Unifying Consent Standards for Implantable Brain-Computer Interfaces

Abstract

Implantable brain-computer interfaces (iBCIs) are approaching clinical deployment and can transform care for people with speech and motor impairment by restoring their ability in communication, movement, and aspects of agency. As a means of neurological intervention, iBCIs are not ethically or clinically analogous to current clinically established procedures or devices. They combine invasive neurosurgery, continuous neural data capture, adaptive machine-learning-based decoding, software dependence, and functionality that can change over time. These features create distinctive ethical, legal, clinical, and practical challenges that conventional informed consent frameworks do not adequately address. In this review and analysis, we present a framework and checklist to help guide more consistent and comprehensive informed consent for iBCIs to strengthen respect for autonomy, align stakeholder expectations, reduce fragmentation across sites, and support ethically robust translation of iBCIs into clinical practice.

Graphical Abstract

eTOC

Young et al. examine key considerations in the consent process for implantable brain-computer interfaces (iBCIs), frontier devices that may restore function for people with disabling neurological conditions, including severe speech and motor impairments. The authors propose unifying consent standards and a corresponding iBCI consent checklist to advance patient-centered clinical translation across a lifecycle process spanning pre-implantation, peri-implantation, and long-term use.

Introduction

Implantable brain-computer interfaces (iBCIs) are being developed with aims to restore communication (including speech restoration), movement, control of robotic effectors, and self-independence for those living with neurologic disorders or injuries.^1,2 Yet the same characteristics that make iBCIs transformative also complicate the ethical landscape of informed consent.^3,4 iBCIs require neurosurgical implantation,⁵ rely on adaptive algorithms that evolve with use, and continuously record and interpret sensitive neural data.^6,7 Moreover, for many users, iBCIs may become a principal channel for expression and independent function.^8,9 Collectively, these features challenge the adequacy of traditional informed consent frameworks.³ Across sites and studies, the absence of unifying standards for iBCI informed consent may give rise to inconsistency, which may compromise the rigor of the consent process, create avoidable omissions of ethically essential information, and require each team to independently reconstruct complex consent materials and processes.^10-13 It also potentially heightens risk of undue influence,¹⁴ especially when potential iBCI users harbor otherwise incurable or progressive disorders and may view an iBCI as one of the few available possibilities for restoring or supporting function.^15,16 To address these challenges, here we identify and unify informed consent standards for iBCIs.

Because iBCIs may be used in investigational research and, as devices mature and regulatory approval or clearance is obtained, in clinical care, individuals who receive iBCIs may be research participants and/or patients from a clinician’s perspective. To maintain setting-agnostic language, we use ‘iBCI user’ as an umbrella term for the individual considering, receiving, or using an iBCI in either context. Where a distinction is material, ‘research participant’ is used for investigational activities and ‘patient’ for clinical care. ‘Prospective iBCI user’ refers to pre-enrollment or pre-implant phases, and ‘iBCI recipient’ refers to post-implant. Throughout, ‘surrogate’ denotes a legally authorized representative, such as a health care proxy or court-appointed guardian, recognizing that the specific title and scope of authority may vary across jurisdictions and care settings.¹⁷ Accordingly, when a legally authorized surrogate is involved, consent-related communication concerning a prospective or current iBCI user includes the surrogate as appropriate, while preserving direct engagement with the prospective or current user to the greatest extent feasible. Although most iBCI use currently occurs in clinical trials, many, but not all, consent considerations addressed here will persist after regulatory approval in clinical (non-investigational) deployment. Throughout, when considerations are only relevant to a single context (e.g., relevant only to research consent) this is indicated accordingly.

As the gateway to participation in iBCI trials and programs, informed consent is not a single encounter or unitary event, but a longitudinal process that may evolve over weeks or months, and unfolds across pre-implantation, peri-implantation, and post-implantation phases, and is a decisive ethical juncture where theoretical principles meet practice.^18,19 To address these challenges and advance a more rigorous, consistent, and ethically robust approach to informed consent for iBCIs as these technologies reach a precipice of clinical translation, the Ethics, Neural Data Privacy, and Data Security Workgroup of the Implantable Brain-Computer Interface Collaborative Community (iBCI-CC), a regulatory science initiative, developed a set of unifying standards to guide practice across the clinical neuroscience and neurotechnology community.

In our proposed framework, we highlight elements of the consent encounter distinct to iBCIs that require particular attention along the arc of user’s iBCI journey spanning pre-implantation, peri-implantation, and post-implantation (including long-term use and potential explantation). Importantly, this framework is meant to complement, not substitute, standard requirements, and to prompt critical reflection and local adaptation as iBCIs evolve. Our framework operationalizes classical elements of informed consent as articulated in bioethics and regulatory practice with particular attention to distinctive features of iBCIs. For example, disclosure^20,21 is addressed through transparent discussions of device, surgery, software evolution, and neural data practices. Competence and capacity^22,23 are supported through multimodal assessment, communication support, attention to liminal or fluctuating capacity, and principled use of surrogate decision-making anchored in known preferences. Comprehension^24,25 is supported, for example, through adaptive communication strategies and teach-back methods tailored to individuals with speech and motor impairments. Voluntariness²⁶ is reinforced, for example, by decoupling device and data decisions and guarding against undue influence in populations that face limited therapeutic alternatives.

Users of this framework should continue to adhere to foundational legal and ethical standards applicable in their jurisdiction, including but not limited to the Common Rule (including 45 Code of Federal Regulations [CFR] 46, subpart A),²⁷ World Medical Association’s Declaration of Helsinki, ²⁸ Declaration of Taipei,²⁹ Belmont Report,³⁰ Nuremberg Code,³¹ Food and Drug Administration (FDA) regulations (including 21 CFR parts 50 and 56), the Health Insurance Portability and Accountability Act (HIPAA), the General Data Protection Regulation (GDPR), and applicable Institutional Review Board (IRB) procedures. We highlight features likely to be unfamiliar or under-specified in current practice, and offer practical guidance for implementation in translational research studies, clinical trials, and early clinical use. Our intended scope encompasses research and clinical encounters with individuals considering iBCIs. Because prospective users differ in speech, cognitive, and motor capacities and in their access to communication supports where necessary, the framework is deliberately modular and intended to be tailored to individual abilities and needs; its focus is deliberately on informed consent elements distinctive to the iBCI context rather than a restatement of foundational general biomedical consent practices and principles.

Distinguishing Features of iBCI Consent

Medical informed consent typically captures discrete, procedure-bound risks and benefits.³² For significant-risk clinical investigations (including those of iBCIs) conducted in the US, informed consent is subject to the required elements specified in 21 CFR §50.25. iBCIs problematize ordinary approaches to informed consent, as they involve a complex compounding of procedural consent for neurosurgical placement, data use consent for neural data capture, use and potential sharing, and device consent for the iBCI itself, which consists of sensors, decoders and effectors. The device may only be implanted once, but its behavior and functionality can change as decoders are trained, algorithms update, and the user’s goals, capacities and environments shift. ¹ For some prospective iBCI users, the impairments that make an iBCI relevant may complicate the ordinary mechanics of informed consent. Some individuals may be unable to place a written signature, reliably speak, or provide verbal confirmation, despite retaining decisional capacity. Conversely, severe motor and speech impairment may make it more difficult to synchronously assess understanding, appreciation, reasoning, and choice. Neural signals and BCI-derived outputs can later become the user’s primary channel for expression and synchronously-actualized agency. ^2,33When self-expression depends on an iBCI’s calibration and reliability, questions about authenticity, accuracy, and bias become particularly relevant.^34,35 Hardware or software malfunctions, signal degradation, or biocompatibility issues may also emerge, occasionally necessitating surgical revisions, repositioning, or hardware adjustments to maintain stable performance and safety.^36,37 For some users with progressive neurodegenerative conditions, iBCI control may decline or be lost over time because of disease progression even if the device remains technically intact,^38-40 creating the possibility that some users may later be unable to use the iBCI for its intended purpose. Furthermore, some forms of iBCI data may appear unusually sensitive insofar as they may be more challenging to deidentify even when surface level identifiers (e.g., via the HIPAA Safe Harbor method⁴¹) have been stripped, may permit unique, intimate inferences about the user, and could be valuable to multiple parties, raising unresolved issues of ownership, portability, and benefit sharing,^7,42 though some have argued that these concerns are exaggerated. ^7,43 Furthermore, the combined speech and motor impairments that may render one eligible for an iBCI may complicate one’s ability to participate in the consent dialogue, sometimes requiring reliance on a surrogate decision maker and increasing the risk of goal-discordant decision making if appropriate safeguards are missing.^44-46

Although some of the most ethically complex use cases for iBCIs involve individuals with severe speech and motor impairment, many prospective iBCI users will retain reliable speech or other reliable means of communication, and will be receiving iBCIs with the goal of restoring mobility or to support other functions rather than communication.^2,47 The framework is therefore designed as modular, with special attention, where relevant, to those with liminal or fluctuating communicative abilities. In the sections that follow, we accordingly treat communication status as a variable that shapes how consent might be obtained and revisited rather than as a defining feature of iBCI candidacy. Issues that are specific to locked-in syndrome, cognitive motor dissociation (CMD), or disorders of consciousness are highlighted as special considerations that can be consulted when relevant and otherwise set aside.

Core domains of the iBCI Informed Consent Framework

The framework and corresponding checklist are organized across the lifecycle of iBCI care: pre-implantation, peri-implantation (i.e. immediately before and after implantation surgery), and post-implantation (Figure 1). In each phase it pairs concrete prompts with the ethical commitments that motivate them (Table S1). Elements of this framework reflect lessons from long-standing research consortia such as BrainGate and its relied-upon IRB at Mass General Brigham, which have refined iBCI consent processes over more than two decades,^48,49 while aiming to distill lessons learned to a broader and rapidly diversifying^4,50 iBCI landscape. The framework structure, content and sequence were developed through multidisciplinary deliberation within the iBCI Collaborative Community Ethics, Neural Data Privacy, and Data Security Workgroup, incorporating perspectives from researchers, clinicians, ethicists, regulators, and individuals with lived experience of neurologic disability.

Figure 1.

Unifying Consent Standards for Implantable Brain-Computer Interfaces (iBCIs). Overview of selected elements of longitudinal consent process across iBCI lifecycle. Designed in BioRender with icons from Flaticon.

Pre-implantation

The pre-implantation period sets a foundation for the dialogue with the prospective user that will allow for development of shared expectations and reference points for both the team providing the iBCI and the prospective user to refer back to when needed. Attending to these domains carefully at the beginning sets up the team and prospective user for success, and is instrumental in preempting avoidable conflicts that can later arise if preferences, values, expectations and questions surrounding iBCI use are not explicitly and proactively discussed.

a. Evaluate and engage liminal capacities and define a communication strategy

For many iBCI candidates, speech or other communication modalities will be preserved, and a standard consent dialogue, using plain language and teach-back,⁵¹ will be appropriate. Even in these settings, the framework encourages teams to make explicit how consent discussions will occur, to confirm that the prospective user has adequate opportunity to ask questions, and to document the approach. For many candidates with severe speech and motor impairment, obtaining first-person permission is often possible with assistive technology and clinical support. At times, this could mean communicating with a prospective user one letter at a time through an assistive keyboard or eye tracker, or even the serial letter selection indicated by upward eye movements when the correct letter is read aloud by a care partner.^52,53 The framework encourages use of adaptive communication strategies, involvement of speech-language therapists when helpful, and teach-back to confirm understanding.^54-58 Where known or reasonably determinable, the preferred communication method for consent conversations is to be elicited and respected. When consent follows an acute neurologic event (e.g., stroke; brain injury), the framework prompts teams to consider the timing of the discussion relative to the injury and to distinguish between function unlikely to be regained from deficits for which the likelihood of recovery remains uncertain.⁵⁹

When prospective iBCI users have lost speech or rely on minimal residual communication signals, teams should not only determine whether a communication signal is present, but whether it can be interpreted reliably enough to support informed consent. This may require involvement of clinicians experienced in augmentative and alternative communication, documentation of error rates or test-retest reliability of the communication channel where possible, and procedures for resolving ambiguity. In addition, assessment should extend beyond preserved awareness or consciousness to include cognitive abilities and psychological status relevant to the capacity to consent.^60,61 Vansteensel et al. have examined the rationale and potential procedures for these steps, including an iterative information process tailored to communication capabilities; validation of a reliable yes/no channel using questions whose answers are definitively known to others; appropriate cognitive and psychological assessments; relevant comprehension assessments; consideration of video documentation of the consent procedure; involvement of an independent observer where appropriate; and repeated, unambiguous affirmative responses before a legal representative signs on a prospective user’s behalf. ⁶¹

When overt communication or volitional behavior of the potential participant is silent or ambiguous (as it may be in complete locked-in syndrome or advanced neurological disease), teams should consider multimodal assessment, including task-based EEG or functional neuroimaging paradigms, to assess preserved awareness (i.e., covert consciousness or cognitive motor dissociation), as well as consideration of sensory evoked potentials where appropriate, which could inform impressions of BCI candidacy, and to share those results with surrogates. ^62-67 When task-based EEG or functional neuroimaging paradigms are used to assess preserved awareness and consciousness, empirically supported paradigms and transparent, prespecified analytic criteria should be used.^65,68,69 Where widely agreed-upon or consensus criteria exist, these should guide use and interpretation. These safeguards can protect against under-ascription or over-ascription of consciousness and allow teams to rationally and rigorously tailor their communication strategy to the prospective user’s capacities and limitations, which may at times evade routine behavioral detection.

b. Recognize surrogates’ role and assess authentic preferences

For progressive conditions like ALS (amyotrophic lateral sclerosis, a motor neuron disease), values and priorities are often articulated well before capacity wanes. Where feasible, advance directives specific to iBCI use and research may be employed, and surrogates invited to anchor decisions in those known preferences rather than their own hopes or fears (consistent with the substituted judgement standard).^70,71 We anticipate iterative consent as capacity changes, so that earlier choices can be revisited if and when the iBCI restores a reliable channel for expression.

c. Discuss iBCI device, surgical, and neural data-related factors separately

Instead of introducing the device as a single package, teams should disentangle neurosurgical details, device features, and functional claims of the device in plain language and, wherever possible, with visual demonstrations. It encourages separating neurosurgical planning and risk from the risks and potential benefits related to device operation and maintenance. Finally, it creates a distinct track for neural data: what will be captured, where it is stored, who can see or use it, and what rights follow from possession of both raw data and trained decoders. This decoupling serves two goals. It reduces undue bundling pressure that can distort voluntariness, and it clarifies accountability. Adverse events related to the initial placement or chronic presence of the device, device malfunctions, and data governance failures are different potential risks, with different mitigations and remedies.⁴ Although a thoroughgoing exposition of what may distinguish iBCI data qua health information is beyond the present scope, it is important to recognize that high-resolution iBCI data may, at least in principle, support unusually intimate inferences about an individual, be harder to robustly de-identify, especially given the small and therefore more readily identifiable population of current iBCI users, and thus warrant particular attention to privacy, re-identification risk, and downstream uses during consent.^72,73 While analogous issues have been appraised in the context of other implanted medical devices and wearables,^74,75 they may be especially salient and prevailing approaches problematized in the iBCI context, where brain recordings may be more closely linked to aspects of personal identity^76,77 and may contain highly granular and often not-yet-fully-understood information, depending on sensor location and type. BCI sensor types under development span multiple approaches, as illustrated in Figure 2, each carrying distinct device-, surgical-, and data-related benefits and risks for discussion during the consent process.

Figure 2.

Magnified views of selected BCI sensor classes for showcasing the evolving landscape of iBCI sensors This schematic is for general illustrative and educational purposes only and is not intended to depict exact scale or coverage. iBCIs under development span multiple approaches, ranging from subscalp, intracalvarial, endovascular, electrocorticographic (ECoG), cortical surface-penetrating microelectrodes, laminar/ depth probes, neurotrophic/bioelectronic electrodes, flexible penetrating threads, and microwires to distributed microimplants. These vary by anatomic compartment, surgical access route, depth, brain coverage, recording resolution, signal type, reversibility, data transmission pathway, and long-term longevity, with distinct device-, surgical-, and data-related benefits and risks for discussion during the consent process. Artwork by Tatiana Gandlin.

d. Share key information with the prospective user

Across these decoupled consent procedures for device, surgery, and data, the prospective user needs to be informed about a variety of topics. This, of course, must include information that we expect will be covered by default in most settings, such as information about surgical risks, loss of (additional) function, and the possibility of interfering with future neurorehabilitation potential. However, there are also less apparent considerations that remain highly important, and these must be communicated to the prospective user to set realistic expectations and ensure fully informed consent for the implantation of an iBCI. These less apparent pieces of information are the ones we focus on here:

d1. Set Realistic Expectations: Anticipated Benefit and Real-World Function

Potential users may encounter media narratives that over-promise function, usability, speed, reliability, and generalizability of the iBCI.⁷⁸ Teams should discuss anticipated benefit and real-world function. Systems may differ in whether they function only during scheduled research sessions, and/or can also be used at home in the absence of technical support from the research team or medical device manufacturer. Some may require broadband connectivity and frequent in-person recalibration, while others are designed for more autonomous use. Additional considerations include whether a system can operate during travel, hospitalizations for other conditions, or only within controlled environments (including the user’s own home or place of residence). It also surfaces lifestyle constraints that should be addressed directly, such as the implant’s impact on MRI eligibility, airport security, hair care, and showering; battery charging; and the practicalities of percutaneous connectors when they will be present.⁷⁹

Discussions of anticipated benefit should also include the possibility that iBCI control may be incomplete, inconsistent, lost, or limited to particular settings. Loss or reduction of control may arise from factors relating to hardware, decoding, change in clinical status, progressive disease, or other factors. The burdens of participation beyond surgical risk, including recurrent visits/appointments, prolonged sessions, dependence on caregivers or technical staff, and the possibility of substantial effort with uncertain functional progress, warrant discussion. In progressive neurodegenerative conditions prospective users should also be informed that iBCI control may decline or be lost over time because of disease progression, changes in neural signal quality, evolving cognitive or attentional capacities, or other clinical changes, which may not always be recoverable,^39,40,80 requiring proactive discussion during consent of the possibility that some such users may later be unable to use the iBCI for its intended purpose. Accordingly, opportunities exist to examine and discuss the potential psychological effects of such loss of function, especially after a period of realizing the function gained, and appropriate psychological supports.

d2. Cost, compensation, and post-implantation support

Cost and post-implantation support pathways should be explained in the same concrete detail as surgical risk.^81,82 Prospective users should know who pays for the procedure, device, and long-term maintenance; circumstances that could lead to an explantation and how it would be handled; as well as what happens and options for alternatives if a sponsor withdraws or is dissolved. This conversation would likely differ in research contexts versus post-market approval clinical use, reflecting the different goals, expectations, regulations and obligations in each context.^83-85

In the context of iBCI clinical trial enrollment, the nature and scope of research participant payment(s) should be carefully planned and discussed, with safeguards to ensure that compensation is proportionate and does not exert undue influence or compromise the voluntariness of consent; this is particularly relevant in the context of iBCI trials where prospective research participants face severe disability, limited vocational options, paucity of therapeutic alternatives, and thus potentially heightened vulnerability to therapeutic misconception or increased susceptibility to financial influence. Approaches to participant payment will foreseeably vary across research sponsors, potentially ranging from reimbursement for trial-related expenses incurred by virtue of study participation to incentive payments for enrollment and continued engagement.^86-88 FDA’s current guidance emphasizes that payments to research participants should be fair, proportionate, and structured to avoid undue influence on voluntary consent.⁸⁹ While it is beyond the scope of the present project to articulate all potential options or adjudicate the optimal approach to participant payment in iBCI research programs (which will likely vary by program), it is crucial for these informed consent-relevant issues to be carefully and proactively considered, recognizing, as noted above, that these conversations will differ by context. In post-market clinical use, manufacturers in most regulated health-care systems are prohibited from providing direct payments to patients or clinicians to encourage iBCI adoption. However, forms of financial assistance intended to reduce access barriers (rather than to incentivize uptake) may play a role and could be transparently discussed during consent.^90,91

d3. Neural data use, privacy, and publicity

Neural data may reveal information beyond the task at hand. ^92-94 The Common Rule (45 CFR §46.116(a)(4) stipulates that ‘‘[t]he prospective subject or the legally authorized representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information. There is a need for clear, accessible, pre-emptive explanations of foreseeable secondary uses such as algorithm improvement, commercial development, or external research databases. It also creates a space for users to accept the iBCI but decline specified neural data-sharing pathways. In addition, it asks teams to explain which protections are in place and what kind of neural data transfers may occur.⁹⁵ In research contexts, opportunities exist to clarify how sponsor requirements for open-data deposition might be optimally reconciled with efforts to honor participant preferences regarding iBCI data sharing and downstream use.^96-98

Because some iBCI users (especially those who may be among the first to use a highly anticipated technology) may attract public or media attention, opportunities exist for consent discussions to address preferences and risks related to publicity. Prospective users could be informed that sharing information about participation on social media, in institutional communications, or through press coverage may generate unsolicited attention from journalists, advocacy groups, or members of the public. Prospective users’ interest in, or aversion to, media engagement should be proactively clarified, with explicit provisoins that media participation is voluntary, separable from participation, and revisitable as results, capabilities, or interests evolve.

d4. Ownership, portability, and benefit sharing

It is important to make explicit three considerations that should not be left to inference. First, who possesses and controls the device, the data, and the decoder? Second, what is portable and interoperable if a user transitions to another system, site, or sponsor?⁹⁹ Third, how will any profits derived from a person’s neural data be handled, and under what circumstances might the user share in them? This question is especially fraught, as individual contributions to AI/ML models trained on collective datasets are hard to isolate, while profit-sharing risks coercion if promised before implantation and presents formidable ethical and logistical hurdles if pursued afterward. Although “data dividends”, licensing agreements, or cooperative models may enable some measure of shared benefit from the use of personal iBCI data, the prevailing digital experience is one of lengthy end-user license agreements that effectively require ceding broad rights to data generated through device use.¹⁰⁰ iBCI consent processes should avoid opaque agreements and instead provide clear mechanisms for participants to understand and meaningfully control how their neural data are used. Answers will likely vary by jurisdiction and iBCI program,^101,102 and articulating the approach will ensure prospective users are optimally informed. Importantly, these should not be treated as one-time conversations but as lifecycle obligations, revisited throughout the peri-implantation and post-implantation phases as the technological, legal, and economic landscapes evolve. In post-market contexts, responsibility for these ongoing discussions could parallel established models for other implantable medical devices, where physicians remain responsible for placement, clinical management and counseling (often through dedicated device clinics), manufacturers for device performance, tuning (often in collaboration with physicians), and updates, and healthcare organizations for establishing local norms and rules for secondary data-use, privacy, and related practices compliant with legal and regulatory standards. Clarifying role-based obligations in advance can protect iBCI users from being left without a clear point of accountability once an iBCI is implanted. Embedding an expectation of ongoing engagement into the consent process may help safeguard users’ interests as the iBCI ecosystem matures, particularly as new secondary uses emerge, monetization of neural data is contemplated, or adjunctive or alternative devices that data might be ported to or from become available.

Peri-Implantation

The time surrounding implantation provides an opportunity to reinforce the relationship and build trust with the iBCI user and to revisit the initial work in the consent process. Directly before the implantation is a last opportunity for prospective users to change their minds about the surgery and it is an opportunity to reinforce the collaborative nature of the work that will occur post implant. The peri-implantation phase is a time when the process becomes very real.¹⁰³

e. Peri-Implantation Documentation, Affirmation and Communication

Directly before implantation offers a final opportunity for prospective users to affirm or withdraw consent, ask clarifying questions, and reinforce the collaborative partnership that will guide iBCI use, follow-up care, and shared decision-making. Documenting final consent affirmation in the electronic health record (EHR) at the medical center where the iBCI implantation is planned, along with the full consent record, enables timely, informed clinical decisions and situational awareness about iBCI management and safety precautions, supporting autonomy, continuity of care, and risk mitigation in the peri-implantation period. Chart-wide EHR availability and visibility equips downstream teams with relevant info about the iBCI and user preferences surrounding it, including device identifiers, configuration and safety limits (e.g., MRI conditionality), potential for and risks associated with iBCI removability, the recipient’s neural data sharing preferences, and legally authorized representative (LAR) status. A chart banner or flag can prevent this info from being difficult to expediently locate. Following implantation, a plain-language debrief should be provided and the discussion documented in the EHR, summarizing the procedure and any unexpected intraoperative events, reiterating iBCI restrictions and device-use considerations, and confirming 24/7 clinical and technical contacts to support safe recovery and adherence.^104-107

Post-Implantation

The post-implantation phase constitutes the bulk of effort and time for both iBCI teams and users. Once implanted there are opportunities for the user to engage in additional activities or to engage less than expected. The ongoing nature of the participation may be easy to overlook when focusing on the initial consent forms and ongoing risks.^108,109

f. Validate via iBCI-mediated consent

If an iBCI demonstrates the ability to support user expression or communication, the ethics of consent may require a method for verifying when iBCI outputs are sufficiently reliable enough to be granted legal and clinical significance. Teams should take care to document calibration procedures, error rates, and predefined thresholds for reliability. If an iBCI enables binary (“yes/no”) responses with greater-than-chance but imperfect accuracy (e.g., 70%), it may be acceptable for low-stakes, reversible decisions. By contrast, an iBCI that enables the user to generate a multi-element, propositionally complex request with high test-retest reliability approaches the threshold at which its outputs might reasonably be treated as specific, high-fidelity communicative acts reflecting fine-grained preferences, but such outputs would still require independent confirmation and a high degree of certainty before being treated as actionable for high-stakes decisions (for example, goals-of-care decisions). There may also be a role for neutral observers or ethics consultation in cases of dispute or uncertainty, and encourages transparent documentation of any consent decisions that are revised in light of new, iBCI-mediated communication. These post-implantation procedures parallel and extend pre-implantation methods for confirming reliability of residual communication channels in prospective users who have lost speech;^60,61 both before and after implantation, teams should document how any communication channel being relied upon was validated, what error rates or reliability estimates are known, what kinds of decisions the channel is considered adequate to support, and when additional confirmation or neutral adjudication is required, inter alia.^60,61 These steps make the process auditable and protect both the user and the clinical/research team. (iBCIs placed to restore mobility or support other functions and not communication may bypass the need for some of these steps.)

g. Implement a layered consent architecture

After implantation, new iBCI features, capabilities, limitations or data uses may materialize. Teams might consider treating these as consent addenda when accompanied by new significant risks/benefits, rather than silent extensions, with opt-in or opt-out choices explained in clear, non-technical terms. A relevant threshold for deciding whether a consent update may be needed is whether new developments or information could reasonably affect one’s decision or willingness to continue iBCI use or participation. This standard is grounded in the Common Rule and FDA informed consent regulations, which require, when appropriate, disclosure of “significant new findings” that may relate to a one’s “willingness to continue participation”.¹¹⁰ FDA guidance offers examples of what might constitute relevant new information of this kind, including unanticipated adverse events or events occurring with greater frequency/severity than previously disclosed, or significant information about effectiveness.¹¹¹ In the iBCI context, this could include newly identified safety, cybersecurity, privacy, or device-performance risks; substantial alterations in device function or data use; or material changes in support, access, or maintenance. These addenda could be revisited at set intervals throughout the collaboration with the user that can be marked by time periods or milestones. We also encourage teams to proactively clarify that capabilities vary across iBCI device/decoder/effector models (Figure 2) and across individuals, so a feature demonstrated in one setting is not necessarily transferrable to another. From an ethical and legal standpoint, any refusal to consent to such addenda should not be construed as disqualifying or punitive. This approach balances respect for autonomy with the need for just structuring of benefits.

h. Iteration, withdrawal, long-term support, and capacity shifts

iBCI informed consent, an ongoing process rather than a unitary transaction, should be revisited on a regular schedule and at defined triggers, including major software updates, clinical changes, hospitalizations, expected or unexpected adverse events or life transitions. Some users may choose to turn off specific functions, limit data transmission, or shift to local storage if feasible, as they continue to gain experience living with their iBCI. Others may want to explore device explantation, which may not be feasible for some iBCIs, and, even where it is feasible in principle, may be limited by risks, costs, or access to specialized care. We encourage teams to discuss these realities proactively and to ensure continuity of clinical and psychosocial support if a user withdraws. Post-study (in the case of research participation) or post-explanation (in the case of clinical withdrawal) expectations and obligations should be made clear to iBCI users and surrogates so that expectations are aligned throughout the lifecycle of iBCI use.^81,112

Guidance for translational research and clinical teams

Moving a framework from intention to practice requires workflow changes that do not overburden clinicians, researchers, prospective users or families. Modular consent materials that match the framework’s separation of domains can be helpful here. A brief, plain-language overview for each module can be paired with a deeper technical explainer and a short video or visual demonstration to allow prospective iBCI users and surrogates choose the level of detail they need or prefer, regarding distinct authorizations for iBCI surgery, device use, data practices, and tracking of each consent status over time. Documentation should specify who obtained each element of consent and at what time, including the communicative supports employed and capacity evaluation(s) conducted, where applicable. When features or data uses evolve and the risk/benefit balance changes, consent should be updated through an addendum. It is advisable to schedule prospective iterations of informed consent in advance, and to link additional reviews to predefined triggers, such as an iBCI firmware update that introduces new significant risk, change in clinical diagnosis, or transitions from research to clinical funding.

Sponsor context may also materially affect iBCI consent. Federal, foundation, academic, and industry sponsors can differ in priorities, obligations, funding models, governance, and expectations regarding data sharing, publication, intellectual property, commercialization, post-trial access, long-term maintenance, and accountability infrastructure.^113,114 These differences warrant further systematic study, and transparent discussion during consent. Relevant sponsor-specific features can include who controls neural data and trained decoders; who is responsible for device maintenance, technical support, and post-trial provisions; what happens if an entity is acquired, dissolves, or discontinues a device; and what institutional, contractual, or regulatory mechanisms support follow-through on commitments made during consent.

The framework offered here is best understood as a starting point for local adaptation and step toward harmonization rather than an exhaustive account of program-specific obligations. The iBCI Informed Consent framework and accompanying checklist can serve prospectively leading up to and at implantation, longitudinally as a guide for ongoing engagement, and retrospectively for quality review and improvement. Teams can regard this framework as a flexible operational aid to support the iBCI-Informed Consent process rather than an all-encompassing or rigidly prescriptive protocol. In practice, teams may use this framework to inform the design of local consent materials and map workflows across the pre, peri- and post-implantation continuum and align them with the framework’s principal domains. Although some early iBCI trials have enrolled individuals with profound speech and motor impairment, iBCIs are also being developed for users who retain speech and can engage in a conventional consent discussion. The framework is structured to be modular across this spectrum, with targeted additions for situations in which communication or capacity is limited or fluctuating. When iBCI-mediated communication is used following implantation for subsequent consent discussions, predefined reliability thresholds, error rate documentation/tracking, and neutral adjudication mechanisms can safeguard interpretive validity. Centers may find value in maintaining a layered consent record with time-stamped addenda for new risk-introducing iBCI features, functions, or neural data streams, along with tracking of device changes or shifts in clinical status. Local adaptation is expected and encouraged within applicable institutional and statutory frameworks. Future research opportunities to shed light on implementation experiences should be recognized and sustained.

To be sure, the existence of an iBCI informed consent framework and associated checklist does not ensure its adoption. Prior empirical work on consent practices suggests that even well-supported interventions may falter in adoption or become derailed when lacking appropriate dissemination techniques, or if they are perceived as unduly time/resource-consuming, difficult to integrate into prevailing workflows, insufficiently supported by institutions, or otherwise misaligned with practical constraints.¹¹⁵ Implementation science¹¹⁶ scholarship has therefore supported treating uptake as an active process requiring deliberate strategy rather than a passive consequence of innovation.¹¹⁷ Strategies to facilitate meaningful adoption in this setting require further study, and may include designating local champions,¹¹⁸ providing role-specific trainings,¹¹⁹ developing implementation toolkits, embedding prompts into existing review or documentation workflows, monitoring use, engaging communities,¹²⁰ adapting tools to local contexts and settings, and allowing for feedback and iteration over time.¹¹⁷

Optimal implementation strategies may differ by setting. In iBCI research, checklist elements may be incorporated into protocol development, IRB review, consent form drafting, clinical research coordinator training, sponsor agreements, and monitoring procedures. In future postclearance clinical use, implementation strategies could include electronic health record integration, manufacturer- and clinician-facing educational materials, reimbursement mechanisms to support clinician time spent counseling patients and caregivers, and medical center policies. Further iBCI-specific implementation science research is needed to determine which strategies optimally support feasible, consistent, and user-centered adoption across sites and settings, including evaluation of feasibility, participant understanding, end user experience, and workflow burden. The framework is therefore intended not as a self-executing rigid mandate, but as a practical foundation for intentional dissemination, local adaptation, prospective evaluation, and refinement as iBCI systems and workflows mature.

CONCLUSION AND OUTLOOK

Optimal informed consent for iBCIs can be understood as a longitudinal, modular, and revisitable process extending across the full device lifecycle. Within this process, opportunities exist to distinguish among considerations related to neurosurgical implantation, device operation, software, decoder and effector capabilities, neural data collection and use, and long-term support and provisions, while ensuring that each domain is explained in accessible terms, as summarized in Figure 3. Particular attention is required to support users with impaired or fluctuating cognition or communication, validate the reliability of communication channels, engage surrogates appropriately, and preserve direct participation by both current and prospective users whenever possible. The unifying standards and cognate checklist presented here can promote consistency while providing a shared ethical foundation that remains adaptable across devices, users, institutions, and regulatory contexts.

Figure 3.

Landscape of brain-computer interface device systems, including varied sensors, signals, and effectors under development. BCI systems may vary substantially across devices and individuals, including by sensor type (top left), signal modality (top right), decoder architecture, output pathway, and effector type (bottom right). iBCIs may be designed to control varied effectors, including communication interfaces, external devices, environmental control systems, robotics or prosthetics, somatosensory or functional stimulation, or closed-loop neuromodulation. Consent-related considerations differ across pre-implantation, peri-implantation, and post-implantation phases, and may include device-, surgical-, data-, decoder-, autonomy-, safety-, maintenance-, upgrade-, explantation-, and long-term support-related dimensions, risks and benefits. Sensor type artwork by Tatiana Gandlin.

Unifying consent standards will not solve all the normative questions iBCIs raise.^36,54 Further study is needed to develop and evaluate methods for validating iBCI-mediated communication of high-stakes decisions, normative thresholds for actionability, and strategies for communicating uncertainty to surrogates in ways that support decision-making and iBCI user agency. In addition, practical templates for iBCI-specific advance directives should be created to support clinicians and prospective users. Establishing shared expectations for interoperability and portability is also essential with standards that are realistic for engineers/clinicians while remaining meaningful for users. Finally, approaches to individual iBCI data sharing must be designed to ensure fairness, administrative feasibility, and alignment with the dual goals of public research and responsible commercialization. At the same time, safeguards that exceed those for comparable neurological devices could risk deterring innovation and slowing progress for patients with urgent needs. Proportional, unifying standards attuned to the distinctive features of iBCIs are thus needed to balance protection of users with the responsibility to advance care and translational neuroscience. The iBCI Informed Consent framework is offered as an initial foundation towards this balance.

As iBCIs move from feasibility trials to translational use and approach market approval, the iBCI Informed Consent framework and associated checklist presented here aims to be a practical instrument and modular resource for the community, and a starting point for unifying standards for iBCI informed consent and translational ethics in this evolving domain of neuroscience and medicine.

Bigger picture.

Implantable brain-computer interfaces (iBCIs) are devices nearing clinical reality and could transform care for people with neurological conditions such as speech and motor impairment. Breakthroughs in neural decoding have enabled restoration of communication, control, and autonomy, but iBCIs raise challenges and opportunities that extend beyond ordinary device consent in uniting neurosurgery, adaptive software, AI/ML, and continuous high-resolution neural data capture. Informed consent for iBCIs should be understood as a lifecycle process spanning pre-implantation, peri-implantation, long-term use, and potential explantation. In this review and analysis, we provide unifying consent standards to help the field scale responsibly by protecting autonomy, clarifying responsibilities, and guiding future work on individual neural data governance, post-trial support, and user-centered clinical translation of these devices.