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

Saskia Hendriks^{1

2}, Christine Grady¹, Khara M Ramos², Winston Chiong³, Joseph J Fins^{4

5}, Paul Ford⁶, Sara Goering^{7

8}, Henry T Greely⁹, Katrina Hutchison^{10

11}, Michael L Kelly¹², Scott Y H Kim¹, Eran Klein^{7

8

13}, Sarah H Lisanby¹⁴, Helen Mayberg¹⁵, Hannah Maslen¹⁶, Franklin G Miller⁴, Karen Rommelfanger¹⁷, Sameer A Sheth¹⁸, Anna Wexler¹⁹

Affiliations

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

PMID: 31621797
PMCID: PMC9395156
DOI: 10.1001/jamaneurol.2019.3523

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

Saskia Hendriks et al. JAMA Neurol. 2019.

. 2019 Dec 1;76(12):1506-1514.

doi: 10.1001/jamaneurol.2019.3523.

Authors

Affiliations

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

PMID: 31621797
PMCID: PMC9395156
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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Figures

**Figure 1.**
Potential Paths for Neural Devices and Implications for Posttrial Access and Maintenance The green timeline shows the neural device developmental path; red indicates scenarios in which trial participants may have posttrial needs. The yellow boxes include recommendations for researchers and funders.

**Figure 2.**
Risk, Informed Consent, and Posttrial Responsibilities for a Hypothetical Case Involving a Hand Prosthesis

See this image and copyright information in PMC

References

1. WHO. Neurological Disorders: Public Health Challenges. Geneva, Switzerland: World Health Organization;2006.
1. Presidential Commission. Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society, Volume II. Washington, D.C.: Presidential Commission for the Study of Bioethical Issues 2015.
1. Walker ER, McGee RE, Druss BG. Mortality in mental disorders and global disease burden implications: a systematic review and meta-analysis. JAMA psychiatry. 2015;72(4):334–341. - PMC - PubMed
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1. Goering S, Yuste R. On the Necessity of Ethical Guidelines for Novel Neurotechnologies. Cell. 2016;167(4):882–885. - PubMed

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

Affiliations

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

Authors

Affiliations

Abstract

Figures

References

Grants and funding

LinkOut - more resources

Full Text Sources