Informing is an initiative behavior of medical staff in their clinical practice. Besides, informing is a key principle of informed consent. The number of cases of infringing upon patient’s informed consent is increasing because of the underestimate or ignorance of the obligation of informing. This paper discusses the concept, significance, content, and procedure of informing as well as the relationship between informed consent and informing.
Through reviewing the regulations on the right of emergency treatment of hospitals, we analyzed reasons of emergency treatment of hospitals, including uninformed patients and informed patients without consent in emergency situations, as well as the risk of emergency rescue of hospitals. We put forward how to consider the judgment of emergency situations, justification of emergency treatment of hospitals, and risk attribution. We suggested improving the related legislation and regulations, developing compulsory medical insurance and a medical rescue system on emergency treatment.
【摘要】目的探讨新型医患沟通范式的临床价值。方法分析新型医患沟通范式的基本文书和临床应用效果。结果自2002年1月2009年12月,新型医患沟通范式应用于9800余例住院患者,无1起医疗事故发生。结论新型医患沟通范式从形式上和内容上对患者知情权进行了充分的保障,对构建和谐医患关系具有重大价值。【Abstract】Objective To explore the clinical value of new doctorpatient communication paradigms. Methods The primary documents and clinical application results of new doctorpatient communication paradigms were analyzed in our study. Results We applied the new doctorpatient communication paradigms to more than 9800 patients of inpatient from January 2001 to December 2009. No medical negligence was observed. Conclusion The new doctorpatient communication paradigms can ensure the patient’s right of informed consent in form and in content. Its value to construct harmony doctorpatient relationship is great.
ObjectivesTo investigate the status of clinical trial registrations (CTRs), ethical reviews (ERs) and informed consent forms (ICFs) of randomized controlled trials (RCTs), which were published in the top 20 journals included by Chinese Science Citation Database (CSCD), and evaluate the methodological quality of RCTs.MethodsWe selected top 20 high impact factor Chinese medical journals indexed by CSCD, the RCTs published between 2016 and 2017 were searched. The CTR, ER and ICFs for all RCTs were analyzed.ResultsA total of 395 RCTs were included for data analysis. Nineteen RCTs (4.8%) reported the information of registration. For the 4 traditional Chinese medicine journals, only 4 (1.9%) of 207 RCTs reported the registered information. For the 16 western medical journals, only 15 (8%) of 188 RCTs reported the registered information. There were 185 RCTs (46.8%) which reported the information of ethical review. Among them, 66 RCTs (31.9%) were published in traditional Chinese medical journals and 119 RCTs (63.3%) were published in western medical journals. There were 253 RCTs (64.1%) which reported the information of informed consent. Among them, 154 RCTs (74.4%) were published in Chinese medical journals and 199 RCTs (52.7%) were in western medical journals. In terms of methodology, approximately 299 RCTs (75.7%) reported the type of randomization where 60 RCTs (15.2%) reported the information of allocation concealment and 38 RCTs (59.6%) reported blinding.ConclusionsThe proportion of RCTs registration, ethical review and informed consent is still low and the methodological quality of the studies require to be improved. Therefore, it is necessary to strengthen the training of clinical trial methodology.
On the basis of fundamental ethical principles and requirements, combining the practice of ethical management and according to the characteristics and requirements of the prospective cohort study of natural populations, this paper probes into the many key points of ethical design, including the use of existing data, the choice of exposures, the protection of special population subjects and the renewal of informed consent, and the selection of prospective cohort study of natural populations, to provide the beneficial reference to maximize the guarantee of the safety and rights and interests of the subjects.
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.
With the gradual standardization and improvement of the real-world study system, real-world evidence, as a supplement to evidence from classical randomized controlled trials, is increasingly used to evaluate the effectiveness and safety of pharmaceuticals and medical devices. High-quality real-world evidence is not only related to the quality of real-world data, but also depends on the type of study design. Therefore, as one of the important designs for pragmatic clinical trials, the Zelen design has received much attention from investigators in recent years. This paper discussed the implementation processes, subtypes of design, advantages, limitations, statistical concerns, and appropriate application scenarios of the Zelen design, on the basis of published papers, in order to clarify its application value, and to provide references for future research.
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.
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.