Consenting of the vulnerable: the informed consent procedure in advanced cancer patients in Mexico [Book Review]
BMC Medical Ethics 7 (1):1-12 (2006)
|Abstract||Background 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. Methods 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. Results 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. Conclusion 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.|
|Keywords||No keywords specified (fix it)|
|Categories||categorize this paper)|
|Through your library||Configure|
Similar books and articles
Jane L. Hutton & Richard E. Ashcroft (2000). Some Popular Versions of Uninformed Consent. Health Care Analysis 8 (1):41-53.
James R. P. Ogloff & Randy K. Otto (1991). Are Research Participants Truly Informed? Readability of Informed Consent Forms Used in Research. Ethics and Behavior 1 (4):239 – 252.
Caroline Jones (2010). An Australian Based Study on the Readability of HIV/AIDS and Type 2 Diabetes Clinical Trial Informed Consent Documents. Journal of Bioethical Inquiry 7 (3):313-319.
Piotr Zaborowski & Adam Górski (2004). Informed Consent and the Use of Placebo in Poland: Ethical and Legal Aspects. Science and Engineering Ethics 10 (1).
N. Waller Bruce (1995). Individual Autonomy and the Double-Blind Controlled Experiment: The Case of Desperate Volunteers. Journal of Medicine and Philosophy 20 (1).
Dayna Bowen Matthew (2008). Race, Religion, and Informed Consent - Lessons From Social Science. Journal of Law, Medicine and Ethics 36 (1):150-173.
Laura Buccini, Donald Iverson, Peter Caputi & Caroline Jones (2010). An Australian Based Study on the Readability of HIV/AIDS and Type 2 Diabetes Clinical Trial Informed Consent Documents. Journal of Bioethical Inquiry 7 (3):313-319.
Piotr S. Iwanowski (2007). Informed Consent Procedure for Clinical Trials in Emergency Settings: The Polish Perspective. Science and Engineering Ethics 13 (3):333-336.
H. El-Wakeel (2006). What Do Patients Really Want to Know in an Informed Consent Procedure? A Questionnaire-Based Survey of Patients in the Bath Area, UK. Journal of Medical Ethics 32 (10):612-616.
Martin Gunderson, David J. Mayo & Frank S. Rhame (1996). Routine HIV Testing of Hospital Patients and Pregnant Women: Informed Consent in the Real World. Kennedy Institute of Ethics Journal 6 (2):161-182.
Akira Akabayashi & Brian Taylor Slingsby (2006). Informed Consent Revisited: Japan and the U.S. American Journal of Bioethics 6 (1):9 – 14.
Sheila McLean (2010). Autonomy, Consent and the Law. Routledge-Cavendish.
Susan S. Khalil, Henry J. Silverman, May Raafat, Samer El-Kamary & Maged El-Setouhy (2007). Attitudes, Understanding, and Concerns Regarding Medical Research Amongst Egyptians: A Qualitative Pilot Study. [REVIEW] BMC Medical Ethics 8 (1):9.
Added to index2010-11-17
Total downloads2 ( #245,680 of 722,764 )
Recent downloads (6 months)0
How can I increase my downloads?