Beijing, 7 February 2024 (TDI): China has issued an ethical guideline for brain-computer interfaces (BCI), a technology that connects the human brain with machines, to regulate the development and application of BCI research and prevent potential ethical risks.
The guideline, released by the Ministry of Science and Technology on Friday, comes in the wake of Tesla CEO Elon Musk’s announcement of a successful implantation of Neuralink’s brain chip into a human patient.
The guideline was compiled by the artificial intelligence ethics subcommittee of the National Committee for Science and Technology Ethics, and serves as a reference for scientific research institutions and researchers.
Basic Principles of BCI Research
The guideline outlines the basic principles that should be followed in conducting BCI research, which are:
- Safeguarding health and enhancing well-being: BCI research should aim to improve the quality of life of users and respect their dignity and autonomy.
- Respecting subjects involved and applying the technology moderately: BCI research should respect the rights and interests of the subjects involved. It should also avoid excessive or unnecessary use of the technology.
- Adhering to fairness and ensuring equity: BCI research should promote social justice and inclusion, and prevent discrimination and exploitation of vulnerable groups.
- Risk management and ensuring safety: BCI research should identify and assess the potential risks and harms of the technology, and take effective measures to prevent and mitigate them.
- Information disclosure and ensuring informed consent: BCI research should disclose relevant information to the subjects and the public. It should obtain their voluntary and informed consent before conducting any experiments or applications.
- Supporting innovation and strict regulation: BCI research should encourage innovation and creativity, and comply with relevant laws, regulations, and standards.
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Specific Requirements and Guidelines for BCI Research
The guideline also puts forward specific requirements and guidelines for seven aspects of BCI research, including:
Legality and compliance: BCI research should abide by the laws and regulations of China and the countries where the research is conducted, and respect the local customs and cultures.
Social and scientific values: BCI research should conform to the values and ethics of the society and the scientific community. It should also contribute to the public good and human progress.
Informed consent: BCI research should obtain the informed consent of the subjects before, during, and after the research, and respect their right to withdraw at any time.
Privacy protection and personal information protection: BCI research should protect the privacy and personal information of the subjects. It should also prevent unauthorized access, use, or disclosure of their data.
Risk prevention and control: BCI research should establish a safety risk prevention and control mechanism. This mechanism should include strict operating procedures, common error correction mechanisms, emergency plans, suspension procedures.
Additionally, it should have emergency remedial guidelines to ensure the safety of subjects.
Qualification requirements: BCI research should be conducted by qualified researchers and institutions. It should ensure the professional competence and ethical integrity of the research team.
Responsibility mechanisms: BCI research should clarify the roles and responsibilities of the researchers, institutions, sponsors, regulators, and users. Also, it should establish effective mechanisms for supervision, evaluation, feedback, and dispute resolution.
Ethical Guidelines for Different Types of BCI Research
The guideline also provides ethical guidelines for five types of BCI research, which are:
1. Non-invasive restorative BCI research: This type of research collects patients’ brain signals in a non-invasive manner and decodes the signals to control external devices, improving patients’ motor and communication functions.
The guideline suggests that this type of research should respect the preferences and needs of the patients. Moreover, it should ensure the safety and effectiveness of the devices.
2. Invasive restorative BCI research: This type of research involves neurosurgical procedures and implant placement, which pose short-term and long-term safety risks.
The guideline stipulates that this type of research should comply with relevant national laws, regulations, and standards. It should also adhere to medical ethics norms and monitor long-term safety risks, including brain injury.
3. Interventional BCI research: This type of research aims to intervene in the brain functions of normal or impaired subjects, such as modifying their emotions, memories, or behaviors.
The guideline also emphasizes that this type of research should not replace or weaken human judgment and decision-making abilities. It should not significantly interfere with or blur human autonomy and self-awareness, or violate human dignity and rights.
4. Enhanced BCI research: This type of research refers to brain-machine interface technologies that enhance users’ perception, cognition, and motor abilities of normal bodily functions.
The guideline clarifies that this type of research should be avoided. It should only be pursued if it has been fully proven to be superior to human capabilities and has gained social consensus.
5. Animal BCI research: This type of research uses animals as subjects or models for BCI research.
The guideline requires that this type of research should respect the welfare and rights of the animals. It should also follow the principles of replacement, reduction, and refinement.
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