Abstract
BackgroundA 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.MethodsTo 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.ResultsThirty 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.ConclusionThe 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.
Highlights
A topic of great concern in bioethics is the medical research conducted in poor countries sponsored by wealthy nations
The purpose of this paper is to assess some aspects of the informed consent (IC) procedure from different perspectives in order to detect possible ways to improve the procedure in the near future, including: 1) experiences regarding the IC of a group of patients enrolled in clinical research trials, 2) doctors' perception about the consent procedure, of international sponsored trials and 3) review of several features from randomly selected consent forms
What is the purpose of the informed consent? To inform the patient about the treatment A requirement of the hospital authorities A requirement of the Mexican health authorities A requirement of the international sponsors A requirement of the Clinical Research Organizations (CRO)
Summary
A topic of great concern in bioethics is the medical research conducted in poor countries sponsored by wealthy nations. Participants from developing countries may have little or non alternative means of treatment other than that offered through clinical trials. BMC Medical Ethics 2006, 7:13 http://www.biomedcentral.com/1472-6939/7/13 according to the standards and theories available at the time that it was conducted [1]. A topic of great concern in medical ethics is the biomedical research being sponsored by wealthy nations and conducted in underprivileged countries. Unequal resource distribution between external research sponsors and health care facilities in developing countries may increase the hazard of exploitation [7]. During the course of the disease, standard approved treatments are exhausted; most cancer patients will eventually participate in experimental clinical trials [26,27]
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