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The Effects of Closed-Loop Medical Devices on the Autonomy and Accountability of Persons and Systems

Published online by Cambridge University Press:  16 September 2016

PHILIPP KELLMEYER ,
THOMAS COCHRANE ,
OLIVER MÜLLER ,
CHRISTINE MITCHELL ,
TONIO BALL ,
JOSEPH J. FINS  and
NIKOLA BILLER-ANDORNO
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Abstract:

Closed-loop medical devices such as brain-computer interfaces are an emerging and rapidly advancing neurotechnology. The target patients for brain-computer interfaces (BCIs) are often severely paralyzed, and thus particularly vulnerable in terms of personal autonomy, decisionmaking capacity, and agency. Here we analyze the effects of closed-loop medical devices on the autonomy and accountability of both persons (as patients or research participants) and neurotechnological closed-loop medical systems. We show that although BCIs can strengthen patient autonomy by preserving or restoring communicative abilities and/or motor control, closed-loop devices may also create challenges for moral and legal accountability. We advocate the development of a comprehensive ethical and legal framework to address the challenges of emerging closed-loop neurotechnologies like BCIs and stress the centrality of informed consent and refusal as a means to foster accountability. We propose the creation of an international neuroethics task force with members from medical neuroscience, neuroengineering, computer science, medical law, and medical ethics, as well as representatives of patient advocacy groups and the public.

Keywords

autonomyaccountabilityneurotechnologybrain-computer interfacesneuroethics
Type
Articles
Information
Cambridge Quarterly of Healthcare Ethics , Volume 25 , Special Issue 4: Clinical Neuroethics , October 2016 , pp. 623 - 633
Copyright
Copyright © Cambridge University Press 2016 

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References

Notes

1. Fairclough, S. A closed-loop perspective on symbiotic human-computer interaction. In: Blankertz, B, Jacucci, G, Gamberini, L, Spagnolli, A, Freeman, J, eds. Symbiotic Interaction. Berlin, Germany: Springer International; 2015:57–67.CrossRefGoogle Scholar

2. Wilmshurst JM, Berg AT, Lagae L, Newton CR, Cross JH. The challenges and innovations for therapy in children with epilepsy. Nature Reviews Neurology 2014;10:249–60.

3. Bensmaia SJ, Miller LE. Restoring sensorimotor function through intracortical interfaces: Progress and looming challenges. Nature Reviews Neuroscience 2014;15:313–25.

4. Baranauskas, G. What limits the performance of current invasive brain machine interfaces? Frontiers in Systems Neuroscience 2014;8:68.CrossRefGoogle ScholarPubMed

5. Hochberg LR, Bacher D, Jarosiewicz B, Masse NY, Simeral JD, Vogel J, et al. Reach and grasp by people with tetraplegia using a neurally controlled robotic arm. Nature 2012;485:372–5.

6. Schneider MJ, Fins J, Wolpaw JR. Ethical issues in BCI research. In: Wolpaw JR, Wolpaw EW, eds. Brain-Computer Interfaces: Principles and Practice. Oxford: Oxford University Press; 2012:373–86. doi:10.1093/acprof:oso/9780195388855.001.0001.

7. Birbaumer N, Ghanayim N, Hinterberger T, Iversen I, Kotchoubey B, Kübler A, et al. A spelling device for the paralysed. Nature 1999;398:297–8.

8. Silvoni S, Ramos-Murguialday A, Cavinato M, Volpato C, Cisotto G, Turolla A, et al. Brain-computer interface in stroke: A review of progress. Clinical EEG and Neuroscience 2011;42:245–52.

9. Chatelle C, Chennu S, Noirhomme Q, Cruse D, Owen AM, Laureys S. Brain–computer interfacing in disorders of consciousness. Brain Injury 2012;26:1510–22.

10. Naci L, Monti MM, Cruse D, Kübler A, Sorger B, Goebel R, et al. Brain–computer interfaces for communication with nonresponsive patients. Annals of Neurology 2012;72:312–23.

11. Beauchamp, TL, Childress, JF. Principles of Biomedical Ethics. Oxford: Oxford University Press; 2001.Google ScholarPubMed

12. Mormann F, Andrzejak RG, Elger CE, Lehnertz K. Seizure prediction: The long and winding road. Brain 2007;130:314–33.

13. Nagaraj, V, Lee, ST, Krook-Magnuson, E, Soltesz, I, Benquet, P, Irazoqui, PP, et al. Future of seizure prediction and intervention: Closing the loop. Journal of Clinical Neurophysiology: Official Publication of the American Electroencephalographic Society 2015;32:194–206.CrossRefGoogle Scholar

14. Falcone R, Castelfranchi C. The human in the loop of a delegated agent: The theory of adjustable social autonomy. IEEE Transactions on Systems, Man and Cybernetics, Part A: Systems and Humans 2001;31:406–18.

15. Russell, S, Norvig, P. Artificial Intelligence: A Modern Approach. Englewood Cliffs, NJ: Prentice Hall; 2013.Google Scholar

16. Hoppe C, Feldmann M, Blachut B, Surges R, Elger CE, Helmstaedter C. Novel techniques for automated seizure registration: Patients’ wants and needs. Epilepsy & Behavior 2015;52, Part A:1–7.

17. Holmes, NP, Snijders, HJ, Spence, C. Reaching with alien limbs: Visual exposure to prosthetic hands in a mirror biases proprioception without accompanying illusions of ownership. Perception & Psychophysics 2006;68:685–701.CrossRefGoogle Scholar

18. Hoffmann M, Marques HG, Hernandez Arieta A, Sumioka H, Lungarella M, Pfeifer R. Body schema in robotics: A review. IEEE Transactions on Autonomous Mental Development 2010;2:304–24.

19. Given the presence of predictive algorithms in everyday devices like “smart” phones, most of us have experienced the unease (and sometimes the time-saving pleasure) that results from an algorithm inferring one’s intention by autocorrecting text messages.

20. Barber KS, Goel A, Martin CE. Dynamic adaptive autonomy in multi-agent systems. Journal of Experimental & Theoretical Artificial Intelligence 2000;12:129–47.

21. Veruggio G, Operto F. Roboethics: Social and ethical implications of robotics. In: Siciliano B, Oussama K, eds. Springer Handbook of Robotics. Berlin: Springer-Verlag; 2008:1499–524.

22. Sharkey N. The ethical frontiers of robotics. Science 2008;322:1800–1.

23. Bostrom, N. Superintelligence: Paths, Dangers, Strategies. Oxford: Oxford University Press; 2014.Google Scholar

24. Murphy, RR, Woods, DD. Beyond Asimov: The three laws of responsible robotics. IEEE Intelligent Systems 2009;24:14–20.CrossRefGoogle Scholar

25. Holz EM, Botrel L, Kaufmann T, Kübler A. Long-term independent brain-computer interface home use improves quality of life of a patient in the locked-in state: A case study. Archives of Physical Medicine and Rehabilitation 2015;96:S16–S26.

26. Liberati G, Pizzimenti A, Simione L, Riccio A, Schettini F, Inghilleri M, et al. Developing brain-computer interfaces from a user-centered perspective: Assessing the needs of persons with amyotrophic lateral sclerosis, caregivers, and professionals. Applied Ergonomics 2015;50:139–46.

27. Fins, JJ. Rights Come to Mind: Brain Injury, Ethics, and the Struggle for Consciousness. Cambridge: Cambridge University Press; 2015.CrossRefGoogle ScholarPubMed

28. Gilbert F. A threat to autonomy? The intrusion of predictive brain implants. American Journal of Bioethics Neuroscience 2015;6:4–11.

29. Lahr J, Schwartz C, Heimbach B, Aertsen A, Rickert J, Ball T. Invasive brain–machine interfaces: A survey of paralyzed patients’ attitudes, knowledge and methods of information retrieval. Journal of Neural Engineering 2015;12:043001.

30. Mathews DJH. Deep brain stimulation, personal identity and policy. International Review of Psychiatry 2011;23:486–92.

31. Smeding HMM, Goudriaan AE, Foncke EMJ, Schuurman PR, Speelman JD, Schmand B. Pathological gambling after bilateral subthalamic nucleus stimulation in Parkinson disease. Journal of Neurology, Neurosurgery & Psychiatry 2007;78:517–19.

32. Gilbert F. The burden of normality: From “chronically ill” to “symptom free.” New ethical challenges for deep brain stimulation postoperative treatment. Journal of Medical Ethics 2012;38:408–12.

33. As another somewhat related example, distress can occur when a patient at genetic risk for Huntington’s disease is told that he or she is not carrying the mutation.

34. Schüpbach M, Gargiulo M, Welter ML, Mallet L, Béhar C, Houeto JL, et al. Neurosurgery in Parkinson disease: A distressed mind in a repaired body? Neurology 2006;66:1811–16.

35. Clausen J. Ethical brain stimulation—neuroethics of deep brain stimulation in research and clinical practice. European Journal of Neuroscience 2010;32:1152–62.

36. Kelley AS, Reid MC, Miller DH, Fins JJ, Lachs MS. Implantable cardioverter-defibrillator deactivation at the end of life: A physician survey. American Heart Journal 2009;157:702–8.

37. McLeod CJ, Boersma L, Okamura H, Friedman PA. The subcutaneous implantable cardioverter defibrillator: State-of-the-art review. European Heart Journal 2015;ehv507. [Epub ahead of print.] doi:10.1093/eurheartj/ehv507.

38. Maisel WHM. Safety issues involving medical devices: Implications of recent implantable cardioverter-defibrillator malfunctions. [Editorial]. JAMA 2005;294:955–8.

39. Vinck I, Laet CD, Stroobandt S, Brabandt HV. Legal and organizational aspects of remote cardiac monitoring: The example of implantable cardioverter defibrillators. EP Europace 2012;14:1230–5.

40. Shuster E. Fifty years later: The significance of the Nuremberg Code. New England Journal of Medicine 1997;337:1436–40.

41. Habermas, J. Three normative models of democracy. Constellations 1994;1:1–10.CrossRefGoogle Scholar

42. Chambers S. Deliberative democratic theory. Annual Review of Political Science 2003;6:307–26.

43. Landwehr C. Democratic and technocratic policy deliberation. Critical Policy Studies 2010;3:434–9.

44. Travis J. Germline editing dominates DNA summit. Science 2015;350:1299–300.

45. In Freiburg (the academic environment of authors PK, OM, and TB), for example, the interdisciplinary research consortium BrainLinks-BrainTools—which is sponsored as a “cluster of excellence” (Exzellenzcluster, in German) by the German Research Foundation (DFG)—includes science communication and public outreach as an integral part of its work. See BrainLinks-BrainTools. Science communication and public outreach; available at http://www.brainlinks-braintools.uni-freiburg.de/research/projects/reaching-out-science-communication-and-public-outreach/ (last accessed 2 Mar 2016).

46. Joffe S, Manocchia M, Weeks JC, Cleary PD. What do patients value in their hospital care? An empirical perspective on autonomy centred bioethics. Journal of Medical Ethics 2003;29:103–8.

47. Musschenga AW. Empirical ethics, context-sensitivity, and contextualism. Journal of Medicine and Philosophy 2005;30:467–90.

48. Nijboer F, Clausen J, Allison BZ, Haselager P. The Asilomar Survey: Stakeholders’ opinions on ethical issues related to brain-computer interfacing. Neuroethics 2011;6:541–78.