It used to feel like the edge of science fiction to put a computer in someone’s brain. Today it is a reality. Academic and commercial groups are testing “brain-computer interface” devices to enable people with disabilities to function more independently.
Yet Elon Musk’s company, Neuralink, has put this technology at the center of debates over safety, ethics and neuroscience.
In January 2024, Musk announced that Neuralink had implanted his first chip in a human brain.
The conversation reached out to two scientists from the University of Washington School of Medicine – Nancy Jecker, a bioethicist, and Andrew Ko, a neurosurgeon who implants brain chips – for their thoughts on the ethics of this new horizon in neuroscience.
How does a brain chip work?
Neuralink’s coin device, called N1, is designed to allow patients to perform actions by focusing on them, without moving their bodies.
Subjects in the company’s PRIME trial – short for Precise Robotically Implanted Brain-Computer Interface – undergo surgery to place the device in a part of the brain that controls movement. The chip records and processes the brain’s electrical activity and then sends this data to an external device, such as a phone or computer.
The external device ‘decodes’ the patient’s brain activity and learns to associate certain patterns with the patient’s goal: for example, moving a computer cursor across a screen. Over time, the software can recognize a pattern of neural firing that occurs consistently as the participant imagines that task, and then perform the task for the person.
Neuralink’s current trial aims to help people with paralyzed limbs control computers or smartphones. Brain-computer interfaces, commonly called BCIs, can also be used to control devices such as wheelchairs.
A few companies are testing BCIs. What’s different about Neuralink?
Non-invasive devices placed on the outside of a person’s head have long been used in clinical trials but have not yet received approval from the Food and Drug Administration for commercial development.
There are other brain computing devices, such as Neuralink’s, that are completely implanted and wireless.
However, the N1 implant combines more technologies into a single device: it can target individual neurons, record from thousands of locations in the brain, and charge its small battery wirelessly. These are important developments that can lead to better results.
Why is Neuralink being criticized?
Neuralink received FDA approval for human trials in May 2023. Musk announced the company’s first human trial on his social media platform X – formerly Twitter – in January 2024.
However, information about the implant is scarce, apart from a brochure aimed at recruiting test subjects. Neuralink has not registered on ClinicalTrials.gov, as is common practice and required by some scientific journals.
Some scientists are concerned about this lack of transparency. Sharing information about clinical trials is important because it helps other researchers learn more about areas related to their research and can improve patient care. Academic journals may also have a bias toward positive results, preventing researchers from learning from failed experiments.
Fellows at the Hastings Center, a bioethics think tank, have warned that Musk’s “press release science, while increasingly common, is not science.” They advise against relying on anyone with a large financial interest in a research result as the sole source of information.
When scientific research is funded by government agencies or philanthropic groups, its purpose is to promote the public good. Neuralink, on the other hand, embodies a private equity model, which is becoming increasingly common in science.
Companies that pool money from private investors to support breakthroughs in science may strive to do good, but they also strive to maximize profits, which can conflict with the interests of patients.
In 2022, the U.S. Department of Agriculture investigated animal abuse at Neuralink, according to a Reuters report, after employees accused the company of rushed testing and botched procedures on laboratory animals in a race for results.
The agency’s inspection found no violations, according to a letter from the USDA secretary to lawmakers, which Reuters reviewed. However, the secretary noted an “adverse surgical event” in 2019 that Neuralink had self-reported.
In a separate incident also reported by Reuters, the Transport Ministry fined Neuralink for violating rules on the transport of hazardous materials, including a flammable liquid.
What other ethical issues does Neuralink’s lawsuit raise?
When brain-computer interfaces are used to help patients suffering from disabling conditions function more independently, for example by helping them communicate or get around, it can significantly improve their quality of life. In particular, it helps people regain a sense of their own agency or autonomy – one of the most important tenets of medical ethics.
No matter how well-intentioned, medical interventions can have unintended consequences. At BCIs, scientists and ethicists are particularly concerned about the risk of identity theft, password hacking and blackmail. Given the way the devices access users’ thoughts, there is also the possibility that their autonomy could be manipulated by third parties.
The ethics of medicine require doctors to help patients while minimizing potential harm. In addition to errors and privacy risks, scientists are concerned about potential adverse effects from a fully implanted device like Neuralink, because device parts cannot be easily replaced after implantation.
When considering an invasive medical intervention, patients, providers and developers seek a balance between risk and benefit. At current levels of safety and reliability, the benefit of a permanent implant would have to be large to justify the uncertain risks.
What’s next?
For now, Neuralink’s studies are focused on patients with paralysis. However, Musk has said that his ultimate goal for BCIs is to help humanity – including healthy people – “keep pace” with artificial intelligence.
This raises questions about another core principle of medical ethics: justice. Some forms of supercharged brain-computer synthesis could worsen social inequality if only wealthy citizens have access to improvements.
What is of more immediate concern, however, is the possibility that the device could be increasingly useful for people with disabilities, but will no longer be available due to the loss of research funding.
For patients whose access to a device is tied to a research study, the prospect of losing access after the study ends can be devastating. This raises thorny questions about whether it is ever ethical to provide early access to breakthrough medical interventions before they receive full FDA approval.
Clear ethical and legal guidelines are needed to ensure that the benefits arising from scientific innovations such as Neuralink’s brain chip are balanced with patient safety and societal well-being.
Nancy S. Jecker, Professor of Bioethics and Humanities, School of Medicine, University of Washington and Andrew Ko, Assistant Professor of Neurological Surgery, School of Medicine, University of Washington
This article is republished from The conversation under a Creative Commons license. Read the original article.
