Ethics and Informed Consent of Vagus Nerve Stimula

Authors: Fabrice Jotterand Shawn M McClintock Archie A Alexander Mustafa M Husain

Publish Date: 2010/01/12

Volume: 3, Issue: 1, Pages: 13-22

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Abstract

Since the Nuremberg trials 1947–1949 informed consent has become central for ethical practice in patient care and biomedical research Codes of ethics emanating from the Nuremberg Code 1947 recognize the importance of protecting patients and research subjects from abuses manipulation and deception Informed consent empowers individuals to autonomously and voluntarily accept or reject participation in either clinical treatment or research In some cases however the underlying mental or physical condition of the individual may alter his or her cognitive abilities and compromise the informed consent process This is particularly true in chronic psychiatric conditions such as TreatmentResistant Depression TRD where individuals may fail to respond to traditional antidepressant treatments eg psychotherapy pharmacotherapy Moreover it may raise further concerns for an individual’s motivation to consent and the level of understanding of the treatment or research procedure This paper focuses on the informed consent process for Vagus Nerve Stimulation VNS in the treatment of individuals diagnosed with TRD Specifically the paper addresses how depression may affect the decisionmaking capacity of an individual and the potential ethical and legal impact of failure to appreciate the seven elements of the consenting process competence voluntariness disclosure recommendation understanding decision and authorization To ensure the protection of vulnerable individuals with psychiatric disorders such as TRD and promote ethical behavior in biomedical research and patient care while avoiding potential legal pitfalls we propose a paradigm that requires a stringent evaluation process of decisionmaking capacity for informed consent

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