In recent two decades, the incidence and severity of medical disputes have been dramatically increasing in China which has a negative influence for patients, doctors and hospitals. It must be seriously regarded that 80% of the medical disputes are caused by the bad attitude of health care professionals, ethical problems, and poor communication skill with patients. Chinese health care professionals should be aware of how to establish a good doctor-patient relationship. The development of evidence-based medicine (EBM) will help us bridge a gap between medical science and clinical practice, revise our opinions, update our knowledge and improve our service. Cooperation with the Chinese Evidence-Based Medicine Center (CEBMC), and the Chinese Medical Doctor Association (CMDA) will help doctors practice legally and in an evidence-based manner so as to protect both rights of patients and doctors.
Artificial intelligence-enhanced brain-computer interfaces (BCI) are expected to significantly improve the performance of traditional BCIs in multiple aspects, including usability, user experience, and user satisfaction, particularly in terms of intelligence. However, such AI-integrated or AI-based BCI systems may introduce new ethical issues. This paper first evaluated the potential of AI technology, especially deep learning, in enhancing the performance of BCI systems, including improving decoding accuracy, information transfer rate, real-time performance, and adaptability. Building on this, it was considered that AI-enhanced BCI systems might introduce new or more severe ethical issues compared to traditional BCI systems. These include the possibility of making users’ intentions and behaviors more predictable and manipulable, as well as the increased likelihood of technological abuse. The discussion also addressed measures to mitigate the ethical risks associated with these issues. It is hoped that this paper will promote a deeper understanding and reflection on the ethical risks and corresponding regulations of AI-enhanced BCIs.
Objective To explore the current problems of training on ethics reviews in clinical trials in China. Methods We designed a quantitative survey to collect participants’ feedbacks on the training workshop on ethics reviews, which included contents, arrangement and structure, relevant to the workshop and their difficulties on ethics review work. Results A total of 60 questionnaires were sent and the response rate was 56.7% (34/60). A total of 120 participants from 18 provinces of China. Most of them were members of the virtual research center of evidence-base medicine of the Ministry of education. A total of 78.1% (25/32) participants thought they achieved their purpose after training, and 12.5% (4/32) did not meet their needs due to the poor language. The feedbacks of contents and quality of the workshop on ethics were shown in Table 1. The top useful contents (cents in 8-10) were: clinical trial registration, policies of WHO and China (93.8%, 30/32), data management and quality control in clinical trials, the roles of clinical trial registries and ethics committees (93.3%, 28/30), transparency in clinical trials (93.3%, 28/30), informed consent and beyond (91.8%, 31/34), and how to approach ethical review case studies (90.9%, 30/33), etc. Nobody considered workshop of less help.The majority (85.1%, 23/27) thought difficulties on ethic reviews existed and the main difficulties include: short of operational administrative rules (82.6%, 19/23), poor training opportunity (52.1%, 12/23), less supports from administrative (30.4%, 7/23) and financial (21.7%, 5/23), etc. The relevance (8-10 cents) to ethics workshop was: methods of teaching 75.9% (22/29), PPT 75% (21/28) and materials 42.9% (12/28). Conclusions There is some limitations in the first workshop on ethic reviews due to the lower response rate. However, it still shows the importance of training on ethics reviews. Training strategies should focus on different participants’ needs and the relevance to methods of teaching, and materials, etc. Workshopadopted lectures, cases studies analysis, more discussions and necessary translation will be welcome.
In order to promote the responsible development of precision medicine in China, the current situation of precision medicine in three major fields (clinical, research and commercial) was briefly introduced, and key ethical issues or disputes in each field (including informed consent, return of incidental findings, and allocation of medical resources in the clinical field; informed consent, return of research results, and data use and sharing in the research field; genetic counseling, clinical utility of genetic testing, and use of data in the field of direct-to-consumer genetic testing) were discussed. It is necessary to actively meet these ethical challenges for the development of precision medicine in China.
In the clinical trials, the rights and interests of participants must be considered. Ethical principles including the Declaration of Helsinki for clinical research have been established, and the institutional review board (IRB) and informed consent are important for protecting the rights and interests of participants. Whether a clinical trial is in accordence with the ethics depends on if the available clinical evidence is valuable and credible. The better candomize controlled trial (RCT) is one of the best evidence which will make different results equal between the treatment group and the controlled group. Thus benefits and risks of participants are allocated equitably and useless treatment is prohibited when the effective treatment affirmed at the same time. Economic health evaluation and outcome measurements are emphasized in EBM, and the clinical evidence is updated regularly. It is EBM and its emphasis of evidence that need the high-quality clinical trials, therefore the problems of ethics involved in clinical trials is important.
ObjectiveThis study investigates the adherence to ethical principles in doctoral dissertations focused on human as the research subject, aiming to provide a foundation for enhancing ethical awareness among medical doctoral candidates. MethodsUtilizing the Chinese database of doctoral dissertations, a total of 1 733 relevant papers published in 2021 were collected. The study compared ethical considerations among double first-class universities, other high-ranking institutions, different university types, various disciplines, diverse training orientations, enrollment types, and medical doctoral dissertations from different regions. ResultsIn 2021, among Chinese medical doctoral dissertations involving human as the research subject, 73.34% mentioned ethical considerations, and 86.27% mentioned informed consent. Dissertations reporting ethical approval descriptions, approval numbers, ethical approvals, and informed consent constituted only 2.19%. Notably, 12.52% of medical doctoral dissertations failed to incorporate ethical considerations and informed consent details in their content. ConclusionThe ethical awareness of medical doctoral candidates in China and the reporting of ethical information in their dissertations require urgent enhancement and improvement.
Under the background of the global COVID-19 pandemic, electronic informed consent (eConsent) utilizes technology to provide a new method and idea for clinical trials. It has the advantages of convenience and efficiency, which greatly improves the efficiency of clinical trials. At present, this concept has not been put forward in China while it has been clarified clearly abroad, and some countries have launched a variety of trials and formulated various regulations to further standardize the eConsent. Based on the current situation of eConsent in China, this study analyzed the design and implementation of eConsent, summarized relevant domestic and foreign laws and regulations, and proposed opportunities and challenges for electronic informed consent as well as the relevant preparations for the implementation of this technology in China.
The development and potential application of brain-computer interface (BCI) technology is closely related to the human brain, so that the ethical regulation of BCI has become an important issue attracting the consideration of society. Existing literatures have discussed the ethical norms of BCI technology from the perspectives of non-BCI developers and scientific ethics, while few discussions have been launched from the perspective of BCI developers. Therefore, there is a great need to study and discuss the ethical norms of BCI technology from the perspective of BCI developers. In this paper, we present the user-centered and non-harmful BCI technology ethics, and then discuss and look forward on them. This paper argues that human beings can cope with the ethical issues arising from BCI technology, and as BCI technology develops, its ethical norms will be improved continuously. It is expected that this paper can provide thoughts and references for the formulation of ethical norms related to BCI technology.
Ethical issues in clinical research are receiving increasing attention. The application of research projects, the registration of clinical trials and the publication of scientific researches have always been involved with ethical issues. This paper elaborates ethical development and changes in Chinese clinical research from the aspects of the development of medical ethics, the establishment of ethics laws and regulations, international certification of medical ethics committee, the advantages, challenges, opportunities and innovation and development of TCM clinical research ethics as well as the certification system of TCM research ethics.
With the development of brain-computer interface (BCI) technology and its translational application in clinical medicine, BCI medicine has emerged, ushering in profound changes to the practice of medicine, while also bringing forth a series of ethical issues related to BCI medicine. BCI medicine is progressively emerging as a new disciplinary focus, yet to date, there has been limited literature discussing it. Therefore, this paper focuses on BCI medicine, firstly providing an overview of the main potential medical applications of BCI technology. It then defines the discipline, outlines its objectives, methodologies, potential efficacy, and associated translational medical research. Additionally, it discusses the ethics associated with BCI medicine, and introduces the standardized operational procedures for BCI medical applications and the methods for evaluating the efficacy of BCI medical applications. Finally, it anticipates the challenges and future directions of BCI medicine. In the future, BCI medicine may become a new academic discipline or major in higher education. In summary, this article is hoped to provide thoughts and references for the development of the discipline of BCI medicine.