"Ethical Guidelines for Brain-Computer Interface Research" and "Ethical Guidelines for Human-Non-Human Animal Chimera Research" released

Date: 22:23 February 2, 2024 Source: Ministry of Science and Technology

In order to promote normative research in the fields of brain-computer interfaces, human-non-human animal chimerism, the National Science and Technology Ethics Committee has studied and compiled the "Ethics Guidelines for Brain-computer Interface Research", and the Life Science Ethics Committee has studied and compiled the "Human" ——Guidelines for the research of non-human animal chimera” for reference and use by relevant scientific research institutions and researchers.

Attachment: 1. Ethical Guidelines for Brain-Computer Interface Research

2. Ethical Guidelines for Research on Human-Non-Human Animal Chimerism

Attachment 1

Ethical Guidelines for Research on Brain-Computer Interface

1. Purpose

In order to guide the compliance of brain-computer interface research, prevent scientific and technological ethical risks in the process of brain-computer interface research and technology application, and promote the healthy and orderly development of this field, we will study and propose ethical guidance for brain-computer interface research.

2. Term 2.1 Brain-computer interface (BCI)

The brain-computer interface is a new cross-over technology that creates information channels between the brain and external devices to realize direct information interaction between the two. It collects brain neural activities in the cranial or external brain through the recording device, decodes neural activities through machine learning models, analyzes the subjective intentions and other information contained in neural activities, and outputs corresponding instructions based on these information, and controls external devices to achieve the implementation. Behaviors consistent with human subjective will and receiving feedback signals from external devices form an interactive closed-loop system. Brain-computer interface applications mainly include medical and health, communication, life and entertainment, etc., especially to improve the motor, communication and perception functions of patients with neurological paralysis.

2.2 Non-invasive brain-computer interface (BCI)

Non-invasive brain-computer interface refers to brain-computer interface technology that collects brain signals in a non-invasive way on the outside of the scalp, including scalp EEG and functional near-infrared signals.

2.3 Invasive Brain-Computer Interface (BCI)

Invasive brain-computer interface refers to a brain-computer interface technology that uses neurosurgery to implant electrodes and other signal recording devices into specific parts of the brain to achieve precise positioning.

2.4 Interventional Brain-Computer Interface (BCI)

Interventional brain-computer interface refers to a brain-computer interface technology that introduces electrodes and other signal recording devices from blood vessels to specific brain areas through interventional surgery, realizing low-damage, high-precision, and high-throughput neural signal acquisition in the brain.

2.5 Repaired Brain Computer Interface (BCI)

Restorative brain-computer interface refers to brain-computer interface technology that helps some clinical patients or disabled people recover and replace some missing functions, including perceptual function, motor function and language function.

2.6 Enhanced Brain-Computer Interface (BCI)

Enhanced brain-computer interface refers to a brain-computer interface technology that enhances the perception, cognition and motor ability of users with normal body functions.

2.7 EEG (, EEG)

EEG records the changes in electrical signals during brain activity, which is a general reflection of the electrophysiological activity of nerve cells in the brain on the surface of the brain or scalp.

3. Basic Principle 3.1 Protect health and improve well-being

Brain-computer interface research should be moderate and harmless. The fundamental purpose of the research is to assist, enhance and repair the human body's sensation-motor function or improve human interaction capabilities and improve human health and well-being.

3.2 Respect the subjects and apply them appropriately

Brain-computer interface research should respect the subjects' right to know and personal dignity, respect their own right to make decisions, and maximize the integrity of the human brain in structural function and spiritual consciousness. Brain-computer interface research should fully consider risks and benefits. Research on neurodevelopment in children and adolescents should adopt stricter ethical assessment review and risk prevention measures. The development of enhanced brain-computer interfaces should follow the principle of moderation. Without properly addressing various risks, relevant technology applications should not be rashly carried out to minimize the negative impact on humans.

3.3 Adhere to fairness and ensure fairness

The key technologies, performance indicators and acquisition methods of brain-computer interface research should be open and transparent to ensure people's fairness in obtaining brain-computer interface technology; strictly regulate the research on brain-computer interface technology in the fields of social competition such as medical care, education, and employment. Applications ensure the fairness of social competition; prevent prejudice and discrimination between the audience and non-audiences of brain-computer interfaces, and protect the legitimate rights and interests of the audience and non-audiences and fair treatment.

3.4 Risk control and safety protection

Brain-computer interface research should adhere to high-level scientific standards, professional norms and ethical principles. Ensure high-quality research design, effectively control research risks, conduct ethical review and data security review of research plans and research results, promote risk monitoring throughout the research process, dynamically adjust risk control and management measures, and ensure the safety and privacy of the subjects Security, personal information security, data security and legitimate rights and interests.

3.5 Information disclosure and informed protection

Brain-computer interface research should actively share information to ensure openness and transparency, and to protect the right to know of all stakeholders. Relevant research should disclose information and report research results accurately and in a timely manner to ensure the quality of research. When new and potentially controversial technologies are involved, they should be fully discussed and widely listened to stakeholders and the public.

3.6 Support innovation and strict regulations

For rare diseases that are seriously life-threatening and have no other effective treatment methods, clinical trials of innovative brain-computer interface products can be carried out with full informed consent under the conditions of strictly complying with relevant national regulations on medical devices, clinical research, etc.

4. General requirements 4.1 Legal and compliant

Carrying out brain-computer interface research must comply with relevant laws and regulations in my country, follow internationally recognized ethical standards, and professional consensus and technical specifications reached by the scientific community. Illegal activities, infringe on the legitimate rights and interests of others, or undermine social stability through brain-computer interface research. False advertising information that does not match the actual effect of the brain-computer interface shall not be spread.

Carrying out brain-computer interface research on the human body should apply for and pass ethical review in accordance with the "Ethical Review Measures for Life Science and Medical Research Involving Humans" and other relevant regulations. It should be based on the guiding principles of surgical implants and active implants and related standards , conduct full verification of safety and effectiveness, including providing biocompatibility testing reports, type testing reports, safety and effectiveness reports of large animals, etc.

In invasive brain-computer interface research, it should be carried out with sufficient safety and benefits provided evidence. Medical personnel should adhere to "patient-centeredness", abide by professional ethics, and conscientiously abide by relevant laws, regulations, standards and specifications for medical quality management. The medical quality management regulations of this institution standardize clinical diagnosis and treatment behaviors, ensure medical quality and medical safety, try to avoid and reduce the risk of tissue damage and infection during and after surgery, and ensure patient safety.

4.2 Social and scientific value

Carrying out brain-computer interface research should ensure that research has social value, and should mainly focus on repair brain-computer interface technology, emphasizing serving the public's health needs through the development of technology. Enhanced brain-computer interface technologies such as attention regulation, sleep regulation, memory regulation, and exoskeleton for non-medical purposes should encourage exploration and development to a certain extent under the premise of strict normative and clear benefits. Research design should be scientific and reasonable, operational, and scientifically valuable.

4.3 Informed consent

When conducting brain-computer interface research, the written informed consent of the subject or his/her guardian or legal representative should be obtained. Before participants participate in the study, they should fully understand the risk-benefit assessment results of the surgery and related treatment. The informed consent form and informed consent process should be standardized and approved by the Ethics Review Committee. During the implementation of the study, if new risk information is found or may affect the subject's wishes, informed consent should be re-obtained. Subjects are allowed to exit unconditionally at any stage.

4.4 Privacy protection and personal information protection

Neural data or experimental samples collected during the brain-computer interface research reflect the subject's mental state, physiological health information, personality characteristics, property information and other privacy data. The scope of the collected data and the authority of the persons that can be viewed and approved by the Ethics Committee. A proper disposal and management plan should be established, and the collection, storage, use, processing, transmission, and release of data or samples should be systematically guaranteed in the entire process in accordance with the relevant laws, regulations and technical standards for information security management; strict compliance should be carried out; The "Personal Information Protection Law of the People's Republic of China" and the "Data Security Law of the People's Republic of China" will strengthen risk monitoring, prevent the leakage of neural data or experimental samples, and ensure data security and the privacy and personal information of the subjects.

4.5 Risk prevention and control

Brain-computer interface research should establish a safety risk prevention and control mechanism, including strict operating procedures, common error-operation correction mechanisms, plans in emergencies, suspension procedures and emergency response guidelines, etc., to ensure the personal safety of the subjects; strengthen the identity of equipment and devices. Certification, information encryption, system protection and other mechanisms, establish emergency response mechanisms; continue to pay attention to and solve internal security risks of the system, enhance system reliability, controllability and security, steadily improve the security level of the system, and carry out long-term security assessment of the system and verify to ensure the long-term security of the system.

4.6 Qualification Requirements

Personnel who conduct brain-computer interface research should have the corresponding professional level and ability, and undergo special skills and ethical training. If clinical research is carried out with patients as the subject, clinical physicians must participate and meet relevant clinical research requirements. The research team and related research institutions should have key technologies, research conditions and infrastructure to meet research requirements. Invasive brain-computer interface research should use professionally certified equipment, and the safety of drug equipment should comply with the requirements of the "Drug Administration Law of the People's Republic of China", "Medical Device Supervision and Administration Regulations" and other laws and regulations and national standards and specifications.

4.7 Responsibility Mechanism

Brain-computer interface research should enhance the transparency, interpretability, reliability and controllability of the system to ensure that the technical design, research and development, use, deployment and other stages can be held accountable; follow relevant national laws, regulations and standards and specifications, and clarify brain-computer interface products. The mechanism for division of responsibilities between service providers, researchers and subjects.

5. Research Type 5.1 Research on non-invasive repair brain-computer interface

Non-invasive repair brain-computer interface studies the non-invasive way to collect the patient's brain signals, control external devices through signal decoding and outputting instructions, improve the patient's movement, communication and other functions, and improve the patient's quality of life.

Brain-computer interface research should be conducive to improving the health of the human brain and the human body. Since the brain is an extremely fragile and sensitive organ of human beings, research applicants should bear the burden of proof during the ethical review process to fully explain the risks and preventive measures of the research; The personnel must clearly inform the subjects of the potential research risks and the corresponding risk-benefit assessment in advance, clearly obtain the consent of the subject or his legal authorized person, and respect the subject's right to suspend at any time.

During the research, it is necessary to ensure that the safety of equipment and devices that contact the human body meets relevant national standards or specifications, continue to pay attention to and solve internal security risks of the system, and improve the short-term and long-term safety level of the system; strictly control and interfere with the process of human thinking, mental and neural activities. Research on research should avoid all kinds of direct and indirect harms as much as possible, respect human autonomy; brain signal data collection, storage, processing, transmission, disclosure and other links should be transparent to the subjects, strictly abide by relevant laws, standards and norms to ensure that Data security and the privacy of the subjects; we must fully recognize the impact of brain-computer interface research on the neurodevelopmental processes of children and adolescents, and take strict ethical assessment and prevention measures for the possible physical and mental harm and rights violations caused by related research.

5.2 Research on invasive repair-type brain-computer interface

Invasive repair-type brain-computer interface research usually requires neurosurgery, which collects neural signals in the brain through electrodes and other devices implanted in the brain, generates instructions based on signal decoding, controls external devices or controls neural stimulation, and improves patient perception and cognition. , exercise and other functions improve patients' quality of life.

Invasive brain-computer interfaces pose long-term and short-term safety risks caused by neurosurgery and implant placement. Therefore, in addition to following the ethical guidelines related to non-invasive repair brain-computer interfaces, invasive repair brain-computer interfaces, they must comply with the following requirements.

During the research, it is necessary to comply with medical ethical norms in accordance with relevant national laws, regulations and standards; its risks and benefits must be fully evaluated, and compared with other treatment methods, and to fully consider and avoid physical and mental harm and rights infringement, and have sufficient scientific evidence. Under the premise of strict and prudent procedures, the necessity and rationality of using invasive brain-computer interface technology should be determined; the various specifications of medical surgery should be strictly followed, and the implantation of electrodes and other equipment should be carried out by professional doctors to avoid and reduce the risk of tissue damage and infection during and after surgery; monitor long-term safety risks, including brain damage, inflammatory response, skin erosion and abnormal bone growth, electromagnetic radiation risks, etc.; monitor the disappearance of brain signal attenuation during research, and The device is disabled and handled in a timely manner to ensure the safety of the patient. After the study is completed, the doctor should determine whether to remove the implant based on the patient's condition to ensure the patient's safety to the greatest extent.

5.3 Research on interventional brain-computer interface

Interventional brain-computer interface research usually requires interventional surgery to introduce sensors into specific brain areas through blood vessels, collect neural signals in the brain through imported electrodes and other devices, generate instructions based on signal decoding, control external devices or control neural stimulation, and improve patient perception. , cognitive, exercise and other functions to improve patients' quality of life.

The interventional brain-computer interface has long-term and short-term safety risks caused by interventional surgery and intravascular introduction placement. Therefore, in addition to following the ethical guidelines related to non-invasive and invasive brain-computer interfaces, interventional brain-computer interfaces must comply with the following requirements.

In the study, it is necessary to strictly follow the medical specifications of interventional surgery, and in accordance with relevant national laws, regulations and standards, professionals shall carry out vascular introduction operations of interventional surgery and interventional sensors to reduce the short-term risk of vascular damage during the introduction process; Monitor the infection risk of long-term introduction equipment, closely observe adverse reactions such as thrombosis in blood vessels, monitor the patient's coagulation status, and reduce the risk of abnormal coagulation function; monitor the interventional sensor during long-term introduction process to attenuate signal attenuation and even disappear due to tissue wrapping and inflammatory reactions. The long-term risk of device failure to ensure patient safety. After the study is completed, the doctor should determine whether to remove the import according to the patient's condition to ensure the safety of the patient to the greatest extent.

5.4 Research on Enhanced Brain-Computer Interface

Enhanced brain-computer interface refers to a brain-computer interface technology that enhances the perception, cognition and motor ability of users with normal body functions. It is generally non-invasive. Since the technology is still in its early stages of development, the application areas and reasonable degree of enhancement of the technology are still uncertain, and its long-term impact on human beings is still unclear, and there are unknown risks.

In addition to following the ethical guidelines related to non-invasive repair brain-computer interfaces, the enhanced brain-computer interfaces must comply with the following requirements: they must fully examine risks and benefits, be used in moderation, and minimize the negative impact on humans; strictly Research on controlling possible addiction and affecting human normal thinking and behavior; strictly control the research and application of related technologies in the field of social competition to ensure the fairness of social competition; emphasize human autonomy, and fail to adequately enhance the brain-computer interface technology When proving that it is superior to humans and obtaining social consensus, avoid brain-computer interfaces to replace or weaken human judgment and decision-making capabilities, and avoid brain-computer interface research that obviously interferes with and blurs human autonomy and self-cognition.

5.5 Research on animal brain-computer interface

Animal experiments have laid a solid preliminary foundation for promoting the research and application of human brain-computer interfaces. During the research process of animal brain-computer interfaces, it involves animal surgery, experiments, feeding and other links. If the operation is improper, the living welfare of the animals will be reduced and even endanger their life and health. Research on animal brain-computer interfaces should follow my country's "Regulations on the Management of Experimental Animals" and "Guiding Opinions on Treating Experimental Animals with Good Treatment", and follow the principle of "replacement, reduction, and optimization".

6. Popular science publicity

Scientific and technological personnel engaged in brain-computer interface research should actively participate in and carry out popularization of science and technology for the public to help the public correctly understand the purpose and significance of brain-computer interface research.

When the research results of brain-computer interface are released, the research results should be evaluated objectively and accurately, avoid one-sided exaggeration of the role of research results, correct misleading statements in a timely manner, guide the public to treat brain-computer interface research results scientifically, and create a good atmosphere conducive to the development of brain-computer interface technology. .

This guideline is studied and formulated by the National Science and Technology Ethics Committee Artificial Intelligence Ethics Sub-Committee, and is regularly evaluated and revised in a timely manner.

National Science and Technology Ethics Committee Artificial Intelligence Ethics Sub-Committee

December 2023

Main reference documents

[1] "Civil Code of the People's Republic of China" (2020)

[2] "Personal Information Protection Law of the People's Republic of China" (2021)

[3] "Data Security Law of the People's Republic of China" (2021)

[4] "Drug Administration Law of the People's Republic of China" (2019)

[5] "Regulations on Supervision and Administration of Medical Devices" (2020)

[6] "Regulations on the Management of Experimental Animals" (2017)

[7] "Measures for the Ethical Review of Life Sciences and Medical Research Involving Humans" (2023)

[8] "Medicine Quality Management Measures" (2016)

[9] "Key Points of the Core System of Medical Quality and Safety" (2018)

[10] "Guiding Opinions on Treating Experimental Animals with Good Treatment" (2006)

[11] Brain- (BCI) for with or - Non- and (US Food & Drug, 2021)

[12] (IRBs) and of Human in (US Food & Drug, 2019)

[13]Guide for the Care and Use of (US, 2011)