Disclosure: The Hidden Weakness in Informed Consent
Dissertation, University of Minnesota (
2004)
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Abstract
For centuries, doctors have been required to obtain a patient's consent before beginning treatment. However, informed consent ---the doctrine that requires a doctor also to inform the patient of a treatment's risks, benefits, and alternatives---is relatively new, having been introduced in the last half century. ;Standard accounts consider informed consent to consist of five elements: professional disclosure of information, comprehension of that information, competence to decide, freedom from undue influence, and the intentional act of consenting. Of these, disclosure is the element that has escaped close scrutiny in terms of its quality , in particular, its provision of reliable information is taken for granted. But the question of the integrity of the information is of fundamental importance. There is evidence of systemic and widespread failings in disclosure: The information is not known or not known well enough. The information may be incomplete, biased, or mistaken. And sometimes there is deception and suppression of information. ;This dissertation examines the failings of disclosure in drug-therapy, in the standard therapeutic relationship, and in medical research. Suggestions are given for policy reforms to improve the quality of the disclosed information. Finally, an amendment is offered to the standard accounts of informed consent: because disclosure too frequently fails to provide complete and reliable information, patients should undertake independent research to ensure that the medical care to which they consent is indeed the care that they wish to receive. The active-patient model of informed consent incorporates such independent research into the informed-consent process