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.”
