메뉴 건너뛰기




Volumn 7, Issue , 2006, Pages

Consenting of the vulnerable: The informed consent procedure in advanced cancer patients in Mexico

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; ADVANCED CANCER; AGED; ARTICLE; BIOETHICS; CANCER PATIENT; CLINICAL ARTICLE; COMPREHENSION; CONFLICT OF INTEREST; CONTROLLED STUDY; DEVELOPING COUNTRY; FEMALE; HEALTH SURVEY; HUMAN; INFORMED CONSENT; MALE; MEDICAL RESEARCH; PHYSICIAN; QUESTIONNAIRE; SOCIOECONOMICS; VULNERABLE POPULATION; ATTITUDE; CLINICAL TRIAL (TOPIC); DRUG INDUSTRY; EDUCATION; EVALUATION STUDY; FINANCIAL MANAGEMENT; HUMAN EXPERIMENT; INFORMATION PROCESSING; MEXICO; NEOPLASMS; PATIENT; PSYCHOLOGY; PUBLIC HOSPITAL; STANDARDS;

EID: 33846471617     PISSN: None     EISSN: 14726939     Source Type: Journal    
DOI: 10.1186/1472-6939-7-13     Document Type: Article
Times cited : (44)

References (62)
  • 2
    • 85008556170 scopus 로고    scopus 로고
    • The Nuremberg Code. JAMA 1996, 276:1691.
    • The Nuremberg Code. JAMA 1996, 276:1691.
  • 3
    • 0031578033 scopus 로고    scopus 로고
    • Declaration of Helsinki
    • World Medical Association
    • World Medical Association: Declaration of Helsinki. JAMA 1997, 277:925-926.
    • (1997) JAMA , vol.277 , pp. 925-926
  • 7
    • 0028455540 scopus 로고
    • The impact of HIV infection on society's perception of clinical trials
    • Levine RJ: The impact of HIV infection on society's perception of clinical trials. Kennedy Institute J Ethics 1994, 4:93-98.
    • (1994) Kennedy Institute J Ethics , vol.4 , pp. 93-98
    • Levine, R.J.1
  • 8
    • 0030775618 scopus 로고    scopus 로고
    • Ethics of clinical research in third world
    • Angell M: Ethics of clinical research in third world. N Engl J Med 1997, 337:847-92.
    • (1997) N Engl J Med , vol.337 , pp. 847-892
    • Angell, M.1
  • 9
    • 0030888982 scopus 로고    scopus 로고
    • An ethical dilemma: Availability of antiretroviral therapy after clinical trials with HIV infected patients re ended
    • Cleaton-Jones PE: An ethical dilemma: availability of antiretroviral therapy after clinical trials with HIV infected patients re ended. BMJ 1997, 314:887-91.
    • (1997) BMJ , vol.314 , pp. 887-891
    • Cleaton-Jones, P.E.1
  • 10
    • 0023802363 scopus 로고
    • Ethical considerations of human investigation indeveloping countries: The AIDS dilemma
    • Barry M: Ethical considerations of human investigation indeveloping countries: the AIDS dilemma. N Engl J Med 1988, 319:1083.
    • (1988) N Engl J Med , vol.319 , pp. 1083
    • Barry, M.1
  • 11
    • 0023766364 scopus 로고
    • Ethical imperialism-ethics in international collaborative clinical research
    • Angell M: Ethical imperialism-ethics in international collaborative clinical research. N Engl J Med 1988, 319:1081-83.
    • (1988) N Engl J Med , vol.319 , pp. 1081-1083
    • Angell, M.1
  • 12
    • 0031875308 scopus 로고
    • Human rights and maternal-fetal HIV transmission prevention trials in Africa
    • Annas GJ, Grodin MA: Human rights and maternal-fetal HIV transmission prevention trials in Africa. Am J Public Health 1988, 88:560-3.
    • (1988) Am J Public Health , vol.88 , pp. 560-563
    • Annas, G.J.1    Grodin, M.A.2
  • 13
    • 0025172950 scopus 로고
    • African AIDS: Whose research rules?
    • Palca J: African AIDS: Whose research rules? Science 1990, 250:199-201.
    • (1990) Science , vol.250 , pp. 199-201
    • Palca, J.1
  • 14
    • 0034737962 scopus 로고    scopus 로고
    • What makes clinical research ethical?
    • Emanuel EJ, Wendler D, Grady C: What makes clinical research ethical? JAMA 2000, 283:2701-2711.
    • (2000) JAMA , vol.283 , pp. 2701-2711
    • Emanuel, E.J.1    Wendler, D.2    Grady, C.3
  • 15
    • 0347480384 scopus 로고    scopus 로고
    • Empty Ethics: The problem with informed consent
    • Corrigan O: Empty Ethics: The problem with informed consent. Sociology & Health Illness 2003, 25:768-792.
    • (2003) Sociology & Health Illness , vol.25 , pp. 768-792
    • Corrigan, O.1
  • 16
    • 33846524738 scopus 로고    scopus 로고
    • Encyclopaedia of Bioethics, [New York: Simon Schuster Macmillan, 1995, 1XXI, cited by Jonsen A.R. Source book
    • Warren Reich T, editor:, Edited by:, Georgetown University Press, Washington DC;
    • Warren Reich T, editor: Encyclopaedia of Bioethics, [New York: Simon Schuster Macmillan, 1995, 1XXI, cited by Jonsen A.R. Source book. In Bioethics. A documentary History Volume 4. Edited by: Jonsen AR, Veatch RM, Malters LR. Georgetown University Press, Washington DC; 1998.
    • (1998) Bioethics. A documentary History , vol.4
  • 17
    • 77958137588 scopus 로고    scopus 로고
    • The ethics of research with human subjects: A short history
    • Edited by: Jonsen AR, Veatch RM, Malters LR. Georgetown University Press, Washington DC;
    • Jonsen AR: The ethics of research with human subjects: A short history. In Source book in Bioethics. A documentary History Edited by: Jonsen AR, Veatch RM, Malters LR. Georgetown University Press, Washington DC; 1998.
    • (1998) Source book in Bioethics. A documentary History
    • Jonsen, A.R.1
  • 18
    • 0037329215 scopus 로고    scopus 로고
    • Some limits of informed consent
    • doi:10.1136/jme.29.1.4. Downloaded Oct 11
    • O O'Neill: Some limits of informed consent. J Med Ethics 2003, 29:4-7. doi:10.1136/jme.29.1.4. Downloaded Oct 11,2006
    • (2006) J Med Ethics , vol.2003 , Issue.29 , pp. 4-7
    • O'Neill, O.1
  • 22
    • 0037180251 scopus 로고    scopus 로고
    • Can transnational research be ethical in developing world?
    • Farmer P: Can transnational research be ethical in developing world? Lancet 2000, 360:1266.
    • (2000) Lancet , vol.360 , pp. 1266
    • Farmer, P.1
  • 23
    • 33846518100 scopus 로고    scopus 로고
    • Pellegrino E: 2005 [http://clinicalbioethics.georgetown.edu/faculty/edp. html].
    • (2005)
    • Pellegrino, E.1
  • 24
    • 0002112226 scopus 로고    scopus 로고
    • Davies : International variation in ethics committee requirements: comparisons across five Westernised nations
    • Goodyear-Smith F, Lobb B, Davies : International variation in ethics committee requirements: comparisons across five Westernised nations. BMC Med Ethics 2002, 3:2.
    • (2002) BMC Med Ethics , vol.3 , pp. 2
    • Goodyear-Smith, F.1    Lobb, B.2
  • 25
    • 11144328940 scopus 로고    scopus 로고
    • The battering of informed consent
    • Kottow M: The battering of informed consent. J Med Ethics 2004, 30:565-569.
    • (2004) J Med Ethics , vol.30 , pp. 565-569
    • Kottow, M.1
  • 27
    • 0035944839 scopus 로고    scopus 로고
    • Quality of informed consent in cancer clinical trials: A cross-sectional survey
    • Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC: Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet 2001, 358:1772-1777.
    • (2001) Lancet , vol.358 , pp. 1772-1777
    • Joffe, S.1    Cook, E.F.2    Cleary, P.D.3    Clark, J.W.4    Weeks, J.C.5
  • 29
    • 7644233007 scopus 로고    scopus 로고
    • Bhutta ZA: Beyond Informed Consent
    • B, /10/, Downloaded April
    • B Bhutta ZA: Beyond Informed Consent. Bulletin of the World Health Organization 2004 [http://www.who.int/bulletin/volumes/82/10/]. Downloaded April 2005
    • (2004) Bulletin of the World Health Organization
  • 30
    • 33846530478 scopus 로고    scopus 로고
    • De Young K, Nelson D: Latin America Is Ripe for Trials, and Fraud. Frantic Pace Could Overwhelm Controls. [http://www.washingtonpost.com]. Thursday, December 21, 2000. Page A01
    • De Young K, Nelson D: Latin America Is Ripe for Trials, and Fraud. Frantic Pace Could Overwhelm Controls. [http://www.washingtonpost.com]. Thursday, December 21, 2000. Page A01
  • 33
    • 33846501388 scopus 로고    scopus 로고
    • Any circumstances in which individuals are in a position of dependency (research subjects, elderly, indigenous, poor people, dying patients) makes them potentially vulnerable. Research Involving Vulnerable Participants. In Manual for Research Ethics Committees Edited by: Eckstein S. Centre of Medical Law and Ethics, Kings College, London. Cambridge University Press; 2003:105.
    • Any circumstances in which individuals are in a position of dependency (research subjects, elderly, indigenous, poor people, dying patients) makes them potentially vulnerable. Research Involving Vulnerable Participants. In Manual for Research Ethics Committees Edited by: Eckstein S. Centre of Medical Law and Ethics, Kings College, London. Cambridge University Press; 2003:105.
  • 34
    • 33846525926 scopus 로고    scopus 로고
    • Reglamento de la Ley General de Salud en Materia de Investigación para la Salud. Titulo Segundo: De los Aspectos Éticos de la Investigación en Seres Humanos. Articulo 14 Fracción -V [http://www.salud.gob.mx/unidades/cdi/nom/compi/rlgsmis.html].
    • Reglamento de la Ley General de Salud en Materia de Investigación para la Salud. Titulo Segundo: De los Aspectos Éticos de la Investigación en Seres Humanos. Articulo 14 Fracción -V [http://www.salud.gob.mx/unidades/cdi/nom/compi/rlgsmis.html].
  • 35
    • 33846522207 scopus 로고    scopus 로고
    • International Conference for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: ICH Good Clinical Practices. In Manual for Research Ethics Committees Edited by: Eckstein S. Centre of Medical Law and Ethics, Kings College, London. Cambridge University Press; 2003:133-149
    • International Conference for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: ICH Good Clinical Practices. In Manual for Research Ethics Committees Edited by: Eckstein S. Centre of Medical Law and Ethics, Kings College, London. Cambridge University Press; 2003:133-149.
  • 36
    • 33846535181 scopus 로고    scopus 로고
    • Contract regulated by the Mexican civil code Artículo 1794 (Libro Cuarto De las Obligaciones, el Título Décimo, Capítulo II De la prestación de servicios profesionales). .
    • Contract regulated by the Mexican civil code Artículo 1794 (Libro Cuarto "De las Obligaciones", el Título Décimo, Capítulo II "De la prestación de servicios profesionales"). .
  • 37
    • 33846491199 scopus 로고
    • Código Civil para el Distrito Federal en Materia Común, y para toda la República en Materia Federal
    • Trejo GG: Código Civil para el Distrito Federal en Materia Común, y para toda la República en Materia Federal. Editorial Sista, S.A. de C.V. México 1995.
    • (1995) Editorial Sista, S.A. de C.V. México
    • Trejo, G.G.1
  • 38
    • 33846470362 scopus 로고
    • Los derechos del paciente
    • Sepúlveda B: Los derechos del paciente. Gac Méd Méx 1984, 120:271-272.
    • (1984) Gac Méd Méx , vol.120 , pp. 271-272
    • Sepúlveda, B.1
  • 39
    • 0037456358 scopus 로고    scopus 로고
    • Readability Standards for Informed-Consent Forms as Compared with Actual Readability
    • Paasche-Orlow MK, Taylor HA, Brancati FL: Readability Standards for Informed-Consent Forms as Compared with Actual Readability. N Eng J Med 2003, 348:721-726.
    • (2003) N Eng J Med , vol.348 , pp. 721-726
    • Paasche-Orlow, M.K.1    Taylor, H.A.2    Brancati, F.L.3
  • 41
    • 0032922146 scopus 로고    scopus 로고
    • Impact of Therapeutic Research on Informed Consent and the Ethics of Clinical Trials: A Medical Oncology Perspective
    • Daugherty CK: Impact of Therapeutic Research on Informed Consent and the Ethics of Clinical Trials: A Medical Oncology Perspective. J Clin Oncol 2003, 17:1601-1617.
    • (2003) J Clin Oncol , vol.17 , pp. 1601-1617
    • Daugherty, C.K.1
  • 42
    • 33846532167 scopus 로고    scopus 로고
    • Normas Éticas para la Investigación Clínica
    • Rueda Mancini, Roberto : Normas Éticas para la Investigación Clínica. Disponible en [http://www.uchile.cl/bioetica/doc/normas.htm].
    • Disponible en
    • Rueda Mancini, R.1
  • 43
    • 33846481821 scopus 로고    scopus 로고
    • La Rocca S, Martinez G, Rascio A, et al.: Biomedical Investigation and Informed Consent in Vulnerable Populations and Individuals. Acta Bioeth. [Online] 2005, 112169-181 [http://scielotest.conicyt.cl/scielo.php?script=sci_arttext&pid= S1726-69X2005000200007&lng=en&nrm=iso]. [cited 31 October 2006], ISSN 1726-569X
    • La Rocca S, Martinez G, Rascio A, et al.: Biomedical Investigation and Informed Consent in Vulnerable Populations and Individuals. Acta Bioeth. [Online] 2005, 11(2169-181 [http://scielotest.conicyt.cl/scielo.php?script=sci_arttext&pid= S1726-69X2005000200007&lng=en&nrm=iso]. [cited 31 October 2006], ISSN 1726-569X
  • 45
    • 0141797654 scopus 로고    scopus 로고
    • A critique of clinical equipoise. Therapeutic misconception in the ethics of clinical trials
    • Miller F, Brody H: A critique of clinical equipoise. Therapeutic misconception in the ethics of clinical trials. Hasting Center Report 2003, 33:19-28.
    • (2003) Hasting Center Report , vol.33 , pp. 19-28
    • Miller, F.1    Brody, H.2
  • 46
    • 0037417240 scopus 로고    scopus 로고
    • The therapeutic orientation of clinical trials
    • Miller F, Rosenstein D: The therapeutic orientation of clinical trials. New Eng J Med 2003, 348:1383-1386.
    • (2003) New Eng J Med , vol.348 , pp. 1383-1386
    • Miller, F.1    Rosenstein, D.2
  • 47
    • 1442325354 scopus 로고    scopus 로고
    • The ethical relevance of thestandard of care in the design of clinical trials
    • Miller F, Silverman H: The ethical relevance of thestandard of care in the design of clinical trials. AM J Respir Crit Care Med 2004, 169:562-564.
    • (2004) AM J Respir Crit Care Med , vol.169 , pp. 562-564
    • Miller, F.1    Silverman, H.2
  • 49
    • 0036490656 scopus 로고    scopus 로고
    • The case of Chester M. Southam. Research ethics and the limits of professional responsibility
    • Preminger BA: The case of Chester M. Southam. Research ethics and the limits of professional responsibility. Pharos Alpha Omega Alpha Honor Med Soc 2002, 65:4-9.
    • (2002) Pharos Alpha Omega Alpha Honor Med Soc , vol.65 , pp. 4-9
    • Preminger, B.A.1
  • 50
    • 0034735830 scopus 로고    scopus 로고
    • To protect those who serve
    • Drazen JM, Koski G: To protect those who serve. N Engl J Med 2000, 343:1643-1645.
    • (2000) N Engl J Med , vol.343 , pp. 1643-1645
    • Drazen, J.M.1    Koski, G.2
  • 51
    • 0036816823 scopus 로고    scopus 로고
    • The Inter-role Confidentiality Conflict in Recruitment for Clinical Research
    • Habiba M, Evans M: The Inter-role Confidentiality Conflict in Recruitment for Clinical Research. The Journal of Medicine and Philosophy 2002, 27:565-587.
    • (2002) The Journal of Medicine and Philosophy , vol.27 , pp. 565-587
    • Habiba, M.1    Evans, M.2
  • 52
    • 33746041073 scopus 로고    scopus 로고
    • Distinguishing treatment from research : A functional approach
    • Lewens T: Distinguishing treatment from research : a functional approach. J Med Ethics 2006, 32:424-429.
    • (2006) J Med Ethics , vol.32 , pp. 424-429
    • Lewens, T.1
  • 53
    • 0033858159 scopus 로고    scopus 로고
    • HIV vaccine trials: Critical issues in informed consent
    • Lindegger G, Richter LM: HIV vaccine trials: Critical issues in informed consent. South African J of Sci 2000, 313:317.
    • (2000) South African J of Sci , vol.313 , pp. 317
    • Lindegger, G.1    Richter, L.M.2
  • 54
    • 4143062563 scopus 로고    scopus 로고
    • Oversight of Human Participants Research: Identifying Problems To Evaluate Reform Proposals
    • Emanuel EJ, Wood A, Fleischman A, Bowen A: Oversight of Human Participants Research: Identifying Problems To Evaluate Reform Proposals. Ann Intern Med 2004, 141:282-291.
    • (2004) Ann Intern Med , vol.141 , pp. 282-291
    • Emanuel, E.J.1    Wood, A.2    Fleischman, A.3    Bowen, A.4
  • 55
    • 4644281540 scopus 로고    scopus 로고
    • Flory J, Emanuel E: Interventions to Improve Research Participants' Understanding in Informed Consent for Research A Systematic Review. JAMA 2004, 292:1593-1601 [http://www.jama.com]. INS Nacional, on October 5, 2006
    • Flory J, Emanuel E: Interventions to Improve Research Participants' Understanding in Informed Consent for Research A Systematic Review. JAMA 2004, 292:1593-1601 [http://www.jama.com]. INS Nacional, on October 5, 2006
  • 56
    • 0026948334 scopus 로고
    • Consent forms: How to determine and improve their readability
    • Meade CD, Howser DM: Consent forms: how to determine and improve their readability. Oncol Nurs Forum 1992, 19:1523-1528.
    • (1992) Oncol Nurs Forum , vol.19 , pp. 1523-1528
    • Meade, C.D.1    Howser, D.M.2
  • 57
    • 33846539593 scopus 로고    scopus 로고
    • Beyond the socialscience critique of applied ethics
    • on line
    • Hedegecoe A: Beyond the socialscience critique of applied ethics. Bioethics 2004, 18:1467-8519. (on line)
    • (2004) Bioethics , vol.18 , pp. 1467-8519
    • Hedegecoe, A.1
  • 58
    • 33747961811 scopus 로고    scopus 로고
    • Empirical research on informed consent: An annotated bibliography
    • Sugarman J, McCrory DC, Powell D: Empirical research on informed consent: an annotated bibliography. Hastings Cent Rep 1999, 29:S1-S42.
    • (1999) Hastings Cent Rep , vol.29
    • Sugarman, J.1    McCrory, D.C.2    Powell, D.3
  • 59
    • 0038501058 scopus 로고    scopus 로고
    • Oversight of Clinical Research
    • American Society of Clinical Oncology Policy Statement
    • American Society of Clinical Oncology Policy Statement. Oversight of Clinical Research. Journal of Clinical Oncology 2003, 21:2377-2386.
    • (2003) Journal of Clinical Oncology , vol.21 , pp. 2377-2386
  • 60
    • 0018240061 scopus 로고
    • Videotape aids informed consent decision
    • Barbour GL, Blumenkrantz MJ: Videotape aids informed consent decision. JAMA 1978, 240:2741-2742.
    • (1978) JAMA , vol.240 , pp. 2741-2742
    • Barbour, G.L.1    Blumenkrantz, M.J.2
  • 61
    • 0031951886 scopus 로고    scopus 로고
    • Communicating with patients who have limited literacy skills: Report of the National Work Group on Literacy and Health
    • Communicating with patients who have limited literacy skills: Report of the National Work Group on Literacy and Health. J Fam Pract 1998, 46:168-176.
    • (1998) J Fam Pract , vol.46 , pp. 168-176
  • 62
    • 4043134573 scopus 로고    scopus 로고
    • Ethics review procedures for research in developing countries: A basic presumption of guilt
    • Gilman RH, Garcia HH: Ethics review procedures for research in developing countries: a basic presumption of guilt. Can Med Assoc J 2004, 171:248-249.
    • (2004) Can Med Assoc J , vol.171 , pp. 248-249
    • Gilman, R.H.1    Garcia, H.H.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.