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

Saskia Hendriks, Christine Grady, Khara M. Ramos, Winston Chiong, Joseph J. Fins, Paul Ford, Sara Goering, Henry T. Greely, Katrina Hutchison, Michael L. Kelly, Scott Y.H. Kim, Eran Klein, Sarah H. Lisanby, Helen Mayberg, Hannah Maslen, Franklin G. Miller, Karen Rommelfanger, Sameer A. Sheth, Anna Wexler

Research output: Contribution to journalReview article

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..

Original languageEnglish (US)
JournalJAMA Neurology
DOIs
StateAccepted/In press - Jan 1 2019

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Informed Consent
Equipment and Supplies
Research
Research Personnel
Disclosure
Ethical Analysis
Privacy
Research Ethics Committees
Central Nervous System Diseases
National Institutes of Health (U.S.)
Emotions
Brain

ASJC Scopus subject areas

  • Clinical Neurology

Cite this

Ethical Challenges of Risk, Informed Consent, and Posttrial Responsibilities in Human Research with Neural Devices : A Review. / Hendriks, Saskia; Grady, Christine; Ramos, Khara M.; Chiong, Winston; Fins, Joseph J.; Ford, Paul; Goering, Sara; Greely, Henry T.; Hutchison, Katrina; Kelly, Michael L.; Kim, Scott Y.H.; Klein, Eran; Lisanby, Sarah H.; Mayberg, Helen; Maslen, Hannah; Miller, Franklin G.; Rommelfanger, Karen; Sheth, Sameer A.; Wexler, Anna.

In: JAMA Neurology, 01.01.2019.

Research output: Contribution to journalReview article

Hendriks, S, Grady, C, Ramos, KM, Chiong, W, Fins, JJ, Ford, P, Goering, S, Greely, HT, Hutchison, K, Kelly, ML, Kim, SYH, Klein, E, Lisanby, SH, Mayberg, H, Maslen, H, Miller, FG, Rommelfanger, K, Sheth, SA & Wexler, A 2019, 'Ethical Challenges of Risk, Informed Consent, and Posttrial Responsibilities in Human Research with Neural Devices: A Review', JAMA Neurology. https://doi.org/10.1001/jamaneurol.2019.3523
Hendriks, Saskia ; Grady, Christine ; Ramos, Khara M. ; Chiong, Winston ; Fins, Joseph J. ; Ford, Paul ; Goering, Sara ; Greely, Henry T. ; Hutchison, Katrina ; Kelly, Michael L. ; Kim, Scott Y.H. ; Klein, Eran ; Lisanby, Sarah H. ; Mayberg, Helen ; Maslen, Hannah ; Miller, Franklin G. ; Rommelfanger, Karen ; Sheth, Sameer A. ; Wexler, Anna. / Ethical Challenges of Risk, Informed Consent, and Posttrial Responsibilities in Human Research with Neural Devices : A Review. In: JAMA Neurology. 2019.
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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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AU - Lisanby, Sarah H.

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AU - Maslen, Hannah

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