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Beyond Consent in Research: Revisiting Vulnerability in Deep Brain Stimulation for Psychiatric Disorders


Neuroethics Now welcomes papers addressing the ethical application of neuroscience in research and patient care, as well as its impact on society.



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1. Rosenstein, DL, Miller, FG. Ethical considerations in psychopharmacological research involving decisionally impaired subjects. Psychopharmacology (Berl) 2003;171(1):92–7.

2. Goodman, WK, Alterman, RL. Deep brain stimulation for intractable psychiatric disorders. Annual Review of Medicine 2012;63:511–24.

3. Bell, E, Mathieu, G, Racine, E. Preparing the ethical future of deep brain stimulation. Surgical Neurology 2009;72(6):577–86.

4. Bell, E, Racine, E. Ethical guidance for the use of deep brain stimulation in psychiatric trials and emerging uses: Review and reflections. In: Denys, D, Feenstra, M, Schuurman, R, eds. Deep Brain Stimulation: A New Frontier in Psychiatry. New York: Springer; 2012:273–88.

5. Dunn, LB, Holtzheimer, PE, Hoop, JG, Mayberg, HS, Weiss Roberts, L, Appelbaum, P. Ethical issues in deep brain stimulation research for treatment-resistant depression: Focus on risk and consent. American Journal of Bioethics 2011;2(1):2936.

6. Glannon, W. Consent to deep brain stimulation for neurological and psychiatric disorders. Journal of Clinical Ethics 2010;21(2):104–11.

7. Ford, PJ. Neurosurgical implants: Clinical protocol considerations. Cambridge Quarterly of Healthcare Ethics 2007;16(3):308–11.

8. Fins, JJ, Rezai, AR, Greenberg, BD. Psychosurgery: Avoiding an ethical redux while advancing a therapeutic future. Neurosurgery 2006;59(4):713–6.

9. Rabins, P, Appleby, BS, Brandt, J, DeLong, MR, Dunn, LB, Gabriels, L, et al. Scientific and ethical issues related to deep brain stimulation for disorders of mood, behavior, and thought. Archives of General Psychiatry 2009;66(9):931–7.

10. Nickel, PJ. Vulnerable populations in research: The case of the seriously ill. Theoretical Medicine and Bioethics 2006;27(3):245–64.

11. Cohen, BJ, McGarvey, EL, Pinkerton, RC, Kryzhanivska, L. Willingness and competence of depressed and schizophrenic inpatients to consent to research. Journal of the American Academy of Psychiatry and the Law 2004;32(2):134–43.

12. Appelbaum, PS, Grisso, T, Frank, E, O’Donnell, S, Kupfer, DJ. Competence of depressed patients for consent to research. American Journal of Psychiatry 1999;156(9):1380–4.

13. Okai, D, Owen, DG, McGuire, H, Singh, S, Churchill, R, Hotopf, M. Mental capacity in psychiatric patients: Systematic review. British Journal of Psychiatry 2007;191:291–7.

14. Ford, PJ. Vulnerable brains: Research ethics and neurosurgical patients. Journal of Law, Medicine & Ethics 2009;37(1):7382.

15. See note 2, Goodman, Alterman 2012.

16. Lipsman, NP, Giacobbe, NP, Bernstein, M, Lozano, AM. Informed consent for clinical trials of deep brain stimulation in psychiatric disease: Challenges and implications for trial design. Journal of Medical Ethics 2012;38(2):107–11.

17. Bell, EB, Maxwell, B, McAndrews, MP, Sadikot, A, Racine, E. Hope and patients’ expectations in deep brain stimulation: Healthcare providers’ perspectives and approaches. Journal of Clinical Ethics 2010;21(2):112–24.

18. See note 6, Glannon 2010.

19. See note 5, Dunn et al. 2011.

20. See note 16, Lipsman et al. 2012.

21. Fisher, CE, Dunn, LB, Christopher, PP, Holtzheimer, PE, Leykin, Y, Mayberg, HS, et al. The ethics of research on deep brain stimulation for depression: Decisional capacity and therapeutic misconception. Annals of the New York Academy of Sciences 2012;1265:6979.

22. See note 10, Nickel 2006.

23. Dubois, JM, Beskow, L, Campbell, J, Dugosh, K, Festinger, D, Hartz, S, et al. Restoring balance: A consensus statement on the protection of vulnerable research participants. American Journal of Public Health 2012;102:2220–5.

24. Miller, FG, Fins, JJ. Protecting vulnerable research subjects without unduly constraining neuropsychiatric research. Archives of General Psychiatry 1999;56(8):701–2.

25. See note 5, Dunn et al. 2011.

26. See note 21, Fisher et al. 2012.

27. Pentz, RD, White, M, Harvey, RD, Farmer, ZL, Liu, Y, Lewis, C, et al. Therapeutic misconception, misestimation, and optimism in participants enrolled in phase 1 trials. Cancer 2012;118(18):4571–8.

28. See note 24, Miller, Fins 1999.

This article is coauthored by participants of a one-day workshop that took place in Montreal in September 2012. We would like to thank Dr. Sidney Kennedy, Baptiste Moutaud, Dr. Abbas Sadikot, and Dr. Thomas Schlaepfer for participation in the workshop.

Neuroethics Now welcomes papers addressing the ethical application of neuroscience in research and patient care, as well as its impact on society.



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