed June 15, 2011. http://www.pharmalot.com/2011/05/clinical-trial-deaths-andcompensation-in-india/.
Strauss et al. 2001. “Community-Based Participatory Research.” American Journal of Public Health 91(12): 1938–1943.
Strauss, R., P., Sengupta, S., Quinn, S., C., Goep**er, J., Spaulding, C., Kegeles, S., M., Millett, G. 2001. “The Role of Community Advisory Boards: Involving Communities in the Informed Consent Process,” American Journal of Public Health. 91(12): 1938–1943.
Williams, J. R. 2012. “Exploitation and Develo** Countries: The Ethics of Clinical Research.” Edited by Jennifer S. Hawkins and Ezekiel J. Emanuel, 327. Princeton and Oxford: Princeton University Press, 2008. The Heythrop Journal, 53: 895–897. doi: 10.1111/j.1468–2265.2012.00757_46.x.
Williams, J. R. (2012), Exploitation and Develo** Countries: The Ethics of Clinical Research. Edited by Jennifer S. Hawkins and Ezekiel J. Emanuel. Pp. 327, Princeton and Oxford, Princeton University Press, 2008, $14.95. The Heythrop Journal, 53: 895–897. doi: 10.1111/j.1468–2265.2012.00757_46.x.
Zaman, S., and P. Nahar. 2011. “Searching for a Lost Cow: Ethical Dilemmas in Doing Medical Anthropological Research in Bangladesh.” Medische Antropologie 23(1). Accessed March 10, 2012. http://tma.socsci.uva.nl/23_1/abstracts.htm.
Editor information
Copyright information
© 2014 Nora Engel, Ine Van Hoyweghen, and Anja Krumeich
About this chapter
Cite this chapter
van Alphen, I.A.S., Engel, N., Vaz, M. (2014). Local Perspectives on Universal Bioethics—A Qualitative Study on Informed Consent in South India. 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_3
Download citation
DOI: https://doi.org/10.1057/9781137456038_3
Publisher Name: Palgrave Macmillan, New York
Print ISBN: 978-1-349-49831-4
Online ISBN: 978-1-137-45603-8
eBook Packages: Palgrave Social Sciences CollectionSocial Sciences (R0)