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

Aman MG, Wolford PL. Consumer satisfaction with involvement in drug research: A social validity study. Journal of the American Academy of Child and Adolescent Psychiatry 1995; 34:940-945

Beecher HK. Ethics in clinical research. NEJM 1966; 274:1354-1360

Belsky L, Richardson HS. Medical researchers’ ancillary clinical care responsibilities. BMJ 328 (7454): 1494-1496

Bickerstaffe R, Brock P, Husson JM, Rubin I, Bragman K, Paterson K, Sommerville A. Ethics and pharamceutical medicine – the full report of the Ethical Issues Committee of the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the UK. International Journal of Clinical Practice 2006; 60(2): 242-252. El resumen esta disponible en http://cat.inist.fr/?aModele=afficheN&cpsidt=17515360

Brody BA, McCullough LB, Sharp RR. Consensus and controversy inclinical research ethics. JAMA 2005; 294(11):1411-1414 (doi:10.1001/jama.294.11.1411) http://www.deptmedicine.utoronto.ca/Assets/CanMeds/Consensus+and+controversies+in+clinical+research+ethics.pdf

Buchanan DR. Autonomy, paternalism, and justice: ethical priorities in public helath. American Journal of Public Health 2008; 28 (1): 15-21. El resumen esta disponible en http://www.ajph.org/cgi/content/abstract/AJPH.2007.110361v1

Cassileth BR, Lusk EJ, Miller DS, Hurwitz S. Attittudes toward clinical trials among patients and the public. JAMA 1982; 248:968-970

Chalmers I, Milne I, Tröhler U, Vendenbroucke J, Morabia A, Tait G, Dukan E. The James Lind Library: explaining and illustrating the evolution of fair tests of medical treatments. J.R. Coll Physcians Edinb 2008; 38:259-64.

Cheng JD, Hitt J, Koczwara B, Schulman KA, Burnet CB et al. Impact of quality of life on patient expectations regarding phase I clinical trials. Journal of Clinical Oncology 2000; 18 (2): 421-428

Coker R, McKee M. Ethical approval for health research in central and eastern Europe: an internacional survey. Clinical Medicine 1003; 1(3):197-199

Collier R. Rapidly rising clinical trial costs worry researchers. CMAJ 2009; 180(3): 277-8 http://www.canadianmedicaljournal.ca/cgi/content/full/180/3/277

Christakis NA. Ethics are local: engaging cross-cultural variations in the ethics for clinical research. Social Science and Medicine 1992; 35:1079-91

Crooks SW, Colman SB, Campbell IA. Costs and getting ethical approval deter doctors from participating in multi-centre trials [carta]. BMJ 1996; 312(7047):1669

Dawson L, Zarin DA, Emanuel EJ et al.Considering usual medical care in clinical trial design. PLoS Medicine, 2009; 6(9)e1000111
www.plosmedicine.org/article/metrics/info:doi%2F10.1371%2Fjournal.pmed.1000111

Didarbora E. Responsabilidad en la ejecución de ensayos clínicos. Boletín Red Sudamericana de Atención Farmacéutica 2008; 2(2) www.redsaf.org/index.php?pag=boletin

Dresser R. The ubiquity and utility of the therapeutic misconception. Social Philosophy and Policy 2002; 19: 271-294

Dubois JM. Hidden data for research ethicists: an introduction to the concept and a series of papers. J Empir Res Hum Res Ethics 2008; 3(3):3-5 doi: 10.1525/jer.2008.3.3.3. http://caliber.ucpress.net/doi/abs/10.1525/jer.2008.3.3.3

Dubois JM, James M. Is compliance a professional virtue of researchers? Reflections on promoting the responsible conduct of research. Ethics and Behavior 2004; 14:383-395

Dubois JM, Volpe RL, Rangel EK. Hidden empirical research ethics: A review of three health journals from 2005 through 2006. Journal of Empirical Research Ethics on Human Research Ethics 2008; 3(3)7-18

Emanuel EJ, Grady C. Four paradigms of clinical research and research oversight. Cambridge Quarterly of Health Care Ethics 2007; 16:82-96 http://journals.cambridge.org/abstract_S0963180107070090

Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000; 283(20):2701-2711 doi:10.1001/jama.283.20.2701 http://ped1.med.uth.tmc.edu/neo/center/programs/documents/Emanuel.pdf

Evans D, Smith M, Willen L. Human guinea pigs pay for lax FDA rules. The Seattle Times, Novembr 6, 2005. http://seattletimes.nwsource.com/html/businesstechnology/2002606640_drugtesting06.html Traducido en Boletin Farmacos 2005; 8 (5) http://www.saludyfarmacos.org/boletin-farmacos/boletines/nov2005/etica-y-medicamentos

Fisher AB. A summary of important documents in the field of research ethics. Schizophrenia Bulletin 2006; 32(1):69-80. http://schizophreniabulletin.oxfordjournals.org/cgi/content/abstract/32/1/69

Fisher AJ. Re-inscribing gender in new modes of medical expertise: the investigator-coordinator relationship in the clinical trials industry. Gender, Work and Organization 2009 http://www.jillfisher.net/papers/gwo.pdf

Fundació Institut Català de Farmacología. Hacia una concepción de la bioética apta para el siglo XXI. Investigación Clínica y Bioética 2001; 37 http://www.icf.uab.es/icbdigital/pdf/boletines/icb3701.pdf

Garattini S, Bertele V. Non-inferiority trials are unethical becasue they disregard patients’ interests. The Lancet 2007; 370:1875-77

Gray BH, Cooke RA, Tannenbaum AS. Research involving human subjects. Science 1978; 201:1094-1101

Gunsalus CK. The nanny state meets the inner lawyer: overregulating while underprotecting human participants in research. Ethics and Behavior 2004; 14(4):369-382

Heaven B, Murtagh M, Rapley T, May C, Graham R, Kaner E, Thompson R. Patients or research subjects? A qualitative study of participation in a randomized controlled trial of a complex intervention. Patient Education and Counseling 2006; 62(2):260-270

Helton-Fauth W, Gaddis B, Scoot G, Mumford M, Devenport L, Connelly S et al. A new approach to assessing ethical conduct in scientific work. Accountability in Research 2003; 10:205-228

Hietanen P, Aro AR, Holli K, Absetz P. Information and communication in the context of a clinical trial. European Journal of Cancer 2000; 36 (16):2096-21-4

Hirchfeld RMA, Winsalde W, Krause TL. Protecting subjects and fostering research: striking the proper balance. Archives in General Psychiatry 1997; 54:121-123

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

Holtedahl KA, Meland E. Drug trials in general practice: time for a quality check before recruiting patients. BMJ 2007;335:7

Hoeyer K, Dahlager L, Lynoe N. Conflicting notions of research ethics: the mutually challenging traditions of social scientists and medical researchers. Social Science and Medicine 2005; 61(8):1741-9

Ineke Neutel C. The dilemma of using humans as research subjetcs. An assessment of risks and benefits. Drug Information Journal 2004; 38:113-126.

Justo, L  Trust, understanding and utopia in the research setting. American Journal of Bioethics 2005; 5(1):pp. 56-58.

Justo, L and Villerral, J Autonomy as Universal Expectation: A Review and a Research Proposal. Eubios Journal of Asian and International Bioethics 2003; 13(2):pp. 53-57.

Kalberg JPE. Uninterrupted globalization of industry sponsored clinical trials. Clinical Trial Magnifier 2009; 2(2):79-94 www.ClinicalTrialMagnifier.com

Kalberg J PE. 2008. Characteristics of “True” Global Sponsored Clinical Trials. Clinical Trial Magnifier 2005; 1(7): 123-146

Kao AC, Green DC, Zaslavsky AM, Koplan JP, cleary PD. The relationship between method of physician payment and patient trust. JAMA 1998; 280 (19):1708-1714

Kass N, Sugarman J, Faden R et al. Trust: the fragile foundation of contemporary biomedical research. The Hastings Center Report 1996; 26:25-29

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

Koepsell D, Arp R, Fostel J, Smith B. Creating a controlled vocabulary for the ethics os human research: towards a biomedical ethics ontology. Journal of Empirical Research on Human Research Ethics 2009; 4(1): 43-58

Levine IS. Experimenting with drugs. The pros and cons of taking brand-new medications. AARP Bulletin, February 2006: 12-15. http://209.85.173.104/search?q=cache:q1ZsTNGK7kwJ:irenelevine.com/articles/aarptestingdrugs.pdf+Experimenting+with+Drugs.+The+pros+and+cons+of+taking+brand-new+medications&hl=en&ct=clnk&cd=1&gl=us

Litton P, Miller FG. A normative justification for distinguishing eht ethics of clinical research from the ethics of medical care. The Journal of Law Medicine and Ethics, 2005, Fall: 566-574

Marshall E. Lemons, oranges, and complexity, Science 2008; 322:209  

Malakoff D. Spiraling costs threaten gridlock. Science 2008; 322:210

McCullough LB. Holding the present and future accountable to the past: History and the maturation of clinical ethics as a field of humanities. Journal of Medicine and Philosophy 2000; 25(1): 5-11

McDonald M, Townsend A, Cox SM, Paterson ND, Lafrenière D. Trust in health research relationships: accounts of human subjects. Journal of Empirical Research on Human Research Ethics 2008; 3(4): 35-47

McManus R. ”Abolitionist” Angell calls for clinical trials reform. The NIH record. 2001; LIII (15) http://nihrecord.od.nih.gov/newsletters/07_24_2001/story01.htm

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

Santolaya Perrín R, Garcia López FJ. Incremental drug treatment cost in HIV-positive patients in industry-sponsored clinical trials. The Annals of Pharamcotherapy 2008; 42:1586-1591 http://www.theannals.com/cgi/content/abstract/42/11/1586

Sleight P. Where are clinical trials going? Society and clinical trials. Journal of Internal Medicine 2004; 255(2): 235-241

Sotelo J. Regulation of clinical research sponsored by pharmaceutical companies: a proposal. PLoS Medicine 2006; 3(7)e306. http://www.pubmedcentral.nih.gov/picrender.fcgi?artid=1489183&blobtype=pdf

Steinbrook R. Improving protection for research subjects. NEJM 2002; 346 (18):1425-1430

Strech D. Evidence-based ethics- what it should be and what it shouldn’t. BMC Medical Ethics 2008; 9:16 doi:10.1186/1472-6939/9/16 http://www.biomedcentral.com/1472-6939/9/16

Verheggen FWS, Nieman FHM, Jonkers R. Determinants of patient participation in clinical studies requiring informed consent: Why patients enter a clinical trial. Patient Education and Counseling 1998; 35(2):111-125

Verheggen FWS, Nieman FHM, Reerink E, Kok GJ. Patient satisfaction with clinical trial participation. International Journal for Quality in Health Care 1998; 10(4): 319-330

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

Walsh MK, McNeil JJ, Breen KJ. Improving the governance of helath research. Medical Journal of Australia 2005; 182 (9):468-471

Weijer C, Goldsand G, Emanuel EJ. Protecting communities in research: current guidelines and limits of extrapolation. Nature Genetics 1999; 23:275-280 http://www.med.utah.edu/ethics/RCREthics/Weijer_communities_Nature_Genetics.pdf

Weinfurt KP, Sulmasy DP, Schulman KA, Meropol NJ. Patient expectations of benefit from phase I clinical trials: linguistic considerations in diagnosing a therapeutic misconception. Theoretical Medicine and Bioethics 2003; 24(4):329-344

Wrobel AJ, Shapiro NE. Conducting research with urban elders: issues of recruitment, data collection, and home visits. Alzheimer Disease and Associated Disorders. 1999; 13 (Supplement 1), S34-38

Zarin DA, Tse T. Moving towards transparency of clinical trials. Science, 2008; 319(5868):1340-1342. http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2396952

Australia

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

Canada

Lexchin J. Clinical trials in Canada: whose interests are paramount? International Journal of Health Services. Pendiente de publicación.

O’Neil P. Ethics guidelines for clinical trials to be revised. CMAJ 2008; 178(2):138 http://www.cmaj.ca/cgi/content/full/178/2/138

Shuchman M. Clinical trials: the balance between protecting participants and promoting drug and product development. CMAJ 2009; 180(6):603-606. http://www.cmaj.ca/cgi/content/figsonly/180/6/603

Silversides A. Clinical Trials: the muddled Canadian landscape. CMAJ 2009; 180 (1):20-22. http://www.cmaj.ca/cgi/content/full/180/1/20

Croacia

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

 

 

EE.UU.

 

Brandt AM. Racism and research; the case of the Tuskegee Syphilis Study. Hastings Center Report 1978; 8(6): 21-29.

 

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

 

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

 

Department of Health and Human Services. Office of Inspector General. Challenges to FDA’s ability to monitor and inspect foreign clinical trials. Rockville (Maryland): Department of Health and Human Services. June 2010 OEI-01-08-00510.

 

Department of Health and Human Services. Office of Inspector General. The Food and Drug Administration’s Oversight of clinical Trials. Rockville (Maryland): Department of Health and Human Services. Septiembre de 2007 OEI-01-06-00160.

 

Government Accountability Office (GAO). Human Subjects Research: Undercover Tests Show the Institutional Review Board System Is Vulnerable to Unethical Manipulation. GAO-09-448T 26 de marzo de 2009 

 

Kalberg JPE. USFDA site inspections findings, 1997-2008, fail to justify globalization concerns. Clinical Trial Magnifier 2009; 2(4): 194-212.

 

Kalberg JPE. Office of Human Research Protection Assurance. Clinical Trials Magnifier 2009c; 2(8):418-433.

 

Fisher JA. Governing human subjects research in the USA: individualized ethics and structural inequalities. Science and Public Policy 2007; 34(2):117-126

http://www.ingentaconnect.com/content/beech/spp/2007/00000034/00000002/art00005 

 

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

 

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

 

National Cancer Institute. Initiative to speed clinical trial negotiations moves forward. NCI Bulletin, October 7, 2008.

 

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

Francia

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 
 
 Holanda
 

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

 
 
 
 
 
 
 

Aman MG, Wolford PL. Consumer satisfaction with involvement in drug research: A social validity study. Journal of the American Academy of Child and Adolescent Psychiatry 1995; 34:940-945

Beecher HK. Ethics in clinical research. NEJM 1966; 274:1354-1360

Belsky L, Richardson HS. Medical researchers’ ancillary clinical care responsibilities. BMJ 328 (7454): 1494-1496

Bickerstaffe R, Brock P, Husson JM, Rubin I, Bragman K, Paterson K, Sommerville A. Ethics and pharamceutical medicine – the full report of the Ethical Issues Committee of the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the UK. International Journal of Clinical Practice 2006; 60(2): 242-252. El resumen esta disponible en http://cat.inist.fr/?aModele=afficheN&cpsidt=17515360

Brody BA, McCullough LB, Sharp RR. Consensus and controversy inclinical research ethics. JAMA 2005; 294(11):1411-1414 (doi:10.1001/jama.294.11.1411) http://www.deptmedicine.utoronto.ca/Assets/CanMeds/Consensus+and+controversies+in+clinical+research+ethics.pdf

Buchanan DR. Autonomy, paternalism, and justice: ethical priorities in public helath. American Journal of Public Health 2008; 28 (1): 15-21. El resumen esta disponible en http://www.ajph.org/cgi/content/abstract/AJPH.2007.110361v1

Cassileth BR, Lusk EJ, Miller DS, Hurwitz S. Attittudes toward clinical trials among patients and the public. JAMA 1982; 248:968-970

Chalmers I, Milne I, Tröhler U, Vendenbroucke J, Morabia A, Tait G, Dukan E. The James Lind Library: explaining and illustrating the evolution of fair tests of medical treatments. J.R. Coll Physcians Edinb 2008; 38:259-64.

Cheng JD, Hitt J, Koczwara B, Schulman KA, Burnet CB et al. Impact of quality of life on patient expectations regarding phase I clinical trials. Journal of Clinical Oncology 2000; 18 (2): 421-428

Coker R, McKee M. Ethical approval for health research in central and eastern Europe: an internacional survey. Clinical Medicine 1003; 1(3):197-199

Collier R. Rapidly rising clinical trial costs worry researchers. CMAJ 2009; 180(3): 277-8 http://www.canadianmedicaljournal.ca/cgi/content/full/180/3/277

Christakis NA. Ethics are local: engaging cross-cultural variations in the ethics for clinical research. Social Science and Medicine 1992; 35:1079-91

Crooks SW, Colman SB, Campbell IA. Costs and getting ethical approval deter doctors from participating in multi-centre trials [carta]. BMJ 1996; 312(7047):1669

Dawson L, Zarin DA, Emanuel EJ et al.Considering usual medical care in clinical trial design. PLoS Medicine, 2009; 6(9)e1000111
www.plosmedicine.org/article/metrics/info:doi%2F10.1371%2Fjournal.pmed.1000111

Didarbora E. Responsabilidad en la ejecución de ensayos clínicos. Boletín Red Sudamericana de Atención Farmacéutica 2008; 2(2) www.redsaf.org/index.php?pag=boletin

Dresser R. The ubiquity and utility of the therapeutic misconception. Social Philosophy and Policy 2002; 19: 271-294

Dubois JM. Hidden data for research ethicists: an introduction to the concept and a series of papers. J Empir Res Hum Res Ethics 2008; 3(3):3-5 doi: 10.1525/jer.2008.3.3.3.

http://caliber.ucpress.net/doi/abs/10.1525/jer.2008.3.3.3

Dubois JM, James M. Is compliance a professional virtue of researchers? Reflections on promoting the responsible conduct of research. Ethics and Behavior 2004; 14:383-395

Dubois JM, Volpe RL, Rangel EK. Hidden empirical research ethics: A review of three health journals from 2005 through 2006. Journal of Empirical Research Ethics on Human Research Ethics 2008; 3(3)7-18

Emanuel EJ, Grady C. Four paradigms of clinical research and research oversight. Cambridge Quarterly of Health Care Ethics 2007; 16:82-96 http://journals.cambridge.org/abstract_S0963180107070090

Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000; 283(20):2701-2711 doi:10.1001/jama.283.20.2701 http://ped1.med.uth.tmc.edu/neo/center/programs/documents/Emanuel.pdf

Evans D, Smith M, Willen L. Human guinea pigs pay for lax FDA rules. The Seattle Times, Novembr 6, 2005. http://seattletimes.nwsource.com/html/businesstechnology/2002606640_drugtesting06.html Traducido en Boletin Farmacos 2005; 8 (5)

http://www.saludfarmacos.org/boletin-farmacos/boletines/nov2005/etica-y-medicamentos/

Fisher AB. A summary of important documents in the field of research ethics. Schizophrenia Bulletin 2006; 32(1):69-80. http://schizophreniabulletin.oxfordjournals.org/cgi/content/abstract/32/1/69

Fisher AJ. Re-inscribing gender in new modes of medical expertise: the investigator-coordinator relationship in the clinical trials industry. Gender, Work and Organization 2009

http://www.jillfisher.net/papers/gwo.pdf

Fundació Institut Català de Farmacología. Hacia una concepción de la bioética apta para el siglo XXI. Investigación Clínica y Bioética 2001; 37 http://www.icf.uab.es/icbdigital/pdf/boletines/icb3701.pdf

Garattini S, Bertele V. Non-inferiority trials are unethical becasue they disregard patients’ interests. The Lancet 2007; 370:1875-77

Gray BH, Cooke RA, Tannenbaum AS. Research involving human subjects. Science 1978; 201:1094-1101

Gunsalus CK. The nanny state meets the inner lawyer: overregulating while underprotecting human participants in research. Ethics and Behavior 2004; 14(4):369-382

Heaven B, Murtagh M, Rapley T, May C, Graham R, Kaner E, Thompson R. Patients or research subjects? A qualitative study of participation in a randomized controlled trial of a complex intervention. Patient Education and Counseling 2006; 62(2):260-270

Helton-Fauth W, Gaddis B, Scoot G, Mumford M, Devenport L, Connelly S et al. A new approach to assessing ethical conduct in scientific work. Accountability in Research 2003; 10:205-228

Hietanen P, Aro AR, Holli K, Absetz P. Information and communication in the context of a clinical trial. European Journal of Cancer 2000; 36 (16):2096-21-4

Hirchfeld RMA, Winsalde W, Krause TL. Protecting subjects and fostering research: striking the proper balance. Archives in General Psychiatry 1997; 54:121-123

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

Holtedahl KA, Meland E. Drug trials in general practice: time for a quality check before recruiting patients. BMJ 2007;335:7

Hoeyer K, Dahlager L, Lynoe N. Conflicting notions of research ethics: the mutually challenging traditions of social scientists and medical researchers. Social Science and Medicine 2005; 61(8):1741-9

Ineke Neutel C. The dilemma of using humans as research subjetcs. An assessment of risks and benefits. Drug Information Journal 2004; 38:113-126.

Justo, L (2005) Trust, understanding and utopia in the research setting. American Journal of Bioethics 5(1):pp. 56-58.

Justo, L and Villerral, J (2003) Autonomy as Universal Expectation: A Review and a Research Proposal. Eubios Journal of Asian and International Bioethics 13(2):pp. 53-57.

Kalberg JPE. Uninterrupted globalization of industry sponsored clinical trials.  Clinical Trial Magnifier 2009; 2(2):79-94 www.ClinicalTrialMagnifier.com

Kalberg J PE. 2008. Characteristics of “True” Global Sponsored Clinical Trials. Clinical Trial Magnifier 2005; 1(7): 123146

Kao AC, Green DC, Zaslavsky AM, Koplan JP, cleary PD. The relationship between method of physician payment and patient trust. JAMA 1998; 280 (19):1708-1714

Kass N, Sugarman J, Faden R et al. Trust: the fragile foundation of contemporary biomedical research. The Hastings Center Report 1996; 26:25-29

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

Koepsell D, Arp R, Fostel J, Smith B. Creating a controlled vocabulary for the ethics os human research: towards a biomedical ethics ontology. Journal of Empirical Research on Human Research Ethics 2009; 4(1): 43-58

Levine IS. Experimenting with drugs. The pros and cons of taking brand-new medications. AARP Bulletin, February 2006: 12-15. http://209.85.173.104/search?q=cache:q1ZsTNGK7kwJ:irenelevine.com/articles/aarptestingdrugs.pdf+Experimenting+with+Drugs.+The+pros+and+cons+of+taking+brand-new+medications&hl=en&ct=clnk&cd=1&gl=us

Litton P, Miller FG. A normative justification for distinguishing eht ethics of clinical research from the ethics of medical care. The Journal of Law Medicine and Ethics, 2005, Fall: 566-574

Malakoff D. Spiraling costs threaten gridlock. Science 2008; 322:210

McCullough LB. Holding the present and future accountable to the past: History and the maturation of clinical ethics as a field of humanities. Journal of Medicine and Philosophy 2000; 25(1): 5-11

McDonald M, Townsend A, Cox SM, Paterson ND, Lafrenière D. Trust in health research relationships: accounts of human subjects. Journal of Empirical Research on Human Research Ethics 2008; 3(4): 35-47

McManus R. ”Abolitionist” Angell calls for clinical trials reform. The NIH record. 2001; LIII (15) http://nihrecord.od.nih.gov/newsletters/07_24_2001/story01.htm

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

Santolaya Perrín R, Garcia López FJ. Incremental drug treatment cost in HIV-positive patients in industry-sponsored clinical trials. The Annals of Pharamcotherapy 2008; 42:1586-1591

http://www.theannals.com/cgi/content/abstract/42/11/1586

Sleight P. Where are clinical trials going? Society and clinical trials. Journal of Internal Medicine 2004; 255(2): 235-241

Sotelo J. Regulation of clinical research sponsored by pharmaceutical companies: a proposal. PLoS Medicine 2006; 3(7)e306. http://www.pubmedcentral.nih.gov/picrender.fcgi?artid=1489183&blobtype=pdf

Steinbrook R. Improving protection for research subjects. NEJM 2002; 346 (18):1425-1430

Strech D. Evidence-based ethics- what it should be and what it shouldn’t. BMC Medical Ethics 2008; 9:16 doi:10.1186/1472-6939/9/16

http://www.biomedcentral.com/1472-6939/9/16

Verheggen FWS, Nieman FHM, Jonkers R. Determinants of patient participation in clinical studies requiring informed consent: Why patients enter a clinical trial. Patient Education and Counseling 1998; 35(2):111-125

Verheggen FWS, Nieman FHM, Reerink E, Kok GJ. Patient satisfaction with clinical trial participation. International Journal for Quality in Health Care 1998; 10(4): 319-330

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

Walsh MK, McNeil JJ, Breen KJ. Improving the governance of helath research. Medical Journal of Australia 2005; 182 (9):468-471

Weijer C, Goldsand G, Emanuel EJ. Protecting communities in research: current guidelines and limits of extrapolation. Nature Genetics 1999; 23:275-280 http://www.med.utah.edu/ethics/RCREthics/Weijer_communities_Nature_Genetics.pdf

Weinfurt KP, Sulmasy DP, Schulman KA, Meropol NJ. Patient expectations of benefit from phase I clinical trials: linguistic considerations in diagnosing a therapeutic misconception. Theoretical Medicine and Bioethics 2003; 24(4):329-344

Wrobel AJ, Shapiro NE. Conducting research with urban elders: issues of recruitment, data collection, and home visits. Alzheimer Disease and Associated Disorders. 1999; 13 (Supplement 1), S34-38

Zarin DA, Tse T. Moving towards transparency of clinical trials. Science, 2008; 319(5868):1340-1342. http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2396952

Australia

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

Canada

Lexchin J. Clinical trials in Canada: whose interests are paramount? International Journal of Health Services. Pendiente de publicación.

O’Neil P. Ethics guidelines for clinical trials to be revised. CMAJ 2008; 178(2):138 http://www.cmaj.ca/cgi/content/full/178/2/138

Shuchman M. Clinical trials: the balance between protecting participants and promoting drug and product development. CMAJ 2009; 180(6):603-606. http://www.cmaj.ca/cgi/content/figsonly/180/6/603

Silversides A. Clinical Trials: the muddled Canadian landscape. CMAJ 2009; 180 (1):20-22. http://www.cmaj.ca/cgi/content/full/180/1/20

Croacia

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

EE.UU.

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

Fisher JA. Governing human subjects research in the USA: individualized ethics and structural inequalities. Science and Public Policy 2007; 34(2):117-126

http://www.ingentaconnect.com/content/beech/spp/2007/00000034/00000002/art00005

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

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

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

Francia

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

Holanda

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

 

 

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

 

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

 

Department of Health and Human Services. Office of Inspector General. Challenges to FDA’s ability to monitor and inspect foreign clinical trials. Rockville (Maryland): Department of Health and Human Services. June 2010 OEI-01-08-00510.

 

Department of Health and Human Services. Office of Inspector General. The Food and Drug Administration’s Oversight of clinical Trials. Rockville (Maryland): Department of Health and Human Services. Septiembre de 2007 OEI-01-06-00160.

 

Government Accountability Office (GAO). Human Subjects Research: Undercover Tests Show the Institutional Review Board System Is Vulnerable to Unethical Manipulation. GAO-09-448T 26 de marzo de 2009

 

Kalberg JPE. USFDA site inspections findings, 1997-2008, fail to justify globalization concerns. Clinical Trial Magnifier 2009; 2(4): 194-212.

 

Kalberg JPE. Office of Human Research Protection Assurance. Clinical Trials Magnifier 2009c; 2(8):418-433.

 

Fisher JA. Governing human subjects research in the USA: individualized ethics and structural inequalities. Science and Public Policy 2007; 34(2):117-126

http://www.ingentaconnect.com/content/beech/spp/2007/00000034/00000002/art00005

 

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

 

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

 

National Cancer Institute. Initiative to speed clinical trial negotiations moves forward. NCI Bulletin, October 7, 2008.

 

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

 

Francia

 

 

Francia

 

 
 
 
 
 
 

Brandt AM. Racism and research; the case of the Tuskegee Syphilis Study. Hastings Center Report 1978; 8(6): 21-29.

 

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

 

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

 

Department of Health and Human Services. Office of Inspector General. Challenges to FDA’s ability to monitor and inspect foreign clinical trials. Rockville (Maryland): Department of Health and Human Services. June 2010 OEI-01-08-00510.

 

Department of Health and Human Services. Office of Inspector General. The Food and Drug Administration’s Oversight of clinical Trials. Rockville (Maryland): Department of Health and Human Services. Septiembre de 2007 OEI-01-06-00160.

 

Government Accountability Office (GAO). Human Subjects Research: Undercover Tests Show the Institutional Review Board System Is Vulnerable to Unethical Manipulation. GAO-09-448T 26 de marzo de 2009 

 

Kalberg JPE. USFDA site inspections findings, 1997-2008, fail to justify globalization concerns. Clinical Trial Magnifier 2009; 2(4): 194-212.

 

Kalberg JPE. Office of Human Research Protection Assurance. Clinical Trials Magnifier 2009c; 2(8):418-433.

 

Fisher JA. Governing human subjects research in the USA: individualized ethics and structural inequalities. Science and Public Policy 2007; 34(2):117-126

http://www.ingentaconnect.com/content/beech/spp/2007/00000034/00000002/art00005 

 

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

 

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

 

National Cancer Institute. Initiative to speed clinical trial negotiations moves forward. NCI Bulletin, October 7, 2008.

 

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

 

Brandt AM. Racism and research; the case of the Tuskegee Syphilis Study. Hastings Center Report 1978; 8(6): 21-29.

 

 

 

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

 

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

 

Department of Health and Human Services. Office of Inspector General. Challenges to FDA’s ability to monitor and inspect foreign clinical trials. Rockville (Maryland): Department of Health and Human Services. June 2010 OEI-01-08-00510.

 

Department of Health and Human Services. Office of Inspector General. The Food and Drug Administration’s Oversight of clinical Trials. Rockville (Maryland): Department of Health and Human Services. Septiembre de 2007 OEI-01-06-00160.

 

Government Accountability Office (GAO). Human Subjects Research: Undercover Tests Show the Institutional Review Board System Is Vulnerable to Unethical Manipulation. GAO-09-448T 26 de marzo de 2009 

 

Kalberg JPE. USFDA site inspections findings, 1997-2008, fail to justify globalization concerns. Clinical Trial Magnifier 2009; 2(4): 194-212.

 

Kalberg JPE. Office of Human Research Protection Assurance. Clinical Trials Magnifier 2009c; 2(8):418-433.

 

Fisher JA. Governing human subjects research in the USA: individualized ethics and structural inequalities. Science and Public Policy 2007; 34(2):117-126

http://www.ingentaconnect.com/content/beech/spp/2007/00000034/00000002/art00005 

 

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

 

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

 

National Cancer Institute. Initiative to speed clinical trial negotiations moves forward. NCI Bulletin, October 7, 2008.

 

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

Holanda

 

 

modificado el 28 de Noviembre de 2013


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