Informed Consent: Substantive v. Formalistic Approach and the Law

Eubios Journal of Asian and International Bioethics 27 (1):22-22 (2017)
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Abstract

The rule of informed consent is universally regarded as a cornerstone in governing patientphysician relationships. The key element of “informed” stresses that only the consent given after consideration of sufficient information constitutes valid consent. However, various studies in many countries have shown inadequate information can often take place resulting in lack of understanding of medical procedures. What role does the legal system play in promoting substantive informing and respecting the will of the patients? And how does it realize the true idea of informed consent? Taking Taiwan as an example, this paper reveals the dynamic and interactive relationships between law and practices on this issue. First, the law may incorporate the idea of informed consent into specific mandates to prompt its implementation. Second, however, the need of evidence in court may sustain or even reinforce undesirable formalistic practices that largely focus on written consent forms rather than substantive explanation. Third, to respond to these formalistic practices, courts could reconstruct the shape of the legal requirement and guide institutions and physicians to the new direction. The assertion of this paper is that formalistic practices are inconsistent with the legal nature of informed consent, regardless of whether they appear to have complied with the law or not. If courts can acknowledge the problem of formalism and are willing to actively investigate or request institutions for alternative evidence to determine whether a meaningful dialogue existed or not, the practices may be directed further towards fulfilling the spirit of informing.

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