Una organización internacional sin ánimo de lucro para fomentar el acceso y el uso adecuado de medicamentos entre la población hispano-parlante
Una organización internacional sin ánimo de lucro para fomentar el acceso y el uso adecuado de medicamentos entre la población hispano-parlante
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Geissler PW, Kelly A, Imoukhuede B, Pool R. ”He is now like a brother, I can even give him some blood” – Relational ethics and material exchanges in a malaria vaccine ”trial community” in the Gambia. Social Science and Medicine 2008; 65(5):696-707
Glickman SW et al. Ethical and scientific implications of the globalization of clinical research. NEJM 2009; 360 (8): 816-823
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Hyder AA, Wall SA, Khan AN, Teoh NB, Kass NE, Dawson L. Ethical review of health research: a perspective from developing country researchers. J Med Ethics 2004; 30:68-72 http://jme.bmj.com/cgi/content/abstract/30/1/68
Kass N, Maman S, Atkinson J. Motivations, understanding and voluntariness in international randomized tirals. IRB: Ethics and Human Research 2005; 27 (6):1-8
Kent DM, Mwamburi DM, Bennish ML et al. Clinical trials in Sub-Saharan Africa and established standards of care: a systematic review of HIV, Tuberculosis, and Malaria Trials. JAMA, 2004; 292(2):237-242 doi:10.1001/jama.292.2.237 http://jama.ama-assn.org/cgi/reprint/292/2/237
Killen J, Grady C, Gregory K. Folkers GK, Fauci AS. Ethics of clinical research in the developing world. Nature Reviews Immunology 2, 210-215 (28 February 2002) doi:10.1038/nri745 Perspective
Kimmelman J. Weijer C, Meslin EM. Helsinki discords: FDA, ethics, and international drug trials. The Lancet 2009; 373 (3):13-14
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Kopelman LM. The incompatibility of the United Nations’ goals and conventionalist ethical relativism. Developing World Bioethics 2005; 5(3):234-243
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Krleza-Jeric K, Lemmens T. 7th Revision of the Declaration of Helsinki: good news for the transparency of clinical trials. Canadian Medical Journal 2009, 50:105-110
Landman W, Schüklenk U. From the Editors. UNESCO declares universals on bioethics and human rights – many unexpected universal truths unearthed by UN body. Developing World Bioethics 2005; 5(3): iii-vi
Lie KR. Ethical issues in clinical trial collaborations with developing countries – with special reference to preventive HIV vaccine trials with secondary endpoints. Geneva: OMS. http://www.ethica.uib.no/who.pdf
Lie RK, Emanuel EJ, Grady C, Wendler D. The standard of care debate: the Declaration of Helsinki versus the international consensus opinion. J. Med. Ethics 2004; 30:190-193 http://jme.bmj.com/cgi/content/abstract/30/2/190
MacQueen KM, Shapiro K, Karim QA, Sugarman J. Ethical challenges in international HIV prevention research. Accountability in Research 2004; 11:48-61
McAdam K. The ethics of research related healthcare in developing countries. Acta Bioethica 2004; X (1):49-56. http://www.scielo.cl/scielo.php?pid=S1726-569X2004000100006&script=sci_arttext
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Meslin EM, Kinney ED, Evans BJ, Flockhart D, Fife R, Shekhar A. Putting research ethics on the (road) map: building ethics, law and policy building capacity through a trasnational ethics organization (TREO). Documento inedito.
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Generales por País
Bangladesh
Lynoe H, Hyder Z, Chowdhury M, Ekstrom L. Obtaining informed consent in Bangladesh. NEJM 2001; 344(6):460-1
Cambodia
Mills E, Rachlis B, Wu P, Wong E, Wilson K, singh S. Media reporting of tenofovir trials in Cambodia and Cameroon. BMC International Health and Human Rights 2005; 5(6)
Page-Shafer K, Saphonn V, Sun LP, Vun MD, Cooper DA, Kaldor JM. HIV prevention research in a resource-limited setting: the experience of planning a trial in Cambodia. The Lancet 2005; 366(9495):1499-1503
Camerun
Mills E, Rachlis B, Wu P, Wong E, Wilson K, singh S. Media reporting of tenofovir trials in Cambodia and Cameroon. BMC International Health and Human Rights 2005; 5(6)
China
Adams V, Miller S, graig S et al. The challenge of cross-cultural clinical trials research: case report from the Tibetan Autonomous Region, Perople’s Republic of China. Medical Anthropology Quarterly 2005; 19 (3): 267-289
Cyranoski D. Chinese clinical trials; consenting adults? Not necessarily. Nature 2005; 435:138
Wang H, Erickson JD, li Z, Berry RJ. Evaluation of the informed consent process in a randomized controlled trial in China. The Sino-US NTD Project. The Journal of Clinical Ethics 2004; 15 (1):61
Gambia
Fairhead J, Leach M, Small M. Public engagement with science? Local understandings of a vaccine trial in the Gambia. Journal of Biosocial Science 2006; 38 (1):103-116
Geissler PW, Kelly A, Imoukhuede B, Pool R. ”He is now like a brother, I can even give him some blood” – Relational ethics and material excanges in a malaria vaccine ”trial community” in the Gambia. Social Science and Medicine 2008; 65(5):696-707
Leach A, Hilton S, Greenwood BM, Manneh E, Dibra B, Wilkins A, Mulholland EK. An evaluation of the informed consent procedure used during a trial of a Haemophilus influenzae type B conjugate vaccine undertaken in the Gambia, West Africa. Social Science and Medicine 1999; 48 (2):139-48
Ghana
Hill Z, Tawiah-Agyemang C, Odei-Danso E, Kirkwood B. Informed consent in Ghana: what do participants really understand. J Med Ethics 2008; 34:48-53. doi:10.1136/jme.2006.019059 http://jme.bmj.com/cgi/content/abstract/34/1/48
India
Acharya K. India: Prime destination for unethical clinical trials. Inter Press Service December 14, 2007 http://www.commondreams.org/archive/2007/12/14/5838/
Arun B. Clinical trials in India: pangs of globalization. Indian Journal of Pharmacology 2004; 36 (4):207-208. http://medind.nic.in/ibi/t04/i4/ibit04i4p207.pdf or http://www.ijp-online.com/article.asp?issn=0253-7613;year=2004;volume=36;issue=4;spage=207;epage=208;aulast=Bhatt
Chatterjee P. Clinical Trials in India: ethical concerns. Bulletin of the World Health Organization 2008; 86(8): 581-582.
DeCosta A, D’Souza N, Krishnan S et al. Community based trials and informed consent in rural north India. Journal of Medical Ethics 2004; 30:318-323
Lipman HM. Strengthening Clinical Research in India. The Lancet 2007; 369:1233 http://download.thelancet.com/pdfs/journals/0140-6736/PIIS0140673607605686.pdf
Nundy S, Gulhati CM. A New Colonialism ? Conducting Clinical Trials in India. NEJM 2005;352:1633-36 http://openmed.nic.in/212/01/nundy.pdf
Sriram TG, Kishore KV, Jayaprakash MR et al. Informed consent: a study of experiences and opinion of utilizers of health services from India. Social Science and Medicine 1991; 32(12): 1389-92
WHO. Clinical trials in India: ethical concerns. Bulletin of the World Health Organization 2008; 86 (8):581-2
Kenia
Gikonyo C, Bejon P, Marsh V, Molyneux S. Taking social relationships seriously: lessons learned from the informed consnt practices of a vaccine trial on the Kenyan Coast. Social Science and Medicine 2008; 67(5): 708-720
Lairumbi GM, Molyneux S, Snow RW, Marsh K, Peshu N, English M. Promoting the social value of research in Kenya: examining the practical aspects of collaborative partnerships using an ethical framework. Social Science and Medicine 2008; 67(5): 734-747
Marsh V, Kamuya D, Rowa Y, Gikonyo C, Molyneux S. Beginning community engagement at a busy biomedical research programme: Experiences from the KEMRI CGMRC-Wellcome Trust Research Programme, Kifili, Kenya. Social Science and Medicine 2008; 67(5): 721-733
Molyneux CS, Peshu N, Marsh K. Understanding of informed consent in a low-income setting: three case studies from the Kenyan coast. Social Science and Medicine 2004; 59(12):2547
Molyneux CS, Peshu N, Marsh K. Trust and informed consent: insight from community members on the Kenyan coast. Social Science and Medicine 2005; 61(7):1463-1473
Patel, Vaishalee. Clinical trials in Kenya. SOMO: The Netherlands. May 2006. http://www.somo.nl/html/paginas/pdf/Kenya_clinical_trials_2006_EN.pdf
Shaffer DN, Yebei VN, Ballidawa JB, Sidle JE, Greene JY. Equitable treatment for HIV/AIDS clinical trial participants: a focus group study of patients, clinician researchers, and administrators in western Kenya. J Med Ethics 2006; 32:55-60 doi:10.1136/jme.2004.011106 http://jme.bmj.com/cgi/content/abstract/32/1/55
Vreeman RC, Nyandiko WM, Meslin EM. Pediatric assent for a study of antirretroviral therapy dosing for children in Western Kenya: A case stidy in international reseach collaboration. Journal of Empirical Research on Human Research Ethics 2009; 4(1): 3-16
Malawi
Corneli A, Sorenson J, Nkhoma J, Moses A, Zulu C et al. Evaluation of three informed consent processes for a clinical trial on the prevention of mother-to-child transmission of HIV through breastfeeding in Lilongwe, Malawi. Oral presentation at XV international AIDS Conference in Bangkok, Thailand.
Nigeria
Fadare JO, Porteri C. Informed consent on human subject research: a comparison of current international and Nigerian guidelines. Journal for Empirical Research on Human Research Ethics 2010: 5(1): 67-73
Falusi AG, Olopade OI, Olopade CO. Establishement of a stanting ethics/institutional review board in a Nigerian university: A blueprint for developing countries. Journal for Empirical Research on Human Research Ethics 2007: 2(1): 21-30
Sri Lanka
Sumathipala A, Siribaddana S, Hewege S et al. Ethics review committee approval and informed consent: an analysis of biomedical publications originating from Sri Lanka. BMC Medical Ethics 2008; 9:3 doi: 10.1186/1472-6939-9-3 http://www.biomedcentral.com/1472-6939/9/3
Sudáfrica
Henley L, Benatar SR, Robertson BA, Ensink K. Informed consent: a survey of doctors’ practices in South Africa. South African Medical Journal 1995; 85:1273-1278
Karim QA, Karim S, Coovadia HM, Susser M. Informed consent for HIV testing in a South African hospital: is it truly informed and truly voluntary? AJPH 1998; 88:637-640
Tucker T, Slack C. Not if but how? Caring for HIV-1 vaccine trial participants in South Africa. The Lancet 2003; 362 (9388):995
Tailandia
Achrekab A, Gupta R. Informed consent for a clinical trial in Thailand. NEJM 1998; 339(18): 1331-2
Pace C, Emanuel EJ, Chuenyam T, Duncombe C, berchuk JD, Wendler D et al. The quality of informed consent in a clinical research study in Thailand. IRB: Ethics and Human Research 2005; 27(1): 9-17
Uganda
Loue S, Okello D, Kawuma M. Research bioethics in the Ugandan context: A program summary. Journal of Law, Medicine and Ethics 1996; 24:47-53
Pace C, Talisuna A, Wendler D. Quality of parental consent in a Ugandan malaria study. AJPH 2005; 95(7):1184-9
Vietnam
Ethical and regulatory challenges in a randomized control trial of adjuvant treatment for breast cancer in Vietnam. Journal of Investigative Medicine 1997; 45(8):423-31
