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Informed consent: theory versus practice

Nature Clinical Practice Cardiovascular Medicine volume 2, pages 270–271 (2005)Cite this article

Informed consent has been defined as “an individual's autonomous authorization of a medical intervention or of participation in research”.1 In professional and legal regulations it is widely established that informed consent is a necessary element of good clinical practice.2,3 Beyond providing information to patients and potential research participants, it is important that the physician or investigator assesses the patients' competence and understanding, promotes their comprehension and facilitates their participation in the decision-making process. In fact, providing information ensures patients have sufficient understanding so they have a real chance of making a choice in their best interests. This viewpoint examines how consent procedures should be adapted to match a patient's capacity to understand, their preferences in terms of information and their degree of involvement in the decision. In order to provide a nuanced description and analysis of the concept of informed consent, it should be discussed in the light of how things are in the real world.

Defining the key pieces of information that should be presented to patients could help to improve the practice of informed consent. It is difficult, however, to set strict guidelines or refer to a particular standard that constitutes adequate disclosure of information across different clinical contexts. The subjective standard acknowledges that the information given should be tailored to match the specific informational needs of the patient, taking into account factors such as their health beliefs and cultural background. This might be the best ethical standard of disclosure, but referring exclusively to this standard is not sufficient. For example, many patients do not know what information might be relevant to their decision.1 Physicians have a responsibility, therefore, to provide information that is regarded as essential from a professional perspective and insure that patients do not base their decisions on false beliefs. It should also be noted that although patients might feel they have been satisfactorily informed, this is not a guarantee that they know the fundamental facts related to the study or treatment option.4 A real picture of patients' understanding can be obtained by asking them about information previously given and about their beliefs and concerns.

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  1. senior physician and specialist at the Department of Medicine at Sahlgren's University Hospital, Göteborg, Sweden

    Anders Ågård

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  1. Anders Ågård
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Correspondence to Anders Ågård.

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Ågård, A. Informed consent: theory versus practice. Nat Rev Cardiol 2, 270–271 (2005). https://doi.org/10.1038/ncpcardio0220

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