Brain-Implant Trial Volunteers Push for More Say, Privacy, and Post-Trial Care

People who volunteer for brain-computer interface (BCI) trials are asking researchers to rethink how those studies are run. The BCI Pioneers Coalition, co-founded by Ian Burkhart, has published recommendations across 13 categories aimed at making trials more respectful of participants’ autonomy. MIT Technology Review reports that the guidelines were released on Tuesday.

Burkhart’s experience shapes the effort. He was paralyzed from the chest down after a diving accident in 2010, when he was 19. About four years later, he volunteered for the first trial of a brain implant designed for hand control, according to the report. The implant used a 96-electrode array in the part of the brain that controls movement. A cable connected the array to a computer, where algorithms interpreted neural signals and sent commands to a sleeve of electrodes on his arm. The system eventually let him pour beads from bottles, handle small objects, and play Guitar Hero during lab visits.

He took part in two multiyear trials over the seven and a half years the array remained implanted. Burkhart calls the experience fantastic, but says that knowing what he knows now, he would want some things handled differently.

The guidelines focus partly on recognition and compensation. Burkhart recalls spending two or three days a week in the lab, four hours at a time, which he describes as easily comparable to a part-time job. Participants who contribute intellectual effort as trials progress might want to be named as research collaborators or listed as coauthors on papers, he says. The coalition acknowledges that not everyone will want that visibility.

Privacy is another central issue. The guidance says researchers should prepare participants for media attention and recognize that concealing a volunteer’s identity may sometimes be difficult. It also takes a position on neural data: brain data should be understood as the participant’s personal information. The coalition wants participants to be able to access their own brain data when they want and to share it with their own doctors without being blocked by embargoes or nondisclosure agreements. Burkhart says firm NDAs have not been especially common in trials, but the guidelines aim to keep that from becoming a problem.

The document also addresses what happens when a study ends. Burkhart’s implant was removed in 2021 after an infection developed where the cable entered his scalp. Before that, funding problems had raised the possibility that the device would be removed and later reimplanted once money was secured. Losing the implant meant losing arm movement he had regained, which he describes as difficult.

The report also cites Rita Leggett, an Australian woman whose epilepsy implant was removed against her will after the company that made it collapsed. Ethicists have described that removal as a potential breach of human rights, according to MIT Technology Review. The guidelines recommend that researchers commit to maintaining devices for a reasonable period after a trial, give participants time to prepare for removal surgery, and set aside funds to support them through that process.

The coalition’s recommendations are not a complete solution. The report notes that some are vague, overlap with existing ethics standards, and do not all offer explicit fixes. They were also shaped by feedback from a small group, reflecting the still-small number of people living with BCIs. The team intends the guidelines to evolve. Jennifer Chandler, a law and neuroethics professor at the University of Ottawa who worked on them, described the document as a starting point.

The broader significance is that BCI research is moving from technical demonstrations toward longer-term relationships with volunteers. The guidelines argue that those relationships should include recognition, access to personal neural data, and planning for life after the trial. Whether researchers and companies adopt those practices remains to be seen.