Nuestras miradas, nuestras realidades (IV)

En Developing World Bioethics (OnlineEarly Articles) aparece un trabajo de las brasileñas Silvana Ferreira Bento, Ellen Hardy y María José Duarte Osis, de la Universidad de Campinhas, sobre el consentimiento informado. Trabajaron con 8 grupos focales, y un total de 51 mujeres participaron (habían participado o lo estaban haciendo en un estudio sobre anticoncepción). Es muy interesante y recomendable leer la discusión metodológica y los resultados, que ilustran sobre aspectos cualitativos del proceso de CI.

Final comments

The results presented here contribute to the discussion on the process of obtaining informed consent, particularly with respect to questioning the more simplistic approaches of the issue, which emphasize only the need for an informative document and the signature of the volunteer(s). Analysis of the statements and suggestions made by the women who participated in the focus groups reveals that they, in agreement with specialists on the subject, do not view obtaining informed consent as a ritual, synthesized by the moment at which the volunteer signs the document.56 Likewise, the participants of this study did not consider consent to be a form of bureaucracy aimed at exempting the investigator from his/her responsibilities.57 On the contrary, they understood that, by its very nature, the informed consent created a link between the potential volunteers and the investigator, albeit indirectly through another member of the research team.

Since informed consent is seen as being essential in guaranteeing respect for the autonomy of volunteers when they decide to accept or refuse to participate in a study,58 the findings of this study indicate the need for a constant critical reflection by investigators and institutional review boards in order to avoid the mere ritualism of obtaining a signature on a document. Means need to be found of promoting a real interaction between investigator and volunteers which will guarantee volunteers the liberty to question aspects of the study and request clarification prior to taking a decision. However, even if this dynamic is promoted, it should not be forgotten that, for example, in the context of a developing country such as Brazil, volunteers are frequently people who face difficulties in obtaining even the most basic healthcare, which, without doubt, may increase the difficulties in exercising their autonomy as potential research subjects.59 It should be remembered that the promotion of justice as a social equity is also a principle of bioethics and should be included in the agenda of discussions and interventions, the objective of which is to improve the health conditions of populations as well as placing an emphasis on the need for research to increase scientific knowledge.

Developing World Bioethics (OnlineEarly Articles).

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