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Review
October 17, 2019

Ethical Challenges of Risk, Informed Consent, and Posttrial Responsibilities in Human Research With Neural Devices: A Review

Author Affiliations
  • 1Clinical Center, Department of Bioethics, National Institutes of Health, Bethesda, Maryland
  • 2National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Maryland
  • 3Department of Neurology, University of California, San Francisco
  • 4Division of Medical Ethics, Weill Cornell Medical College, New York, New York
  • 5Consortium for the Advanced Study of Brain Injury, Weill Cornell Medical College, New York, New York
  • 6Center for Bioethics, Cleveland Clinic, Cleveland, Ohio
  • 7Department of Philosophy, University of Washington, Seattle
  • 8Center for Neurotechnology, University of Washington, Seattle
  • 9Stanford Law School, Stanford University, Stanford, California
  • 10Department of Philosophy, Macquarie University, Sydney, New South Wales, Australia
  • 11Australian Research Council, Centre of Excellence for Electromaterials Science, Wollongong, Australia
  • 12MetroHeath Medical Center, School of Medicine, Department of Neurosurgery, Case Western Reserve University, Cleveland, Ohio
  • 13Department of Neurology, Oregon Health and Sciences, University of Portland, Portland, Oregon
  • 14Division of Translational Research, National Institute of Mental Health, Bethesda, Maryland
  • 15Center of Advanced Circuit Therapeutics, Icahn School of Medicine at Mount Sinai, New York, New York
  • 16The Oxford Uehiro Centre for Practical Ethics, University of Oxford, Oxford, United Kingdom
  • 17Division of Medical Ethics, Weill Cornell Medical College, New York, New York
  • 18Department of Neurology, Emory University, Atlanta, Georgia
  • 19Cognitive Science and Neuromodulation Program, Department of Neurological Surgery, Columbia University College of Physicians and Surgeons, New York, New York
  • 20Department of Medical Ethics and Health Policy, University of Pennsylvania, Philadelphia
JAMA Neurol. 2019;76(12):1506-1514. doi:10.1001/jamaneurol.2019.3523
Abstract

Importance  Developing more and better diagnostic and therapeutic tools for central nervous system disorders is an ethical imperative. Human research with neural devices is important to this effort and a critical focus of the National Institutes of Health Brain Research Through Advancing Innovative Neurotechnologies (BRAIN) Initiative. Despite regulations and standard practices for conducting ethical research, researchers and others seek more guidance on how to ethically conduct neural device studies. This article draws on, reviews, specifies, and interprets existing ethical frameworks, literature, and subject matter expertise to address 3 specific ethical challenges in neural devices research: analysis of risk, informed consent, and posttrial responsibilities to research participants.

Observations  Research with humans proceeds after careful assessment of the risks and benefits. In assessing whether risks are justified by potential benefits in both invasive and noninvasive neural device research, the following categories of potential risks should be considered: those related to surgery, hardware, stimulation, research itself, privacy and security, and financial burdens. All 3 of the standard pillars of informed consent—disclosure, capacity, and voluntariness—raise challenges in neural device research. Among these challenges are the need to plan for appropriate disclosure of information about atypical and emerging risks of neural devices, a structured evaluation of capacity when that is in doubt, and preventing patients from feeling unduly pressured to participate. Researchers and funders should anticipate participants’ posttrial needs linked to study participation and take reasonable steps to facilitate continued access to neural devices that benefit participants. Possible mechanisms for doing so are explored here. Depending on the study, researchers and funders may have further posttrial responsibilities.

Conclusions and Relevance  This ethical analysis and points to consider may assist researchers, institutional review boards, funders, and others engaged in human neural device research.

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