<< Previous Section | < Previous Page | Next Page > | Next Section >> Bibliography (page 2 of 2) Upvall, M. and S. Hashwani (2001). "Negotiating the informed-consent process in developing countries: a comparison of Swaziland and Pakistan." Int Nurs Rev 48(3): 188-92.      This study describes and analyzes the issues in protecting the rights of research participants in developing countries with emphasis on Pakistan and Swaziland. The main issues related to gatekeepers at all levels who were either eager to exercise control or to protect their positions. It emphasizes just how much prelim work had to be done before research could commence. http://www.blackwell-synergy.com/doi/abs/10.1046/j.1466-7657.2001.00063.x Emanuel, E., W. D, et al. (2004). "What makes clinical research in developing countries ethical? The benchmarks of ethical research." J Infect Dis 189(5): 930-7.      The authors provide a comprehensive set of guidelines to investigators engaged in or considering research in developing countries. In these guidelines they elaborate in the communities (social) concerns in clinical research and the avoidance of exploitation using a 33 point table. This is a real contribution. http://www.journals.uchicago.edu/JID/journal/issues/v189n5/31380/31380.html Kirigia, J., C. Wambebe, et al. (2005). "Status of national research bioethics committees in the WHO African region." BMC Medical Ethics 6(1): 10.      This is a description of the research ethics committee status of the 46 countries in Sub-Saharan Africa that are related to WHO. IT indicates that only 2/3 have a research ethics committee (as of 2001) although 80% hard some sort of review process. They propose that even the poorest country should set up a review system. http://www.biomedcentral.com/1472-6939/6/10 Hyder, A. A., S. A. Wali, et al. (2004). "Ethical review of health research: a perspective from developing country researchers." J Med Ethics 30(1): 68-72. This empirical study investigates the reality of clinical research carried out in developing countries sometimes in collaboration with US investigators. They found that many of the studies being carried out by over 600 investigators had no IRB approval and that many of the recommendations of the US National Bioethics Advisory Commission were not in effect for example, language-appropriate consent forms. http://jme.bmjjournals.com/cgi/content/full/30/1/68 Kottow, M. H. (2003). "The Vulnerable and the Susceptible." Bioethics 17(5-6): 460-471.      The author distinguishes the word vulnerable -- the underlying state of mankind requiring government to keep us from each other's throats; and susceptible -- a state of defective health that makes some of us ethically entitled to help others. Applied to research on humans, this applies to subjects from developing countries. http://www.blackwell-synergy.com/doi/abs/10.1111/1467-8519.00361 Creed-Kanashiro, H., B. Ore, et al. (2005). "Conducting Research in Developing Countries: Experiences of the Informed Consent Process from Community Studies in Peru." J. Nutr. 135(4): 925-928.      The authors present their experiences and raise questions about the meaning of informed consent and how the model of implementation could be changed. http://jn.nutrition.org/cgi/content/full/135/4/925 Kass, N. E., L. Dawson, et al. (2003). "Ethical oversight of research in developing countries." IRB: Ethics & Human Research 25(2): 1-10.      A unique survey conducted under the auspices of the NBAC studying researchers from developed countries perspectives on oversight of research in developing countries. They developed an instrument using focus groups. They identified appropriate researchers and got a 47% response rate. The results indicated beliefs of the investigators regarding the oversight of studies they were conducting in a number of domains. Well worth reading. Dickens, B. M. and R. J. Cook (2003). "Challenges Of Ethical Research In Resource-Poor Settings." International Journal of Gynecology & Obstetrics 80(1): 79.       This study focuses on reproductive studies of women from developing countries. It details barriers that are institutional, issues with informed consent, use of placebos, problems with ethics review committees, etc. http://www.sciencedirect.com/science/article/B6T7M-47MNYN7 -G/2/8fb17bab203b70338b01aeb84eb01186 Lie, R. K., E. Emanuel, et al. (2004). "The Standard Of Care Debate: The Declaration Of Helsinki Versus The International Consensus Opinion." J Med Ethics 30(2): 190-193.       This brief paper reviews the controversy surrounding the limitations on clinical research resulting from the requirement of the Declaration of Helsinki year 2000 version's absolute requirement for the best standard therapy in controls of therapeutic trials. The authors point out that other groups give investigators more experimental design options. So, the debate over treatment options in studies in developing countries persists. http://jme.bmjjournals.com/cgi/content/full/30/2/190 << 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)