Informed consent and quality of available information

Abstract

Standard versions of the requirement of informed consent state that patients who are offered to enter a clinical trial of a medical procedure should be informed about risks and possible benefits of this procedure (compared to available alternatives) in order to facilitate a rational decision whether or not to participate. However, in many real cases where new medical procedures are to be clinically tested for the first time the information available for such communication to prospective patients is very scarce, vague and/or uncertain. This phenomenon is illustrated by the clinical introduction of new procedures in reproductive medicine, such as preimplantation genetic diagnosis (PGD). Regarding such procedures, it has ben argued that, in such cases, the quality of the available information may be too low for the obtaining of informed consent to be possible, even if it is successfully communicated. Others, instead, holds that informed consent may always be obtained regardless of the quality of the available information. Unfortunately, the standard litterature on informed consent give no clue as to which of these interpretations is correct. This issue is explored by connecting the concept of informed consent to ethical ideas of respect for autonomy and ideas of rational decision making. It is argued, first, that low quality of available information regarding the risks and possible benefits of a medical procedure may indeed make the obtaining of informed consent from patients to undergo this procedure impossible even in theory. However, it is also argued that whether or not this is the case must be relativized to the actual needs and deires of individual patients. Thus, regarding one and the same procedure, informed consent may be impossible to obtain from some patients due to the low quality of the available information regarding this procedure, but still be possible to obtain from other patients.

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Christian Munthe
University of Gothenburg

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