Ethics and informed consent of vagus nerve stimulation (VNS) for patients with treatment-resistant depression (TRD)

Fabrice Jotterand, Shawn M. McClintock, Archie A. Alexander, Mustafa M. Husain

Research output: Contribution to journalArticle

5 Citations (Scopus)

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 Treatment-Resistant Depression (TRD), where individuals may fail to respond to traditional antidepressant treatments (e.g., 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 decision-making 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 decision-making capacity for informed consent.

Original languageEnglish (US)
Pages (from-to)13-22
Number of pages10
JournalNeuroethics
Volume3
Issue number1
DOIs
StatePublished - Apr 2010

Fingerprint

Treatment-Resistant Depressive Disorder
Vagus Nerve Stimulation
Informed Consent
Ethics
Psychiatry
Biomedical Research
Decision Making
Patient Care
Research Subjects
Codes of Ethics
Aptitude
Disclosure
Therapeutics
Deception
Research
Psychotherapy
Mental Competency
Antidepressive Agents
Motivation
Depression

Keywords

  • Informed consent
  • Neuroethics
  • Policy
  • Treatment resistant depression
  • Vagus nerve stimulation

ASJC Scopus subject areas

  • Health Policy
  • Neurology
  • Psychiatry and Mental health

Cite this

Ethics and informed consent of vagus nerve stimulation (VNS) for patients with treatment-resistant depression (TRD). / Jotterand, Fabrice; McClintock, Shawn M.; Alexander, Archie A.; Husain, Mustafa M.

In: Neuroethics, Vol. 3, No. 1, 04.2010, p. 13-22.

Research output: Contribution to journalArticle

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