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.

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.

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.

The investigator-initiated trials （IIT）， as a widely existing form of clinical research both domestically and internationally， have attracted the attention of governments around the world due to the potential legal risks and issues they may cause， and the trend of legal supervision has gradually strengthened. The legal regulation of IIT in China is still in its early stages， with numerous legal issues that need to be clarified and sorted out. Based on the domestic and international legal reviews of IIT， this paper systematically sorted out the current situation of legal supervision of IIT in China and examined the existing issues， including weak legislative rules， incomplete regulatory systems， imperfect protection rules for research participants and informed consent systems， inadequate regulation of conflicts of interest management， and lax legal supervision of ethical review. Furthermore， this paper proposed suggestions for legal regulation of IIT from three perspectives， including strengthening legislation and emphasizing regulation， improving the mechanism for protecting research participants’ rights and interests， and balancing the legalization of IIT and the scientific development of clinical research， with a view to providing references for legal regulatory paths of IIT in China.

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.

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.

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.

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.