Consenting of the vulnerable: the informed consent procedure in advanced cancer patients in Mexico
- Emma L Verástegui
- … show all 1 hide
A topic of great concern in bioethics is the medical research conducted in poor countries sponsored by wealthy nations. Western drug companies increasingly view Latin America as a proper place for clinical research trials. The region combines a large population, modern medical facilities, and low per capita incomes. Participants from developing countries may have little or non alternative means of treatment other than that offered through clinical trials. Therefore, the provision of a valid informed consent is important.
To gain insight about some aspects of the informed consent procedure in a major cancer centre in Mexico, we conducted a three-step evaluation process: 1) a ten point multiple choice survey questionnaires, was used to explore some aspects of the patients' experiences during the informed consent process, 2) researchers' knowledge about specific aspects of the informed consent was evaluated in this study using survey questionnaires; and 3) the comprehensibility, readability and number of pages of the consent forms were analysed. The socioeconomic and educational level of the patients, were also considered. Results were reported using a numerical scale.
Thirty five patients, 20 doctors, and 10 individuals working at the hospital agreed to participate in the study. Eighty three percent of the patients in the study were classified as living in poverty; education level was poor or non existent, and 31% of the patients were illiterate. The consent forms were difficult to understand according to 49% of the patients, most doctors agreed that the forms were not comprehensible to the patients. The average length of the IC documents analysed was 14 pages, and the readability average score was equivalent to 8TH Grade.
The results presented in this work describe some relevant characteristics of the population seen at public health care institutions in Mexico. Poverty, limited or no education, and the complexity of the information provided to the patients may question the validity of the informed consent procedure in this group of patients.
- Porter R: The Greatest Benefits to Mankind. Harper Collins. London, Chapter VII, cited in: British Medical Association. The Medical Profession and Human Rights: Handbook for a Changing Agenda. Research and Experimentation in Humans Zed Books Ltd. New York, NY, US 1997., 206:
- The Nuremberg Code JAMA 1996, 276:1691.JAMA 1996,276:1691.
- Declaration of Helsinki. JAMA 277: pp. 925-926 CrossRef
- The Belmont Report National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research Washington, DC: US Government Printing Office 1979.
- International Ethical Guidelines for Biomedical Research Involving Human Subjects. CIOMS, Geneva, Switzerland
- Hawkins, JS, Emanuel, EJ (2005) Clarifying confusions about coercion. Hasting Center Report 35: pp. 16-19
- Levine, RJ (1994) The impact of HIV infection on society's perception of clinical trials. Kennedy Institute J Ethics 4: pp. 93-98
- Angell, M (1997) Ethics of clinical research in third world. N Engl J Med 337: pp. 847-92 CrossRef
- Cleaton-Jones, PE (1997) An ethical dilemma: availability of antiretroviral therapy after clinical trials with HIV infected patients re ended. BMJ 314: pp. 887-91
- Barry, M (1988) Ethical considerations of human investigation indeveloping countries: the AIDS dilemma. N Engl J Med 319: pp. 1083 CrossRef
- Angell, M (1988) Ethical imperialism-ethics in international collaborative clinical research. N Engl J Med 319: pp. 1081-83 CrossRef
- Annas, GJ, Grodin, MA (1988) Human rights and maternal-fetal HIV transmission prevention trials in Africa. Am J Public Health 88: pp. 560-3 CrossRef
- Palca, J (1990) African AIDS: Whose research rules?. Science 250: pp. 199-201 CrossRef
- Emanuel, EJ, Wendler, D, Grady, C (2000) What makes clinical research ethical?. JAMA 283: pp. 2701-2711 CrossRef
- Corrigan, O (2003) Empty Ethics: The problem with informed consent. Sociology & Health Illness 25: pp. 768-792 CrossRef
- Warren ReichT, editor: Encyclopaedia of Bioethics, [New York: Simon Schuster Macmillan, 1995, 1XXI, cited by Jonsen A.R. Source book. Bioethics. A documentary History (Edited by: Jonsen AR, Veatch RM, Malters LR). Georgetown University Press, Washington DC 1998., 4:
- Jonsen, AR The ethics of research with human subjects: A short history. In: Jonsen, AR, Veatch, RM, Malters, LR eds. (1998) Source book in Bioethics. A documentary History. Georgetown University Press, Washington DC
- O, O'Neill (2003) Some limits of informed consent. J Med Ethics 29: pp. 4-7 CrossRef
- Dworkin, G (1988) The Theory and Practice of Autonomy. Cambridge University Press, New York, NY CrossRef
- Wolpe, P The Triumph of Autonomy in American Medical Ethics. In: DeVries, R, Subedi, H eds. (1998) Bioethics and Society: Sociological Investigations of the Enterprise of Bioethics. Prentice-Hall, New York, pp. 38-59
- Beauchamp, TL, Childress, J (1996) The Principles of Biomedical Ethics. Oxford University Press, New York, NY
- Farmer, P (2000) Can transnational research be ethical in developing world?. Lancet 360: pp. 1266 CrossRef
- Pellegrino E[http://clinicalbioethics.georgetown.edu/faculty/edp.html] 2005.
- Goodyear-Smith, F, Lobb, B, Davies, (2002) International variation in ethics committee requirements: comparisons across five Westernised nations. BMC Med Ethics 3: pp. 2 CrossRef
- Kottow, M (2004) The battering of informed consent. J Med Ethics 30: pp. 565-569 CrossRef
- Daugherty, C, Ratain, MJ, Grochowski, E, Stocking, C, Kodish, E, Mick, R (1995) Perceptions of cancer patients and their physicians involved in phase I trials. J Clin Oncol 13: pp. 1062-72
- Joffe, S, Cook, EF, Cleary, PD, Clark, JW, Weeks, JC (2001) Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet 358: pp. 1772-1777 CrossRef
- Seguro Popular Fondo de Gastos Catastróficos.
- B Bhutta ZA: Beyond Informed Consent. [http://www.who.int/bulletin/volumes/82/10/]Bulletin of the World Health Organization 2004. Downloaded April 2005
- De Young K, Nelson D: Latin America Is Ripe for Trials, and Fraud. Frantic Pace Could Overwhelm Controls. [http://www.washingtonpost.com]
- Impact of the Pharmaceutical Industry on Medical Research: House of Commons Health Committee August 2004[http://info.cancerresearchuk.org/publicpolicy/consultations/pharmaceuticals/] 2005.
- Verástegui E: Are we working for the pharmaceutical industry? Dissertation Paper. The London School of Economics. MSc BIOS 2005, in press.
- 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 Manual for Research Ethics Committees (Edited by: Eckstein S). Centre of Medical Law and Ethics, Kings College, London. Cambridge University Press 2003, 105.
- 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. [http://www.salud.gob.mx/unidades/cdi/nom/compi/rlgsmis.html]Articulo 14 Fracción -V
- ICH Good Clinical Practices. Eckstein, S eds. (2003) Manual for Research Ethics Committees. Centre of Medical Law and Ethics, Kings College. Cambridge University Press, London, pp. 133-149
- 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")
- 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.
- Sepúlveda, B (1984) Los derechos del paciente. Gac Méd Méx 120: pp. 271-272
- Paasche-Orlow, MK, Taylor, HA, Brancati, FL (2003) Readability Standards for Informed-Consent Forms as Compared with Actual Readability. N Eng J Med 348: pp. 721-726 CrossRef
- Kincaid JP, Fishburne RP, Rogers RL, Chissom BS: Derivation of new readability formulas (Automated Readability Index, Fog Count, and Flesch Reading Ease Formula) for Navy enlisted personnel. Research Branch report 8–75. Memphis: Naval Air Station, Doak CC 1975.
- Daugherty, CK (2003) Impact of Therapeutic Research on Informed Consent and the Ethics of Clinical Trials: A Medical Oncology Perspective. J Clin Oncol 17: pp. 1601-1617
- Rueda Mancini, Roberto : Normas Éticas para la Investigación Clínica. [http://www.uchile.cl/bioetica/doc/normas.htm]Disponible en
- La Rocca, S, Martinez, G, Rascio, A (2005) Biomedical Investigation and Informed Consent in Vulnerable Populations and Individuals. Acta Bioeth. [Online] 11: pp. 169-181
- Skinner, MW, Lillicrap, DP, McMillan, J (2003) What is cure and how do we get there?. Haemophilia 10: pp. 115-188 CrossRef
- Miller, F, Brody, H (2003) A critique of clinical equipoise. Therapeutic misconception in the ethics of clinical trials. Hasting Center Report 33: pp. 19-28 CrossRef
- Miller, F, Rosenstein, D (2003) The therapeutic orientation of clinical trials. New Eng J Med 348: pp. 1383-1386 CrossRef
- Miller, F, Silverman, H (2004) The ethical relevance of thestandard of care in the design of clinical trials. AM J Respir Crit Care Med 169: pp. 562-564 CrossRef
- Katz, J (1972) Experimentation with human beings: the authority of the investigator, subject, professions, and state in the human experimentation process. Russell Sage Foundation, New York
- Preminger, BA (2002) The case of Chester M. Southam. Research ethics and the limits of professional responsibility. Pharos Alpha Omega Alpha Honor Med Soc 65: pp. 4-9
- Drazen, JM, Koski, G (2000) To protect those who serve. N Engl J Med 343: pp. 1643-1645 CrossRef
- Habiba, M, Evans, M (2002) The Inter-role Confidentiality Conflict in Recruitment for Clinical Research. The Journal of Medicine and Philosophy 27: pp. 565-587 CrossRef
- Lewens, T (2006) Distinguishing treatment from research : a functional approach. J Med Ethics 32: pp. 424-429 CrossRef
- Lindegger, G, Richter, LM (2000) HIV vaccine trials: Critical issues in informed consent. South African J of Sci 313: pp. 317
- Emanuel, EJ, Wood, A, Fleischman, A, Bowen, A (2004) Oversight of Human Participants Research: Identifying Problems To Evaluate Reform Proposals. Ann Intern Med 141: pp. 282-291
- Flory, J, Emanuel, E (2004) Interventions to Improve Research Participants' Understanding in Informed Consent for Research A Systematic Review. JAMA 292: pp. 1593-1601 CrossRef
- Meade, CD, Howser, DM (1992) Consent forms: how to determine and improve their readability. Oncol Nurs Forum 19: pp. 1523-1528
- Hedegecoe, A (2004) Beyond the socialscience critique of applied ethics. Bioethics 18: pp. 1467-8519
- Sugarman, J, McCrory, DC, Powell, D (1999) Empirical research on informed consent: an annotated bibliography. Hastings Cent Rep 29: pp. S1-S42
- American Society of Clinical Oncology Policy Statement. Oversight of Clinical Research Journal of Clinical Oncology 2003, 21:2377–2386.
- Barbour, GL, Blumenkrantz, MJ (1978) Videotape aids informed consent decision. JAMA 240: pp. 2741-2742 CrossRef
- 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.
- Gilman, RH, Garcia, HH (2004) Ethics review procedures for research in developing countries: a basic presumption of guilt. Can Med Assoc J 171: pp. 248-249 CrossRef
- The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1472-6939/7/13/prepub
- Consenting of the vulnerable: the informed consent procedure in advanced cancer patients in Mexico
- Open Access
- Available under Open Access This content is freely available online to anyone, anywhere at any time.
BMC Medical Ethics
- Online Date
- December 2006
- Online ISSN
- BioMed Central
- Additional Links
- Emma L Verástegui (1) (2)
- Author Affiliations
- 1. Ethics Committee, Instituto Nacional de Cancerologia, Avenida San Fernando 22, Mexico City, Mexico
- 2. Comision Nacional de Bioetica, Torre Zafiro 1, Periferico Sur 4118, piso 1, México City, Mexico