China has rolled out an ethical guideline for brain-computer interfaces (BCI) aiming to better guide the compliant development of BCI research and prevent ethical risks in the process of research and technological applications. Application scenarios of future BCI technology are very extensive. By recording and interpreting brain signals, direct communication between the brain and the computer can be achieved. This technology can not only help patients with brain diseases such as amyotrophic lateral sclerosis (motor neuron disease), spinal cord injury and epilepsy to recover, but also has the potential to achieve brain-computer fusion intelligence and expand the brain’s information processing capabilities.
For rare diseases that seriously endanger life and have no other effective treatment methods, clinical trials of innovative BCI products can be conducted with full informed consent under strict compliance with national regulations on medical devices and clinical research, the guideline pointed out.
In specific human experimentation studies, there may be ethical conflicts between the health benefits of the subjects and the scientific development and social benefits. The guideline provides ethical guidelines for five types of research:
- non-invasive restorative BCI research,
- invasive restorative BCI research,
- interventional BCI research,
- enhanced BCI research, and
- animal BCI research.
Research that may cause addiction, affect normal human thinking and behavior should be strictly controlled,
Zhang noted that the guideline highlights China’s long-standing value placed on the protection of subjects in medical research.
Chinese scientists recently made a breakthrough in the world’s first patient BCI rehabilitation trial. Led by principal Biomedical Engineering researcher Hong Bo from the School of Medicine with Tsinghua University, the trial designed and developed the wireless minimally invasive implanted BCI technology device called NEO (Neural Electronic Opportunity). A NEO device was successfully implanted into a patient’s brain for the BCI-assisted treatment trial at Xuanwu Hospital in Beijing on October 24, 2023. The NEO technology has the advantages of higher safety and long-term use.