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Commentary: The Value of Patient Benefit: Consideration of Framing Contingencies to Guide the Ethical Use of DBS—a Case Analysis

  • James Giordano

Extract

Here we have a case in which (1) the outcome(s) for the patient do not comport with the projected—or initially defined—outcomes of the research study, and (2) these outcomes represent cognitive and behavioral effects that are positively interpreted by the patient, but not by the patient’s immediate family. The 6Cs approach, which frames the technique or technology—and its effects—within defined considerations of domains and dimensions, can be used as part of a multistep approach to addressing issues arising from the use of neurotechnology. 1 The approach recommends that the medical team consider the following domains and dimensions when engaging neuroethical analyses:

  • The capacities and limitations of current neuroscience and technology (neuroS/T), and the capacity of the patient
  • The consequences incurred by neuroS/T on recipients, families, and society in the short, intermediate, and long term
  • The character of the recipient (e.g., patterns of cognition, emotion, and behavior) affected by neuroS/T
  • The continuity of research and clinical care
  • The contexts of need and value that influence the use or nonuse of neuroS/T
  • Consent through provision of the most information possible 2

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References

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Notes

1. Giordano, J. A preparatory neuroethical approach to assessing developments in neurotechnology. AMA Journal of Ethics 2015;17(1):5661.

2. Adapted from Giordano 2015 (see note 1).

3. Jotterand, F, Giordano, J. Transcranial magnetic stimulation, deep brain stimulation and personal identity: Ethical questions and neuroethical approaches for medical practice. International Review of Psychiatry 2011;23(5):476–85.

4. Lewis, CJ, Maier, F, Horstkötter, N, Zywczok, A, Witt, K, Eggers, C, et al. Subjectively perceived personality and mood changes associated with subthalamic stimulation in patients with Parkinson’s disease. Psychological Medicine 2015;45(1):7385.

5. Pham U, Solbakk AK, Skogseid IM, Toft M, Pripp AH, Konglund AE, et al. Personality changes after deep brain stimulation in Parkinson’s disease. Parkinson’s Disease 2015.

6. Pellegrino, ED, Thomasma, DC. For the Patient’s Good: The Restoration of Beneficence in Health Care. New York: Oxford University Press; 1988.

7. Rossi, PJ, Okun, M, Giordano, J. Translational imperatives in deep brain stimulation research: Addressing neuroethical issues of consequences and continuity of clinical care. AJOB-Neuroscience 2014;5(1):46–8.

8. Rossi PJ, Giordano J, Okun M. Uncertain coverage for off-label deep brain stimulation: Neuroethical challenges—and possible inroads—to research and the provision of care. AJOB-Neuroscience 2016.

9. Appelbaum, PS, Roth, LH, Lidz, CW, Benson, P, Winslade, W. False hopes and best data: Consent to research and the therapeutic misconception. Hastings Center Report 1987;17(2):20–4.

10. Horng, S, Grady, C. Misunderstanding in clinical research: Distinguishing therapeutic misconception, therapeutic misestimation, and therapeutic optimism. IRB 2003;25(1):1116.

11. Gilbert, F. A threat to autonomy? The intrusion of predictive brain implants. AJOB-Neuroscience 2015;6(4):14.

12. Giordano, J. Conditions for consent to the use of neurotechnology: A preparatory neuroethical approach to risk assessment and reduction. AJOB-Neuroscience 2015;6(4):1214.

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Commentary: The Value of Patient Benefit: Consideration of Framing Contingencies to Guide the Ethical Use of DBS—a Case Analysis

  • James Giordano

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