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

Marco Legal y Regulatorio

Normas Internacionales

Andorno R. Biomedicine and international human rights law: In search of a global consensus. Bulletin of the World Health Organization 2002; 80:959-63

Andorno R. Global bioethics at UNESCO: in defense of the Universal Declaration of Bioethics and Human Rights. Journal of Medical Ethics 2007; 33:150-154

Andorno R. Human dignity and human rights as a common ground for a global bioethics. Journal of Medicine and Philosophy 2009; 34:223-240

Angell, M. Ethical imperialism? Ethics in international collaborative clinical research. New England Journal of Medicine 1988; 319:1081-1083

Asai A, Oe S. A valuable up-to-date compedium of bioethical knowledge. Developing World Bioethics 2005; 5(3): 216-219

Asociación Médica Mundial. Declaración de Helsinki. http://www.bioetica.uchile.cl/doc/helsink.htm

Beecher HK. Ethics in clinical research. New England Journal of Medicine 1966; 274:1354-1360

Benatar SR. Imperialism, research ethics and global health. Journal Medical Ethics 1998; 24:221-2

Benatar SR, Singer P. A new look at international research ethics. British Medical Journal 2000; 321:824-26

Benatar SR. Refletions and recommendations on research ethics in developing countries. Social Science and Medicine 2002; 54:1131-1141

Benatar D. The trouble with universal declarations. Developing World Bioethics 2005; 5(3): 220-224

Caulfield T, McGuire AL, Cho M, et al. Research ethics recommendations for whole-genome research: consensus statement. PLoS Biology 2008; 6(3):e73 http://www.plosbiology.org/article/info:doi/10.1371/journal.pbio.0060073

CIOMS, WHO. Pautas éticas internacionales para la investigación biomédica en seres humanos. Chile: PAHO, 2003. http://www.paho.org/Spanish/BIO/CIOMS.pdf

CIOMS working Group VI. Management of Safety Information from Clinical Trials. http://www.cioms.ch/frame_management_of_safety_information.htm

Council of Europe. Texts of the Council of Europe on Bioethical Matters. Volumen I, 2005. Incluye 3 capítulos de interés para las investigaciones en humanos. http://www.coe.int/t/e/legal_affairs/legal_co-operation/bioethics/texts_and_documents/INF_2005_2e%20vol%20I%20textes%20CoE%20bioethique.pdf  El volumen 2 incluye las recomendaciones, resoluciones y opiniones del Parlamento Europeo sobre los mismos asuntos. http://www.coe.int/t/e/legal_affairs/legal_co-operation/bioethics/texts_and_documents/INF_2005_2e%20vol%20II%20textes%20CoE%20bioethique.pdf

De Abajo, FJ. La declaración de Helsinki VI: una revisión necesaria, pero ¿suficiente? Revista Española de Salud Pública 2001; 75:407-420

Department of Health and Human Services (DHHS), Food and Drug Administration. Human subject protection; foreign clinical studies not conducted under an investigational new drug application: final rule. Federal Register 2008, 73 (82), abril 28, 2008: 22800-22816

Declaración de Helsinki – Seúl 2008. (Acceso febrero 2010) En: http://www.wma.net/es/30publications/10policies/b3/index.html

Declaración de Bioética y Derechos Humano UNESCO – 2005. (Acceso junio 2009) En: http://portal.unesco.org/shs/en/ev.php-URL_ID=1372&URL_DO=DO_TOPIC&URL_SECTION=201.html

Editorial. War crimes and medical science. British Medical Journal 1996; 313:1413-1415

Emanuel EJ, Wendler D, Killen J, Grady C. What makes clinical research in developing countries ethical? The benchmarks for ethical research. The Journal of Infectious Diseases 2004; 189:930-937. http://www.sanpad.org.za/portal/images/databases/policybriefs/emanuel%20et%20al%20(2004)%20benchmarks%20jid%20-%20lecture%201.pdf

EMEA/17424/01. EMEA/CPMP position statement on the use of placebo in clinical trials with regard to the revised declaration of Helsinki. Londres 28 junio 2001. Citado en Klimovsky et al, 2002

European Council and European Parliament (EU). Directive 2001/20/EC of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the member States relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, April 2001, adopted by Member states by May 2003, brought into force May 2004. http://europa.eu.int/eur-lex/pri/en/oj/dat/2001/1_12120010501en00340044.pdf

Faden RR, Lederer SE, Moreno JD. US medical researchers, the Nuremberg Doctors trial, and the Nuremberg code: A review of findings of the Advisory Committee on Human Radiation Experiments. Journal of the American Medical Association 1996; 276:1667-1671

Faunce TA, Nasu H. Normative foundations of technology transfer and transnational benefit principles in the UNESCO Universal Declaration on Bioethics and Human Rights. Journal of Medicine and Philosophy 2009; 34:296-321

FDA. Center for Drug Evaluation and Research. Guidance for Industry: acceptance of foreign clinical studies. March 2001

Fischer IV BA. A summary of important documents in the field of research ethics. Schizophrenia Bulletin 2005; 32 (1): 69-80 http://schizophreniabulletin.oxfordjournals.org/cgi/rapidpdf/sbj005v1

Fluss S.S. International guidelines on bioethics: informal listing of selected international codes, declarations, guidelines, etc. on medical ethics/ bioethics/ health care ethics/human rights aspects of health. Geneva, Council for International Organizations of Medical Sciences, 2000. http://www.efgcp.be/Downloads/EFGCP%20International%20Guidelines%20-%20Bioethics.pdf

Garrafa V, Machado do Prado M. Alteracoes na Declaracao de Helsinque – a história continua. Revista Bioética 2007; 15(1):11-25.

Garrafa V. & Lorenzo C. Helsinque 2008: redução de proteção e maximização de interesses privados. Rev. Assoc. Med. Bras. 2009;55 (5): 497-520.

Garrafa V, Lorenzo C. Moral imperialism and multi-centric clinical trials in peripheral countries. Cadernos de Saúde Pública 2008; 24(10):2219-26

Garrafa, V e Prado, MM. Mudanças na Declaração de Helsinki: fundamentalismo econômico, imperialismo ético e controle social. Cad Saúde Pública 2001;17(6): 1489-1496.

Glantz L H, Annas G. Grodin MA, Mariner WK. Research in developing countries: taking « benefit » seriously. Hastings Center Report 1998; 28 (6): 38-42

Goodyear MDE, Krleza-Jeric K, Lemmens T. The Declaration of Helsinki: Mosaic tablet, dynamic document, or dinosaur? British Medical Journal 2007; 335: 624-625

Goodyear MDE, Lemmens T, Sprumont D, Tangwa G. The FDA and the Declaration of Helsinki. BMJ 2009; 338:1157-8.

Greco D. A cure at any cost? New Scientist 2001; 167:42-3

Greco, DB. Editorial Especial. As modificações propostas para o parágrafo 30 da Declaração de Helsinque 2000 diminuirão os requisitos relacionados ao acesso aos cuidados de saúde para os voluntários de ensaios clínicos. Rev Bras Epidemiol 2003; 6 (4): 284-290.

Greco, D. Acesso a tratamento para os voluntários de pesquisa clínica: Direito inquestionável com a perspectiva de expandir para a saúde pública o acesso aos produtos desenvolvidos. Rev n. Esp. Fapemig. 2008; nov Disponible en http.revistafapemig.br ( consultado el 23-10-2009)

Gunson D. Solidarity and the universal declaration on bioethics and human rights. Journal of Medicine and Philosophy 2009; 34:241-260

Häyry M, Takala T. Human dignity, bioethics and human rights. Developing World Bioethics 2005; 5(3): 225-233

Human D, Fluss SS. The world medical association’s Declaration of Helsinki: historical and contemporary perspectives. Unpublished document. 2001

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

ICH-GCPs Normas de buenas prácticas clínicas http://www.fda.gov/cder/guidance/959fnl-spanish.pdf

ICH-E2a International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use http://www.ich.org/LOB/media/MEDIA436.pdf

Kimmelman J, Weijer C, Meslin EM. Helsinki discords: FDA, ethics and international drug trials. Lancet 2009; 373(9657):13-4.

Krleža-Jerić K , Lemmens T . 7th Revision of the Declaration of Helsinki: Good News for the Transparency of Clinical Trials. Croat Med J 2009; 50; 105-10 http://www.cmj.hr/?show=25301

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

Levine RJ. The ‘best proven therapeutic method’ standard in clinical trials in technologically developing countries. IRB:A Review of Human Subjects Research 1998; 20(1):5-9

Levine RJ. The need to revise the Declaration of Helsinki. New England Journal of Medicine 1999; 341:531-34

Lie RK. Emanuel E, Grady C, Wendler D. The standard of care debate: the Declaration of Helsinki versus the international consensus opinion. Journal of Medical Ethics 2004; 30:190-193

Loff B, Black J. The declaration of Helsinki and research in vulnerable populations. Medical Journal of Australia 2000; 172:292-295

London AJ. The ambiguity and the exigency: clarifying standard of care arguments in international research. Journal of Medicine and Philosophy 2000; 25(4): 379-397

Lurie P, Wolfe SM. Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries. New England Journal of Medicine 1997; 337:853-856

Macpherson CC. Global bioethics: did the universal declaration on bioethics and human rights miss the boat? Journal of Medical Ethics 2007; 33:588-590

Macklin R. Yet another guideline? The UNESCO draft declaration. Developing World Bioethics 2005; 5(3): 244-250

Macrae DJ. The Council of International Organizations and Medical Sciences (CIOMS). Guidelines on Ethics and Clinical Trials. Proc Am Thorac Soc 2007; 4:176-177 http://www.ph.ucla.edu/epi/Epi273/Macrae_PATS_2007.pdf

McIntosh S, Sierra E, Dozier A, Quinones SDZ, Primack A, Chadwick G, Ossip-Klein DJ. Ethical review issues in collaborative research between the US and low-middle income country partners: A case example. Bioethics 2008; 22:414-22

National Bioethics Advisory Committee. Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries. Bethesda, MD: NBAC. 2001

Nicholson RH. If it ain’t broke don’t fix it. Hastings Center Report 2000; 3:1

Normile D. Clinical trials guidelines at odds with US policy. Science 2008; 322:516

Nuffield Council of Bioethics. The ethics of research related to healthcare in developing countries. London: Nuffield Council of Bioethics, 2002.

Nuffield Council of Bioethics. The ethics of research related to healthcare in developing countries. A follow-up discussion paper. London: Nuffield Council of Bioethics, 2005

O’Neil P. Ethics guidelines for clinical trials to be revised. Canadian Medical Association Journal 2008; 178(2): 138

Participants in the 2001 conference on ethical aspects of research in developing countries “Fair Benefits for Research in Developing countries. Science 2002; 298:2133-34

Ramsay S. World Medical Association strengthens Declaration of Helsinki. Lancet 2000; 356:1389

Rawlison MC, Dochin A. The quest for universality: reflections on the Universal Draft Declaration on Bioethics and Human Rights. Developing World Bioethics 2005; 5:258-66

Redbioética. Carta de Córdoba sobre ética en investigaciones con seres humanos. Córdoba (Argentina): Redbioética UNESCO, 18 de octubre 2008.

Rid A, Schmidt H. The 2008 Declaration of Helsinki- First among equals in research ethics? Journal of Law, Medicine and Ethics. 2010; 38(1):143-148

Rothman KJ, Michels KB, Baum M. For and against. Declaration of Helsinki should be strengthened. British Medical Journal 2000; 321: 442-5

Schüklenk U. Unethical perinatal HIV transmission trials establish bad precedent. Bioethics 1998; 12:312-8

Selgelid MJ. Universal norms and conflicting values. Developing World Bioethics 2005; 5(3):267-273

Shapiro HT, Meslin EM. Ethical issues in the design and conduct of clinical trials in developing countries. New England Journal of Medicine 2001; 345 (2):139-142

Sidle JE, Were E, Wools-KaloustianK, Chuani C, Salmon K, Tierney WM, Meslin EM. A needs assessment to build international research ethics capacity. Journal of Empirical Research on Human Research Ethics 2006; 1(2): 23-38

Singer Pa, Benatar S. Beyond Helsinki: a new vision for global ehalth ethics. BMJ 2000; 322:747-48

Skene L. Undertaking research in other countries: national ethico-legal barometers and international ethical consensus statements. PLoS Medicine 2007; 4(2):e10  http://medicine.plosjournals.org/archive/1549-1676/4/2/pdf/10.1371_journal.pmed.0040010-L.pdf

Snead OC. Bioethics and self-governance: the lessons of the Universal Declaration on Bioethics and Human Rights. Journal of Medicine and Philosophy 2009; 34:204-222.

Squire, Sanders and Dempsey LLP. Conducting clinical trials in the US and abroad: Navigating the rising tide of regulation and risk. www.ssd.com

Stockhausen K. The Declaration of Helsinki: revising ethical research guidelines for the 21st century. Medical Journal of Australia 2000; 172:252-3

Tealdi JC. Historia y significado de las normas éticas internacionales sobre investigaciones biomédicas. En G Keyeux, V Penchaszadeh, A Saada (coords). Ética de la Investigación en Seres Humanos y Políticas de Salud Pública. Bogotá: Universidad Nacional de Colombia-Unibiblos, UNESCO. 2006, pás 33-62

Temple R. Impact of the Declaration of Helsinki on medical research from a regulatory perspective. Address to the Scientific Session, World Medical Association General Assembly, September 2003.

Toebes B. Towards an improved understanding of the international human right to health. Human Rights Quarterly 1999; 21:661-79

Trotter G. The UNESCO Declaration on Bioethics and Human Rights: A Canon for the Ages? Journal of Medicine and Philosophy 2009; 34:195-203

Ugalde A, Homedes N. Discrepancies around Helsinki: are we missing the point? Clinical Trials Magnifier 2009; 2(3):106-111

UNESCO. Declaración Universal de Bioética y Derechos Humanos. UNESCO. 2005. http://unesdoc.unesco.org/images/0014/001461/146180s.pdf

United Nations. Universal declaration of human rights. Aprobada el 10 de diciembre de 1948. GA Res 217 A (III). UN doc A/810 1948 71

United Nations. International covenant on civil and political rights. Aprobado el 16 de diciembre de 1966, entra en vigor el 23 de marzo 1976. GA Res 2200ª (XXI). UN GAOR supp (no 16) 52. UN doc A/6316. UNTS 999:17

United Nations. International covenant on economic, cultural and social rights. UNTS 993:3. Aprobada el 16 de diciembre de 1966, entra en vigor el 3 de enero 1976. GA Res 2200ª (XXI) UN Doc A/6316

Vidal S. UNESCO Universal Declaration on Bioethics and Human Rights. Pondering over its contributions. Experiencia Médica (Córdoba) 2007, 24 (3)

Vollmann J, Winau R. Informed consent in human experimentation before the Nuremberg code. British Medical Journal 1996; 313: 1445-7

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

Williams JR. UNESCO’s proposed declaration on bioethics and human rights – a bland compromise. Developing World Bioethics 2005; 5(3): 210-215

Williams JR. The Declaration of Helsinki and public health. Bulletin of the World Health Organization 2008; 86(8):650-1 doi:10.2471/BLT.08.050955 www.who.int/bulletin/volumes/86/8/08-050955.pdf

Wolinski H. The battle of Helsinki. European Molecular Biology Organization 2006; 7(7): 670-672 http://www.pubmedcentral.nih.gov/picrender.fcgi?artid=1500825&blobtype=pdf

World Medical Association. Declaration of Helsinki http://www.wma.net/e/policy/pdf/17c.pdf

Zion D, Guillam L, Loff B. The Declaration of Helsinki, CIOMS and the ethics of research on vulnerable populations. Nature Medicine 2000; 6(6):615-617

Zumla A, Costello A. Ethics of healthcare research in developing countries. Journal of the Royal Society of Medicine 2002; 95(6): 275-279

 

Conferencia Internacional de Armonización

Alés Martínez JE. Guía ICH de buena práctica clínica. Implicaciones para los CEIC. Investigación Clínica y Bioética 2001: 39:17-24 http://www.icf.uab.es/icbdigital/pdf/boletines/icb3901.pdf

ICH-GCPs Normas de buenas prácticas clínicas http://www.fda.gov/cder/guidance/959fnl-spanish.pdf

ICH-E2a International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use http://www.ich.org/LOB/media/MEDIA436.pdf

OPS/OMS Buenas Prácticas Clínicas. Documento de las Américas http://www.paho.org/spanish/ad/ths/ev/BPC-doct-esp.doc

Rockhold FW. Industry perspectives on ICH guidelines. Statistics in Medicine 2002; 2949-2957

Agencias que regulan la realización de ensayos clínicos (por país)

Leyes y regulaciones (por país)

Canadá

McDonald M. Introduction: Canadian governance for ethical research involving humans. Health Law Review 2005; 13 (2-3): 4-12

Shuchman M. Clinical trials regulation –how Canada compares. CMAJ 2008; 179(7):635-638. http://www.ecmaj.com/cgi/content/full/cmaj;179/7/635

EE.UU.

Code of federal Regulations. Institutional Review Boards http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=56.108

National Bioethics Advisory Commission. Ethical and Policy Issues in Research Involving Human Participants. Volume I. Bethesda: National Bioethics Advisory Commission, 1995 http://www.bioethics.gov/reports/past_commissions/nbac_human_part.pdf En http://bioethics.georgetown.edu/nbac/pubs.html se puede obtener acceso a un resumen y a los estudios que se solicitaron para elaborar este documento.

National Bioethics Advisory Commission. Ethical and Policy Issues in International Research: clinical trials in developing countries. Volume I. Bethesda: National Bioethics Advisory Commission, 2001 http://bioethics.georgetown.edu/nbac/clinical/Vol1.pdf    Los estudios que sirvieron de base para elaborar este documento están en: http://bioethics.georgetown.edu/nbac/clinical/Vol2.pdf

Food and Drug Administration Amendments Act (FDAAA) of 2007. Disponible en http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/default.htm

U.S Food and Drug Administration. FDA Regulations Relating to Good Clinical Practice and Clinical Trials [http://www.fda.gov/oc/gcp/regulations.html].

Europa

Directiva Europea 2001/20/CE Articulo 16. Sobre la aplicación de buenas prácticas clínicas en la realización de ensayos clínicos de medicamentos de uso humano http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-1/dir_2001_20/dir_2001_20_es.pdf

EC/Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use. http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-10/21_susar_rev2_2006_04_11.pdf

EMEA strategy paper: acceptance of clinical trials conducted in third countries for evaluation in Marketing Authorisation Applications. London 5 de diciembre 2008. Doc Ref. General-EMEA/228067/2008.

Lewis JA. The European regulatory experience. Statistics in Medicine 2002; 21:2931-2938

Berendt L, et al. Effect of European clinical trials directive on academic drug trials in Denmark: retrospective study of applications to the Danish Medical Agency, 1993-2006. BMJ 2008; doi:10.1136/bmj.39401.470648.BE

Reino Unido

Al-shahi Salmen R, Brock TM, Dennis MS et al. Research governence impediments to clinical trials: a retrospective survey. Journal of the Royal Society of Medicine 2007; 100:101-104 http://jrsm.rsmjournals.com/cgi/content/abstract/100/2/101

Nufflied Council on Bioethics. The ethics of research related to healthcare in developing countries. Plymouth: Nuffield Council on Bioethics. 2002. Incluye las normativa inernacional. http://www.nuffieldbioethics.org/go/ourwork/developingcountries/publication_309.html

 

Manuales/normas (por país)

Argentina

Ministerio de Salud. Salud Pública. Resolución 1678/2007 Ensayos Clínicos en Seres Humanos. Bs. As., 6/12/2007 http://www.cmpc.org.ar/imagenes/Resolucion_1678-2007.pdf

Brasil

Conselho Federal de Medicina. Resolução CMF 1885/2008m Oct 22

Ministerio da Saúde (Brasil). Normas para pesquisa envolvendo seres humanos (Res. CNS n. 196/96 e outras) Brasilia 2003. http://bvsms.saude.gov.br/bvs/publicacoes/norma_pesq_seres_hum.pdf     En inglés http://bvsms.saude.gov.br/bvs/publicacoes/normas_pesquisa_sereshumanos_I.pdf

Ministério da Saúde. Capacitaçăo para comitês d’ética em pesquisa. Volume 1. Brasilia: Ministério da Saúde. 2006. http://www.unifesp.br/reitoria/orgaos/comites/etica/volume1.pdf

Ministério da Saúde. Capacitaçăo para comitês d’ética em pesquisa. Volume 2. Brasilia: Ministério da Saúde. 2006. http://www.unifesp.br/reitoria/orgaos/comites/etica/volume2.pdf

Ministério da Saúde. CONEP. Manual operacional para comitês d’ética em pesquisa. Brasilia: CONEP. 2002 http://conselho.saude.gov.br/biblioteca/livros/Manual_ceps.pdf

Ministério da Saúde de Brasil. Conselho Nacional de Saúde. Manual operacional para comitês de ética em pesquisa. Brasília: Ministério da Saúde, 2006. Disponíble en http://www.conselho.saude.gov.br

Resolución 251/97 de la CONEP-Consejo Nacional de Salud http://conselho.saude.gov.br/docs/Resolucoes/Reso251.doc

Resolución 346/05 de la CONEP-consjeo Nacional de Salud 5.a) http://conselho.saude.gov.br/docs/Resolucoes/Reso346.doc

Conselho Federal de Medicina. 2008. Resoluçāo CMF 1885/2008m Oct. 22 http://www.ufrgs.br/bioetica/cfm1885-08.htm

Chile

Regulación de la ejecución de ensayos clínicos que utilizan productos farmacéuticos en seres humanos http://www.ispch.cl/formularios/norma_tec/norm_tec_n_57.pdf

Comisión Europea

European Commission. Experiences of capacity-building in research ethics and reflections on the socio-cultural aspects. http://ec.europa.eu/research/science-society/document_library/pdf_06/lorenzo_14_5_session1_en.pdf

Costa Rica

CCSS. 1998a. Reglamento para la Investigación en los Servicios Asistenciales de la Caja Costarricense de Seguro Social. Aprobado por la Junta Directiva, artículo 17 de la sesión número 7211 de 24 de marzo de 1998. La Gaceta no 91, 13 de mayo.

CCSS. 1998b. Comité Institucional de Bioética e Investigación. Nota CIBI-104-09-98. Citado en Auditoría Interna. CCSS. 2000, pág. 15.

Elizondo Ruiz, M.  Elaboración de una guía de procedimientos en investigación clínica en seres humanos en Costa Rica. Informe de práctica de especialidad. Instituto Tecnológico de Costa Rica. Escuela de Biología. Ingeniería y Biotecnología. 2003 http://bibliodigital.itcr.ac.cr:8080/dspace/bitstream/2238/225/1/PROYECTO+DE+GRADUACI%C3%93N.pdf

Ministerio de Salud. 1976. Veto. Comunicación del Presidente de la República Daniel Oduber  y el Ministro de Salud Herman Weinstock. Casa Presidencial, San José, 22 de diciembre de 1977.

República de Costa Rica. 1998. Reglamento para las Investigaciones en que Participan Seres Humanos. Decreto no 27349-S. La Gaceta no. 198. 13 de octubre.

Sala Constitucional. Tribunal Supremo de Justicia. Carta dirigida al Sr. Hernán Collado Martínez. Expediente no. 09-12222-0070-CO          

España

Guía ICH de buena práctica clínica. Implicaciones para los CEIC. Boletín de la Sociedad Española de Farmacología Clínica dirigido a los Comités Éticos de Investigación Clínica Julio-Septiembre 2001 (39). http://www.icf.uab.es/icbdigital/pdf/boletines/icb3901.pdf

México

Reglamento de la Ley General de Salud en materia de investigación para la salud. http://www.salud.gob.mx/unidades/cdi/nom/compi/rlgsmis.html

OPS

OPS/OMS Buenas Prácticas Clínicas. Documento de las Américas http://www.paho.org/spanish/ad/ths/ev/BPC-doct-esp.doc

Perú

Amplían conformación de Comisión técnica encargada de analizar sugerencias o recomendaciones recibidas respecto del proyecto de Modificación del Reglamento de Ensayos Clínicos. Resolución Ministerial Nº 225-2007/MINSA del 19 de marzo del 2007. El Peruano Diario Oficial. Normas legales

Conforman Comisión Técnica que analizara sugerencias o recomendaciones al proyecto de Modificación del Reglamento de Ensayos Clínicos. Resolución Ministerial Nº 164-2007/MINSA del 23 de febrero del 2007. El Peruano Diario Oficial. Normas legales

Creed-Kanashiro H, Ore B, Scurrah M, Gil A, Penny M. Conducting research in developing countries: experiences of the informed consent process from community studies in Peru. Journal of Nutrition 2003; 133 (11 Supple 2) 3987S-3991S

Decreto supremo 017/06 http://www.ins.gob.pe/gxpsites/hgxpp001.aspx?2,13,331,0,S,0

Disponen que proceso administrativo establecido en el TUPA del Ministerio sea competencia del Instituto Nacional de Salud. Resolución Ministerial Nº 089-2003-SA/DM del 30 de enero de 2003. El Peruano Diario Oficial. Normas legales

Instituto Nacional de Salud. Manual de Procedimientos Versión 01. En: http://www.ins.gob.pe/gxpsites/hgxpp001.aspx?2,13,326,O,S,0

Foro Salud. Pronunciamiento público: por una normatividad sobre ensayos clínicos protectora de los derechos humanos. Febrero 2007. http://correo.inictel.gob.pe/pipermail/dep/2007-February/000033.html

Modifican el Reglamento de Ensayos Clínicos en el Perú. Decreto Supremo Nº 006-2007-SA. del 8 de junio de 2007.  El Peruano Diario Oficial. Normas legales.

Normas para el Uso de Drogas en Ensayos Clínicos. Resolución Ministerial Nº 0212-81-SA/DVM

Órgano de Línea o central del MINSA. Decreto Supremo  Nº 013-2002-SA del 22 de noviembre del 2002. Reglamento de la Ley del MINSA. Artículo 11. Encargado del Control de Medicamentos, Insumos y Drogas; con el objetivo funcional general de poner al alcance de la población productos farmacéuticos y afines, de calidad, seguros y eficaces, y promocionar el uso racional de medicamentos

Reglamento de Organización y Funciones del Ministerio de Salud. Artículo 74 Decreto Supremo Nº 002-002-92-SA del 20 de agosto de 1992. El Peruano Diario Oficial. Normas legales

Reglamento de Ensayos Clínicos en el Perú. Decreto Supremo Nº 017-2006-SA del 26 de juliodel 2006. El Peruano Diario Oficial. Normas legales

Resolución Jefatural. Nº 177-2006-J-OPD/INS. Instituto Nacional de Salud. Ministerio de Salud

 

Uruguay

Medicamentos: MSP aumenta los controles. El País.com, 3 de junio de 2009
www.elpais.com.uy/090603/pnacio-421035/nacional/Medicamentos-MSP-aumenta-los-controles

modificado el 28 de Noviembre de 2013


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