Informed consent: A study of patients with life-threatening illnesses

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Abstract

Background:

The relationship between healthcare professionals and patients in the Spanish health sector has undergone dramatic change. One aspect of this is that the use of informed consent has become a key factor in the delivery of adequate healthcare. But although a certain period of time has already passed since informed consent started to be used, in Spain there is still doubt about how adequately informed consent is being used.

Objectives:

(a) To look at how patients understand the notion and purpose of informed consent, and (b) how the informed consent is applied – the way patients receive such information affects their level of participation and decision making during the time they receive medical care.

Methodology:

We use interpretative description of interviews with patients. We developed guiding questions for the interviews with patients in two preliminary and exploratory focus groups. Then, we carried out 20 personal open-ended interviews with 20 purposive selected patients with illnesses that had a serious impact on their lives.

Ethical considerations:

Permission from ethical committees and institutions involved in the study, and consent and confidentiality were ensured before conducting the research.

Results:

The findings show that while patients agreed that their consent should be necessary for health professionals to be able to intervene, they had serious difficulty obtaining and then understanding information offered to them at the moment when they were being asked to sign informed consent documents. The participants were critical of the consent documents, which they considered were treated as merely a formality and even some of them had felt coerced to sign.

Discussion:

Participants confirmed that the informed consent documents that they signed did not meet their ethical objectives. Their perception of the purpose of consent indicates that informed consent document may still be largely understood as a formality rather an ethical obligation.

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