De Helsinki à Fortaleza: uma declaração dessangrada

bioet Revista Bioética Rev. Bioét. 1983-8042 1983-8034 Conselho Federal de Medicina Brasília, DF, Brazil A Declaração de Helsinki de 1964 vem sendo submetida a numerosas revisões e emendas, sendo a mais recente a de Fortaleza (2013). A frequência dessas reformulações tem sido considerada necessária, dados os avanços da medicina contemporânea, mas também criticada por conferir pouca estabilidade e autoridade ao documento. A versão de Edimburgo (2000) marcou a política de tolerância ao uso de placebo e de escasso apoio aos benefícios pós-estudo aos sujeitos e à comunidade, desestimulando os esforços da Argentina e Brasil para reforçar a proteção aos participantes dos estudos. Se aceita assim - de fato - o duplo standart em ética em pesquisa, que de forma progressiva debilita a Declaração como normativa ética para a pesquisa envolvendo seres humanos. A dominação cada vez mais acentuada de interesses corporativos de investigadores e patrocinadores sugere que a bioética latino-americana deve desenvolver seu próprio documento normativo, em respeito a nossa realidade social, voltado a proteção às comunidades da região. 1 1. Editorial. Dismantling the Helsinki Declaration. Canadian Medical Association Journal. 2003; 169(10): 1-2. Editorial. Dismantling the Helsinki Declaration Canadian Medical Association Journal 2003 1 2 10 169 2 2. Camporesi S. The FDA decision to shelve the Helsinki Declaration: ethical considerations. Ecancermedicalscience. 2008; Doi 10.3332/eCMS.2008.LTR76. (acesso 2 jan. 2014). The FDA decision to shelve the Helsinki Declaration: ethical considerations 2008 Camporesi S 3 3. Kimmelman J, Weijer C, Meslin RM. Helsinki discords: FDA, ethics, and international drug trials. The Lancet. 2009 jan. 3; 373:13-14. 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Rothman DJ. The shame of medical research. The New York Review of Books. 2000; 47 (19): 60-4. The shame of medical research The New York Review of Books 2000 60 4 19 47 Rothman DJ 9 9. Gilder S. World Medical Association meets in Helsinki. Brit. Med. J. 1964; 2: 299-300. World Medical Association meets in Helsinki Brit. Med. J 1964 299 300 2 Gilder S 10 10. Ethical Committee of the World Medical Association. Draft code of ethics on human experimentation. BMJ. 1964;2:177-80. Draft code of ethics on human experimentation BMJ 1964 177 80 2 11 11. Jonas H. Philosophical reflections on experimenting with human subjects. In: Freund PA, editor. Experimentation with human subjects. New York: George Braziller; 1969. p. 1-31. Experimentation with human subjects 1969 1 31 Jonas H Freund PA 12 12. Brennan TA. Proposed revisions to the Declaration of Helsinki – will they weaken the ethical principles underlying human research. The New England Journal of Medicine. 1999; 341 (7): 527-30. Proposed revisions to the Declaration of Helsinki - will they weaken the ethical principles underlying human research The New England Journal of Medicine 1999 527 30 7 341 Brennan TA 13 13. Levine RJ. The need to revise the Declaration of Helsinki. The New England Journal of Medicine. 1999; 341 (7): 531-4. The need to revise the Declaration of Helsinki The New England Journal of Medicine 1999 531 4 7 341 Levine RJ 14 14. Brody H, Miller FG. The clinician-investigator: unavoidable but manageable tension. Kennedy Institute of Ethics Journal. 2003; 13(4): 329-46. The clinician-investigator: unavoidable but manageable tension Kennedy Institute of Ethics Journal 2003 329 46 4 13 Brody H Miller FG 15 15. Miller FG, Brody H. A critique of clinical equipoise. Hastings Center Report. 2003; 33(3): 19-28. A critique of clinical equipoise Hastings Center Report 2003 19 28 3 33 Miller FG Brody H 16 16. World Medical Association. Declaration of Helsinki – Ethical principles for medical research involving human subjects. Fortaleza: WMA; 2013. Declaration of Helsinki - Ethical principles for medical research involving human subjects 2013 17 17. Emanuel EJ. Reconsidering the Declaration of Helsinki. The Lancet. 2013 May 4; 381: 1.532-3. Reconsidering the Declaration of Helsinki The Lancet 05 04 2013 1.532 3 381 Emanuel EJ 20. MacPherson CC. Carta al editor. The New England Journal of Medicine. 1999; 341 (24): 1.852. Carta al editor The New England Journal of Medicine 1999 1.852 24 341 MacPherson CC 21. Levine RJ. Carta al editor. The New England Journal of Medicine. 1999; 341 (24): 1.853. Carta al editor The New England Journal of Medicine 1999 1.853 24 341 Levine RJ 22. Parsa-Parsi R, Blackmer J, Ehni H-J, Janbu T, Kloiber O, Wiesing U. Reconsidering the Declaration of Helsinki. The Lancet. 2013 out. 20; 382: 1.246-7. Reconsidering the Declaration of Helsinki The Lancet 10 20 2013 1.246 7 382 Parsa-Parsi R Blackmer J Ehni H-J Janbu T Kloiber O Wiesing U 23. Emanuel EJ. Author's reply. The Lancet. 2013 out. 12; 382: 1.247-8. Author's reply The Lancet 10 12 2013 1.247 8 382 Emanuel EJ 24. Ndebele P. The Declaration of Helsinki, 50 years later. Jama. 2013. doi:10.100/jama.2013.281316. (acesso 21 out. 2013). The Declaration of Helsinki, 50 years later Jama 2013 Ndebele P 25. Millum J, Wnedler D, Emanuel EJ. The 50th anniversary of the Declaration of Helsinki. Progress but many remaining challenges. Jama. 2013; 310 (20): 2.143. The 50th anniversary of the Declaration of Helsinki. Progress but many remaining challenges Jama 2013 2.143 20 310 Millum J Wnedler D Emanuel EJ 26. Kottow M. Latinoamérica lesionada. Revista de la Red Latinoamericana de Bioética. 2013; 4 (2): en edición. Latinoamérica lesionada Revista de la Red Latinoamericana de Bioética 2013 2 4 Kottow M 27. Kottow M. El ocaso de los placebos. Conferencia y discusión. Florianópolis: X Congreso Brasileño de Bioética; 2013. In: Bioética, saúde, pesquisa e educação. Brasília: CFM; 2014. (no prelo). Bioética, saúde, pesquisa e educação 2014 Kottow M