RÉSUMÉ
Regarding biological samples， compared to the Measures of Ethical Review of Biomedical Research Involving Humans， the newly released Measures of Ethical Review of Life Science and Medical Research Involving Humans updated the definitions， clarified the scope， defined the responsibilities of the subject， as well as emphasized the management system， ethical review， and informed consent. By comparing and analyzing the current management status of biological samples at home and abroad， it was found that there were still many problems in the management and ethical review of biological samples in China， such as a chaotic management system of biological samples， unclear responsible entities for management， lack of widely recognized management standards of biological samples in the industry， absence of ethics committee， the non-standard ethical review， the inadequacy or inability to implement informed consent， and the difficulty in providing feedback on research results. Therefore， it is recommended to establish a standardized management system of biological samples， conduct a standardized and effective ethical review， as well as sufficient and necessary informed consent， in order to comply with the requirements of the Measures of Ethical Review of Life Science and Medical Research Involving Humans on biological samples， and enhancing the quality of the management of biological samples in China.
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To further standardize the ethical review of life science and medical research involving humans， the National Health Commission， the Ministry of Education， the Ministry of Science and Technology， and the State Administration of Traditional Chinese Medicine jointly issued the Measures of the Ethical Review of Life Science and Medical Research Involving Humans in 2023. The provisions concerning research related to health information data within it include： emphasizing the protection of personal information and privacy rights， personal information can only be collected， stored， and used under the premise that research participants know and permit， and must not be disclosed to third-party without the authorization of research participants； the ethical committee should focus on reviewing the adequacy of confidentiality measures of personal information； for research that provides information and data or cooperation with external organizations， it is necessary to fully understand the research， conduct a full ethical review， and clarify the use， processing， and disposal after completion of information data through an agreement. The research institutions should improve the information data governance and supervision system in conjunction with the key points of information data management in the new regulations. The initial ethical review should focus on the risk-benefit ratio of the research， the reasonableness of the informed consent procedure， the feasibility of the opt-out procedure， the protection measures for the privacy of the research participants， and the data management capability of the research team. The knowledge training of researchers should be strengthened， policy advisory services should be provided for them， and even a unified information data management platform should be built for them from the overall level of research institutions. The ethical follow-up review emphasizes whether the researchers continue to protect the participant’s right to independent information or personal information， and privacy. It is believed that through a series of governance measures， the health information data of research participants in China will be better protected， thus safeguarding their legitimate rights and interests.
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Decentralized clinical trials （DCT） are bringing new changes to clinical trials， the core concept of “patient-centered” must be adhered， and the safety and rights of research participants must be adequately safeguarded. Although DCTs have similarities with traditional clinical trials， they are not suitable for all clinical trials， and are more suitable for oral administration， stable condition of study participants， and longer duration of treatment in clinical trials. DCT， elements must be selected based on the characteristics of clinical trials， and strike a balance between improving the sense of gain， safety， and rights and dignity of research participants， as well as the quality of data collected. Currently， DCT in China face many challenges. To actively promote DCTs in China， regulatory regulations and guiding principles should be improved. Based on patient-centered design principles， the first discussion requires real-time online communication. Researchers should provide more clinical trial services， improve risk control and accessibility of medical assistance， use third-party convenient payments， ensure fair recruitment of research participants， consider compliance， validate digital health technology， remote monitoring and electronic informed consent compliance， ensure the security of data collection， transmission， and analysis， as well as strengthen multi-party training. Ethical review is one of the important means to protect the safety and rights of research participants. Ethics committees should focus on appropriate DCTs elements that are patient-centered， compliance and effectiveness of electronic informed consent， processing and reporting of security information， privacy protection of data collection， compliance of remote monitoring， family health follow-up， management of biological samples and experimental medical products， and training programs. The author believed that the complementarity and combination with traditional clinical trials will make DCTs elements implemented more easily and smoothly. By leveraging the power of scientific and technological advances， DCTs will boost the speed of China’s drug and medical device research and development， enhance international competitiveness， and benefit more patients.
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In the implementation of exemption from ethical review， medical institutions equate exemption from ethical review with no ethical review or simple review， misunderstand the scope of exemption from ethical review， confuse the concepts of de-identification and anonymization， and equate privacy with personal information. The implementation faced challenges such as the coordination of conditions for exempt review with other regulations， the lack of clear decision-making subjects for exempting from ethical review， the legality and compliance of using general informed consent for biological samples and information data， as well as non-traceability and the risk of being re-identified of anonymous information for exemption from ethical review. Measures such as improving relevant laws and regulations， perfecting the construction and management of information databases and biological sample libraries， strengthening the project management and process supervision of exemption from ethical review， and implementing scientific review can ensure the legal and compliant implementation of exemption from ethical review by medical and health institutions.
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The supervision of cosmetics started relatively late in China， and corresponding laws and regulations on ethical review are not yet perfect. The Cosmetics Supervision and Administration Regulations， which came into force on January 1， 2021， had stricter requirements for cosmetic efficacy claims， requiring that cosmetic efficacy claims should have a sufficient scientific basis. Cosmetic efficacy claims evaluation trials include human efficacy evaluation trials， consumer use tests， and laboratory trials. Human efficacy evaluation trials and consumer use tests should comply with the requirements of ethical principles， the necessary product safety evaluation should be completed before the tests are carried out， to ensure that there is no harm to the human health of research participants （or consumers） under normal， foreseeable circumstances. The Regulations on the Administration of Registration and Filing Materials for Cosmetics required that product test reports should include microbiological and physical-chemical tests， toxicological trials， human safety trial reports， and human efficacy trial reports. The key points of the ethics committee’s review of cosmetic efficacy claims evaluation trials include the reasonableness of the trial protocol， consumer survey and expert evaluation， selection of detection methods， study population and sample size， safety evaluation of the cosmetics， risk assessment of cosmetic raw materials， protection of privacy， and qualifications of the testing institutions and researchers. High-quality ethical review is conducive to safeguarding the safety and rights of research participants （or consumers）， and will also promote the quality of cosmetic efficacy claims evaluation trails in China.
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The Regulations on Donation and Transplantation of Human Organs were issued on December 14， 2023. It was interpreted in terms of improving the human organ donation system and clarifying the responsibilities of the Red Cross Society； adding a new system for the acquisition and distribution of human organs， emphasizing the independence of the organ acquisition department， and implementing the priority right of organ distribution； strengthening the management of human organ transplantation， strictly limiting the scope of recipients of living organ transplantation； and regulating the operation of the ethics committee for human organ transplantation and stepping up the crackdown on violations of the regulations. This paper then considered how to implement and improve incentives for human organ donation， including the implementation of the priority rights of organ donors and their close relatives， the improvement of the organ donation compensation system， and the establishment of a humanitarian assistance system； the implementation of a system for the acquisition and distribution of organ donation organization； the acceleration of the construction of the personnel team of the organ acquisition organization； the increase of efforts to advocate and mobilise； and the enhancement of the construction of the ethics committee for human organ transplantation. The Regulations on Donation and Transplantation of Human Organs help to give fuller play to the enthusiasm and creativity in the field of organ transplantation， and all departments should revise the systems and administrative rules relating to human organ donation and transplantation in time， so as to facilitate the work of donation and transplantation of human organ.
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Nowadays， both international and domestic scientific and technological innovation activities are facing different types and degrees of ethical risks， which bring many negative impacts to human society and even threaten the safety of individuals’ lives and properties. To further standardize the ethics review of science and technology， strengthen risk prevention and control， and promote responsible innovation， ten ministries and commissions jointly issued the Measures for Scientific and Technological Ethics Review （for Trial Implementation） in September 2023. The Measures for Scientific and Technological Ethics Review （for Trial Implementation） required that ethical review should be implemented for science and technology innovation activities in many fields， ethical review should be more practicable. It strengthened emergency management of major public emergencies， proposed that research institutions should establish risk assessment methods， new unorganized personnel can apply for entrusted ethical review， and an ethics committee certification system should be established. The Measures for Scientific and Technological Ethics Review （for Trial Implementation） had outstanding highlights and distinctive features， clarified the responsible parties for scientific and technological innovation activities， strengthened their responsibilities and management of ethical review， introduced a management system for the list of scientific and technological activities， and created an expert review model for addressing the challenges of greater ethical risks. The interpretation and implementation reflection on the Measures for Scientific and Technological Ethics Review （for Trial Implementation） can provide a reference for the implementation of it， with a view to promoting the ethical review of science and technology as a normative force， as well as facilitating the upward and positive development of scientific and technological innovation activities for the benefit of humanity.
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Patient-centered clinical trials refer to clinical trials that take participant’ needs as the starting point， regard participant as active participants， and take clinical values as the ultimate goals. This concept has become the core guiding ideology of current pharmaceutical research and development， and the model of the patient-centered clinical trial will gradually become the mainstream model of pharmaceutical research and development. Patient-centered clinical trials in China have challenges such as difficulty in changing the way of trial thinking and quality control， increased difficulty in participant’ privacy protection， lack of training for all research parties， and unfair recruitment of research participants. Then suggestions were proposed for patient-centered clinical trials in China from three aspects， including relevant departments provide more policy support， sponsors and relevant third parties timely transform ideas of research and development， as well as researchers and research participants strengthen awareness. This paper also put forward the key points of ethical review of patient-centered clinical trials from 8 aspects， including the trial design that incorporated preference information on patients and took into account the assessment of clinical outcomes， protection of the safety and rights of research participants， recruitment based on the needs of research participants， acceptable informed consent， the rationality of selection of decentralssed clinical trials elements， privacy protection of research participants， training and education of researchers and research participants， and compensation and indemnity of research participants， so as to standardize the ethics review of patient-centered clinical trials and ensure the quality of patient-centered clinical trials.
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It is worth pondering how to seek advantages and avoid disadvantages in stem cell clinical research and give full play to the advantages of technology for the benefit of mankind. Through the analysis of the status of stem cell clinical research, including technology and related management methods, proposed the main problems existing in stem cell research, such as the risks of technological uncertainty, ambiguity between research and treatment, over-treatment and technological innovation. Then this paper discussed the ethical and legal risks of stem cell clinical research in China, mainly related to the problems that the construction of laws and regulations is lagging behind, the regulatory challenges of administrative departments are large, the ethical awareness of researchers needs to be further improved, the principle of fairness and justice is not taken into account, the research platform construction of medical institutions is not in place and the protection system of subjects is imperfect, and the organization construction and review capacity of the ethics committee is still lacking.
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In order to speed up the review and approval of new drugs of Traditional Chinese Medicine (TCM) in China, it is accelerating the construction of TCM registration review evidence system, which combines the theory of TCM, human experience and clinical trials, and optimizing the technical requirements for the review of and approval of new drugs of TCM based on ancient classic prescriptions, famous old Chinese medicine prescriptions, and medical institution preparations. The United States has strict requirements on the application for the marketing of herbal medicines. According to the characteristics of herbal medicines and combined with human experience, the European Union has classified registration management, reflecting the regulatory concept of inheritance and innovation. TCM has a long history of human use experience in China, its application has a scope of application, basic requirements, and it is necessary to classify and exempt the declaration materials according to the evidence grading evaluation standards. When the ethics committee reviews the research scheme of human experience of TCM, it should pay attention to the review points such as scientific basis for new drugs or prescriptions of TCM, clinical positioning, applicable population, effectiveness and safety information, research design, sample size, conflict of interest management and informed consent. Finally, Human experience is helpful to formulate the research scheme of new drugs of TCM, which can not only improve the success rate of research and development, but also reduces the cost of research and development, accelerate the marketing of new drugs of TCM, and can benefit more patients.
RÉSUMÉ
The frequent several ethical events in recent years suggested carry out the construction of ethical governance system involving human health-related research under the background of national governance. The subjects of ethical governance include the government, medical institutions, universities, scientific research institutes, enterprise, ethics committees, researchers, the public, etc., the multiple subjects are interrelated and interact with each other to restrict and standardize ethics through different governance tools. However, there are some problems in China’s ethical governance, such as the relative lag in the construction of ethical governance concept and system, insufficient multi-party participation, the difficulty in sole legislation to solve risk and ethical problems, the specification cannot be met, inadequate supervision, insufficient accountability for violations, researchers lack ethical awareness, ethical education lags behind and insufficient information disclosure to the public. It should be taken such as countermeasures as paying attention to the theoretical research of ethical governance system, strengthening the construction of ethical governance system, pluralistic co governance, agile governance, strengthening legislation, improving norms, implementing supervision, strengthening the construction of ethics committee, talent training, training researchers, ethical education, popular science public, academic self-discipline, information disclosure and public participation, so as to build a scientific and technological ethics governance system in line with China’s national conditions and in line with international standards, and contribute China’s wisdom for world ethical governance.
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The construction of clinical application and ethics committee of human organ transplantation technology is constantly improving in China. The review of clinical application and ethics committee of human organ transplantation technology should follow the principle of prudence, with high requirements for timeliness and cumbersome preparation, and living organ transplantation needs to weigh the risk benefit ratio of both donors and recipients. According to the problems often existing in China’s clinical application and ethics committee of human organ transplantation technology, such as lack of supervision and guidance, lack of unified standard operating procedures, insufficient attention to the rights and interests of organ donors after citizens’death, the difficulties to judge and implement of brain death, lack of psychological assessment requirements and procedures, inadequate informed consent, etc. It can be solved from the following aspects: ensuring the independence of ethical review, strengthening the risk benefit ratio assessment of both donors and recipients of living organ transplantation, standardizing the review content, strictly implementing informed consent and medical psychological assessment to reduce the risks of both sides, enriching review methods to ensure timeliness, and strengthening the ethical review and supervision of organ donation.
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In-utero pediatrics is a fetal general medicine for perinatal medicine redevelopment,with the main purpose of preventing and treating fetal diseases,which studies the early prevention,screening,diagnosis,and treatment of diseases from gametes,fertilized eggs,and embryos sequential to children,adolescents,adolescence,and even the entire life cycle.Medical ethics provides strong support for the normative development of this discipline.This paper summarized the formation and development of in-utero pediatrics,analyzed the vulnerability of service subjects within in-utero pediatrics,and sorted out their ethical issues in the prevention and control of birth defects,fetal intrauterine diagnosis and treatment,as well as multidisciplinary collaborative diagnosis and treatment.It was proposed that in-utero pediatrics should follow the medical principle of maternal and fetal interests first,the principle of respect,and the principle of no harm.Finally,suggestions for ethical review of clinical and research projects on in-utero pediatrics were proposed,including strengthening the advisory service role of the ethics committee in clinical practice,timely launching the guidelines of ethical review for clinical research,and enhancing the ethical awareness of medical staff.
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With the change of medical technology from "access management" to "filing management" in China, it is necessary for medical institutions, as the main responsibility, to pass standardized ethical review and supervision. However, there are many problems at present, such as the absence of regulations and guidelines for ethical review of clinical application of medical technology, the lack law of medical technology ethical review standard operating procedures, the insufficient review capacity, the lack of standardization in the choice of ethical review methods, the elements of informed consent and its examination need to be discussed, the lack of appropriate continuing review mode, as well as the confirmation of technical team members and department qualifications is not clearly defined. In order to safeguard the safety and rights of patients, it is important to take the following measures, including carrying out the whole-process supervision of medical institutions, clarifying the supervision process, improving the multi-departmental communication and cooperation mechanism, establishing a management committee for clinical application of medical technology, standardizing the review system of the medical technology ethics committee, clarifying submit the list of materials for ethical review, implementing classified ethical review and supervision to improve efficiency, exploring the tracking review mode, ensuring the whole-process supervision, and carrying out popular and professional ethics training. In the review of ethics committee, more attention should be paid to the main points of review, such as technical scheme, informed consent, qualifications of technical team members and departments, management system, risk assessment and emergency plan, patient compensation and other materials. While ensuring the safety and rights of patients, it also helps to accelerate the healthy development of medical technology.
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At present, there are no laws and regulations, ethical standards, and regulatory requirements related to ethical review of case reports at home and abroad. Whether ethical review is required for case reports, there are different norms in different regions, countries and medical institutions, and the provisions of different journals at home and abroad are also inconsistent. Through the discussion on whether the publication of case reports needs ethical review and approval, this paper summarized the problems of privacy protection and informed consent existing in the publication of case reports, and proposed the key points of ethical review of case reports, including the scientific nature of case reports, patient privacy protection, informed consent and conflict of interest management, with a view to making case reports conform to ethical standards and promoting the development of medical science.
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In February 2023, the National Health Commission, together with the Ministry of Science and Technology, the Ministry of Education, and the State Administration of Traditional Chinese Medicine issued the Ethical Review Measures for Life Science and Medical Research Involving Humans, which emphasizes that research participants involving vulnerable groups such as children, intellectual disabilities, and mental disabilities should be given special protection. This paper expounded the current situation of protecting vulnerable groups from six aspects: inadequate protection of vulnerable groups by relevant laws and regulations, unclear definition of vulnerable groups, insufficient supervision by relevant departments, insufficient review ability of ethics committee to satisfy the protection of vulnerable groups, difficulty in fair inclusion of vulnerable groups, and the need to improve the ethical awareness of researchers and vulnerable groups. This paper also analyzed the new requirements for the protection of vulnerable groups in the Ethical Review Measures for Life Science and Medical Research Involving Humans from the following three aspects: expanding attention to potentially vulnerable research participants, paying more attention to the consent of research participants without or with limited capacity for civil conduct, and re-informed consent after the improvement of civil capacity level. Finally, suggestions on strengthening the protection of vulnerable groups were put forward from six aspects: improving the relevant legal system, clarifying the category of vulnerable groups, strengthening the implementation by regulatory departments, establishing a research participant protection system by research institutions, improving the ethical review capacity of ethics committees, formulating review guidelines by industry associations, and strengthening the education and training of all parties, so as to minimize the risk of vulnerable groups participating in clinical research and boost the quality and speed of clinical research in China.
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Ethical review is an important protective measure for research participants when conducting life sciences and medical research involving humans. "Exemption from ethical review" was proposed in The Measures for Ethical Review of Human Life Sciences and Medical Research Involving Humans issued in February 2023. To implement the exemption from ethical review within the permitted scope of laws and regulations, and to protect the privacy and rights of research participants when utilizing their data information and biological samples, multiple factors need to be considered, including the person responsible for exemption from ethical review, the conditions for exemption from ethical review, and the specific process for exemption from ethical review. As with other review procedures, exemption from ethical review also required the development of corresponding systems, implementation of responsibilities, and reliance on the construction of subject protection systems. It is hoped that this discussion can provide considerations for the implementation of exemption from ethical review.
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To reduce the burden of researchers, Article 32 of the Measures for Ethical Review of Life Sciences and Medical Research Involving Human issued in February 2023 proposed that the review could be exempted. Normative exemption from review can not only relieve the burden of researchers, but also reduce the work pressure of the ethics committee, and devote limited time and energy to the review and supervision of high-risk research. This paper analyzed the four criteria for exemption from review first, and then summarized the situation of exemption from ethics review in the International Ethical Guidelines for Health-related Research Involving Humans and in the United States. In view of the fact that there are no relevant regulations on exemption from ethics review, though some medical and health institutions have implemented exemption from ethics review for some studies, the ethics committee often lacks standard operating procedures, corresponding documents, and experience for exemption from ethics review, researchers lack training for exemption from ethics review, and institutions have no supporting measures for exemption from review. To effectively implement the exemption from review, this paper proposed the following suggestions:developing standard operating procedures for exemption from review, and clarifying the review process, which can be simplified to secretary reviews, with senior secretaries or office directors judging whether they meet the exemption criteria, and the chairman reviewing and signing to convey the review decision. Refining the criteria that meet the exemption from ethics review, and providing cases and explanations as necessary, which will help researchers accurately understand the connotation of each criterion, and also provide reference for researchers to make their own preliminary judgments. Strengthening the training of researchers’ exemption from review criteria. The study should obtain the project proposal first, and provide scientific demonstration opinions. To explore the implementation of continuing review, institutions should accelerate the standardized construction of biological sample banks and databases to ensure the provision of compliant sources of biological samples and information data. Exemption from ethics review should not be abused, and the relationship between reducing the burden on researchers and ensuring the quality of ethical review should be balanced.
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With the progress of life sciences and medicine and the improvement of laws, regulations and rules, to meet the objective needs and further standardize the ethical review of life sciences and medical research involving humans, it is necessary to refer to international ethical standards to integrate with international standards. On February 18, 2023, the National Health Commission, together with the Ministry of Education, the Ministry of Science and Technology, and the National Administration of Traditional Chinese Medicine, issued the Measures for the Ethical Review of Life Sciences and Medical Research Involving Humans. The scope of this revision is large, the content is more detailed, and many details and specific requirements are added. It expanded the extent of jurisdiction to include colleges and universities, scientific research institutes and other institutions; the scope of review included the field of life sciences; the ethical review and supervision efficiency problems caused by the requirement of multiple departments coordinated supervision required the cooperation of the National Health Commission, the Ministry of Education, the Ministry of Science and Technology, and the National Administration of Traditional Chinese Medicine to strengthen communication and implement supervision. It emphasized the management of conflict of interest, strengthened the protection of privacy and data management, clarified the application of summary procedure review, as well as added the ethical review exemption and the submission of initial review materials, key review content, approval criteria and informed consent content, which improved the operability. It proposed solutions or directions for urgent needs and issues of close concern, allowed commissioned review, strengthened follow-up review, registration and filing, and explored three-level supervision, ethical review collaboration mechanisms, and the construction of regional ethics committees. By continuously improving ethical review and supervision to ensure the safety and rights of research participants, promote the quality of life science and medical research in China, and enhance the international competitiveness of life science and medical research involving humans in China.
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The seventh article of Measures for the Ethical Review of Biomedical Research Involving Humans (2016) stipulated that medical and health institutions without an ethics committee shall not carry out biomedical research involving Humans. The Opinions on Strengthening the Governance of Ethics in Science and Technology, issued in March 2022, clearly stated that the institutions that do not meet the conditions for establishing a scientific and technological ethics (review) committee should entrust other institutions to conduct the review. The fourteenth article of Measures for Ethical Review of Life Science and Medical Research Involving Humans (2023) proposes that if an institution, which carries out life science and medical research involving humans, has not established an ethics committee or its ethics committee is not competent for ethics review, it can entrust a competent ethics committee or regional ethics committee in writing to carry out ethical review. Most medical institutions at or above the second level in China have set up ethics committees. While most universities and colleges, scientific research institutions, enterprises and grass-roots medical and health institutions have not set up ethics committees, which lack a working system to protect the safety and interests of the participants, and is difficult to conduct life sciences and medical research involving humans. At present, there is a need for some research institutions that do not have the conditions to establish ethics committees to entrust their projects of life science and medical research involving humans to other institutions for ethical review. The entrusted review is still in the exploratory stage, and there is no relevant specification. The hasty implementation of entrusted review may not achieve the goal of effectively protecting the safety and interests of the participants, and even cause legal disputes. Based on the thematic discussion, with reference to the relevant laws and regulations, departmental rules, ethical standards, and the experience of the ethics committees of some domestic institutions in implementing the entrusted review, the guideline was formulated for the reference of the current entrusted review to ensure the safety and interests of the participants.