Access to the clinical application of medical technology is one of the core institutional contents of medical quality management， involving medical quality assurance， the achievement of patient safety goals， and medical service satisfaction. Medical technology is only permitted for clinical use after its safety and effectiveness have been verified through clinical research， as well as evaluated and reviewed by the medical technology clinical application management committee and ethics committee of this medical and health institution. Based on the relevant laws， regulations， and ethical principles， combined with the experience of ethical review in the clinical application of medical technology from some medical and health institutions， a thematic discussion was held to formulate ethical review guidelines for the clinical application of medical technology for references. These guidelines elaborated on the management system for access to the clinical application of medical technology in medical and health institutions， the system of ethics committees and the requirements of review norms， technical plans and their review points， key points for the implementation of informed consent， technical teams and conditions， and other aspects.

Investigator-initiated clinical trials （IIT） are an important part of scientific and technological activities involving human study participants. Among them， high-quality IIT can be used to support the marketing and registration application of drugs， medical devices， and other products when conditions permit. Currently， there is a huge gap between IIT and industry-initiated clinical trials. The use of unlisted products in IIT has problems， such as lack of regulatory support， insufficient research funding support， the need to improve the ability of clinical research management departments， the weakness of professional clinical research teams， and the difficulty of ethics review to match the demands. The challenges could be addressed by improving regulations and conducting pilot trials on a small scale， guaranteeing adequate research funding， strengthening the construction of clinical research management systems， building professional clinical research teams， ensuring the quality of ethical reviews and strict follow-up reviews， shifting from ethical reviews to a system for protecting research participants， and reinforcing training for researchers. Ethics committees should strictly review key points， such as the risk-benefit ratio， informed consent， research funding， compensation for damages， qualifications and equipment of research team members， and management of conflict of interest.

Radiopharmaceuticals play an important role in the diagnosis and treatment of cardiovascular and cerebrovascular diseases， malignant tumors， central nervous system diseases， and other diseases. Under the urgent need for clinical diagnosis and treatment as well as medical development， the clinical research of radiopharmaceuticals has become a hotspot in international research. By analyzing the current situation of clinical research on radiopharmaceuticals in Europe， America， and China， the ethical issues of clinical research on radiopharmaceuticals were elaborated from four aspects， including lack of relevant laws and regulations， a higher risk of radiopharmaceuticals， dilemmas in ethical review， and insufficient radiation protection. Response principles and measures were proposed from four aspects， including improving regulations and policies， enhancing radiological protection for all parties involved in the research， strengthening ethical review， and reinforcing the training of relevant personnel， to enhance the quality and level of clinical research on radiopharmaceuticals.

The World Medical Association approved the latest revision of the Declaration of Helsinki on October 19， 2024， which was revised again after 11 years. As the international ethical principles for medical research involving research participants worldwide， this revision aims to respond to the dynamic and rapidly changing research environment and to ensure its relevance. The main contents of this revision include changing subjects to research participants as partners； adding other researchers as the implementing subjects and requiring individuals， teams， and organizations to comply； adding social value， always for the purpose of improving individual and public health； requiring free and full informed consent and maintaining the autonomy of research participants； advocating fair distribution and encouraging community participation； responsibly integrating vulnerable individuals， groups and communities； supporting the maintenance of independent review and authority， and clarifying the dual ethical review of international collaborative research； strengthening the supervision of biological samples and data to prevent risks； emphasizing that the welfare of research participants should be continuously maintained after the end of the clinical trials； adding environmental sustainability and expanding the scope of attention； requiring scientific integrity and maintaining the research environment； demonstrating the scientific validity of research plans and avoiding research waste； adding ethical principles should be observed during public health emergencies； using placebos cautiously and avoiding abuse； clarifying the conditions for the use of unproven interventions. To implement the revised contents of the Declaration of Helsinki， measures that could be taken include applying to all human-related research to protect research participants； centering on patients to ensure that research meets patients’ needs； implementing responsible inclusion through the collaboration of all parties； strictly supervising biological samples and data to protect privacy and maintain sustainable and healthy development； strengthening the supervision of the use of unproven interventions to safeguard the long-term interests of patients； continuously constructing ethics committees and embracing the support of artificial intelligence； standardizing effective informed consent and implementing the principles of freedom and adequacy. The Declaration of Helsinki， which aims to promote and ensure respect and protection of participants in a rapidly innovating medical research ecosystem， will continue to face revisions brought about by new challenges in the future.

Non-human primates are the closest relatives of human beings and possess similar morphological， anatomical， physiological， and behavioral characteristics， making them indispensable in fields such as neuroscience， reproduction， infectious diseases， and drug research and development. Currently， the restrictions on using non-human primates in experiments are becoming increasingly stringent in Europe and the United States. These experiments have ethical particularities that are different from those involving ordinary animals， and they also pose ethical challenges such as lack of necessity assessment， no unified assessment standards， and ethical dumping hazards. Supervision and ethical review should be strengthened. The key points of their ethical review include the necessity of the experiments， the assessment of the harm-benefit ratio， and the implementation of the “3R” principles.

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.

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.

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.

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.

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.