International Perspectives on Integrating Ethical, Legal, and Social Considerations into the Development of Non-Invasive Neuromodulation Devices Proceedings of a Workshop—in Brief (2017) / Chapter Skim
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International Perspectives on Integrating Ethical, Legal, and Social Considerations into the Development of Non-Invasive Neuromodulation Devices: Proceedings of a Workshop - in Brief
International Perspectives on Integrating Ethical, Legal, and Social Considerations into the Development of Non-Invasive Neuromodulation Devices: Proceedings of a Workshop - in Brief
Pages 1-7
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The workshop brought together individuals -- representing public and private sectors, research organizations and universities, public and private funders, and civil institutions from around the world -- to explore approaches to better integrating societal values, scientific advancement, and economic considerations during the development and use of novel neurotechnologies. As part of this overall workshop, the Forum on Neuroscience and Nervous System Disorders of the National Academies organized a session that used non-invasive neuromodulation as a case study to prompt further, concrete discussion about practical concerns and opportunities related to integrating ELSI and RRI throughout research, development, regulation, and use of new neurotechnologies.
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Current neurostimulation tools used in psychiatry (see Figure 1) include surgically implantable devices for vagus nerve stimulation, which are FDA approved for treatment-resistant depression; and deep brain stimulation, which has a humanitarian use device exemption from the FDA for the treatment of obsessive-compulsive disorder and is being investigated by several research groups for use in other disorders, said Lisanby.
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Nye, vice president of Neuroscience Innovation and Scientific Partnership Strategy at Janssen Research and Development, LLC, spoke about the perspective of large pharmaceutical companies on non-invasive neuromodulation technologies. He discussed how the different approaches from the regulatory, payer, and industry sectors to these devices can influence patients' access to treatments, including potentially creating barriers to the use of treatments that may benefit patients more than those readily available.
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Reflecting on potential future opportunities, Nye noted that if device companies invested more heavily in conducting larger studies and performing more analyses of how a new technology fits into the existing therapeutic modality, there would be greater understanding by professional societies and a greater ability to adopt the treatment. The device sector may benefit from conducting more economic impact studies on devices; this is a common practice for pharmaceutical companies developing new medicines.
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Maslen outlined the European Union Medical Devices Directive's definition of a medical device, which includes products intended by their manufacturer to be used specifically for diagnostic and/or therapeutic purposes.6 A similar situation exists in the United States, with medical devices defined as products intended to be used for diagnosis or therapy. Nevertheless, new device regulations and associated legislations have just undergone major review and have gained support in the European Union.
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Other workshop participants noted that current directions include anticipating and planning the potential frameworks, infrastructure, and workforce that would be required to support technological, regulatory, and economic challenges associated with the introduction of new technologies and their use in innovative ways. Lastly, several workshop attendees said it may be helpful to consider the interactions among the various sectors involved in the life cycle and application of non-invasive neuromodulation devices and how differences in their alignment may influence ELSI considerations, such as availability and access to effective treatments for patients across the world or the evaluation of benefits and risks to individuals outside the clinical environment.♦♦♦ 6
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; Eli Lilly and Company; Foundation for the National Institutes of Health; Gatsby Charitable Foundation; Janssen Research & Development, LLC; Lundbeck Research USA; Merck Research Laboratories; The Michael J Fox Foundation for Parkinson's Research; National Multiple Sclerosis Society; National Science Foundation (BCS-1064270)
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