Brain-Computer Interface (BCI) Research and Commercial Consent Agreement

BRAIN-COMPUTER INTERFACE (BCI) RESEARCH AND COMMERCIAL CONSENT AGREEMENT

Sponsoring Entity / Manufacturer: [________________________________]

Principal Investigator (if research): [________________________________], [____] (Credentials)

Clinical Site / Facility: [________________________________]

Device Trade Name: [________________________________]

Device Model / Version: [________________________________]

FDA Submission Number: ☐ IDE #[________________] ☐ PMA #[________________] ☐ De Novo #[________________]

IRB Name (if applicable): [________________________________]

IRB Approval Number: [________________] Approval Date: [__/__/____]

Protocol Number (if research): [________________] Protocol Version: [____]

ClinicalTrials.gov Identifier (if research): NCT[________________]

24-Hour Emergency Contact: [________________________________] Phone: [________________]

Agreement Date: [__/__/____]

PARTICIPANT IDENTIFICATION

Full Legal Name: [________________________________]

Date of Birth: [__/__/____] Age: [____]

Address: [________________________________]

Phone: [________________] Email: [________________________________]

Emergency Contact Name: [________________________________]

Emergency Contact Relationship: [________________] Phone: [________________]

Legally Authorized Representative (if applicable):

Name: [________________________________] Relationship: [________________]

Legal Authority Basis: ☐ Healthcare Power of Attorney ☐ Court-Appointed Guardian ☐ Other: [________________]

PART I: NATURE AND PURPOSE OF THE BCI SYSTEM

Section 1.1 — What Is a Brain-Computer Interface?

A brain-computer interface ("BCI") is a neurotechnology system that creates a direct communication pathway between the brain and an external or internal computing device. The BCI system described in this Agreement records electrical signals generated by neurons in your brain, processes those signals using software algorithms, and translates them into commands that control a computer, prosthetic limb, communication device, or other digital system.

Type of BCI System (select all that apply):

☐ Invasive / Implantable — Electrodes are surgically placed directly on or within brain tissue
☐ Endovascular — Device is delivered through blood vessels to a position near the brain (no open brain surgery)
☐ Partially Implantable — Some components are implanted; others are external
☐ Non-Invasive — Sensors are placed on the scalp or skin surface (e.g., EEG-based)
☐ Hybrid System — Combination of implanted and non-invasive components

Primary Intended Use:

☐ Restore motor control (cursor/device control for individuals with paralysis)
☐ Restore communication (speech synthesis or text generation)
☐ Restore sensory function (e.g., vision, touch feedback)
☐ Neuromodulation / therapeutic stimulation
☐ Cognitive enhancement or augmentation
☐ Research and data collection only
☐ Other: [________________________________]

Section 1.2 — Regulatory Status of This Device

☐ Investigational Device (IDE): This device is an investigational medical device that has NOT been approved or cleared by the U.S. Food and Drug Administration (FDA) for commercial distribution. It is authorized for investigational use only under an Investigational Device Exemption (IDE) pursuant to 21 CFR Part 812. Federal law limits the use of this device to investigational purposes.

☐ FDA-Approved Device (PMA): This device has received Premarket Approval (PMA) from the FDA under 21 CFR Part 814 for the specific indications described in Section 1.1.

☐ FDA-Cleared Device (De Novo / 510(k)): This device has been cleared by the FDA through the De Novo classification process or 510(k) pathway.

☐ Humanitarian Device Exemption (HDE): This device is authorized under an HDE. It has been determined to be safe but its effectiveness has not been established.

Approved / Cleared Indications (if applicable): [________________________________]

Section 1.3 — Purpose of This Agreement

This Agreement serves as your informed consent to:

1. Undergo surgical implantation and/or application of the BCI device described herein;
2. Participate in the associated research study (if applicable) or receive the device for its approved commercial use;
3. Allow the collection, processing, storage, and use of your neural data as described in this Agreement;
4. Acknowledge the risks, benefits, and alternatives explained below; and
5. Establish your rights regarding your neural data, device explantation, and ongoing care.

You have the right to take as much time as you need to review this Agreement. You may consult with family members, friends, independent physicians, attorneys, or patient advocates before making your decision. Your decision to participate or not participate will not affect your current or future medical care.

PART II: STUDY / TREATMENT PROCEDURES

Section 2.1 — Pre-Implantation Evaluation

Before implantation, you will undergo the following assessments:

☐ Comprehensive neurological examination
☐ Brain imaging (MRI, CT, and/or functional MRI)
☐ Neuropsychological and cognitive assessment
☐ Psychiatric evaluation and mental health screening
☐ Baseline functional assessment (motor, communication, quality of life)
☐ Medical history review and physical examination
☐ Laboratory testing (blood work, coagulation studies)
☐ Anesthesia consultation
☐ Neurosurgical consultation and surgical planning
☐ Assessment of home environment and support system
☐ Assessment of decision-making capacity
☐ Other: [________________________________]

Estimated duration of pre-implantation evaluation: [________________________________]

Section 2.2 — Surgical Implantation Procedure

Procedure Description:

[________________________________]
[________________________________]
[________________________________]

Surgical Approach:

☐ Craniotomy (surgical opening of the skull)
☐ Burr hole(s)
☐ Endovascular delivery (catheter-based, no craniotomy)
☐ Minimally invasive robotic placement
☐ Other: [________________________________]

Anesthesia Type: ☐ General Anesthesia ☐ Local with Sedation ☐ Other: [____]

Estimated Surgical Duration: [________________________________]

Expected Hospitalization: [________________________________]

Implant Location(s) in the Brain:

☐ Motor cortex (primary motor area)
☐ Premotor cortex
☐ Somatosensory cortex
☐ Speech/language areas (Broca's area, Wernicke's area)
☐ Visual cortex
☐ Superior sagittal sinus (endovascular)
☐ Other: [________________________________]

Number of Electrodes / Channels: [________________________________]

Implanted Hardware Components:

[________________________________]
[________________________________]

External Hardware Components (if any):

[________________________________]
[________________________________]

Section 2.3 — Post-Implantation and Calibration

Following implantation, you will undergo a calibration and training period that includes:

• Recovery Period: Approximately [____] days/weeks of post-surgical recovery before device activation.
• Calibration Sessions: Approximately [____] sessions over [____] weeks/months to train the BCI algorithms to decode your specific neural signals.
• Training Protocol: You will learn to use the BCI through a structured training program involving [________________________________].
• Software Updates: The decoding algorithms may be updated periodically to improve performance or address safety concerns.
• Home Use (if applicable): After successful calibration, the device may be used in your home environment under the supervision/monitoring protocol described in Section 2.4.

Section 2.4 — Ongoing Monitoring and Follow-Up

Follow-up Visit Schedule:

Remote Monitoring:

☐ The BCI system includes continuous or periodic remote monitoring of device function
☐ Neural signal quality data may be transmitted wirelessly to the study/clinical team
☐ Alerts will be generated if the system detects: [________________________________]

Duration of Study Participation (if research): [________________________________]

Duration of Ongoing Clinical Support (if commercial): [________________________________]

PART III: RISKS AND ADVERSE EVENTS

Section 3.1 — Surgical and Medical Risks

You should carefully consider the following surgical and medical risks. This list is not exhaustive, and additional risks may arise that are not currently foreseeable:

Surgical Risks:

☐ Intracranial hemorrhage (bleeding within the skull) — potentially life-threatening
☐ Infection at the implant site, including meningitis or brain abscess
☐ Cerebral edema (brain swelling)
☐ Stroke (ischemic or hemorrhagic)
☐ Seizures (new onset or worsening of existing seizures)
☐ Damage to brain tissue during electrode insertion
☐ Cerebrospinal fluid (CSF) leak
☐ Adverse reaction to anesthesia
☐ Venous sinus thrombosis (for endovascular devices)
☐ Death (rare but possible with any intracranial procedure)

Device-Related Risks:

☐ Electrode migration, displacement, or thread retraction from brain tissue
☐ Device malfunction, including loss of signal or performance degradation
☐ Hardware failure requiring additional surgery
☐ Battery depletion (if applicable) requiring replacement surgery
☐ Electromagnetic interference with other medical devices (e.g., MRI incompatibility)
☐ Tissue reaction, including gliosis (scarring around electrodes) reducing signal quality
☐ Skin erosion or wound complications at the implant site
☐ Need for device explantation (removal)
☐ Cybersecurity breach or unauthorized access to the device or neural data

Long-Term Medical Risks:

☐ Chronic pain at the implant site
☐ Progressive degradation of electrode performance over months or years
☐ Unknown long-term effects of chronic electrode implantation in brain tissue
☐ Contraindication for future MRI scans (full or conditional MRI compatibility: [____])
☐ Complications if the sponsoring company discontinues support, ceases operations, or recalls the device

Section 3.2 — Neurological and Cognitive Risks

☐ Changes in cognitive function, including attention, memory, or executive function
☐ Changes in speech, language, or communication abilities
☐ Involuntary motor movements or motor deficits
☐ Sensory disturbances (numbness, tingling, altered perception)
☐ Headaches (acute or chronic)
☐ Fatigue or mental exhaustion from BCI use

Section 3.3 — Psychological and Identity-Related Risks

You should be aware that brain-computer interface technology may affect your psychological experience and sense of self. The following risks have been identified in neurotechnology research and clinical experience:

☐ Sense of Agency Disruption: You may experience uncertainty about whether your actions, thoughts, or intentions originate from yourself or are influenced by the device. This may include feelings of external control or loss of autonomy over device-mediated actions.

☐ Identity and Self-Perception Changes: Chronic use of a BCI may alter your perception of your own identity, personality, or sense of self. Some users report feeling that the boundary between themselves and the device becomes blurred.

☐ Psychological Continuity Concerns: Changes in neural patterns caused by the device may raise questions about the continuity of your psychological identity over time.

☐ Emotional and Mood Changes: The device or associated neural stimulation may cause unexpected changes in mood, emotional regulation, or personality traits.

☐ Dependency and Adaptation: You may become psychologically dependent on the device for communication, motor control, or other functions. Removal or failure of the device may cause significant distress, grief, or functional regression.

☐ Social and Relational Effects: The presence of the implant and its capabilities may affect your social relationships, self-image, and how others perceive and interact with you.

☐ Existential and Philosophical Distress: Some participants experience distress related to philosophical questions about the nature of thought, free will, and human-machine integration.

☐ Research Discontinuation Distress: If the research study ends or the device must be removed, you may experience significant psychological difficulty adjusting to loss of function the device provided.

Psychological Support: The study/clinical team will provide access to psychological and psychiatric support, including:

• Pre-implantation counseling regarding identity and adaptation
• Ongoing psychological monitoring at each follow-up visit
• Crisis intervention and mental health referrals as needed
• Peer support connections with other BCI users (if available)
• Transition counseling if the device is removed or deactivated

Section 3.4 — Reproductive and Unknown Risks

☐ The effects of this BCI device on pregnancy, fertility, and fetal development are unknown. If you are pregnant, planning to become pregnant, or breastfeeding, you must discuss this with the study/clinical team immediately.

☐ There may be risks that are currently unforeseeable. As BCI technology is relatively new, long-term risks (beyond [____] years) have not been fully studied in humans.

PART IV: POTENTIAL BENEFITS

Section 4.1 — Potential Benefits to You

☐ Restored ability to control a computer cursor, tablet, phone, or other digital device through thought
☐ Restored ability to communicate through BCI-mediated speech synthesis or text generation
☐ Restored motor function through BCI-controlled prosthetics or functional electrical stimulation
☐ Restored sensory perception (e.g., tactile feedback, vision)
☐ Improved independence and quality of life
☐ Other: [________________________________]

Important: There is no guarantee that you will experience any of the benefits listed above. The device may not work as intended, may lose effectiveness over time, or may provide only limited functional improvement.

Section 4.2 — Potential Benefits to Others and Society

Your participation may contribute to:

• Scientific understanding of brain function and neural coding
• Development and improvement of BCI technology for future patients
• Advancement of treatments for paralysis, ALS, stroke, and other neurological conditions
• Creation of safety and efficacy data supporting broader availability of BCI devices

PART V: ALTERNATIVES

Section 5.1 — Alternative Options

You are not required to participate in this study or receive this device. Alternatives may include:

☐ No BCI device — Continue with your current level of function and assistive technology
☐ Conventional assistive technology — Eye-tracking systems, sip-and-puff devices, switch-based systems, voice recognition software
☐ Non-invasive BCI systems — EEG-based BCI systems that do not require surgery (generally lower performance than implanted systems)
☐ Other investigational BCI devices — Other BCI systems currently in clinical trials, including: [________________________________]
☐ Other surgical interventions — [________________________________]
☐ Rehabilitation therapies — Physical therapy, occupational therapy, speech therapy
☐ No treatment — You may choose not to pursue any intervention at this time

The relative advantages and disadvantages of each alternative have been explained to you by [________________________________].

PART VI: NEURAL DATA RIGHTS AND PRIVACY

Section 6.1 — Definition of Neural Data

For purposes of this Agreement, "Neural Data" means any data generated by the measurement or analysis of your nervous system, including but not limited to:

• Raw electrical signals recorded from brain electrodes (electrocorticography, local field potentials, single-unit action potentials)
• Processed, decoded, or interpreted neural signals (e.g., decoded movement intentions, decoded speech)
• Neural biomarkers or signatures derived from your brain activity
• Metadata associated with neural recordings (timestamps, device settings, signal quality metrics)
• Any inferences, predictions, or classifications derived from your neural signals by algorithms, artificial intelligence, or machine learning models
• Combined datasets that link your neural data with behavioral, physiological, or personal data

Section 6.2 — Neural Data Collection and Use

Your Neural Data will be collected and used for the following purposes (select all that apply):

☐ Device calibration and performance optimization for your personal use
☐ Safety monitoring and adverse event detection
☐ Research purposes as described in the study protocol
☐ Development and improvement of BCI algorithms and software
☐ Publication in scientific journals (de-identified data only, unless you separately consent)
☐ Regulatory submissions to the FDA and other regulatory bodies
☐ Quality assurance and device improvement by the manufacturer
☐ Training of artificial intelligence or machine learning models
☐ Other: [________________________________]

Your Neural Data will NOT be used for:

☐ Sale to third parties for marketing, advertising, or commercial profiling
☐ Employment, insurance, housing, or credit decisions
☐ Law enforcement or surveillance purposes (absent valid legal process, e.g., court order or warrant)
☐ Political profiling or manipulation
☐ Any purpose not disclosed in this Agreement without your separate written consent

Section 6.3 — Neural Data Ownership and Rights

You retain the following rights with respect to your Neural Data:

1. Right of Ownership: You are the owner of the raw neural data generated by your brain. The Sponsoring Entity / Manufacturer may retain a license to use de-identified neural data as described in Section 6.2, but such license does not transfer ownership of the underlying data.

2. Right of Access: You have the right to access your neural data in a readable format upon reasonable written request. The Sponsoring Entity shall respond within [____] business days.

3. Right of Deletion: You have the right to request deletion of your stored neural data, subject to regulatory data retention requirements (e.g., 21 CFR 11, FDA record-keeping obligations). The Sponsoring Entity shall honor deletion requests within [____] business days, except where retention is legally required.

4. Right of Portability: You have the right to receive your neural data in a commonly used, machine-readable, interoperable format to facilitate transfer to another provider or researcher.

5. Right to Know: You have the right to know what neural data has been collected, how it has been used, to whom it has been disclosed, and what inferences or predictions have been derived from it.

6. Right to Correction: You have the right to correct inaccurate inferences or annotations associated with your neural data.

7. Right to Restrict Processing: You have the right to restrict the processing of your neural data beyond what is strictly necessary for device safety and function.

8. Right Against Algorithmic Discrimination: Your neural data shall not be used to discriminate against you on the basis of neurological characteristics, cognitive patterns, mental states, or disability status.

Section 6.4 — Neural Data Security

The Sponsoring Entity shall implement the following safeguards to protect your Neural Data:

• Encryption of neural data in transit and at rest using [________________________________] encryption standards
• Access controls limiting neural data access to authorized personnel on a need-to-know basis
• De-identification or pseudonymization of neural data used for research, development, or publication
• Regular security audits and vulnerability assessments of BCI hardware and software
• Cybersecurity protections against unauthorized access, interception, or manipulation of neural signals
• Incident response procedures for neural data breaches, with notification to you within [____] hours/days of discovery
• Physical security for servers and storage media containing neural data
• Compliance with HIPAA Security Rule (45 CFR Part 164, Subpart C) where applicable

Section 6.5 — State-Specific Neural Data Protections

IMPORTANT NOTICE: Several states have enacted or proposed laws specifically protecting neural data. Depending on your state of residence or the location of the clinical site, additional protections may apply:

Colorado (Effective 2025): Colorado SB 24-058 amended the Colorado Privacy Act to include "biological data" and "neural data" within the definition of "sensitive data," granting Colorado residents additional rights over neural data including the right to opt out of neural data processing, the right to delete neural data, and protections against profiling based on neural data. If you are a Colorado resident, these protections apply in addition to the rights in Section 6.3.

Minnesota (Proposed): Minnesota HF 1370 would establish protections for neurotechnology data, including informed consent requirements and restrictions on neural data use. If enacted and you are a Minnesota resident, additional protections may apply.

California: The California Consumer Privacy Act (CCPA) and California Privacy Rights Act (CPRA) may classify neural data as sensitive personal information under existing provisions. If you are a California resident, you may have additional rights under Cal. Civ. Code § 1798.100 et seq.

Other Jurisdictions: Additional states and countries are actively considering neural data privacy legislation. The Sponsoring Entity will notify you of any new applicable laws that affect your neural data rights.

International Considerations:

• Chile has enshrined neurorights in its constitution (2021)
• The European Union's AI Act and GDPR may impose additional requirements for neural data processing
• Additional international frameworks may apply if data is transferred across borders

PART VII: COGNITIVE LIBERTY AND MENTAL PRIVACY

Section 7.1 — Cognitive Liberty Protections

The Sponsoring Entity acknowledges and agrees to respect your cognitive liberty, defined as your right to mental self-determination, including:

1. Freedom of Thought: Your private thoughts, mental states, and cognitive processes as detected or inferred by the BCI shall not be disclosed to any third party without your explicit, informed consent, except as required by law or to prevent imminent serious harm.

2. Mental Privacy: The BCI system shall not be designed or used to monitor, record, or analyze mental content (e.g., specific thoughts, memories, emotions, beliefs, or intentions) beyond what is strictly necessary for the device's therapeutic function, unless you provide separate written consent for specific research protocols.

3. Freedom from Manipulation: The BCI system shall not be used to manipulate, alter, or influence your thoughts, emotions, beliefs, or decisions without your knowledge and explicit consent. Any neuromodulation or neurostimulation functions must be fully disclosed and subject to your control.

4. Right to Mental Integrity: The BCI system shall not be intentionally designed or used in a manner that fundamentally alters your personality, cognitive capacity, or sense of self without your informed consent and ongoing opportunity to discontinue.

5. Right to Psychological Continuity: You have the right to be informed of any changes to the BCI system, its algorithms, or its operation that could materially affect your psychological experience, cognitive function, or sense of identity.

Section 7.2 — Limits on Neural Data Inference

The Sponsoring Entity agrees to the following limits on neural data inference:

☐ The BCI system will not attempt to decode specific thought content (e.g., inner speech, visual imagery, memories) beyond the therapeutic scope described in Section 1.1, unless separately consented.

☐ Incidental discoveries of mental health conditions, neurological disorders, or other health information from neural data will be handled according to the Incidental Findings Protocol (Appendix [____]).

☐ Neural data shall not be used to infer or predict political opinions, religious beliefs, sexual orientation, emotional states, or other sensitive personal attributes without your separate written consent.

☐ The Sponsoring Entity shall maintain a log of all algorithmic inferences derived from your neural data and make this log available to you upon request.

PART VIII: DEVICE EXPLANTATION AND END-OF-LIFE

Section 8.1 — Your Right to Explantation

You have the right to request removal (explantation) of the BCI device at any time, for any reason, subject to the following:

1. Voluntary Explantation: You may request explantation at any time. The Sponsoring Entity and clinical team will discuss the risks of explantation surgery and any functional consequences of device removal with you before proceeding.

2. Medically Necessary Explantation: If the device causes adverse effects, infection, or other medical complications, explantation may be recommended or required by the clinical team.

3. Explantation Cost Responsibility:

☐ The Sponsoring Entity will bear all costs of explantation surgery and associated medical care for the duration of the study / warranty period of [________________________________].

☐ After the study / warranty period, explantation costs will be allocated as follows: [________________________________].

☐ The Sponsoring Entity commits to covering explantation costs regardless of the reason for removal for a period of [________________________________] from the date of implantation.

4. Explantation Risks: Explantation surgery carries its own risks, which may include but are not limited to:
   - Hemorrhage or bleeding at the explantation site
   - Infection
   - Damage to brain tissue during electrode removal
   - Inability to remove all implanted components safely (partial explantation)
   - Scarring and tissue reaction at former implant site
   - Neurological deficits resulting from removal
   - Loss of BCI-mediated function and associated psychological adjustment

5. Right to Leave Device In Situ: If explantation poses unacceptable risk, you have the right to leave a deactivated device in place, with the understanding that long-term risks of an inactive implant are described in Section 3.1.

Section 8.2 — Sponsor Discontinuation and Orphan Device Protections

If the Sponsoring Entity ceases operations, discontinues the device line, or terminates the study:

1. Advance Notice: The Sponsoring Entity shall provide you with at least [____] days written notice before discontinuing support for the device.

2. Transition Plan: The Sponsoring Entity shall develop and fund a transition plan that includes:
   - Continued clinical support for a minimum of [________________________________] following discontinuation
   - Explantation surgery if requested, at the Sponsoring Entity's expense
   - Transfer of device maintenance and support obligations to a qualified successor entity, if possible
   - Provision of all technical specifications necessary for ongoing device management to your clinical team

3. Data Preservation: In the event of company dissolution, your neural data shall be handled as follows:

☐ Returned to you or your designated representative in a portable, readable format
☐ Securely destroyed, with certification of destruction provided to you
☐ Transferred to a designated data custodian: [________________________________]

4. Escrow / Insurance: The Sponsoring Entity ☐ has / ☐ has not established a financial escrow, insurance policy, or trust fund to cover future explantation and support costs in the event of company dissolution. Details: [________________________________].

Section 8.3 — Device at End of Life

When the device reaches the end of its functional life (estimated: [________________________________]):

☐ The device may be replaced with an updated model, subject to a new consent agreement
☐ The device may be explanted at the Sponsoring Entity's expense
☐ The device may be deactivated and left in situ if medically appropriate
☐ Other: [________________________________]

PART IX: FINANCIAL TERMS AND COMPENSATION

Section 9.1 — Costs to You

Research Track:

☐ There will be no cost to you for the BCI device, implantation surgery, follow-up visits, or study-related procedures during the study period.
☐ Costs NOT covered by the study include: [________________________________]
☐ Standard-of-care medical costs may be billed to your insurance.

Commercial Track:

☐ The cost of the BCI device is: $[________________]
☐ The cost of implantation surgery is: $[________________]
☐ Annual maintenance / subscription costs are: $[________________]
☐ Insurance coverage: ☐ Pre-authorized ☐ Pending ☐ Not covered
☐ Payment plan available: ☐ Yes ☐ No Details: [________________________________]

Section 9.2 — Compensation for Research Participation

☐ You will receive $[________________] per study visit as compensation for time and travel.
☐ You will receive a total of $[________________] for completing the full study.
☐ You will not receive financial compensation for participation.
☐ Other compensation: [________________________________]

Section 9.3 — Compensation for Injury

If you are injured as a direct result of the BCI device or procedures related to this study/treatment:

☐ The Sponsoring Entity will provide / pay for medical treatment for study-related injuries. Details: [________________________________]

☐ The Sponsoring Entity will NOT provide compensation or free medical treatment for study-related injuries beyond what is described herein.

☐ Compensation or treatment does NOT include financial compensation for lost wages, disability, or pain and suffering.

☐ Additional coverage: [________________________________]

Nothing in this Agreement waives any legal rights you may have or releases the Sponsoring Entity, investigators, or clinical site from liability for negligence.

PART X: INTELLECTUAL PROPERTY

Section 10.1 — Inventions and Discoveries

☐ You will NOT receive royalties or intellectual property rights for inventions, algorithms, or discoveries made using your neural data. However, your neural data ownership rights under Section 6.3 are not affected.

☐ You WILL receive the following consideration for use of your neural data in development: [________________________________]

Section 10.2 — Use of Neural Data in AI Training

If your neural data (de-identified) is used to train artificial intelligence or machine learning models:

☐ You consent to such use as described in Section 6.2
☐ You will be notified before such use and have the right to opt out
☐ You will receive compensation of $[________________] or [________________________________]
☐ You do not consent to such use (check this box to opt out)

PART XI: WITHDRAWAL, TERMINATION, AND RESEARCH-SPECIFIC PROVISIONS

Section 11.1 — Your Right to Withdraw

Your participation is entirely voluntary. You may withdraw from the study or discontinue commercial use of the device at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

To withdraw, you may:

• Notify the Principal Investigator, clinical team, or Sponsoring Entity in writing or verbally
• Contact: [________________________________] at [________________]

If you withdraw:

• Data collected prior to withdrawal may be retained for safety and regulatory purposes unless deletion is requested per Section 6.3
• You will continue to receive necessary clinical care related to the implant
• You will have the option of device explantation per Section 8.1
• Your withdrawal will not affect your right to receive standard medical care

Section 11.2 — Sponsor or Investigator Termination

The Sponsoring Entity or Principal Investigator may discontinue your participation if:

☐ The study is terminated by the sponsor, FDA, or IRB
☐ Continued participation poses unacceptable risk to your health or safety
☐ You are unable to comply with study requirements
☐ New information arises that changes the risk-benefit analysis
☐ Other: [________________________________]

If your participation is terminated involuntarily, all obligations regarding explantation (Section 8), neural data (Section 6), and clinical care will continue.

Section 11.3 — New Information

During the course of the study/treatment, you will be informed of any new significant findings (from this study or others) that may affect your willingness to continue participation. You may be asked to sign an updated consent form reflecting new information.

PART XII: CONFIDENTIALITY AND DATA SHARING

Section 12.1 — Who May Access Your Information

The following parties may access your identifiable information and/or neural data as described herein:

☐ The Principal Investigator and study team at the clinical site
☐ The Sponsoring Entity and its authorized representatives
☐ The IRB overseeing this study
☐ The FDA and other regulatory authorities (for inspection, audit, or regulatory review)
☐ Data safety monitoring board (DSMB) or clinical events committee
☐ Your personal physician(s), with your authorization
☐ Health insurance companies, as required for billing (identifiable health data only, not raw neural data)
☐ Other: [________________________________]

Section 12.2 — HIPAA Authorization

By signing this Agreement, you authorize the use and disclosure of your protected health information (PHI) as described herein, in accordance with 45 CFR § 164.508. You have the right to revoke this authorization in writing at any time, except to the extent that action has already been taken in reliance on the authorization.

A copy of the Notice of Privacy Practices ☐ has been / ☐ will be provided to you.

Section 12.3 — Certificate of Confidentiality

☐ This research is covered by a Certificate of Confidentiality issued by the National Institutes of Health (NIH) pursuant to 42 U.S.C. § 241(d). This Certificate protects identifiable research information from forced disclosure in legal proceedings, with limited exceptions.

PART XIII: CONTACT INFORMATION

For questions about the study/device:

Principal Investigator: [________________________________]
Phone: [________________] Email: [________________________________]

For questions about your rights as a research participant:

IRB Contact: [________________________________]
Phone: [________________] Email: [________________________________]

For device emergencies (available 24/7):

Emergency Line: [________________]

For neural data privacy questions or requests:

Privacy Officer: [________________________________]
Phone: [________________] Email: [________________________________]

For independent advice (patient advocate not affiliated with the study/sponsor):

[________________________________]
Phone: [________________] Email: [________________________________]

PART XIV: CONSENT SIGNATURES

Section 14.1 — Participant Acknowledgments

By signing below, I acknowledge and confirm the following:

☐ I have read this entire Agreement, or it has been read to me in a language I understand.

☐ I have had the opportunity to ask questions and all my questions have been answered to my satisfaction.

☐ I understand the purpose, procedures, risks, benefits, and alternatives described in this Agreement.

☐ I understand that my participation is voluntary and I may withdraw at any time without penalty.

☐ I understand the risks to my psychological well-being and sense of identity described in Section 3.3.

☐ I understand my rights regarding my neural data as described in Part VI.

☐ I understand my cognitive liberty protections as described in Part VII.

☐ I understand my rights regarding device explantation as described in Part VIII.

☐ I understand the financial terms described in Part IX.

☐ I have been given sufficient time to consider my decision (a minimum of [____] days/weeks was provided between initial consent discussion and signature).

☐ I have been offered the opportunity to consult with an independent physician, attorney, or patient advocate.

☐ I have been provided a copy of this Agreement for my records.

☐ I consent to the surgical implantation / application of the BCI device described herein.

☐ I consent to the collection, use, and storage of my neural data as described in Part VI.

☐ I consent to participate in the research study described herein (if applicable).

☐ I understand that I will receive a signed copy of this Agreement.

Section 14.2 — Participant Signature

Participant Name (Printed): [________________________________]

Participant Signature: _______________________________ Date: [__/__/____]

Section 14.3 — Legally Authorized Representative (if applicable)

If the participant is unable to provide consent independently:

Representative Name (Printed): [________________________________]

Representative Signature: _______________________________ Date: [__/__/____]

Relationship to Participant: [________________________________]

Basis for Legal Authority: [________________________________]

Section 14.4 — Witness Signature

A witness is ☐ required / ☐ recommended for this consent.

Witness Name (Printed): [________________________________]

Witness Signature: _______________________________ Date: [__/__/____]

Witness Affiliation: ☐ Independent (not affiliated with study) ☐ Study staff ☐ Other: [____]

Section 14.5 — Investigator / Clinician Declaration

I have explained the study/treatment, including the purpose, procedures, risks, benefits, alternatives, neural data rights, cognitive liberty protections, and explantation rights to the participant (or legally authorized representative). I have answered all questions to the best of my ability and believe the participant has demonstrated adequate understanding to provide informed consent.

Investigator / Clinician Name (Printed): [________________________________]

Credentials: [________________________________]

Signature: _______________________________ Date: [__/__/____]

Section 14.6 — Consent for Optional Components

The following optional components require separate consent:

Optional: Use of Neural Data for AI/ML Training (Section 10.2)

☐ I CONSENT to the use of my de-identified neural data for training artificial intelligence and machine learning models.

☐ I DO NOT CONSENT to the use of my neural data for AI/ML training.

Signature: _______________________________ Date: [__/__/____]

Optional: Extended Data Retention for Future Research

☐ I CONSENT to the retention of my de-identified neural data for future research studies not yet designed, subject to future IRB approval.

☐ I DO NOT CONSENT to extended data retention.

Signature: _______________________________ Date: [__/__/____]

Optional: Contact for Future Studies

☐ I CONSENT to being contacted about future BCI research studies.

☐ I DO NOT CONSENT to future contact.

Signature: _______________________________ Date: [__/__/____]

APPENDICES

Appendix A — Device Technical Specifications

Appendix B — Incidental Findings Protocol

In the course of recording and analyzing your neural data, the study/clinical team may discover findings that are not related to the study/treatment purpose but may be clinically significant ("incidental findings"). Examples include previously undiagnosed seizure activity, neurological abnormalities, or patterns suggestive of neurodegenerative disease.

Handling of Incidental Findings:

1. Clinically significant incidental findings ☐ will / ☐ will not be disclosed to you.
2. If disclosed, findings will be communicated by [________________________________] (qualified clinician).
3. You will be referred to appropriate medical specialists for further evaluation.
4. You have the right to choose whether to receive incidental findings.

Your preference:

☐ I WANT to be informed of clinically significant incidental findings.
☐ I DO NOT want to be informed of incidental findings.

Signature: _______________________________ Date: [__/__/____]

Appendix C — Neural Data Processing and Algorithms

Description of algorithms used to decode neural signals:

[________________________________]
[________________________________]
[________________________________]

Types of data outputs generated:

☐ Motor intention decoding (movement commands)
☐ Speech decoding (phonemes, words, sentences)
☐ Emotional state indicators
☐ Cognitive workload metrics
☐ Other: [________________________________]

Algorithm update policy:

☐ Algorithm updates will be made automatically with notification to you
☐ Algorithm updates require your express consent before implementation
☐ You have the right to revert to a previous algorithm version
☐ All algorithm changes will be logged and made available to you upon request

Appendix D — State-Specific Addenda

Instructions: Include the applicable state-specific addendum based on the participant's state of residence and/or clinical site location.

Addendum D-1: CALIFORNIA

If the Participant resides in California or the clinical site is located in California:

• Neural data may constitute "sensitive personal information" under the California Privacy Rights Act (CPRA), Cal. Civ. Code § 1798.140(ae).
• The Participant has the right to limit the use and disclosure of sensitive personal information pursuant to Cal. Civ. Code § 1798.121.
• The Participant may designate an authorized agent to exercise privacy rights.
• The Sponsoring Entity shall not discriminate against the Participant for exercising data rights under CCPA/CPRA.

California Participant Acknowledgment:

☐ I have been informed of my rights under the California Consumer Privacy Act and California Privacy Rights Act.

Signature: _______________________________ Date: [__/__/____]

Addendum D-2: COLORADO

If the Participant resides in Colorado or the clinical site is located in Colorado:

• Pursuant to Colorado SB 24-058 (effective 2025), neural data is classified as "sensitive data" under the Colorado Privacy Act, C.R.S. § 6-1-1303.
• The Sponsoring Entity must obtain the Participant's opt-in consent before processing neural data.
• The Participant has the right to: access, correct, delete, and obtain a portable copy of neural data.
• The Participant has the right to opt out of profiling based on neural data that produces legal or similarly significant effects.
• The Colorado Attorney General may enforce violations.

Colorado Participant Acknowledgment:

☐ I have been informed of my rights under the Colorado Privacy Act, as amended to include neural data protections.

☐ I OPT IN to the processing of my neural data as described in this Agreement.

Signature: _______________________________ Date: [__/__/____]

Addendum D-3: NEW YORK

If the Participant resides in New York or the clinical site is located in New York:

• New York does not currently have a comprehensive consumer privacy law specifically addressing neural data; however, the New York SHIELD Act (N.Y. Gen. Bus. Law § 899-aa) requires reasonable safeguards for private information.
• The Sponsoring Entity shall comply with New York Public Health Law regarding informed consent for medical procedures.
• The Participant may have additional rights under any subsequently enacted New York privacy legislation.

New York Participant Acknowledgment:

☐ I have been informed of applicable New York data security and informed consent requirements.

Signature: _______________________________ Date: [__/__/____]

Addendum D-4: TEXAS

If the Participant resides in Texas or the clinical site is located in Texas:

• The Texas Data Privacy and Security Act (TDPSA), Tex. Bus. & Com. Code Ch. 541, classifies certain biometric and health data as sensitive. Neural data may fall within this classification.
• The Sponsoring Entity must obtain opt-in consent before processing sensitive data.
• The Participant has the right to access, correct, delete, and obtain a portable copy of personal data.
• Texas Medical Disclosure Panel requirements (Tex. Civ. Prac. & Rem. Code Ch. 74) may apply to surgical consent for implantation.

Texas Participant Acknowledgment:

☐ I have been informed of my rights under the Texas Data Privacy and Security Act and Texas medical disclosure requirements.

Signature: _______________________________ Date: [__/__/____]

Addendum D-5: FLORIDA

If the Participant resides in Florida or the clinical site is located in Florida:

• Florida's constitutional right to privacy (Fla. Const. Art. I, § 23) provides broad privacy protections that may extend to neural data.
• The Florida Digital Bill of Rights (Fla. Stat. § 501.701 et seq.) may apply to neural data processing.
• Florida informed consent statutes (Fla. Stat. § 766.103) require specific disclosures for medical procedures.

Florida Participant Acknowledgment:

☐ I have been informed of my rights under Florida privacy law and informed consent requirements.

Signature: _______________________________ Date: [__/__/____]

Appendix E — Glossary of Terms

SOURCES AND REFERENCES

• U.S. Food and Drug Administration, "Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation — Non-Clinical Testing and Clinical Study Design Considerations" (May 2021)
• 21 CFR Part 50 — Protection of Human Subjects (FDA)
• 21 CFR Part 812 — Investigational Device Exemptions
• 21 CFR Part 814 — Premarket Approval of Medical Devices
• 45 CFR Part 46 — Protection of Human Subjects (Common Rule)
• HIPAA Privacy Rule, 45 CFR Parts 160, 164
• Colorado SB 24-058, amending the Colorado Privacy Act to include neural data protections (signed 2024)
• Minnesota HF 1370 (proposed neurotechnology data protections)
• Yuste, R. et al., "Four ethical priorities for neurotechnologies and AI," Nature 551, 159–163 (2017)
• Neurorights Foundation, proposed framework for cognitive liberty, mental privacy, mental integrity, psychological continuity, and fair access to cognitive augmentation
• Chile, Constitutional Amendment on Neurorights (2021)
• Neuralink PRIME Study, FDA IDE Approval (May 2023)
• Synchron, FDA IDE for Stentrode BCI (NCT05035823)
• ICH E6(R2) Guideline for Good Clinical Practice
• IEEE Brain Initiative, Neuroethics Framework

This template is provided by ezel.ai for informational purposes only. It does not constitute legal or medical advice. Brain-computer interface consent agreements involve complex intersections of federal device regulation, state privacy law, research ethics, and neurosurgical informed consent. This template must be reviewed and customized by qualified legal counsel, bioethics specialists, IRB professionals, and the clinical/research team before use with any human participant. Laws governing neural data are rapidly evolving; ensure all provisions reflect current law at the time of use.

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