More autonomy, fewer NDAs: Volunteers have new requests for brain implant trials

Scientists have been working on ways to decode brain activity for decades. Teams have developed brain implants that can be used to control robotic limbs and computers, and even to “speak.”

The people who volunteer for trials of those devices play a vital role in that research, and they ought to be recognized for their contributions, says Ian Burkhart, who had one implanted in his own brain back in 2014. He’s been working on a set of guidelines for researchers developing brain-computer interfaces (BCIs).

Ethics guidelines for clinical trials already exist. But BCI trials are different, says Jennifer Chandler, a professor of law and neuroethics at the University of Ottawa who also worked on the guidelines. “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.”

Burkhart was left paralyzed from the chest down following a diving accident in 2010, when he was 19 years old. Around four years later, he volunteered to become the first person to trial a brain implant designed for hand control.

He had an array of 96 electrodes inserted into the part of his brain that controls movement. The electrodes were connected to a computer via a cable that essentially plugged into his head. Algorithms on the computer were designed to interpret those signals and deliver them to another sleeve of electrodes worn on Burkhart’s arm, allowing him to control it.

The first movements were small, but Burkhart was ultimately able to use the system to pour beads from bottles, move small and delicate objects, and even play Guitar Hero, if only during lab visits. It was a scientific breakthrough.

Burkhart took part in two years-long clinical trials over the seven-and-a-half-year period he had the electrode array implanted in his brain. “It was a fantastic experience,” he says. “But there’s certainly some things that, knowing what I know now, I would want to do a little differently.”

In 2022, Burkhart cofounded BCI Pioneers Coalition—an organization through which people who have taken part in BCI trials can share their experiences, both with each other and with researchers. Over the last year, members of the group have been developing a set of guidelines based on those experiences. The idea is to help academics, clinicians, and companies run ethical trials that respect participants’ autonomy.

The guidelines, published on Tuesday, lay out a list of recommendations that fall within 13 categories. One, for example, focuses on recognizing and compensating trial participants. During the trials that Burkhart participated in, “I was going into the lab two or three days a week, for four hours at a time,” he recalls. “That’s [easily] a part-time job if you just count the hours you’re putting in.”

As the trial progressed, Burkhart says, he learned more and was able to give more constructive feedback on what was working and what wasn’t. He says he was a key member of the research team. Others who find themselves in a similar position might appreciate being listed as a coauthor on scientific publications or publicly named as a research collaborator, he says. Burkhart and his colleagues acknowledge that not everyone will want this, however.

The guidelines also address the thorny question of privacy. That’s important: The public will always be interested in cutting-edge biotechnologies like these—and the guidelines say researchers also have a duty to prepare participants for the possibility of media attention. In some cases, it might be difficult to completely conceal the identity of trial participants.

Things get even more complicated when it comes to the privacy of participants’ brain data. Research teams will need to access, analyze, and—at least temporarily—store this data. Burkhart wasn’t too bothered about that in his case, where scientists were collecting neural activity related to movement. But people who have brain implants designed for turning thoughts into words might feel differently.

The guidelines state that brain data “should be understood as the participant’s personal information.” They are pushing for participants to be able to access their own brain data whenever they want—something that has not always been possible—and want to make sure people aren’t prevented from sharing it with their own doctors because of embargoes or nondisclosure agreements (NDAs) designed to keep findings under wraps from competitors.

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

The guidelines also address what comes after a trial. Around five years after Burkhart had his device implanted, the research team ran into some issues with funding. When we last spoke a few years ago, he recalled how he was told he would have to have the implant removed and could have it put back in once the team had secured funding. (And we’re talking about brain surgery here.)

Ultimately, he kept the implant until 2021, when it was removed after an infection started to develop at the point where the cable led into his scalp. But losing the device after all those years was difficult; he’d regained the ability to move his arm—and then lost it again.

Rita Leggett, an Australian woman who had a device implanted in her brain to treat her epilepsy, has said she felt she “became one” with her implant. When the company that made it went bust two years later, the device was removed against her will—an act ethicists have described as a potential breach of human rights.

Researchers should instead commit to maintaining brain devices for a “reasonable period” after a trial ends, according to the guidelines. Participants should be given plenty of time to prepare for the surgery to remove it. And researchers should set aside extra funds to support trial participants who have to do that.

Some of the guidelines are vague and may overlap with existing ethics standards. They don’t all spell out explicit solutions. They were also developed with feedback from a small group of individuals—the number of people living with BCIs is still very low. The team hopes to grow and expand on the guidelines over time. Burkhart also plans to discuss them with researchers at an upcoming neuroscience conference.

“This is a living document, and this is version one,” says Chandler. “It’s just the starting point.”

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