BCI Trial Participants Issue 13-Category Ethics Guidelines for Researchers

A 96-electrode brain implant pioneer has co-authored guidelines that demand trial participants gain access to their own brain data, protection from restrictive NDAs, and guaranteed maintenance of devices after studies end. The BCI Pioneers Coalition published the recommendations, organized into 13 categories, on Tuesday.

Ian Burkhart, who lived with an implanted electrode array for seven and a half years, cofounded the coalition in 2022. Members developed the guidelines over the last year to help academics, clinicians, and companies run trials that respect participant autonomy.

What did Burkhart's own trial involve?

A diving accident in 2010 left Burkhart paralyzed from the chest down at age 19. Around four years later, he became the first person to trial a brain implant designed for hand control.

Surgeons inserted an array of 96 electrodes into the region of his brain that controls movement. A cable running from his head connected the array to a computer, where algorithms interpreted the neural signals and forwarded them to a sleeve of electrodes worn on his arm.

The first movements were small. Over time, Burkhart learned to pour beads from bottles, manipulate small and delicate objects, and play Guitar Hero — though only during lab visits. The results, published in Nature, marked a scientific breakthrough in intracortical brain-computer interfaces.

Burkhart participated in two years-long clinical trials during his seven-and-a-half-year implant period. "It was a fantastic experience," he said. "But there's certainly some things that, knowing what I know now, I would want to do a little differently."

Why do existing ethics rules fall short?

Jennifer Chandler, a professor of law and neuroethics at the University of Ottawa who worked on the guidelines, argues that generic clinical-trial ethics do not capture the BCI experience. "These are people who have a device embedded in their brain, are in trials sometimes for years and years … [and contribute] a significant investment of time, of the body, and of intellectual effort," she said.

The guidelines call for recognizing and compensating participants. During his trials, Burkhart said, "I was going into the lab two or three days a week, for four hours at a time. That's [easily] a part-time job if you just count the hours you're putting in."

As the trials progressed, Burkhart became, in his view, a key member of the research team. Some participants might appreciate coauthorship on publications or public acknowledgment as research collaborators, the guidelines suggest — though the authors acknowledge not everyone will want that visibility.

What do the guidelines say about brain data?

Privacy receives extended treatment across the 13 categories. The document states that brain data "should be understood as the participant's personal information." Participants should be able to access their own neural recordings whenever they want — something that has not always been possible — and should never be blocked from sharing that data with their own doctors by embargoes or nondisclosure agreements designed to keep findings from competitors.

"It's not super common for there to be firm NDAs within a lot of the trials," Burkhart said. "But it's something where we want to make sure that that does not happen."

The stakes differ by application. Burkhart was not troubled by researchers collecting movement-related neural activity, but participants whose implants translate thoughts into words may feel differently about stored data.

The guidelines also instruct researchers to prepare participants for possible media attention, since concealing identity can be difficult in high-profile biotechnology trials.

What happens when a trial ends?

The document addresses device removal, an issue with documented consequences. Roughly five years after Burkhart's implantation, funding problems led his research team to tell him the device would have to come out — with brain surgery — until new money arrived. He kept the implant until 2021, when surgeons removed it after an infection developed at the cable's entry point in his scalp. Losing the restored arm movement was difficult, he said.

Rita Leggett, an Australian woman implanted with a device to treat her epilepsy, said she "became one" with her implant. When the manufacturer went bankrupt two years later, the device was removed against her will — an act ethicists have described as a potential breach of human rights.

The guidelines ask researchers to maintain devices for a "reasonable period" after trial completion, give participants ample time to prepare for explantation surgery, and set aside extra funds to support those who undergo it.

What are the limitations?

Some recommendations remain vague and overlap with existing ethics standards. The authors developed them with feedback from a small group of individuals, reflecting that the number of people living with BCIs remains very low. Burkhart plans to discuss the guidelines with researchers at an upcoming neuroscience conference hosted by the Society for Neuroscience.

"This is a living document, and this is version one," Chandler said. "It's just the starting point."