Abstract

VISBAL ILLERA, Gloria Cecilia. The Capacity to Make Decisions about the Informed Consent by potentially subjected individuals for Clinical Drug Trials in the city of Barranquilla (Colombia), during the period of May to November 2009.. Salud, Barranquilla [online]. 2010, vol.26, n.1, pp.1-11. ISSN 0120-5552.

Objective: To determine the capacity level to make decisions about the informed consent by potentially subjected individuals for clinical drug trials in the city of Barranquilla. Materials and method's: A cross-sectional descriptive study was made to a group of 100 patients between the ages of 28 and 66 who were diagnosed with Arterial Hypertension and Diabetes Mellitus Type II, who would potentially participate in a voluntary way in experimental clinical studies sponsored by the pharmaceutical industry. In order to develop this project, the investigator used the model of capacity evaluation: MacCAT-CR. Statistics were calculated using non-parametric methods such as X² and median test. Results: Subjects did not have complete understanding of the test's nature, only 3 of the whole group had a score above 42 correct answers, from a total of 46 questions. An important observation made by the investigator, was that although 76% of the subjects admitted to not fully understand the nature of the trial, 86% did not understand how the trial could affect them, but still showed interest in being part of it. In addition, 62% of the subjects did not understand that the main reason of the trial was not to supply medication, but to investigate the efficacy, tolerance and effects of such medication in human beings. Conclusions: It can be concluded that the subjects autonomy to decide whether or not participate in a clinical trials is based on the trust, cooperation, ethics, and open dialogue, according to the data presented in the informed consent. Considering that the information provided in this inform transcends, to more than a document, into an acceptance and legalization of the procedures presented.

Keywords : Ability to make decisions; informed consent; experimental drug trials.

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