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Ethics and Informed Consent of Vagus Nerve Stimulation (VNS) for Patients with Treatment-Resistant Depression (TRD)

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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 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.

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References

  1. Grim, D.A. 2007. Informed consent for all! No exceptions. New Mexico Law Review 37: 39–83.

    Google Scholar 

  2. American Society for Gastrointestinal Endoscopy. 2007. Guideline: Informed consent for GI endoscopy. Gastrointestinal Endoscopy 66: 213–218.

    Article  Google Scholar 

  3. Mello, M.M., D.M. Studdert, and T.A. Brennan. 2003. The rise of litigation in human subjects research. Annals of Internal Medicine 139: 40–46.

    Google Scholar 

  4. Ville, D. and A. Kenneth. 1994. What does the law say? Law, ethics, and medical decision making. Western Journal of Medicine 160: 478–480.

    Google Scholar 

  5. Vars, F.E. 2008. Illusory consent: when an incapacitated patient agrees to treatment. Oregon Law Review 87: 353–400.

    Google Scholar 

  6. Zimring, S.D. 2006. Health care decision-making capacity: a legal perspective for long-term care providers. Journal of American Medical Directors Association 7: 322–326.

    Article  Google Scholar 

  7. Moye, J., R.J. Gurreara, M.J. Karel, B. Edelstein, and C. O’Connell. 2006. Empirical advances in the assessment of the capacity to consent to medical treatment: clinical implications and research needs. Clinical Psychology Review 26: 1054–1077.

    Article  Google Scholar 

  8. Ganzini, L., L. Volier, W.A. Nelson, E. Fox, and A.R. Derse. 2005. Ten myths about decision-making capacity. Journal of American Medical Directors Association 6: S100–S104.

    Article  Google Scholar 

  9. Charles, C., A. Gafni, T. Whelan, and M. OBrien. 2006. Cultural influences on the physician-patient encounter: The case of shared treatment and decision-making. Patient Education and Counseling 63: 262–267.

    Article  Google Scholar 

  10. Marson, D.C., R. Savage, and J. Philips. 2006. Financial capacity in persons with schizophrenia and serious mental illness: clinical and research ethics aspects. Schizophrenia Bulletin 32: 81–91.

    Article  Google Scholar 

  11. Appelbaum, P.S. 2007. Assessment of patients’ competence to consent to treatment. New England Journal of Medicine 357: 1834–1840.

    Article  Google Scholar 

  12. Etchells, E., P. Darzins, M. Silberfeld, P.A. Singler, J. McKenny, G. Naglie, et al. 1999. Assessment of patient capacity to consent to treatment. Journal of Internal Medicine 14: 27–34.

    Google Scholar 

  13. Thase, M.E. 2005. Pharmacologic strategies for treatment-resistant depression: An update on the state of the evidence. Psychiatric Annals 35: 970–978.

    Google Scholar 

  14. Fava, M. and K.G. Davidson. 1996. Definition and epidemiology of treatment resistant depression. The Psychiatric Clinics of North America 19: 179–200.

    Article  Google Scholar 

  15. Rush, A., M.S. George, et al. 2000. Vagus nerve stimulation (VNS) for treatment-resistant depressions: A multicenter study. Biological Psychiatry 47: 276–286.

    Article  Google Scholar 

  16. Hirschfeld, R.M., S.A. Montgomery, E. Aguglia, M. Amore, P.L. Delgado, M. Gastpar, et al. 2002. Partial response and nonresponse to antidepressant therapy: current approaches and treatment options. Journal of Clinical Psychiatry 220(63): 826–837.

    Google Scholar 

  17. Rush AJ, Siefert SE. Clinical issues in considering vagus nerve stimulation for treatment-resistant depression. Experimental Neurology. 2009. In Press, epub ahead of print.

  18. Lisanby, S.H. 2007. Electroconvulsive therapy for depression. New England Journal of Medicine 357: 1939–1945.

    Article  Google Scholar 

  19. Mayberg, H.S., A.M. Lozano, V. Voon, H.E. McNeely, D. Seminowicz, C. Hamani, et al. 2005. Deep brain stimulation for treatment-resistant depression. Neuron. 45: 651–660.

    Article  Google Scholar 

  20. Rado, J. and P.G. Janicak. 2007. Vagus nerve stimulation for severe depression. Journal of Psychosocial Nursing 45: 43–51.

    Google Scholar 

  21. George, M.S., H.A. Sackeim, et al. 2000. Vagus nerve stimulation: A new tool for brain research and therapy. Biological Psychiatry 47: 287–295.

    Article  Google Scholar 

  22. Kosel, M. and T.E. Schlaepfer. 2002. Mechanisms and state of the art of vagus nerve stimulation. Journal of ECT 18: 189–192.

    Article  Google Scholar 

  23. Chae, J.-H., Z. Nahas, M. Lomarev, S. Denslow, J.P. Lorberbaum, D.E. Bohning, et al. 2003. A review of functional neuroimaging studies of vagus nerve stimulation (VNS). Journal of Psychiatric Research 37: 443–455.

    Article  Google Scholar 

  24. Rush, A.J., L.B. Marangell, H.A. Sackheim, M.S. George, S. Brannan, S. Davis, et al. 2005. Vagus nerve stimulation for treatment-resistant depression: A randomized, controlled acute phase trial. Biology Psychiatry 58: 347–354.

    Article  Google Scholar 

  25. Rush, A., H.A. Sackeim, et al. 2005. Effects of 12 months of vagus nerve stimulation in treatment-resistant depression: A naturalistic study. Biological Psychiatry 58: 355–363.

    Article  Google Scholar 

  26. Matthews, K. and M.S. Eljamel. 2003. Vagus nerve stimulation and refractory depression. British Journal of Psychiatry 183: 181–183.

    Article  Google Scholar 

  27. Husain, M.M., K. Trevino, L.A. Whitworth, and S.M. McClintock. 2006. The role of Vagus nerve stimulation as a therapy for treatment-resistant depression. Depression: Mind and Body 2: 114–119.

    Google Scholar 

  28. Sackheim, H.A., A.J. Rush, M.S. George, M.M. Husain, Z. Nahas, C.R. Johnson, et al. 2001. Vagus nerve stimulation (VNS) for treatment-resistant depression: Efficacy, side effects, and predictors of outcome. Neuropsychopharmacology 25: 713–728.

    Article  Google Scholar 

  29. Nahas, Z., C. Teneback, J.-H. Chae, Q. Mu, C. Molnar, F.A. Kozel, et al. 2007. Serial Vagus nerve stimulation functional MRI in treatment-resistant depression. Neuropsychopharmacology 32: 1649–1660.

    Article  Google Scholar 

  30. McDonald, W.M., K. Easley, et al. 2006. Combination rapid transcranial magnetic stimulation in treatment refractory depression. Neuropsychiatric Disease And Treatment 2: 85–94.

    Google Scholar 

  31. Beauchamp, T.L. and J.F. Childress. 2009. Principles of Biomedical Ethics, 6th ed. Oxford: Oxford University.

    Google Scholar 

  32. Brock, D. 1987. Informed Consent. In Health Care Ethics, ed. D. VanDeVeer and T. Regan. Philadelphia: Temple University.

    Google Scholar 

  33. Appelbaum, P.S., T. Grisso, E. Frank, S. O’Donnell, and D.J. Kupfer. 1999. Competence of depressed patients for consent to research. American Journal of Psychiatry 156: 1380–1384.

    Google Scholar 

  34. Lapid, M.I., T.A. Rummans, V.S. Pankratz, and P.S. Applebaum. 2004. Decisional capacity of depressed elderly to consent to electroconvulsive therapy. Journal of Geriatric Psychiatry and Neurology 17: 42–46.

    Article  Google Scholar 

  35. Grisso, T. and P.S. Appelbaum. 1995. Comparison of standards for assessing patients’ capacities to make treatment decisions. American Journal of Psychiatry 152: 1033–1037.

    Google Scholar 

  36. Etchells, E. 1999. Informed consent in surgical trials. World Journal of Surgery 23: 1215–1220.

    Article  Google Scholar 

  37. Garrison, M. 2007. The empire of illness: Competence and coercion in health-care decision making. William & Mary Law Review 49: 781–843.

    Google Scholar 

  38. Cohen, B.J., E.L. McGarvey, R.C. Pinkerton, and L. Kryzhanivska. 2004. Willingness and competence of depressed and schizophrenic inpatients to consent to research. Journal of American Academy of Psychiatry and the Law. 32: 134–143.

    Google Scholar 

  39. Dunn, L.B., M.A. Nowrangi, B.W. Palmer, V.J. Jeste, and E.R. Saks. 2000. Assessing decisional capacity for clinical research or treatment: A review of instruments. American Journal of Psychiatry 163: 1323–1334.

    Article  Google Scholar 

  40. Karlawish, J. 2008. Measuring decision-making capacity in cognitively impaired individuals. Neurosignals. 16: 91–98.

    Article  Google Scholar 

  41. Rosenestein, D.L. and F.G. Miller. 2003. Ethical considerations in psychopharmacological research involving decisionally impaired subjects. Psychopharmocology. 171: 92–97.

    Article  Google Scholar 

  42. Rich, B.A. 2006. Medical paternalism v. respect for patient autonomy: The more things change the more they remains the same. Michigan State Journal of Medicine and Law 10: 87–124.

    Google Scholar 

  43. Rovit, R.L., A.S. Simon, S. Drew, R. Murali, and J. Robb. 2007. Neurosurgical experience with malpractice litigation: an analysis of closed claims against neurosurgeons in New York state, 1999 through 2003. Journal of Neurosurgery 106: 1108–1114.

    Article  Google Scholar 

  44. Studdard, D.M., M.M. Mello, A.A. Gwandi, T.K. Gandhi, A. Kachalia, C. Yoon, et al. 2006. Claims, errors, and compensation payments in medical malpractice litigation. New England Journal of Medicine 354: 2024–2033.

    Article  Google Scholar 

  45. Caplan, R.A. 2000. Informed consent: patterns of liability from the ASA closed claims Project. ASA Newspetter 64: 7–9.

    Google Scholar 

  46. Glabman, M. 2004. The top ten hospital malpractice claims—and how to minimize them. Trustee 57: 12–16.

    Google Scholar 

  47. Institute, E.C.R.I. 2008. Executive summary: informed consent. Healthcare Risk Control 2: 1–15.

    Google Scholar 

  48. King, J.S. and B.W. Moulton. 2006. Rethinking informed consent: The case for shared decision-making. American Journal of Law and Medicine 32: 429–493.

    Google Scholar 

  49. Merz, J.F. 1991. An empirical analysis of the medical informed consent doctrine: search for a “standard of disclosure”. Risk 2: 1–27.

    Google Scholar 

  50. Byatt, N., D. Pinals, and R. Arikan. 2006. Involuntary hospitalization of medical patients who lack decisional capacity: An unresolved issue. Psychosomatics 47: 443–448.

    Article  Google Scholar 

  51. Kim, S.Y.H. 2006. When does decisional impairment become decisional incompetence? Ethical and methodological issues in capacity research in schizophrenia. Schizophrenia Bulletin 32: 92–97.

    Article  Google Scholar 

  52. Agre, P., K. McKee, N. Gargon, and R.C. Kurtz. 1997. Patient satisfaction with an informed consent process. Cancer Practice 5: 151–153.

    Google Scholar 

  53. Bottrell, M.M., H. Alpert, Rl Fischbach, and L.L. Emanuel. 2000. Hospital informed consent for procedure forms: facilitating quality patient-physician interactions. Archives of Surgery 135: 26–33.

    Article  Google Scholar 

  54. Arnold, S.V., C. Decker, H. Ahmad, O. Olabiyi, S. Mundluru, K.J. Reid, et al. 2008. Converting the informed consent from a perfunctory process to an evidence-based foundation for patient decision making. Circulation: Cardiovascular Quality and Outcomes 1: 21–28.

    Article  Google Scholar 

  55. Adler, R.S. and E.M. Silverstein. 2000. When David meets Goliath: Dealing with power differentials in negotiations. Harvard Negotiation Law Review 5: 1–112.

    Google Scholar 

  56. Bagby, R.M., A.G. Ryder, D.R. Schuller, and M.B. Marshall. 2004. The Hamilton depression rating scale: has the gold standard become a lead weight? American Journal of Psychiatry 161: 2163–2177.

    Article  Google Scholar 

  57. Rush, A., C. Gullion, et al. 1996. The inventory of depressive symptomatology (IDS): Psychometric properties. Psychological Medicine 26: 477–486.

    Article  Google Scholar 

  58. Heisler, M., R.R. Bouknight, R.A. Hayward, D.M. Smith, and E.A. Kerr. 2002. The relative importance of physician communication, participatory decision making, and patient understanding in diabetes self-management. Journal of General Internal Medicine 17: 243–252.

    Article  Google Scholar 

  59. Welie, J.V.M. and S.P.K. Welie. 2001. Patient decision-making competence: outlines of a conceptual analysis. Medicine Health Care and Philosophy 4: 127–138.

    Article  Google Scholar 

  60. Welie, S.P.K. 2001. Criteria for patient decision making (in)competence: a review of and commentary on some empirical approaches. Medicine, Health Care and Philosophy 4: 139–151.

    Article  Google Scholar 

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Authors and Affiliations

  1. Department of Clinical Sciences, UT Southwestern Medical Center, Dallas, TX, USA

    Fabrice Jotterand & Shawn M. McClintock

  2. Department of Psychiatry, UT Southwestern Medical Center, Dallas, TX, USA

    Fabrice Jotterand & Mustafa M. Husain

  3. Department of Psychiatry, Division of Brain Stimulation and Therapeutic Modulation, New York State Psychiatric Institute, Columbia University, New York, NY, USA

    Shawn M. McClintock

  4. Independent Consultant for Health Law, Policy and Bioethics, Austin, TX, USA

    Archie A. Alexander

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  1. Fabrice Jotterand
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  2. Shawn M. McClintock
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  3. Archie A. Alexander
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  4. Mustafa M. Husain
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Correspondence to Fabrice Jotterand.

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Jotterand, F., McClintock, S.M., Alexander, A.A. et al. Ethics and Informed Consent of Vagus Nerve Stimulation (VNS) for Patients with Treatment-Resistant Depression (TRD). Neuroethics 3, 13–22 (2010). https://doi.org/10.1007/s12152-009-9051-y

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  • DOI: https://doi.org/10.1007/s12152-009-9051-y

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