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

Brain-computer interface researchers have a new set of ethics guidelines to contend with, published Tuesday by the BCI Pioneers Coalition, an organization formed in 2022 by Ian Burkhart and other former trial participants. Burkhart, who was left paralyzed from the chest down after a diving accident in 2010 at age 19, volunteered around four years later for the first implant trial designed for hand control. The guidelines run to 13 categories of recommendations aimed at helping academics, clinicians, and companies run trials that respect participants' autonomy.

The hardware Burkhart lived with involved 96 electrodes inserted into the brain region controlling movement, wired to a computer that decoded signals and drove a sleeve of electrodes on his arm. Over seven and a half years with the array implanted, he completed two years-long trials, gaining lab-only abilities like pouring beads between objects and playing Guitar Hero. He now argues the hours he spent — two or three lab days a week, four hours each time — amounted to a part-time job, and that his growing expertise made him a genuine member of the research team rather than a passive subject.

One thrust of the guidelines is recognition: participants should have the option to be acknowledged as research collaborators and listed as coauthors on resulting papers. Jennifer Chandler, a University of Ottawa professor of law and neuroethics who worked on the document, notes that standard clinical trial ethics rules don't fully capture the BCI situation, where devices sit embedded in the brain for years in exchange for a significant investment of time, body, and intellectual effort.

A second focus is data ownership. The guidelines treat neural data as personal information and argue that NDAs or embargoes should never prevent a participant from sharing their own brain data with their own doctor. A third addresses what Burkhart describes as losing an implant like losing a limb: when funding ran out or companies folded, participants lost both the device and the abilities it enabled, sometimes with little warning. The guidelines call for researchers to fund and plan removals carefully, giving participants real time to prepare.

What remains open is whether academic labs, startups, and well-funded BCI companies will adopt the recommendations voluntarily or whether they will need to be folded into trial protocols and regulatory requirements. Also unresolved is how coauthorship norms will mesh with existing scientific publishing practices, and who bears the long-term financial responsibility for implant removal when a trial sponsor dissolves — a question the guidelines raise but whose enforcement mechanism is not yet defined.

The coalition's members are continuing to develop the guidance based on their own trial experiences, meaning the document is likely to evolve as more participants join the conversation.