International Legal Approaches to Neurosurgery for Psychiatric Disorders

Jennifer A Chandler¹, Laura Y Cabrera², Paresh Doshi³, Shirley Fecteau^{4

5}, Joseph J Fins^{6

7}, Salvador Guinjoan⁸, Clement Hamani⁹, Karen Herrera-Ferrá¹⁰, C Michael Honey¹¹, Judy Illes¹², Brian H Kopell¹³, Nir Lipsman¹⁴, Patrick J McDonald¹⁵, Helen S Mayberg¹⁶, Roland Nadler¹⁷, Bart Nuttin¹⁸, Albino J Oliveira-Maia^{19

20}, Cristian Rangel²¹, Raphael Ribeiro¹, Arleen Salles²², Hemmings Wu²³

Affiliations

¹ Faculty of Law, University of Ottawa, Ottawa, ON, Canada.
² Center for Ethics & Humanities in the Life Sciences and Dept. Translational Neuroscience, Michigan State University, East Lansing, MI, United States.
³ Department of Neurosurgery, Jaslok Hospital and Research Center, Mumbai, India.
⁴ Department of Psychiatry and Neurosciences, Faculty of Medicine, Université Laval, Quebec City, QC, Canada.
⁵ CERVO Brain Research Center, Center Intégré Universitaire en Santé et Services Sociaux de la Capitale-Nationale, Quebec City, QC, Canada.
⁶ Weill Cornell Medical College, Consortium for the Advanced Study of Brain Injury, Weill Cornell and the Rockefeller University, New York, NY, United States.
⁷ Solomon Center for Health Law & Policy, Yale Law School, New Haven, CT, United States.
⁸ Laureate Institute for Brain Research, Tulsa, OK, United States.
⁹ Harquail Center for Neuromodulation, Sunnybrook Research Institute, Division of Neurosurgery, Sunnybrook Health Sciences Center, University of Toronto, Toronto, ON, Canada.
¹⁰ Asociación Mexicana de Neuroética, Mexico City, Mexico.
¹¹ Section of Neurosurgery, Max Rady College of Medicine, University of Manitoba, Winnipeg, MB, Canada.
¹² Neuroethics Canada, Division of Neurology, Department of Medicine, University of British Columbia, Vancouver, BC, Canada.
¹³ Departments of Neurosurgery, Neurology, Psychiatry and Neuroscience, Icahn School of Medicine at Mount Sinai, New York, NY, United States.
¹⁴ Division of Neurosurgery, Harquail Center for Neuromodulation, Sunnybrook Health Sciences Center, University of Toronto, Toronto, ON, Canada.
¹⁵ Division of Neurosurgery, Faculty of Medicine, BC Children's Hospital, University of British Columbia, Head, Vancouver, BC, Canada.
¹⁶ Departments of Neurology, Neurosurgery, Psychiatry and Neuroscience, Icahn School of Medicine at Mount Sinai, New York, NY, United States.
¹⁷ Peter A. Allard School of Law, University of British Columbia, Vancouver, BC, Canada.
¹⁸ Neurosurgeon, Katholieke Universiteit (KU) Leuven, Universitair Ziekenhuis (UZ) Leuven, Leuven, Belgium.
¹⁹ Champalimaud Research and Clinical Center, Champalimaud Center for the Unknown, Lisbon, Portugal.
²⁰ NOVA Medical School, NMS, Universidade Nova De Lisboa, Lisbon, Portugal.
²¹ Department of Innovation in Medical Education, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.
²² Center for Research Ethics and Bioethics, Uppsala University, Uppsala, Sweden.
²³ Department of Neurosurgery, Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.

PMID: 33519399
PMCID: PMC7838635
DOI: 10.3389/fnhum.2020.588458

Review

International Legal Approaches to Neurosurgery for Psychiatric Disorders

Jennifer A Chandler et al. Front Hum Neurosci. 2021.

. 2021 Jan 13:14:588458.

doi: 10.3389/fnhum.2020.588458. eCollection 2020.

Authors

Affiliations

¹ Faculty of Law, University of Ottawa, Ottawa, ON, Canada.
² Center for Ethics & Humanities in the Life Sciences and Dept. Translational Neuroscience, Michigan State University, East Lansing, MI, United States.
³ Department of Neurosurgery, Jaslok Hospital and Research Center, Mumbai, India.
⁴ Department of Psychiatry and Neurosciences, Faculty of Medicine, Université Laval, Quebec City, QC, Canada.
⁵ CERVO Brain Research Center, Center Intégré Universitaire en Santé et Services Sociaux de la Capitale-Nationale, Quebec City, QC, Canada.
⁶ Weill Cornell Medical College, Consortium for the Advanced Study of Brain Injury, Weill Cornell and the Rockefeller University, New York, NY, United States.
⁷ Solomon Center for Health Law & Policy, Yale Law School, New Haven, CT, United States.
⁸ Laureate Institute for Brain Research, Tulsa, OK, United States.
⁹ Harquail Center for Neuromodulation, Sunnybrook Research Institute, Division of Neurosurgery, Sunnybrook Health Sciences Center, University of Toronto, Toronto, ON, Canada.
¹⁰ Asociación Mexicana de Neuroética, Mexico City, Mexico.
¹¹ Section of Neurosurgery, Max Rady College of Medicine, University of Manitoba, Winnipeg, MB, Canada.
¹² Neuroethics Canada, Division of Neurology, Department of Medicine, University of British Columbia, Vancouver, BC, Canada.
¹³ Departments of Neurosurgery, Neurology, Psychiatry and Neuroscience, Icahn School of Medicine at Mount Sinai, New York, NY, United States.
¹⁴ Division of Neurosurgery, Harquail Center for Neuromodulation, Sunnybrook Health Sciences Center, University of Toronto, Toronto, ON, Canada.
¹⁵ Division of Neurosurgery, Faculty of Medicine, BC Children's Hospital, University of British Columbia, Head, Vancouver, BC, Canada.
¹⁶ Departments of Neurology, Neurosurgery, Psychiatry and Neuroscience, Icahn School of Medicine at Mount Sinai, New York, NY, United States.
¹⁷ Peter A. Allard School of Law, University of British Columbia, Vancouver, BC, Canada.
¹⁸ Neurosurgeon, Katholieke Universiteit (KU) Leuven, Universitair Ziekenhuis (UZ) Leuven, Leuven, Belgium.
¹⁹ Champalimaud Research and Clinical Center, Champalimaud Center for the Unknown, Lisbon, Portugal.
²⁰ NOVA Medical School, NMS, Universidade Nova De Lisboa, Lisbon, Portugal.
²¹ Department of Innovation in Medical Education, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.
²² Center for Research Ethics and Bioethics, Uppsala University, Uppsala, Sweden.
²³ Department of Neurosurgery, Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.

PMID: 33519399
PMCID: PMC7838635
DOI: 10.3389/fnhum.2020.588458

Abstract

Neurosurgery for psychiatric disorders (NPD), also sometimes referred to as psychosurgery, is rapidly evolving, with new techniques and indications being investigated actively. Many within the field have suggested that some form of guidelines or regulations are needed to help ensure that a promising field develops safely. Multiple countries have enacted specific laws regulating NPD. This article reviews NPD-specific laws drawn from North and South America, Asia and Europe, in order to identify the typical form and contents of these laws and to set the groundwork for the design of an optimal regulation for the field. Key challenges for this design that are revealed by the review are how to define the scope of the law (what should be regulated), what types of regulations are required (eligibility criteria, approval procedures, data collection, and oversight mechanisms), and how to approach international harmonization given the potential migration of researchers and patients.

Keywords: deep brain stimulation; law; neuroethics; neurosurgery for psychiatric disorders; psychosurgery; regulation.

Copyright © 2021 Chandler, Cabrera, Doshi, Fecteau, Fins, Guinjoan, Hamani, Herrera-Ferrá, Honey, Illes, Kopell, Lipsman, McDonald, Mayberg, Nadler, Nuttin, Oliveira-Maia, Rangel, Ribeiro, Salles and Wu.

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Conflict of interest statement

JF receives book royalties for Rights Come to Mind: Brain Injury, Ethics and the Struggle for Consciousness from Cambridge University Press. CHa was part of an unrelated advisory board for Medtronic. BK is a consultant with Medtronic and Abbott, has fellow funding from Medtronic, Abbott and Boston Scientific, and holds an MJFF grant. HM receives consulting and intellectual licensing fees from Abbott Neuromodulation. BN has implanted devices, which were generously provided by Medtronic, for deep brain stimulation (DBS) in patients suffering from obsessive compulsive disorder (OCD). Medtronic provided BN grants for research, education and traveling. BN held the Medtronic Chair for Stereotactic Neurosurgery in Psychiatric Disorders at KU Leuven as well as a Chair for Neuromodulation, an endowment from Medtronic. BN co-owns a patent on DBS in OCD. AJO-M is recipient of a grant from Schuhfried GmBH for norming and validation of cognitive tests, and is national coordinator for Portugal of a Non-interventional Study (EDMS-ERI-143085581, 4.0) to characterize a Treatment-Resistant Depression Cohort in Europe, sponsored by Janssen-Cilag Ltd, and a trial of psilocybin therapy for treatment-resistant depression (EudraCT NUMBER: 2017-003288-36), sponsored by Compass Pathways Ltd. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

References

1. 25 Texas Administrative Code § 405.103(15) (1993).
1. Arron K., Oliver C., Moss J., Berg K., Burbidge C. (2011). The prevalence and phenomenology of self-injurious and aggressive behaviour in genetic syndromes. J. Intell. Disabil. Res. 55, 109–120. 10.1111/j.1365-2788.2010.01337.x - DOI - PubMed
1. Bandini F., Primavera Q., Pizzorno M., Cocito L. (2007). Using STN DBS and medication reduction as a strategy to treat pathological gambling in Parkinson's disease. Parkinsonism Relat. Disord. 13, 369–371. 10.1016/j.parkreldis.2006.07.011 - DOI - PubMed
1. Bari A. A., Mikell C. B., Abosch A., Ben-Haim S., Buchanan R. J., Burton A. W., et al. (2018). Charting the road forward in psychiatric neurosurgery: proceedings of the 2016 American Society for Stereotactic and Functional Neurosurgery workshop on neuromodulation for psychiatric disorders. J. Neurol. Neurosurg. Psychiatry 89, 886–896. 10.1136/jnnp-2017-317082 - DOI - PMC - PubMed
1. Belgium (2016). Arrêté ministériel modifiant la liste et les listes nominatives jointes comme annexes 1 et 2 à l'arrêté royal du 25 juin 2014 fixant les procédures, délais et conditions en matière d'intervention de l'assurance obligatoire soins de santé et indemnités dans le coût des implants et des dispositifs médicaux invasifs. Available online at: http://www.ejustice.just.fgov.be/mopdf/2016/07/29_1.pdf#Page45 (accessed July 7, 2016).

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International Legal Approaches to Neurosurgery for Psychiatric Disorders

Affiliations

International Legal Approaches to Neurosurgery for Psychiatric Disorders

Authors

Affiliations

Abstract

Conflict of interest statement

References

Publication types

LinkOut - more resources

Full Text Sources

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