Salud y Fármacos

Una organización internacional sin ánimo de lucro para fomentar el acceso y el uso adecuado de medicamentos entre la población hispano-parlante

Artículos sobre ensayos clínicos y ética

Aspectos Generales de Ensayos Clinicos y Ética en Países en Desarrollo

Ajayi OO. Taboos and clinical researh in West Africa. Journal of Medical Ethics 1980; 6(2):61-3

Barata PC, Gucciardi E, Ahmad F, Stewart DE. Cross-cultural perspectives on research participation and informed consent. Social Science and Medicine 2006; 62:479-490

Benatar SR, Singer PA. A new look at international research ethics. BMJ 2000; 321:824-826 doi:10.1136/bmj.321.7264.824 http://www.bmj.com/cgi/content/extract/321/7264/824

Benatar SR. Reflections and recommendations on research ethics in developing countries. Social Science and Medicine 2002; 54:1131-1141 http://www.saludyfarmacos.org/download/Benatar2002.pdf

Binka F. North-South research collaborations: a move towards a true partnership? Tropical Medicine and International Health 2005;10 (3): 207-209

Borger J. Volunteers or victims? Concern grows over control of drug trials. The Guardian, February 14, 2001. http://www.guardian.co.uk/world/2001/feb/14/argentina.julianborger

Brody BA. Ethical issues in clinical trials in developing countries. Statistics in Medicine 2002; 21:2853-2858

Cabral, MML, Schindler, HC, Abath, FGC. Regulamentações, conflitos e ética da pesquisa médica em países em desenvolvimento. Rev Saúde Pública 2006; 40 (3): 521-527.

Chippaux JP. Pharmaceutical colonialism in Africa. Le Monde Diplomatique. August 2005 http://www.afronets.org/archive/200508/msg00103.php

Christakis NA, Panner MJ. Existing international ethical guidelines for human subjects research: some open questions. Law Medicine and Healh Care 1991; 19:214-221

Costello A, Zumla A. Moving to research partnerships in developing countries. BMJ 2000 ; 321 :827-9 http://www.bmj.com/cgi/content/full/321/7264/827?view=full&pmid=11009530

David TJ. Ethics of healthcare research in developing countries. Journal of the Royal Society of Medicine 2002; 95(4): 275-279

Dawson A, Garrard E. In defense of moral imperialism: four equal and universal prima facie principles. Journal of Medical Ethics 2006; 32:200-4

Editorials. The true story of how multinational drug companies took liberties with African lives. The Independent, UK, September 26, 2005 http://www.independent.co.uk/news/science/the-true-story-of-how-multinational-drug-companies-took-liberties-with-african-lives-508421.html

Ekunwe EO, Kessel R. Informed consent in the developing world. Hastings Center Report 1984; 14(3): 22-4

Emanuel EJ, Currie XE, Herman A on behalf on Project Phidisa. Undue inducement in clinical research in developing countries: Is it a worry? The Lancet 2005; 366(9482):336-340

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

Hasley NA, Sommer A, Henderson DA, Black RE. Ethics and International Research (Editorial). BMJ 1997; 315:965-966. http://www.bmj.com/cgi/content/extract/315/7114/965

Hutton JL. Ethics of medical research in developing countries: the role of international codes of conduct. Stat Methods Med Res 2000;9;185 doi:10.1177/096228020000900302 http://smm.sagepub.com/cgi/content/abstract/9/3/185

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

Klimovsky E, Saidon P, Nudelman L, Bignone I. Declaración de Helsinki: sus vicisitudes en los últimos cinco años. Medicina (Buenos Aires) 2002; 62: 365-370

Kopelman LM. The incompatibility of the United Nations’ goals and conventionalist ethical relativism. Developing World Bioethics 2005; 5(3):234-243

Koski G, Nightingale SL. Research involving human subjects in developing countries. New England Journal of Medicine 2001; 345(2): 136-138

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

McMillan JR, Conlon C. The ethics of research related to health care in developing countries. J Med Ethics 2004; 30:204-206 http://jme.bmjjournals.com/cgi/content/full/30/2/204

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.

Mirpuri D. Ethical and management considerations of conducting international clinical trials in developing countries. Boston University School of Public Health.http://dcc2.bumc.bu.edu/richardl/IH820/Resource_materials/Dina-CRO-Dev_countries-051102.doc

Molineux S, Geissler PW. Ethics and ethnography of medical research in Africa. Social Science and Medicine 2008; 67(5): 685-695.

Normille D. The promise and pitfalls of clinical trials overseas. Science 2008; 322:214-216.

Pace CA, Emanuel EJ. The ethics of research in developing countries: assessing voluntariness. The Lancet 2005; 365:11-12 http://linkinghub.elsevier.com/retrieve/pii/S0140673604176794

Page AK. Ethical issues in international biomedical rsearch: An overview. Journal of Health Law 2004; 37(4):629-65

Participants in the 2006 Georgetown University Workshop on the Ancillary-Care Obligations of Medical Researchers Working in Developing countries. The ancillary-care obligations of medical researcehrs working in developing countries. PLoS Medicine 2008; 5(5):e90, doi:10.1371/journal.pmed.0050090 http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0050090

Patel, Vaishalee. Clinical trials in Kenya. SOMO: The Netherlands. May 2006. http://www.somo.nl/html/paginas/pdf/Kenya_clinical_trials_2006_EN.pdf

Pappas G, Hyder AA. Exploring ethical considerations for the use of biological and physiological markers in population-based surveys in less developed countries. Global Health 2005; (1):16 http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1315319

Participantes en un taller realizado en Georgetown University. The ancillary-care obligations of medical researchers working in developing countries. PLoS Medicine 2008; 5:e90 http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0050090

Petryna A. Ethical variability: Drug development and globalizing clinical trials. American Ethnologist 2005; 32 (2): 183-197

Petryna A. Clinical trials offshored: on private sector science and public health. BioSciences 2007; 2:21-40. Borrador disponible en http://www.fas.harvard.edu/~valuesgh/docs/petryna_gh_markets.pdf

Pol Yaguas E. Investigación clínica en países en desarrollo. Boletín Fármacos 2008; 11(1). http://www.saludyfarmacos.org/ene2008/etica-y-derecho-investigaciones

Rennie S. Is it ethical to study what ought not to happen? Developing World Bioethics 2006; 6(2): 71-77. Resumen disponible en http://www.ncbi.nlm.nih.gov/pubmed/16594969

Rowland, C. Clinical trials seen shifting overseas. International Journal of Health Services 2004; 34(3): 555-556

Shah S, Elmer S, Grady C. Planning for posttrial access to antiretroviral treatment for research participants in developing countries. American Journal of Public Health 2009; 99 (9)1556-1562

Shapiro HT, Meslin EM. Ethical issues in the design and conduct of clinical trials in developing countries. NEJM 2001; 345(2): 139-142. http://content.nejm.org/cgi/content/extract/345/2/139

Simon C, Mosavel M, van Stade D. Ethical challenges in the design and conduct of locally relevant international health research. Social Science and Medicine 2007;64(9):1960-9. Resumen en http://www.ncbi.nlm.nih.gov/pubmed/17321657

SOMO. Briefing paper on ethics and clinical trials. #1; Examples of unethical trials. November 2006. También disponible en español http://somo.nl/html/paginas/pdf/Examples_of_unethical_trials_nov_2006_NL.pdf

Wendler D, Emanuel EJ, Lie RK. The standard of care debate; can research in developing countries be both ethical and responsive to those countries’ health needs? American Journal of Public Health 2004; 94(6): 923-928. http://www.ajph.org/cgi/content/abstract/94/6/923

Zumla A, Costello A. Ethics of healthcare research in developing countries. Journal of the Royal society of Medicine 2002; 95(6): 275-276 http://www.jrsm.org/cgi/content/full/95/6/275

Yusuf S. Clinical research and trials in developing countries. Statistics in Medicine 2002; 21:2859-2867.

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

modificado el 28 de Noviembre de 2013


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