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Ethical Issues in Deep Brain Stimulation Research for Treatment-Resistant Depression: Focus on Risk and Consent.

Laura B Dunn1, Paul E Holtzheimer2, Jinger G Hoop3

  • 1University of California, San Francisco.

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|August 1, 2015
PubMed
Summary

Deep brain stimulation (DBS) for treatment-resistant depression (TRD) raises ethical questions about informed consent. Current evidence does not support extra safeguards beyond standard high-risk study protocols.

Keywords:
decision-making capacitydeep brain stimulationdepressioninformed consentneuroethicspsychiatryresearch ethics

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Area of Science:

  • Neuroscience
  • Bioethics
  • Psychiatry

Background:

  • Deep brain stimulation (DBS) is under investigation for treatment-resistant depression (TRD).
  • DBS research for TRD presents ethical challenges, particularly concerning patient decision-making capacity and informed consent.
  • Concerns are raised by bioethicists, researchers, IRBs, and the public.

Purpose of the Study:

  • To examine informed consent for DBS research in TRD patients.
  • To analyze decision-making capacity in individuals with depression.
  • To explore the implications of TRD and invasive brain surgery on informed consent.

Main Methods:

  • Review of existing evidence on decision-making capacity and depression.
  • Analysis of the ethical considerations specific to DBS as an intervention for TRD.
  • Examination of the procedural and disease-related factors impacting informed consent.

Main Results:

  • Available empirical evidence does not substantiate the need for additional safeguards in DBS research for TRD beyond those for other high-risk studies.
  • The nature of TRD and the invasiveness of DBS surgery are critical factors in informed consent discussions.
  • Limited data exists on invasive procedures for severely ill psychiatric patients.

Conclusions:

  • Current evidence does not support enhanced ethical safeguards for DBS research in TRD.
  • Further research is needed to systematically address the ethical issues of invasive procedures in severely ill psychiatric patients.
  • Advocates for a research agenda to study ethical considerations in DBS for TRD.