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

Abstract

IMPORTANCEDeveloping 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.

Brain–Computer Interfaces in Neurorecovery and Neurorehabilitation

“…Such policies will undoubtedly be easier to develop once BCIs demonstrate a consistent and reliable benefit to even a small group of people, as portrayed, for example, in the development and deployment of the NeuroPace BCI. 126 As BCIs continue to advance in sophistication, ethical questions relating to user agency and responsibility, 127 decision-making capacity, 128 shaping of personal identity, 129 privacy, 122,130,131 storage and sharing of recorded neural data, 132 bioenhancement applications, 133 access disparities, 134 and research ethics 123,135 are anticipated to grow increasingly prevalent and pertinent. Careful anticipation and evaluation of these issues can help ensure bioethical resilience across the BCI development lifecycle and foster successful clinical translation into neurorehabilitation practice.…”

Researcher Perspectives on Ethical Considerations in Adaptive Deep Brain Stimulation Trials

“…Researchers pointed out that while NAD that is recorded and stored by aDBS systems may not itself contain identifiers or other sensitive information presently, this could change in the future, which is a concern frequently raised in the theoretical neuroethics literature (Klein, 2016(Klein, , p.1310Zuk et al, 2018, p.45-46;Aggarwal and Chugh, 2020, p.160). Theoretical work further predicts that privacy concerns will increase as larger amounts of data are collected, advances in technologies make it easier to integrate data, and DBS devices interface with other devices in the future (Hendriks et al, 2019(Hendriks et al, , p.1508Klein, 2020, p.335). Researchers should therefore maintain awareness of advances in neuroscience and technology that could change the degree of NAD sensitivity and implement additional data protections if and when necessary.…”

“…Adequate patient understanding of aDBS research participation will also require that patients are informed about potential post-study uncertainties and issues (Lázaro-Muñoz et al, 2018, p.317-318;Hendriks et al, 2019Hendriks et al, , p.1511Sierra-Mercado et al, 2019, p.760). Researchers expressed the need to help ensure post-trial access to care and device maintenance.…”

“…Ensuring that patients understand these potential limitations to post-trial access to aDBS or conventional DBS was viewed by respondents as a critical aspect of informed consent procedures for these trials (Klein, 2016(Klein, , p.1308. In addition to informing patients of the current realities of post-trial access, ongoing discussions are needed to determine different stakeholders' obligations and potential responses, such as funders making supplementary funds available and device manufacturers covering costs to help improve post-trial access to care and device maintenance (Zuk et al, 2018, p.46;Hendriks et al, 2019Hendriks et al, , p.1511.…”

Neurotechnology ethics and relational agency

“…These neurotechnologies offer not only opportunities to study and understand brain and spinal cord function, but also potentially to “treat, cure, or even prevent” (https://braininitiative.nih.gov/) disorders and injuries. Still, given the significance of our brains for our understanding of ourselves—for example, our identity, authenticity, autonomy, and agency—neuroscientists and ethicists have raised a variety of concerns about the effects these technologies may have on individuals and society more broadly (Hendriks et al., 2019; Yuste et al., 2017, etc.). In this study, we introduce neurotechnologies and summarize three main areas of neuroethical interest in relation to them: identity, authenticity, and autonomy competency.…”