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.

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.

Scientific research is an important part of hospital work,the driving force of hospital construction and development,and the key to the hospital's comprehensive competitiveness and future development potential.Scientific research misconduct,which seriously deviates from the recognized norms of the scientific community,and will cause great harm to groups,society,and the public.It may also lead to the spread of false knowledge,resulting in misconceptions among peers and causing losses.By analyzing the scientific research integrity relationship between clinical doctors and clinical researchers,as well as looking at integrity standards from multiple dimensions,this paper found out the similarities and differences in the extension of integrity between them.Exploring measures to further promote the construction of scientific integrity and ethics,especially increasing the supervisory role of discipline inspection and supervision,which is conducive to the promotion of scientific research in the medical field in China.

This paper discussed the current education status on medical ethics and styles and the assessment condition in the examination of doctors' qualification， as well as the existing problems and potential solutions by reviewing domestic and foreign literature and summarizing the practice experience. Traditionally， medical ethics and styles have always been integrated into clinical medical practice in China. However， under the modern medical education system， it is challenged to integrate traditional education on medical ethics and styles with the rules of modern medical knowledge. By summarizing the education and assessment status of medical ethics and styles in the examination of doctors' qualification， it is found that the current examination is relatively poor in the evaluation content， and the way of evaluation is not diverse， with lack of curriculum of medical humanities. The solutions suggested are enriching relevant examination content， introducing more and comprehensive evaluation method， and establishing more medical humanities-related courses.

Guaranteeing the rights and safety of subjects is an important responsibility of all participants in the medical devices clinical trial, including medical institutions, sponsors and researchers. The legal disputes caused by serious adverse events in the clinical trial of medical devices are characterized by complex legal relationships, great difficulty in handling, and many points of dispute. Based on a typical case of medical device clinical trials, this paper discussed the litigation subject qualification, the treatment of contract breach and tort in medical device clinical trial, analyzed the responsibility of different subjects, and provided constructive suggestions on the risk management of medical device clinical trial.

At the end of February 2023, the new Notice on the Issuance of Ethical Review Measures for Life Science and Medical Research Involving Humans was issued by the National Health Commission, the Ministry of Education, the Ministry of Science and Technology, and the State Administration of Traditional Chinese Medicine. It adheres to the basic principles and institutional framework of the Ethical Review Measures for Biomedical Research Involving Humans , and combines with the actual situation of domestic ethical work to optimize and improve the details and procedures of the review. Based on the Ethical Review Measures for Biomedical Research Involving Humans, the Ethical Review Measures for Life Science and Medical Research Involving Humans have expanded the scope of application of ethical review. Different experts in the field have discussed in detail the changes in the scope of review, and proposed review procedures that may need to be corresponding adjustments based on the changes for the readers’ reference.

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.

Objective:With the rapid increase in the number of real world studies, especially the use of health data in medical institutions, ethical issues such as the use of patient health data and the protection of patient′s privacy rights and the right to know have been gradually exposed. To strike a good balance between promoting data sharing and maintaining subjects′ personal privacy, the mode of informed consent appears to be crucial. This paper provided guidance for the selection of informed consent models for real world research health data utilization.Methods:The authors extensively studied the relevant laws and regulations of health data utilization worldwide, conducted extensive searches in Chinese and English databases, sorted out and analyzed various alternative informed consent models, and summarized their characteristics and applications.Results:At present, five alternative informed consent models were used to conduct real world research based on health data utilization. Researchers can choose informed consent models according to the research purpose, research design, research risk, operability of informed consent, and vulnerable groups.Conclusions:Different alternative informed consent models have varied characteristics. Researchers need to choose informed consent models based on the above factors to ensure the maximum protection of patients' privacy rights while using health data.

Background: Patients with acute gouty arthritis experienc severe pain and often have concomitant limited joint movement. High-dose intake of anti-inflammatory analgesics often results in adverse reactions, such as nausea, vomiting, and diarrhea, and might increase the risk of gastrointestinal bleeding. In order to reduce the adverse reactions by oral intake, local use of externally useddrugs with the same active ingredients as the oral intake is an option in clinical practice. However, externally useddrugs take effect slowly and efficacy to reduce painful feelingis unsatisfactory. Therefore, it is demanding to develop a safe and effective treatment plan. In this regard, researchers have put up a hypothesis. The skin of the human body has a dense stratum corneum, which is difficult for externally used drugs to penetrate effectively; if the keratin barrier of the skin around affected joints can be broken without further damaging the skin, externally applied drugs may safely and effectively alleviate the local symptoms of acute gouty arthritis. The nano plum blossom needle is made of a modern new material. The needle body is thin and the diameter of the needle tip is only 300 nm. The needle is used clinically to break through the keratin barrier of the human skin and promote the absorption of external medicine. Therefore, this trial was designed to preliminarily evaluate the safety and effectiveness of using the nano plum blossom needle for the introduction of diclofenac diethylamine emulgel in the treatment of acute gouty arthritis. Methods: A randomized controlled trial including 83 patients with acute gouty arthritis was conducted, who was assigned to three groups, the intervention group, control group 1, and control group 2 in a ratio of 2:2:1, respectively. The nano plum blossom needle was used for the introduction of diclofenac diethylamine emulgel in the intervention group; the nano plum blossom needle was used as a placebo along with the local use of diclofenac diethylamine emulgel in control group 1; and the nano plum blossom needle was used alone in control group 2. The treatments were applied once a day until the pain was completely relieved and the course of treatment lasted up to 7 days. The primary outcome measurement was the visual analog scale for evaluating the degree of pain. The secondary outcome indicators included scoring of the symptoms and signs with comprehensive consideration of the joint skin color, local tenderness, and degree of joint motion, the time and dose of emergency medication usage during trial, and adverse events. Discussion: This trial couldprovide preliminary evidence for evidence-based practice of using nano plum blossom needle transdermal drug delivery technology for diclofenac diethylamine emulgel for the treatment of acute gouty arthritis, and provide a reference for sample size calculation and experimental design of future clinical trials verifying the effectiveness and safety of such a technical scheme in a larger target population. Registration information This study has been registered in the China Clinical Trial Registry Centerwith the registration code of ChiCTR-IOR-17012154.

Through the questionnaire survey on the current situation of human research ethical management in Beijing medical and health institutions, this paper analyzed the problems existing in ethical management of Beijing medical and health institutions and put forward corresponding countermeasures and suggestions. The results showed that overall status of human research ethical management in Beijing medical and health institutions was satisfying. But the ethical management levels of different types of medical and health institutions were quite different, and medical and health institutions, health family planning administration departments and academic teams should all make corresponding contributions.