Conducting ethical review of investigator-initiated trials （IIT） is one of the important links to ensure the quality of research projects. Currently， the quality of ethical review for IIT projects is greatly influenced by the personal factors of committee members， which to some extent affects the ethical review committee’s judgments of research risks and benefits. Based on the previously developed Risk-Benefit Assessment Scale for Clinical Research， this paper established an ethical review decision-making pathway based on risk-benefit assessment， that is， proposed the “four-step method” for ethical review risk-benefit assessment， including evaluating the research benefits， assessing the research risks， constructing a risk-benefit matrix， and establishing an ethical review pathway. The “four-step method” helps to reduce the impact of committee members’ subjective/intuitive judgments on the quality of ethical review， assists in promoting the implementation of multi-center ethical review policy， narrows the gap in the quality of ethical review among different medical institutions， and provides clearer guidance for the risk judgments of scientific research management and ethical review departments.

Objective:Currently,the medical Institutional Review Board(IRB)mainly rely on experience to analyse the risks and benefits of clinical research,lacking an assessment framework of risks and benefits.Methods:Using grounded theory,interviews were conducted on 29 ethical review workers in China.Through open coding,spindle coding,and selective coding,the framework of risks and benefits for clinical research in China was constructed.NVivo11 software was used for data storage,organization,encoding,and analysis.Results:A framework of risks and benefits for clinical research was proposed based on China's national conditions.Clinical research risks consisted of physiological risk,psychological risk,economic risk,and social risk.Research benefits consisted of subject benefits and society benefits.Conclusion:This paper systematically explained the connotation of the risks and benefits of clinical research,and constructed a framework of the risks and benefits of clinical research applicable to China.It has certain innovations in theoretical research,and also provides use for reference for researchers and ethics committees to evaluate risks and potential benefits in clinical research.

Objective:The aim is to construct an evaluation framework for clinical research benefits,and provide a reference for the formulate of evaluation standards for clinical research benefits.Methods:The Delphi method was used to carry out expert consultation,and the mean,score of importance,coefficient of variation and coordination,etc.of evaluation indicators were summarized and calculated,to screen evaluation indicators for clinical research benefits.Results:Twenty-three experts in this field were selected for correspondence,and their enthusiasm was 100%in both rounds,the authority coefficients were≥0.90,and Kendall's coefficients of concordance were<0.25(P<0.001).By referring to the mean and coefficient of variation of the indicators,as well as combining them with expert suggestions,an evaluation framework for clinical research benefits was ultimately formed with 2 primary indicators,5 secondary indicators,and 8 tertiary indicators.Conclusion:The evaluation framework for clinical research benefits constructed in this paper can comprehensively evaluate the research benefits,as well as provide a basis for reasonably determining the research risk-benefit ratio and developing quantitative evaluation tools for clinical research benefits.

With the rapid development and widespread application of artificial intelligence(AI)technology,it has brought convenience to people's lives and work,while bringing a series of ethical challenges such as lack of transparency,privacy leakage,limited autonomy in decision-making,and blurred responsibility attribution.By comparing the ethical risk governance of the application of AI in the medical field,this paper systematically analyzed 30 policy regulations issued by 10 countries and international organizations,revealing the consensus and differences in ethical governance of medical AI internationally.The results showed that transparency,fairness and justice,non-harm,privacy protection,freedom and autonomy,responsibility,and people-oriented principles were seven internationally recognized ethical principles,providing important guidance for building a safe,trustworthy,and humane-respecting medical AI ecosystem.In addition,this paper deeply compared the risk assessment methods in the guidelines of China,the United States,and the European Union,as well as found differences in risk types,risk grading,and risk assessment process standards.These differences not only reflect diversities in different cultural,legal backgrounds,and regulatory concepts,but also highlight the necessity of strengthening international cooperation in the context of globalization.Therefore,it is recommended to develop ethical risk governance standards and norms for medical AI that applicable to China's national conditions.Based on drawing on international experience,proactively carry out risk assessments,reduce ethical challenges,and promote the healthy and rational application of medical AI technology.

The incidence and prevention of chronic non-communicable respiratory diseases represented by chronic obstructive pulmonary disease, bronchial asthma, and lung cancer, as well asrespiratory communicable diseases such as viral pneumonia and tuberculosis, are becoming increasingly severe and complex.Only by constructing the modern respiratory discipline system of pulmonary and critical care medicine (PCCM) and developing the standardized management of PCCM departments in the hospital, could we achieve the goal of establishing overall specialized capacity for respiratory diseases and improving the ability of disease prevention and treatment in China. This article introducedthe project design and practice exploration based on the standardized construction of PCCM department in hospital, in the context of the new pattern of modern respiratory discipline.It focused on project initiation and management, formulation of evaluation standards, identification process and grading, and phased effectiveness.It also discussed and analyzed the experience, enlightenment, existing problems and suggestions, which could provide reference and advance experience for innovation, governance and improvement of capacity building of respiratory specialty and high-quality development of other medical disciplines and specialties in China.

【Objective:】 To deeply understand the current situation and hotspots of drug clinical trials risk management in China. 【Methods:】 Co-word analysis and social network analysis were used to sort out the study results of risk management in drug clinical trials in China. 【Results:】 The trend of risk research of drug clinical trials in China was generally on the rise. The research hotspots focused on four areas: drug supervision and pharmacovigilance, risk management of drug clinical trial institutions, ethical review of drug clinical trials, and risk management of drug clinical trials. 【Conclusion:】 In the future, China should gradually improve the risk management system and supervision system of drug clinical trials, explore to establish a risk-based quality management and ethical review system of drug clinical trials, and enhance the risk assessment and coping ability of institutions.

【Objective:】 To sort out the influencing factors of drug clinical trial risks and improve the risk management level of drug clinical trials in China. 【Methods:】 The literature analysis method was used to sort out the literature related to the risk management of drug clinical trials in China, and the text analysis method was used to summarize and refine the influencing factors of drug clinical trial risks. 【Results:】 The risk categories of drug clinical trials were divided into 5 parts, namely drug clinical trial institution management, ethics committee management, clinical trial designs, researchers, and subjects, involving 13 main risk influencing factors and 21 specific risk points. 【Conclusion:】 By strengthening the construction of drug clinical trial institutions and ethical management capabilities, optimizing research protocol design, enhancing researchers’ awareness and ability, and establishing a subject management system to improve the quality of drug clinical trials.

The passing of ethical review is a necessary conditions and prerequisite for the development of life science and medical research involving humans. At present, some medical and health institutions have no or insufficient ethical review capabilities. The lack of ethical review ability has become a bottleneck restricting the development of life science and medical research involving humans. According to documents such as Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Pharmaceutical and Medical Devices, Opinions on Strengthening the Ethical Governance of Science and Technology, institutions can entrust competent institutional ethics review committees or regional ethics review committees in writing to conduct ethical review. Entrustment ethical review provides a viable solution for institutions that need to carry out life science and medical research involving humans but do not have an ethics (review) committee or the ethics (review) committee is not competent to review. To conduct the entrustment ethical review, the entrustment between the principal and the trustee is required. According to The Measures for Ethical Review of Life Sciences and Medical Research Involving Humans, if medical and health institutions and their ethical review committees do not accept the formal entrustment to provide the ethical review opinions for other institutions, the local health authorities at or above the county level will impose administrative penalties and sanctions on the relevant institutions and personnel in accordance with the law. Signing the entrustment ethical review contract, implementing legal compliance entrusted ethical review to protect the rights and interests of the trustee and the principal, and protect the research participants.

Risk assessment of clinical trials is of great significance to improve the quality of clinical trials. Through systematic comparative analysis of risk assessment tools for clinical trials in Britain, Germany and France, this paper found that the three countries’ risk assessment tools were consistent in terms of legal system guarantee and assessment process, but there were obvious differences in the basic risk classification and risk grading standards of clinical trials. Based on the experience of Britain, France and Germany, this paper proposed to improve the relevant regulations and documents of clinical trial risk management in China from the perspective of Chinese national conditions, further explore the factors affecting clinical trial risk, and develop and design clinical trial risk assessment tools with different discipline characteristics according to the specialties of the discipline to improve the quality and level of clinical trials.

Objective:To understand the status quo of basic research projects on respiratory diseases in China.Methods:Descriptive statistical methods were used to review the project number, funding input, funding categories and distribution of National Natural Science Foundation of China (NSFC) respiratory disease funding projects from 2009 to 2019.Results:according to the research, the number of NSFC respiratory projects and funding increased significantly, which promoted the development of respiratory science. However, due to the heavy burden of respiratory diseases, it is still necessary to increase the investment in respiratory diseases.Conclusions:taking into account of the importance of respiratory science, this paper suggests that NSFC should increase investment and support for respiratory diseases projects, strengthen the development of existing respiratory advantages, encourage cross-cutting and frontier research on respiration, cultivate a group of internationally influential scientists and research teams, and promote academic innovation in respiratory science.