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Informed Consent: Substantive v. Formalistic Approach and the Law
Journal article   Peer reviewed

Informed Consent: Substantive v. Formalistic Approach and the Law

Chung-Lin Chen
Eubios Journal of Asian and International Bioethics Eubios Journal of Asian and International Bioethics, Vol.27(1), pp.22-28
2017

Abstract

Substantive v. Formalistic Approach;Law
The rule of informed consent is universallyregarded as a cornerstone in governing patientphysicianrelationships. The key element of “informed”stresses that only the consent given afterconsideration of sufficient information constitutes validconsent. However, various studies in many countrieshave shown inadequate information can often takeplace resulting in lack of understanding of medicalprocedures. What role does the legal system play inpromoting substantive informing and respecting the willof the patients? And how does it realize the true ideaof informed consent?Taking Taiwan as an example, this paper revealsthe dynamic and interactive relationships between lawand practices on this issue. First, the law mayincorporate the idea of informed consent into specificmandates to prompt its implementation. Second,however, the need of evidence in court may sustain oreven reinforce undesirable formalistic practices thatlargely focus on written consent forms rather thansubstantive explanation. Third, to respond to theseformalistic practices, courts could reconstruct theshape of the legal requirement and guide institutionsand physicians to the new direction. The assertion ofthis paper is that formalistic practices are inconsistentwith the legal nature of informed consent, regardless ofwhether they appear to have complied with the law ornot. If courts can acknowledge the problem offormalism and are willing to actively investigate orrequest institutions for alternative evidence todetermine whether a meaningful dialogue existed ornot, the practices may be directed further towardsfulfilling the spirit of informing.

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