BCI Trial Participants Set New Ground Rules for Researchers: My Brain Data Belongs to Me, Give Me Advance Notice Before Removing Implants

The rules for brain-computer interface (BCI) trials are being rewritten by the study volunteers themselves.

As reported by MIT Technology Review journalist Jessica Hamzelou, the BCI Pioneers Coalition has published an ethical guideline for BCI research, listing 13 categories of recommendations. The core demands are straightforward: participants' brain data is personal property, and should not be restricted by non-disclosure agreements (NDAs) or publication barriers; long-term trial participants deserve formal recognition and compensation; when a trial ends or the operating company shuts down, device removal cannot be scheduled on short notice — participants must be given sufficient preparation time, and all related costs need to be covered.

Participants Are Not Abstract Data Sources

Ian Burkhart is a key driving force behind this guideline. In 2010, at age 19, he was paralyzed from the chest down in a diving accident. In 2014, he became the first person to trial a brain implant designed to restore hand control. Researchers implanted 96 electrodes in the motor control region of his brain, connected via a cable to a computer. Algorithms interpreted his neural signals and activated the electrode sleeve on his arm, allowing him to regain voluntary control of his limb.

His earliest movements were extremely small. Later, he was able to pour beads out of a bottle, move small objects, and even play Guitar Hero in the lab — a breakthrough MIT Technology Review recognized as a major scientific milestone. Burkhart took part in two multi-year clinical trials over 7.5 years. He visited the lab 2 to 3 times a week for 4 hours each session, which he estimates amounted to nearly a part-time job in terms of total time commitment.

In 2022, he co-founded the BCI Pioneers Coalition, a group for past BCI trial participants to share experiences and formalize demands for researchers. The guideline was developed based on members' real-world experiences, with input from Jennifer Chandler, a professor of law and neuroethics at the University of Ottawa. She points out that BCI trials are fundamentally different from ordinary clinical trials: the device is embedded directly in the brain, trials can last for many years, and participants contribute extensive time, physical involvement, and intellectual input.

The guideline therefore states that participants can choose to be publicly listed as research collaborators, or credited as an author on scientific papers. Burkhart notes that as the trials progressed, he gained deeper understanding of the system and was able to provide highly constructive feedback, effectively acting as a key member of the research team. The guideline also acknowledges that some participants may not want public authorship credit, which is fully respected.

Who Owns Brain Data, and What Limits Can NDAs Impose?

Privacy clauses are far more complicated. Research teams need to access, analyze, and temporarily store participants' brain data. Burkhart's own implant tracked motor-related neural activity, which he did not mind sharing. But the experience would be very different for users of brain implants that translate internal thoughts directly into spoken language.

The guideline explicitly states that brain data should be classified as participants' personal information, and participants should be able to access their own brain data at any time. No NDA or publication restriction should bar them from sharing their data with their own doctors. Burkhart notes that overly strict NDAs are not yet common in BCI trials, but the guideline is designed to prevent that situation from ever becoming the norm.

What Happens to the Implant If the Company Goes Out of Business?

Post-trial arrangements are the most hard-hitting section of this guideline. Around 5 years after Burkhart received his implant, the research team ran into funding shortfalls. He was told his implant would need to be removed, and re-implanted once the team secured new funding — a procedure that requires invasive brain surgery. He ultimately had the device removed in 2021 after an infection developed at the cable entry point, and all the arm control function he had regained was lost along with the implant.

Australian resident Rita Leggett is another documented case. She received a therapeutic implant to treat epilepsy, and once said she felt she had become "one with the implant". Two years after her surgery, the manufacturer of her device went bankrupt, and the implant was removed against her will. Ethicists warn that this may constitute a violation of basic human rights.

The guideline requires researchers to maintain BCI implants for a "reasonable period of time" after a trial ends, give participants adequate lead time to schedule removal surgery, and set aside dedicated reserve funds to cover all related costs. By tying these provisions directly to surgical scheduling and budget allocations, abstract ethical discussions are turned into tangible, actionable requirements.

A Version 1 Living Guideline

This guideline is not perfect. Some clauses are still vague, parts of it overlap with existing ethical standards, and it does not provide clear solutions for every possible scenario. It is built on feedback from a small group of people, as the total number of individuals who have received long-term implanted BCIs is still very small. Chandler describes it as a "living document": this is its first version, and only a starting point. Burkhart plans to discuss the framework with researchers at upcoming neuroscience conferences.

The real outstanding challenge is enforcement. When funding runs out, who will maintain the implant, who will pay for the removal surgery, who gets authorship credit, and who has the right to take their own brain data with them? This guideline elevates BCI trial participants from passive data sources to formal collaborators. It now remains to be seen whether research institutions and private companies are willing to adopt and abide by these new rules.

Source: MIT Technology Review, by Jessica Hamzelou. Full guideline available at BCI Pioneers Coalition, original article at MIT Technology Review.