<< Previous Section | < Previous Page | Next Page > | Next Section >> Bibliography (page 1 of 2) Bhardwaj, M. and D. Macer (2003). "Policy and ethical issues in applying medical biotechnology in developing countries." Med Sci Monit 9(2): RA49-54.      This is a discussion of the problems involved in developing medical technology, including drugs, in India. The authors consider issues with the research and adaptation of Western concepts of ethical clinical research. They also discuss political influences on research decisions including the battle between spending for prestige and spending to relieve the world problems. Levine, R. (2000). "Some Recent Developments in the International Guidelines on the Ethics of Researching Involving Human Subjects." Ann NY Acad Sci November(918): 170-8.       The author carefully reviews the most controversial elements of the Declaration of Helsinki after strong wording had been inserted in relation to use of placebos. He argues both that the concepts of therapeutic vs. non-therapeutic studies and the prohibition of placebo use when effective agents exist are misleading and sometimes embarrassing in their implications. Marshall, P. (2005). "Human Rights, Cultural Pluralism, and International Health Research." Theoretical Medicine and Bioethics 26(6): 529.      This thoughtful paper deals with the ethical obligations to consider human rights, socioeconomic, and political issues in conducting international health research, especially in resource-poor countries. Not only does there have to be a great deal of community input -- to the point of partnership, but physical resources and know-how have to be part of the package so that the community receives continued benefit from the research. One might consider some parts of the US as similarly deprived with similar needs. http://www.springerlink.com/openurl.asp?genre= article&id=doi:10.1007/s11017-005-2199-5 Cooley, D. R. (2001). "Distributive Justice and Clinical Trials in the Third World." Theoretical Medicine and Bioethics 22(3): 151.      This long philosophical paper addresses the claim that in international research in resource-poor countries, those who are non-participants are exploited. They, it is argued, are denied access to reasonable availability of the products of the research. This aspect of distributive justice is argued against in this paper. http://www.springerlink.com/openurl.asp? genre=article&id=doi:10.1023/A:1011452716028 Molyneux, C. S., D. R. Wassenaar, et al. (2005). "'Even if they ask you to stand by a tree all day, you will have to do it (laughter).' Community voices on the notion and practice of informed consent for biomedical research in developing countries." Social Science & Medicine 61(2): 443.      This extremely interesting report was directed at the question of informed consent in a resource-poor area of Kenya where much research was done. They found, in asking who should be asked to give consent that the answer was muddled by the persistent belief that the research was clinical care. This should be a lesson to those dwelling on the nuances of informed consent in such settings. http://www.sciencedirect.com/science/article/B6VBF-4FFN4N5-1 /2/b7d785f694ea7703bdca485d4670769e Molyneux, C. S., N. Peshu, et al. (2004). "Understanding of informed consent in a low-income setting: three case studies from the Kenyan coast." Social Science & Medicine 59(12): 2547.      This really useful paper elaborates with specificity the issues surrounding acceptance of research activities in a very resource-poor environment in Kenya. The limited vocabulary to try to explain research leaves the participants trying to explain why it is that the researchers are doing what they do. There are exaggerated concepts of what such things as blood drawing can do to help individuals in studies designed to help populations. Very worthwhile. http://www.sciencedirect.com/science/article/B6VBF-4CKFGMR -3/2/c2f00be4516113128f7ec7f2c11f9a17 Benatar, S. (2002). "Reflections and recommendations on research ethics in developing countries." Soc Sci Med 54(7): 1131-41.      Benatar, one of the grand elders of international ethics, discusses broad responsibilities for ethics review committees beyond informed consent and risk-benefit ratios. He believes that these committees should communicate at the community level, monitor research, and act to enhance the research capacity of each country by entering the political domain. These very perceptive remarks provoke considerable reflection. << Previous Section | < Previous Page | Next Page > | Next Section >> Chapter 6 Quick Links International Clinical Research Underlying Conditions Approval and Monitoring Issues Study Population Issues Structural Issues Epidemiological and Social Science Research Cases Bibliography Chapter 6 Download (PDF)