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

Sistemas de protección de los participantes en investigación en humanos

Reclutamiento de los participantes en investigación

Department of Health and Human Services. Office of Inspector General. Recruiting Human Subjects. Pressures in industry-sponsored clinical research. Boston: Department of Health and Human Services. Junio de 2000 OEI-01-97-00195.

 McDonald AM, Knight RC, Campbell MK, Entwistle VA, Grant AM, Cook JA, Elbourne DR, Francis D, Garcia J, Roberts I, Snowdon C. What influences recruitment to randomised controlled trials: A review of trials funded by two UK funding agencies. Trials 2006; 7-9

Menon U et al. Recrutiment to multicentre trials-lessons from UKCTOCS: descriptive study. BMJ 2008; 337:a2079

Ramirez AG, Wildes K, Talavera G, Et al. The clinical trials involvement of latino and white physicians. Contemp. Clin Trials 2008; 29(4):482-492. doi:10.1016/j.cct.2007.11.001. http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2587358

Treweek S, Mitchell E, Pitkethly M, Cook J, et al. Strategies to improve recruitment to randomized controlled trials (Review). The Cochrane Collaboration. http??www.thecochranelibrary.com 2010, 1.

Wendler et al. Why patients continue to participate in clinical research. Archives of Internal Medicine 2008; 168 (12): 1294-1299, 1866

Zuckerman DS. Betting on subject enrolment. 7th Annual Partnerships in Clinical Trials 2008. Scrip News Supplement. www.scripnews.com/supplements 2008:9-12

 

Comités de ética en investigación

Ahmad K. Developing countries need effective ethics review committees. Lancet 2003; 362(9384:627

Ahmed AEH, Nicholson KG. Delays and diversity in the practice of local research ethics committees. Journal of Medical Ethics 1996; 22 (5):263-266

Akabayashi A, Slingsby BT, Nagao N, Kai I, Sato H. An eight-year follow-up national study of medical school and general hospital ethics committees in Japan. BMC Medical Ethics 2007; 8(8). Doi: 10.1186/1472-6939-8-8 http://www.biomedcentral.com/1472-6939/8/8

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

Anderlink MR, Elster N. Currents in contemporary ethics: lawsuits against IRBs: accountability or incongruity? Journal of Law, Medicine and Ethics 2001; 29:220-228

Arqué AB, Montalbán AE, Milla LF, Hernández M, Larenas AH, Alvarez CL, Exebio LM, Sánchez KR. Los comités de evaluación ética y ceintífica de la investigación en seres humanos en los países latinoamericanos y el Caribe: Una propuesta para su desarrollo. Santiago, Chile: Centro Interdisciplinario de Estudios de Bioética de la Universidad de Chile. http://www.bioetica.ops-oms.org/E/docs/comite.pdf

Ashcroft RE, Newson AJ, Benn PMW. Reforming research ethics committees. BMJ 2005; 331:587-588 http://www.bmj.com/cgi/reprint/331/7517/587.pdf

Bartlett EE. International analysis of institutional review boards registered with the US office for human research protections. Journal of Empirical Research on Human Research Ethics 2008; 3(4):49-56

Beagan B, McDonald M. Evidence-based practice of ethics review. Health, Law Review 2005; 13 (2-3):62-68.

Benatar SR. Reflections and recommendations on research ethics in developing countries. Social Science and Medicine 2002; 54 (7):1131-1141. http://www.saludyfarmacos.org/download/Benatar2002.pdf

Brown J, Schoenfeld LS, Allan PW. The costs of an institutional review board. Journal of Medical Genetics 1979; 54(4):294-299

Brozeman B, Slade C, Hirsch P. Understanding bureaucracy in health science ethics: toward a better institutional review board. American Journal of Public Health 2009; 99(9): 1549-1556

Buchanan D et al. Assuring adequate protections in international health research: a principled justification and practical recommendations for the role of community oversight. Public Health Ethics 2008; 1:246-257 http://phe.oxfordjournals.org/cgi/reprint/1/3/246

Burke GS. Looking into the institutional review board: observations from both sides of the table. The Journal of Nutrition 2005; 135:921-924

Burman W, Breese P, Weis S,Bock N, Bernardo K and Vernon A. The effects of local review on informed consent documents from multi-center clinical trials consortium. Controlled Clinical Trials 2003; 24(3):245-255

Burris S, Moss K. US health researchers review their ethics review boards: A qualitative study. Journal of Empirical Research on Human Research Ethics 2006; 1(2): 39-58

Campbell EG, Weissman JS, Vogeli C, Clarridge BR, Abraham M, Marder JE et al. Financial relationships between institutional review boeard members and industry. NEJM 2005; 355 (22):2321-2329

Campbell E, Weissman J, Clarridge B, Yucel, R, CausinoN, Blumental D. Characteristics of medical school faculty members serving on institutional review boards: resutls of a national survey. Academy of Medicine 2003; 78:831-836

Campo Hoyos C. Los problemas del dictamen único (una experiencia desde el Centro Coordinador de CEICs). ICB digital 2007; 49:2-8 http://www.icf.uab.es/icbdigital/pdf/articulo/articulo49.pdf

Catania JA, Lo B, Wolf LE, Dolcini MM, Pollack LM, Barker JC, Wertlieb S, Henne J. Survey of US human research protection organizations: workload and membership. Journal of Empirical Research on Human Research Ethics 2008; 4(3):57-69

Coleman CH, Bouesseau MC. How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review. BMC Medical Ethics 2008, 9:6 http://www.biomedcentral.com/content/pdf/1472-6939-9-6.pdf

de Haro, M. La sociedad demanda comités éticos especializados para regular los derechos de las personas que participan en las investigaciones biomédicas El Médico Interactivo, 13 de octubre 2009

Decullier E, Lhéritier V. Chapuis F. The activity of French research ethics committees and characteristics of biomedical research protocols involving humans: a retrospective cohort study. BMC Medical Ethics 2005; 6 (9) doi: 10.1186/1472-6939-6-9 http://www.biomedcentral.com/1472-6939/6/9/

Del Percio D. Un nuevo desafío para los Comités de Ética. Fecicla Report 2009; 4:7-8.
www.fecicla.org

De Ville K, Hassler G, Lewis MJ. Rejuvenating a foundering institutional review board: one institution’s story. Academic Medicine 2007; 82 (1): 11-17

De Vries R, Forsberg C. What do IRBs look like? What kind of support do they receive?. Accountability in Research 2002; 9:199-206

Dziak K, Anderson R, Sevick Ma, Weisman CS, Levine DW, Scholle SH. Variations among institutional review board reviews in a multisite health servicies research study. Health Services Research 2005; 40 (1):279-290

Edgar H, Rothman DJ. The institutional review board and beyond: future challenges to the ethics of human experimentation. The Milkbank Quarterly 1995; 73(4): 489-506

Edwards SJL, Kirchin S, Huxtable R. Research ethics committees and paternalism. Journal of Medical Ethics 2004; 30:88-91

Emanuel EE, Lemmens T, Elliot C. Should society allow research ethics boards to be run as for-profit enterprises? PLoS Medicine 2006; 3(7): e309 http://medicine.plosjournals.org/archive/1549-1676/3/7/pdf/10.1371_journal.pmed.0030309-L.pdf

Emanuel EJ, Wood A, Fleishchman A, Bowen A, Getz KA, Grady C, Levine C, Hammerschmidt DE, Faden R, Eckenwiler L, Muse CT, Sugarman J. Oversight of human participants research: identifying problems to evaluate reform proposals. Ann Intern Med 2004; 141:282-291 http://annals.highwire.org/cgi/reprint/141/4/282.pdf

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

Fauriel I, Moutel G, Ducahnge N, François I, Huriet C, Hervé C. Improving protection of human research subjects in France: Analysis of regional ethics committees. Regulatory Toxicology and Pharmacology 2004; 40(3): 312-318

Feldman JA, Rebholz CM. Anonymous self-evaluation of performance by ethics board members: a pilot study. Journal of Empirical Research on Human Research Ethics 2009; 4(1)63-68

Ferraro FR, Szigeti E, Dawes KJ, Pan S. A survey regarding the University of North Dakota Institutional Review Board: data, attitudes, and perceptions. Journal of Psychology 1999; 133: 272-276

Fitzgerald MH, Phillips PA, Yule E. The research ethics review process and ethics review narratives. Ethics and Behavior 2006; 16(4):377-395

Fitzgerald MH, Phillips PA. Centralized and non-centralized ethics review: A five nation study. Accountability in Research 2006; 13(1):47-74

Freitas CBD. O sistema de avaliação da ética em pesquisa no Brasil: estudo dos conhecimentos e prácticas de lideranças de Comités de Ética em Pesquisa. Tese apresentada à Facultade de Medicina da Universidade de São Paulo para obtenção do título de Doutor em Ciências. 2006

Fuentes D, Revilla D. Acreditación de Comités de Ética en Investigación, como parte de un proceso. Anales de la Facultad de Medicina. Universidad Nacional Mayor de San Marcos. 2007; 68 (1):77-74 http://sisbib.unmsm.edu.pe/bVrevistas/anales/v68n1/pdf/a09v68n1.pdf

Gold JL, Dewa CS. Institutional Review Boards and multisite studies in health services research; Is there a better way? Health Services Research 2005; 40(1): 291-307. http://www.pubmedcentral.nih.gov/picrender.fcgi?artid=1361138&blobtype=pdf

Goldman J, Katz MD. Inconsistency and institutional review boards. JAMA 1982; 248 (2): 197-202

Goodyear-Smith F, Loob B, Davies G, Nachson I, Seelau SM. International variation in ethics committee requirements: comparison across five Westernized nations. BMC Medical Ethics 2002; 3(2)

Gonorazky SE. Comités de ética independientes para la investigación clínica en Argentina. Evaluación y sistema para garantizar su independencia. Medicina (Buenos Aires) 2008; 68:113-119 http://www.medicinabuenosaires.com/revistas/vol68-08/2/v68_n2_p113_119.pdf

Gray BH, Cooke RA, Tannenbaum AS. Research involving human subjects: the performance of institutional review boards is assessed in this empirical study. Science 1978; 4361:1094-1101

Gray B, Cooke R. The impact of insitutional review boards on research. Hastings Center Report 1980; 10 (february) 36-41

Gunsalus CK, Bruner EM, Burbules NC, Dash L, Finkin M, Goldberg JP et al. Mission creep in the IRB world. Science 2006; 312 (5779), 1441

Gunsalus CK, Bruner EM, Burbules NC, Dash L, Finkin M, Goldberg JP et al. the Illinois White Paper: Improving the system for protecting human subjects: Counteracting IRB “mission creep”. Qualitative Inquiry 2007; 13(5):617-649

Hamburger P. The new censorship: institutional review boards. Supreme Court Review 2005; 2004:271

Hayes GJ, Hayes SC, Dykstra T. A survey of university institutional review boards: cahracteristics, policies, and procedures. IRB: A Review of Human Subjects Research 1995; 17:1-6

Hébert P, Saginur R. Research ethics review: do it once and do it well. CMAJ 2009; 180(6):597 http://www.ecmaj.ca/cgi/content/full/180/6/597

Hemminki E. Research ethics committees: agents of research policy? Health Research Policy and Systems 2005; 3:6 http://www.health-policy-systems.com/content/pdf/1478-4505-3-6.pdf

Henderson GE, Corneli AL, Mahoney DB, Nelson DK, Mwansambo C. Applying research ethics guidelines: the view from a sub-Saharan research ethics committee. Journal for Empirical Research on Human Research Ethics 2007; 2(2):41-48

Hirtle M, Lemmens T, Sprumont D. A comparative analysis of research ethics review mechanisms and the ICH Good Clinical Practice Guideline. European Journal of Health Law. 2000; 7:265-29

Howard DL, Boyd CL, Nelson DK, Godley P. Getting from A to IRB: developing an institutional review board at a historically black university. Journal for Empirical Research on Human Research Ethics 2010; 5(1): 75-81

Humphreys K, Trafton J, Wagner TH. The cost of institutional review board procedures in multi-center observational research. Annals of Internal Medicine 2003; 139(1):77

Kancelbaum B. Social scientists and institutional review boards. Social Science Research Council 2002; 3:1-5

Kalberg JPE, Speers MA. Reviewing clinical trials: A guide for the ethics committee. Hong Kong: Clinical Trials Center, The University of Hong Kong, and Washington DC: Assocaition for the Accreditation of Human Research Protection Programs. 2010.

Kass NE, Hyder AA, Ajuwon A, Appiah-Poku J, Barsdorf N, Elsayed DE, Mokhachane M, Mupenda B, Ndebele P, Ndossi G, Sikateyo B, Tangwa G, Tindana P. The structure of function of research ethics committees in Africa: A case study. PLoS Medicine 2007; 4 (1). http://medicine.plosjournals.org/archive/1549-1676/4/1/pdf/10.1371_journal.pmed.0040003-L.pdf

Keith-Spiegel P, Koocher GP. The IRB paradox: could the protectors also encourage deceit? Ethics and Behavior 2005; 15(4): 339-349

Keith-Spiegel P, Koocher GP, Tabachnick B. What Scientists want from their research ethics committee. Journal of Empirical Research on Human Research Ethics 2006: 67-82 http://caliber.ucpress.net/loi/jer?cookieSet=1

Kennedy SB, Harris AO, Oudemans E et al. Developing capacity to protect human research subjects in a post-conflict, resource-constrained setting: procedures and prospects. Journal of Medical Ethics 2006; 32:592-595.

Kirigia JM, Wambebe C, Baba-Moussa A. Status of national research bioethics committees in the WHO African region. BMC Medical Ethics 2005; 6:10 doi:10.1186/1472-6939/6/10  http://www.biomedcentral.com/1472-6939/6/10/abstract

Lemmens T, Freedman, B. Ethics review for sale? Conflict of interest and commercial research review boards. Milbank Quarterly 2000;78 (4):547-584.

Lemmens T, Thompson A. Noninstitutional comercial review boards in North America. IRB Ethics and Human Research 2001; 23(2)1-12 http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1159785

Lescano AR, Blazes DL, Montano SM, Kochel T, Moran Z, Lescano AG, Martin GJ. Supporting the creation of new institutional review boards in developing countries: The US naval medical research center detachment experience. Military Medicine 2008; 173:975-7

Levin LA, Palmer JG. Institutional review boards should require clinical trial registration. Arch Intern Med 2007; 167:1576-80

Levine RJ. Empirical research to evaluate ethics committees’ burdensome and perhaps unproductive policies and practice: a proposal. Journal for Empirical Research on Human Research Ethics 2006; 1(3): 1-4

Levine RJ, Institutional Review Boards: A crisis of confidence. Annals of Internal Medicine 2001; 134:161-163

Levine FJ, Skedsvold PR. Where the rubber meets the road: aligning IRBs and research practice. Political Science and Politics 2008; 41(3):501-505

Loh ED, Meyer RE. Medical school;s attittudes and perceptions regarding the use of central Institutional Review Boards. Academic Medicine 2004; 79(7):644-651

Lux AL, Edwards SW, Osborne JP. Responses of local research ethics committees to a study with approval from a multicentre research ethics committee. BMJ 2000; 320(7243): 1182-1183

Macías, A and Justo, L (2004) Democracia, participación y comités de ética: la experiencia neuquina. In Pfeiffer, ML, Eds. Democracia, participación y comités de ética: la experiencia neuquina Actas del VIII Encuentro Nacional de Comités de Bioética de la Salud (Single issue). BIO&SUR Asociación Civil

Malouff JM, Schutte NS. Academic psychologists’ perspective on the human research ethics review process. Australian Psychologist 2005; 40:57-62

McNeill PM. A critical analysis of Australian clinical ethics committees and the functions they serve. Bioethics 2001; 15(5-6):443-460

McPherson CC. Research ethics committees: A regional approach. Theoretical Medicine and Bioethics 1999; 20(2): 161-179

Milford C, Wassenaar D, Slack C. Resources and needs of research ethics committees in Africa: preparations for HIV vaccine trials. IRB Ethics and Human Research 2006; 28 (2)1-9 http://www.who.int/vaccine_research/diseases/hiv/docs/Resources_needs_HIV_vaccine_trials.pdf

Minaya-Martínez G, Díaz-Sandoval R. Capacidad de evaluación de los ensayos clínicos por los Comités de Ética. Rev Soc Peru Med Interna 2008; 21(4):153-165. http://www.scielo.org.pe/scielo.php?script=sci_serial&pid=1609-7173&lng=es&nrm=iso

Ministério da Saúde. Capacitação para Comitês de Ética em Pesquisa, volume 1 y 2. Brasilia 2006. http://www.cep.famerp.br/

Moreno JD. Goodbye to all that: The end of moderate protectionsm in human research. Hastings Center Report 2001a, 31(3)9-17

Novaes MR, Guilhem D, Lolas F. 2008. Dez anos de experiência do comitê de ética em pesquisa da Secretaria de Saúde do Distrito Federal, Brasil. Acta Bioethica 14 (2):185-192

Nyika A, Kilama W et al. Composition, training needs and independence of ethics review committees across Africa: are the gate-keepers rising to the emerging challenges? J Med Ethics 2009; 35:189-193 doi:10.1136/jme.2008.025189 http://jme.bmj.com/cgi/content/abstract/35/3/189

Palca J. Institutional review boards: A net too thin. Hastings Center Report 1996; 26: 4

Phillips DF. Institutional Review Boards under stress: Will they explode or change. JAMA 1996; 276(20):1623-1626

Reeser JC, Austin DM, Jaros LM, Mukesh BN, McCarty CA. Investigating perceived institutional review board quality and function using the IRB researcher assessment tool. Journal of Empirical Research on Human Research Ethics 2008; 3(1): 25-34

Rivera R, Ezcurra E. Composition and operation of selected research ethics review committees in Latin America. IRB: Ethics and Human Research 2001; 23(5):9-12 Se puede leer la primera página en http://www.jstor.org/pss/3564049

Robinson L, Murdoch-Eaton D, Carte Y. NHS research ethics committees. BMJ 2007;335-6

Rothstein WG, Phuong LH. Ethical attittues of nurse, physician, and unaffiliated members of Institutional Review Boards. Journal of Nursing Scholarship 2007; 39 (1): 75-81

Rubin P, Sieber JE. Empirical research on IRBs and methodologies usually associated with minimal risk. Journal of Empirical Research on Human Research Ethics. 2006; 1(4): 1-4

Salazar-Valadez A.  Problemas que enfrentan los Comités de Ética para la Investigación: experiencia en un hospital de segundo nivel de atención. Bol Mex His Fil Med 2007; 10 (2): 85-88  http://www.medigraphic.com/pdfs/bmhfm/hf-2007/hf072f.pdf

Sansone RA, McDonald S. Quality improvement within institutional review boards. Quality Assurance Journal 2004; 8(4): 258-261

Schopper D et al. Research ethics review in humanitarian contexts: the experience of the independent ethics review board of Médecins sans Frontières. PLoS 2009; 6(7) e1000097. www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1000115

Sengupta S, Lo B. The roles and experiences of nonaffiliated and non-scientist members of institutional review boards. Academic Medicine 2003; 78(2):212-218

Silverman H, Hull S, Sugarman J. Variability among institutional review boards’s decisions within the context of a multicenter trial. Critical Care Medicine 2001; 29(2): 235-241

Sokol DK. The unpalatable truth about ethics committees. BMJ 2009; 339:891

Stair T, reed C, Radeos M, Kiski G, Camargo C. Variation in institutional review board responses to a standard protocol for a multicenter clinical trial. Academic Emergency Medicine 2001; 8(6):636-641

Sugarman J, Getz H, speckman JL, Byrn MM, Gerson J, Emanuel EJ. The cost of institutional review boards in academic medical centers. NEJM 2005; 352:1825-1827

Sumathipala A, Siribaddana S, Hewage S et al. Informed consent in Sri Lanka: A survey among ethics committee members. BMC Medical Ethics 2008; 9(10) doi:10.1186/1472-6939-9-10 http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=18489793

Taylor HA, Currie P, Kass NE. A study to evalute the effect of investigator attendance on the efficiency of IRB review. IRB 2008; 30(1):1-5

UNESCO. Establishing Bioethics Committees. Guide 1. Paris: the United Nations Educational, Scientific and Cultural Organization. 2005.

Valdez-Martínez E, Lifshitz-Guinzberg A, Medesigo-Micete J, Bedolla M. Los comités de ética clínica en México: la ambigua frontera entre la ética asistencial y la ética en investigación clínica. Revista Panamericana de Salud Pública 2008; 24(2): 85-90. http://journal.paho.org/uploads/1221234471.pdf

Valdez- Martínez E, Turnbull B, Garduño-Espinosa J, Porter JDH. Descriptive Ethics: a qualitative study of local research ethics committees in Mexico. Developing World Bioethics 2006; 6 (2):95-105

Valdez- Martínez E, Turnbull B, Garduño-Espinosa J, Porter JDH. Understanding the structure and practices of research ethics committees through research and audit: a study from Mexico. Health Policy 2005; 74 (1): 56-68

Valdez- Martínez E, Garduño-Espinosa J, Porter JDH. Local research ethics committees of the Mexican Institute of Social Security: results of a national survey. Public Health 2004; 118: 329-336

Valdez- Martínez E, Lifshitz-Guinzberg A, Medesigo-Micete J, Bedolla M. Los comités de ética clínica en México: la ambigua frotnera entre la ética asistencial y la ética en investigación clínica. Revista Panamericana de Salud Pública 2008; 24(2): 85-90

Van der Kloot Meijburg H. Different profiles for the institutional ethics committees in the Netherlands HEC Forum 1954; 6:139-57

Vick CC, Finan KR, Kiefe C, Neumayer L, Hawn MT. Variation in institutional review processes for a multisite observational study. American Journal of Surgery 2005; 190 (5):805-809

Vidal SM. A Project for Bioethics Committees Organization in Cordoba Province Health Institutions. Cuadernos de Bioética. AD Hoc, Buenos Aires. 1999, 2- 3: 67- 92

Vidal SM. Research Ethics Committees: current situation. Diaeta (Bs. As) 2006; 24 (117): 21-27

Vitezic D. Centralized national ethical review of clinical trials in Croatia. Croat Med J 2009; 50:111-6 http://www.cmj.hr/?show=25301

Wagner TH, Cruz AM, Chadwick GL. Economies of scale in institutional review boards. Medical Care 2004; 42(8):817-823

Wainwright P, Saunders J. What are local issues? The problem of the local review in research. Journal of Medical Ethics 2004; 30:313-317

Watling M, Dewhurst J. Current experience of central versus local ethics approval in multi-centre studies. Journal of the Royal College of Physicians in London 1993; 27 (4):399-402

White MT. Guidelines for IRB review of international collaborative medical research: A proposal. Journal of Law, Medicine and Ethics 1999; 27 (1):87-94

Whittle A, Shah S, Wilfond B, Gensler G, Wendler D. Insitutional review board practices regarding assent in pediatric research. Pediatrics 2004; 113 (6):1747-1752

Wolf LE, Croughan M, Lo B. The challenges of IRB review and human subjects protections in practice-based research. Medical Care 2002; 40(6):521-529

Wolf LE, Catania JA, Dolcini MM, Pollack LM, Lo B. IRB Chairs’ perspectives on genomics research involving stored biological materials: ethical concerns and proposed solutions. Journal of Empirical Research on Human Research Ethics 2008; 3(4):99-111

Consentimiento informado

Achrekab A, Gupta R. Informed consent for a clinical trial in Thailand. NEJM 1998; 339(18): 1331-2

Agre P, Campbell FA, Goldman BD, Boccia MI, Kass N, McCullough LB et al. Improving informed consent: the medium is not the message. IRB: Ethics and Human Research 2003; 25(5): S11-19

Agre P, Rapkin B. Improving informed consent: a comparison of four consent tools. IRB: Ethics and Human Research 2003; 25 (6):1-7

Andanda P. Module two: informed consent. Developing World Bioethics 2005; 5(1): 14-29

Anderson EE, Iltis AS. Assessing and improving research participants’ understanding of risk: potential lessons from the literature on physician-patient risk communication. Journal of Empirical Research Ethics on Human Research Ethics 2008; 3(3): 27-37-

Annas GJ. Globalized clinical trials and informed consent. NEJM 2009; 360 (20):2050-2053 http://nejm.highwire.org/cgi/content/extract/360/20/2050

Appelbaum PS, Roth LH, Lidz C. The therapeutic misconception: informed consent in psychiatric resarch. International Journal of Law and Psychiatry 1982; 5:319-329

Bertoli AM et al. Lack of correlation between satisfaction and knowledge in clinical trials participants: A pilot study (Argentina). Contemporary Clinical Trials 2007; 28:730-736.

Boulton M, Parker M. Informed consent in a changing environment. Social Science and Medicine 2007; 65:2187-2198

Buccini LD, Caputi P, Iverson D, Jones C. Toward a construct definition of informed consent comprehension. Journal of Empirical Research on Human Research Ethics 2009; 4(1): 17-23

Butters RR, Sugarman J, Kappan L. Semantic and pragmatic variability in medical research terms: implications for obtaining meaningful informed consent. American Speech 2000; 75(2):149-168

Charney DS. New requirements for manuscripts submitted to biological psychiatry: informed consent and protection of subjects. Biol Psychiatry 199; 46:1007 -1008

Clayton EW, Steinberg KK, Khoury MJ, Thomson E, Andrews L, Kahn MJ et al. Informed consent for genetic research on stored tissue samples. JAMA 1995; 274(22): 1786-1792

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.

Corneli AL, Bentey ME, Sorenson JR, Henderson GE, Van der Horst C. Using formative research to develop a context-specific approach to informed consent for clinical trials. Journal of Empirical Research on Human Research Ethics 2006; 1(4):45-60

Corrigan O. Empty ethics: the problem of informed consent. Sociology of Health and Illness 2003; 25(7):768-92

Coyne C, Xu R, Raich P, Plomer K, dignan M et al. Randomized controlled trial of an easy-to-read informed consent statement for clinical trial participation: a study of the Eastern Cooperative Oncology Group. Journal of Clinical Oncology 2003; 21: 836-842

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

Criscione LG, Sugarman J, Sanders K, Pisetsky DS, and St Clair EW. Informed consent in a clinical trial of a novel treatment for rheumatoid arthritis. Arthritis and Rheumatism 2003; 49(3): 361-367

Davis TC, Holcombe RF, Berkel HJ, Pramanik S, Divers SG. Informed consent for clinical trials: a comparative study of standard versus simplified forms. Journal of the National Cancer Institute 1998; 90(9): 668-674

Dawson L, Kass N. Views of US researcehrs about informed consent in international collaborative research. Social Science and Medicine 2005; 61:1211-1222

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

Diallo AD, Doumbo KO, Plowe CV, Wellems TE, Emanuel EJ, Hurst SA. Community permission for medical research in developing countries. Clinical Infectious Diseases 2005; 41: 255-259, 920 Se puede leer el resumen en http://www.popline.org/docs/1622/288679.html

Dresden G, Levitt M. Modifying standard industry clinical trial consent form improves patient information retention as part of the informed consent process. Academic Emergency Medicine 2001; 8:246-252

Dugosh KL, Festinger DS, Croft JR, Marlowe DB. Measuring coercion to participate in research within a doubly vulnerable population: initial development of the coercion assessment scale. Journal for Empirical Research on Human Research Ethics 2010; 5(1):93-102

Dunn LB, Jeste DV. Enhancing informed consent for research and treatment. Neuropsychopharmacology 2001; 24(6):595-607

Dunn L, Lindamer L, Palmer B, Golshn S, Schneiderman L, Jeste D. Improving understanding of research consent in middle-aged and elderly patients with psychotic disorders. American Journal of Geriatric Psychiatry 2002; 10:142-150

Edwards SJL, Lilford RJ, Thornton J, Hewison K. Informed consent for clinical trials: in search of the “best” method. Social Science and Medicine 1998; 47(11) 1825-1840

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

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Consentimiento informado en pediatria

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American Academy of Pediatrics. Committee on Drugs. Guidelines for ethical conduct of studies to evaluate drugs in pediatruic populations. Pediatrics 1995; 95(2):314-317

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Dorn LD, Susman EJ, Fletcher JC. Informed consent in children and adolescents: age, maturation and psychological state. Journal of Adolescent Health: Official Publication of the Society of Adolescent Medicine 1995; 16(3): 185-190

Eder ML, Yanikoski AD, Wittmann PW, Kodish ED. Improving informed consent: suggestions from parents of children with leukemia. Pediatrics 2007; 119(4): e849-e859

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Nelson RM, Reynolds WW. We should reject passive resignation in favor of requiring the assent of younger children for participation in nonbeneficial research. American Journal of Bioethics 2003; 3(4):11-13

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Pérez C. El Consentimiento informado en el menor de edad. Revisión a la luz de la nueva normativa. BSCP Can Ped 2003; 27 (3): 339-344. http://www.comtf.es/pediatria/Bol-2003-3/Consentimiento%20informado…(DCP).pdf

Rothmeir J, Lasley M, Shapiro G. Factors influencing parental consent in pediatric clinical research. Pediatrics 2003; 111 (5): 1037-1041

Tair AR, Voepel-Lewis T, Malviva S. Do they understand? (Part II): Assent of children participating in clinical anesthesia and surgery research. Anesthesiology 2003; 98(3): 609-614

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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

Wendler DS. Assent in paediatric research: theoretical and practical consideations. Journal of Medical Ethics 2006; 32(4):229-234

Whittle A, Shah S, Wilfond B, Gensler G, Wendler D. Insitutional review board practices regarding assent in pediatric research. Pediatrics 2004; 113 (6):1747-1752

Consentimiento informado por personas incapacitadas

Aman MG, Handen B Reactions to “Ethical challenges and complexities of including people with intellectual disability as participants in research” by Dr Teresa Iacono, Journal of Intellectual and Developmental Disabilities 2006; 31:1-3

Geraldi Haase V, et a. Neuropsicologia e autonomia decisória: implicacoes para o consentimento informado. Revista Bioética 2007; 15 (1): 117-132

Mocellin Raymundo M, Goldim JR. Do consentimento por procuracao a autorizacao por representacao. Revista Bioética 2007; 15 (1): 83-100

modificado el 28 de Noviembre de 2013


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