1.Back to the role of guardian of man: on Heidegger’s critique of Sartre’s thought and its bioethical implications
Chinese Medical Ethics 2025;38(1):1-7
The psychological and mental health issues of individuals are becoming increasingly prominent in modern society, and responding to this issue requires a return to understanding man. On the understanding of man, Sartre reversed the position of“essence precedes existence” in traditional metaphysics, and put forward the proposition of“existence precedes essence”. He claimed that man realized and defined himself in his own existence, and that there was not pre-given essence. In this regard, Heidegger considered that Sartre’s proposition was just a copy and continuation of metaphysics, and his humanitarian thought was still based on the perspective of being to understand man, which was a misunderstanding and dwarfization of man. Different from traditional philosophers, he proposed that only by returning to Being, understanding man in relation to the truth of Being, and discovering his role as guardian, can the essence of man be revealed and his proper dignity established. This aspect of Heidegger’s thought contained abundant bioethics implications, which were of great enlightening significance for understanding and responding to the problems of modern individuals’ mind and spiritual order.
2.The concealed bio-conservatism: a study starting from Heidegger’s philosophy of technology
Chinese Medical Ethics 2025;38(1):8-14
The development of biotechnology has made healthcare no longer limited to the general “restoration” of physical and mental functions, but increasingly involves “enhancement.” This has also sparked intense ethical controversies, manifested in deeper thinking about technology and life, human nature, and many other issues. Opponents hold a conservative attitude from the standpoint of humanistic care, believing that the development and use of enhancement technologies pose a serious threat to human society and even human beings. However, looking at their reasons for opposition, many implicit assumptions about the premise of constant health and the stillness of human nature can be found. This not only makes it difficult for their criticism to fully hit the nail on the head, turning them into “inverted” technological determinists, but also reflects a more fundamental misplacement of the relationship between humans and technology, falling into the concealment that Heidegger described as a means of technological unveiling.
3.Guidelines of ethics review for clinical application of medical technology
Jiyin ZHOU ; Mingjie ZI ; Qi LU ; Hui JIANG
Chinese Medical Ethics 2025;38(1):15-22
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.
4.Analysis of the Guidelines for Ethical Review of Clinical Research Involving Mental Disorders
Xueqin WANG ; Hongqiang SUN ; Yiting LI ; Lin LU
Chinese Medical Ethics 2025;38(1):23-30
The ethical review of clinical research involving mental disorders in the ethical governance of scientific and technological has obvious particularities, especially in the field of artificial intelligence and brain-computer interfaces which are reflected in the impact on mental autonomy, the impaired informed consent ability of participants with severe mental disorders in research, and other aspects. In addition, the stigma of illness, the use of placebo, and psychological assessment methods in clinical research have also drawn attention to the ethical review of psychiatry. In 2020, the Beijing Municipal Health Commission issued the Guidelines for Ethical Review of Clinical Research Involving Mental Disorders (Guidelines). Shen Yucun’s Psychiatry, compiled in 2023, revised the application of the Guidelines in the context of ethical governance. An analysis was conducted on the purpose and significance of its issuance and revision, its scope of application, the principal responsibility of ethical review in medical and health institutions, and the key content of ethical review in psychiatry, to improve the quality of ethical review in clinical research involving mental disorders and promote the standardized development of clinical research in psychiatry.
5.Challenges, countermeasures, and key points of ethics review in investigator-initiated clinical trials of unlisted products
Honglei NIAN ; Jihong LI ; Jiyin ZHOU
Chinese Medical Ethics 2025;38(1):31-39
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.
6.Practical exploration of ethical review in decentralized drug clinical trials
Xu ZUO ; Yingshuo HUANG ; Yue LI ; Lihan XING ; Chunxiu YANG ; Yan CUI
Chinese Medical Ethics 2025;38(1):40-45
ObjectiveTo explore the process and guidelines for ethical review in decentralized drug clinical trials, promote clinical trial progress, and ensure drug development progress. MethodsThe key points of the ethical review were summarized by studying the relevant laws and regulations on decentralized drug clinical trials, analyzing the advantages and challenges of decentralized drug clinical trials, and combining the experience of the ethics committee of the institution in reviewing decentralized drug clinical trials. ResultsRelevant laws and regulations were the basis for the ethical review, and the ethics committee should adopt appropriate review methods based on regulations and hospital ethical standard operating procedures. The ethics committee should focus on the feasibility, applicability, and rationality, the adequacy of informed consent, the protection of rights and interests and privacy of subjects, as well as the qualification and standard operating procedures of electronic platforms for conducting decentralized drug clinical trials. ConclusionDecentralized drug clinical trials are in their early stages and urgently require guidance from relevant laws and regulations. Ethical review is also constantly being refined through exploration. It is necessary to supervise the implementation of responsibilities by all parties, pay attention to the rights and interests of subjects, and gradually promote the implementation of decentralized drug clinical trials.
7.Analysis of the dilemmas of the simplified ethical review procedure in practice
Benze HU ; Yuhong HUANG ; Xufang GU ; Weihua GUO ; Siyuan HU ; Yaqing YANG
Chinese Medical Ethics 2025;38(1):46-51
In September 2023, the Measures for Scientific and Technological Ethics Review (Trial Implementation) was issued, revising the provisions related to the simplified procedure for ethical review in Chapter 3, Section 3. This revision of these provisions provides systematic guarantees for further optimizing ethical review work, ensuring that ethical review procedure is well-regulated, and improving scientific research efficiency. The “simplified procedure” does not mean reducing the quality and requirements of the review. Instead, based on always following internationally recognized ethical standards and emphasizing not violating national laws and regulations, improving the efficiency of ethical review and subsequent research work, and promoting the development of life sciences and medical research involving humans. In practical work, it introduces numerous new opportunities and challenges for the improvement of ethics review ability, such as new tests on the judgment and decision-making power of ethics committees, how to ensure the reliability and controllability of the conditions related to the simplified review procedure, and how to determine the basic conditions for adopting the simplified review procedure for review. Therefore, to actively respond to the challenges and possible risks brought by the simplified procedure review, efforts should be made to achieve three “unifications”, including the unification of researchers’ moral autonomy and the heteronomy of supervision implemented by relevant departments; the unification of the standard formulation of the simplified procedure review and the review work in practice; and the unification of ethical responsibility and legal responsibility.
8.Key points for ethical review of investigator-initiated clinical trials on traditional Chinese medicine
Chinese Medical Ethics 2025;38(1):52-57
The academic development of traditional Chinese medicine (TCM) originates from numerous clinical practices. The efficacy of TCM, its mechanism of action, and the unique value of TCM have been verified through clinical research, contributing to TCM’s inheritance and development. At present, there is an increasing number of investigator-initiated clinical trials (IIT). The IIT projects involving TCM intervention have different designs in terms of basic theory, syndrome differentiation, prescription composition, dosage form, dosage, and other aspects, as well as even posing challenges to the project review of the ethics committee. The basic ethical principles followed by clinical research institutions of modern medicine and TCM are consistent. The ethical review of the IIT projects involving TCM intervention needs to reflect the development laws of TCM itself, as well as conform to the characteristics of TCM and the laws of new drug research and development. TCM medical institutions need to combine their professional characteristics, sort out clinical experience, guide researchers to conduct clinical research on TCM in an orderly manner with a patient-centered and clinical value-oriented, verify the clinical value of TCM’s new drugs, and improve the success rate of translating the results of TCM’s new drugs.
9.Practice and reflection on ethical review of multicentre studies in a tertiary hospital
Lingling YU ; Wei LIU ; Pengjun ZHANG
Chinese Medical Ethics 2025;38(1):58-62
ObjectiveTo analyse the implementation of mutual recognition of ethical review in a tertiary hospital, providing ideas for exploring ethical review of multicenter studies. MethodsThe ethical review of multicenter studies conducted by the hospital from 2018 to 2022 was analyzed. ResultsA total of 1,582 projects were reviewed in the hospital from 2018 to 2022, of which 773 (48.9%) were multicentre studies. In multicenter study projects, 70.4% of the studies were conducted as a participating unit. Mutual recognition of ethical review and fast review were implemented for all participating projects. After a rapid review of 24 studies, the presiding committee recommended submitting them for conference review. The reasons for the transfer to conference review included issues with the study protocol (11 projects), informed consent (12 projects), and other supporting documents (5 projects). Twenty-one studies were eventually approved by the ethics committee after modification, and 3 studies were not approved by the ethics committee because the sponsor refused to modify the study protocols. ConclusionFor participating in multicentre studies, the ethics committees of participating units implement mutual recognition of ethical reviews and adopt a rapid review approach to review all study data, which can achieve both quality and efficiency.
10.Cognition and countermeasures of medical science and technology ethics management among medical staff in five tertiary hospitals in Ningxia Hui Autonomous Region
Chinese Medical Ethics 2025;38(1):63-71
ObjectiveTo understand the current situation and influencing factors of cognition level, as well as existing problems in the construction of medical science and technology ethics management among medical staff in five tertiary hospitals in Ningxia Hui Autonomous Region, to provide references for enhancing their awareness of medical science and technology ethics management and improving the quality of clinical research. MethodsUsing a self-designed and validated “Medical Science and Technology Ethics Management Cognitive Questionnaire for Medical Staff,” medical staff from five tertiary hospitals in five cities in Ningxia were selected as the research subjects for investigation. ResultsFinally, 436 valid questionnaires were collected, among which the total average score for medical staff’s cognition of medical science and technology ethics management was (61.58±12.96) points. The scores of ethics system cognition, ethics committee cognition, ethics education and training cognition, and ethics management informatization cognition were (14.18±2.84) points, (24.19±5.47) points, (15.07±4.00) points, and (8.14±4.42) points, respectively. Multiple linear regression analysis showed that age, work city, education level, professional title, whether they had assessed the implementation of the hospital ethics system, whether they had participated in the hospital’s ethics review work, and whether they had organized or participated the hospital’s ethics training, were all influencing factors on the cognitive score of medical science and technology ethics management among medical staff, which can explain 51.00% of the variation (P<0.05). Medical staff considered that inadequate promotion of ethical systems, opaque ethical review procedures and processes, conflicts between ethical training time and work tasks, and the lack of a dedicated ethical review information platform were the main problems in constructing medical science and technology ethics. ConclusionThe cognition level of medical science and technology ethics management among medical staff in tertiary hospitals in Ningxia was generally not high and was influenced by various factors. Hospital managers should strengthen the publicity and training of ethical systems, as well as improve their implementation and supervision mechanisms; standardize ethical review procedures and processes, as well as build an ethical review information platform; increase investment in ethics education and arrange training time reasonably, to enhance the awareness of medical science and technology ethics management among medical staff and improve the quality of clinical research.

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