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

Publication ,  Journal 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 ...
Published in: JAMA Neurol
December 1, 2019

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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Published In

JAMA Neurol

DOI

EISSN

2168-6157

Publication Date

December 1, 2019

Volume

76

Issue

12

Start / End Page

1506 / 1514

Location

United States
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Hendriks, S., Grady, C., Ramos, K. M., Chiong, W., Fins, J. J., Ford, P., … Wexler, A. (2019). Ethical Challenges of Risk, Informed Consent, and Posttrial Responsibilities in Human Research With Neural Devices: A Review. JAMA Neurol, 76(12), 1506–1514. https://doi.org/10.1001/jamaneurol.2019.3523
Hendriks, Saskia, Christine Grady, Khara M. Ramos, Winston Chiong, Joseph J. Fins, Paul Ford, Sara Goering, et al. “Ethical Challenges of Risk, Informed Consent, and Posttrial Responsibilities in Human Research With Neural Devices: A Review.JAMA Neurol 76, no. 12 (December 1, 2019): 1506–14. https://doi.org/10.1001/jamaneurol.2019.3523.
Hendriks S, Grady C, Ramos KM, Chiong W, Fins JJ, Ford P, et al. Ethical Challenges of Risk, Informed Consent, and Posttrial Responsibilities in Human Research With Neural Devices: A Review. JAMA Neurol. 2019 Dec 1;76(12):1506–14.
Hendriks, Saskia, et al. “Ethical Challenges of Risk, Informed Consent, and Posttrial Responsibilities in Human Research With Neural Devices: A Review.JAMA Neurol, vol. 76, no. 12, Dec. 2019, pp. 1506–14. Pubmed, doi:10.1001/jamaneurol.2019.3523.
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. Ethical Challenges of Risk, Informed Consent, and Posttrial Responsibilities in Human Research With Neural Devices: A Review. JAMA Neurol. 2019 Dec 1;76(12):1506–1514.

Published In

JAMA Neurol

DOI

EISSN

2168-6157

Publication Date

December 1, 2019

Volume

76

Issue

12

Start / End Page

1506 / 1514

Location

United States