Participants in clinical trials of brain-computer interfaces have published a set of ethical recommendations to guide this cutting-edge research. They are demanding, in particular, open access to their brain data and recognition of their scientific contribution.
Ian Burkhart was 19 when a diving accident left him paralyzed from the waist down. Four years later, in 2014, he agreed to become the first human to test a brain implant designed to restore hand control. An array of 96 electrodes was inserted into the area of his brain that governs movement, connected by cable to a computer that interpreted the nerve signals and transmitted them to an electrode cuff worn on his arm. His initial movements were minimal, but Burkhart gradually managed to transfer marbles, manipulate fragile objects, and even play Guitar Hero during his laboratory sessions.
For seven and a half years, he participated in two long-term clinical trials. He describes the experience as "fantastic," but it also taught him what he would have liked to do differently. Drawing on this experience, he co-founded the BCI Pioneers Coalition in 2022, an organization bringing together former participants in brain-computer interface trials. The group has just published a set of recommendations for researchers, clinicians, and companies conducting this type of experimentation.
These recommendations are structured around thirteen themes. One of them concerns recognizing the actual role played by the volunteers. Burkhart went to the lab two to three days a week, four hours per session. "It's easily a part-time job if you only count the hours spent," he points out. Over time, his understanding of the program allowed him to provide increasingly precise feedback on what worked and what didn't. Some participants could legitimately be listed as co-authors of scientific publications or be publicly recognized as research collaborators, the document's authors believe, while acknowledging that this visibility will not suit everyone.
The issue of brain data is another key point. This data, collected continuously for years, is considered by the authors of the recommendations to be "personal information" belonging to the participant. They insist that everyone should have free and unrestricted access to it at any time, and that confidentiality agreements or commercial embargoes should not prevent a patient from sharing their own neurological data with their doctor. "It's not very common to have strict confidentiality agreements in these trials," Burkhart acknowledges, "but we want to make sure that doesn't happen."
The recommendations also address the end of trials, an often-overlooked phase. Burkhart himself experienced a difficult situation when the research team encountered funding difficulties: he was informed that the implant would have to be removed and then reinserted once the funds were secured, which would involve two additional neurosurgical procedures. He ultimately kept the device until 2021, when an infection at the point where the cable entered his skull necessitated its permanent removal. Losing the ability to move his arm, which he had regained after years of effort, was a difficult ordeal.
The case of Australian woman Rita Leggett illustrates the potential for abuse: her implant, inserted to treat epilepsy, was removed against her will when the manufacturing company went bankrupt two years after the operation. Medical ethics specialists have described this act as a potential violation of fundamental rights. The new recommendations advise that researchers commit to keeping the devices operational for a "reasonable period" after the completion of a trial, that they allow participants sufficient time to prepare for explantation, and that they allocate specific funds for this purpose.
Jennifer Chandler, a professor of law and neuroethics at the University of Ottawa who helped draft the document, emphasizes the unique nature of these trials compared to traditional clinical protocols: “These are people who have a device implanted in their brain, who sometimes participate in trials for years, with a considerable investment of time, body, and intellectual effort.” Some of the recommendations remain intentionally general and may overlap with existing ethical standards. They were developed with a small group of participants, as the number of people living with a brain implant remains very small worldwide. “This is a living document, and this is version one,” Chandler summarizes. “It’s simply a starting point.”
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