Volunteers in Brain Implant Trials Demand More Autonomy and Recognition

Volunteers participating in brain-computer interface (BCI) trials are calling for better understanding of their critical role in this research and for their rights to be protected. Ian Burkhart, a pioneer in the field who received a brain implant in 2014, has spearheaded the development of new ethical guidelines emphasizing participant autonomy and recognition of their contributions.

These guidelines differ from existing clinical trial ethics by focusing on the unique circumstances of participants who have devices embedded in their brains and dedicate significant time, physical effort, and intellectual input to trials that can last for years. The goal is to help academic institutions, clinicians, and companies conduct more ethical and participant-centric trials.

Highlights

• Participant Recognition and Compensation: The guidelines suggest that the time volunteers invest is equivalent to a part-time job, proposing that their contributions be recognized through co-authorship on scientific publications or public acknowledgment as research collaborators.
• Data Privacy and Access: Brain data should be considered the participant's personal information, with volunteers having access to their own data whenever they wish. Furthermore, non-disclosure agreements (NDAs) should not prevent them from sharing this data with their own doctors.
• Post-Trial Care: It is recommended that brain devices be maintained for a "reasonable period" after a trial concludes. If removal is necessary, participants should be given ample time to prepare for surgery, and researchers should allocate funds to support them.
• Preparation for Media Attention: In cases where completely concealing participants' identities might be difficult, researchers have a duty to prepare them for potential media attention.

Details

Ian Burkhart became paralyzed from the chest down after a diving accident in 2010. In 2014, he became the first person to trial a brain implant designed for hand control. With an array of 96 electrodes inserted into his brain, Burkhart was able to control a robotic arm, performing tasks like moving objects and even playing Guitar Hero. He lived with the implant for seven and a half years, participating in two long-term clinical trials during this period.

In 2022, Burkhart cofounded the BCI Pioneers Coalition, an organization for individuals who have participated in BCI trials to share their experiences. Over the past year, members of this coalition have developed guidelines with recommendations across 13 categories, based on their collective experiences. These guidelines aim to prioritize participant autonomy and well-being. For instance, some participants have faced difficulties accessing or sharing their brain data with their own doctors.

The guidelines also address sensitive issues such as the removal of devices after a trial. In Burkhart's own experience, funding issues nearly led to the removal of his implant. The case of Rita Leggett, an Australian woman whose epilepsy device was removed against her will after the manufacturing company went bankrupt, was described by ethicists as a "potential breach of human rights."

Why it matters

As brain-computer interface technologies rapidly advance, the rights and well-being of the volunteers who form the foundation of this groundbreaking research are paramount. These guidelines aim to provide a framework that ensures future BCI trials are more ethical, transparent, and participant-centric. This will support scientific progress while upholding human dignity. This is considered a "living document," with plans for it to be expanded and refined over time.