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.
ObjectiveTo systematically evaluate the effectiveness, safety and ethics of Da Vinci Surigcal System (dVSS)in the field of cardiothoracic surgery, and provide evidence for its clinical application. MethodsWe searched VIP, CNKI, WanFang Database, CBM, official website of National Health and Family Planning Commission of People's Republic of China, PubMed, Cochrane Library, Google Scholar, WHO ICTRP search portal, ClinicalTrials.gov, Chinese Clinical Trial Registration Center, Australian-New Zealand Clinical Trials Registry and ISRCTN to collect clinical trials of dVSS for thoracic and cardiovascular diseases to evaluate its effectiveness, safety and ethics. The search time was from the establishment of each database to January 2014. The quality of included literatures was evaluated by Grades of Recommendations Assessment, Development and Evaluation (GRADE). ResultsA total of 31 studies were identified including 4 case control studies and 27 retrospective studies involving 1 037 patients. The quality of included literatures was all very low. dVSS had been widely used in cardiothoracic surgery including coronary artery bypass grafting, valvuloplasty or valve replacement, thoracic tumor resection, etc. Compared with conventional surgery and thoracoscopy, the safety and effectiveness of dVSS was good, while its economic burden was heavier for the patients. dVSS could benefit patients and improve clinical level of cardiothoracic surgery. The disciplines and qualification of dVSS application was legal, but the maturity of its clinical use needed improvement, and relevant measures were required. The ethics in the research, introduction and application of dVSS had some problems which deserved more attention. ConclusionsClinical use of dVSS in cardiothoracic surgery is relatively safe and effective, but research quality needs to be improved. More studies on the economics and ethics of dVSS are needed in the field of cardiothoracic surgery. Relevant measures of precaution, accountability and patient protection are required to further improve clinical application of dVSS in cardiothoracic surgery, and whole-process ethical supervision should be conducted with the help of existing clinical ethical review platform.
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.
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.
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.
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.
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.
Implantable brain-computer interfaces (BCIs) have potentially important clinical applications due to the high spatial resolution and signal-to-noise ratio of electrodes that are closer to or implanted in the cerebral cortex. However, the surgery and electrodes of implantable BCIs carry safety risks of brain tissue damage, and their medical applications face ethical challenges, with little literature to date systematically considering ethical norms for the medical applications of implantable BCIs. In order to promote the clinical translation of this type of BCI, we considered the ethics of practice for the medical application of implantable BCIs, including: reducing the risk of brain tissue damage from implantable BCI surgery and electrodes, providing patients with customized and personalized implantable BCI treatments, ensuring multidisciplinary collaboration in the clinical application of implantable BCIs, and the responsible use of implantable BCIs, among others. It is expected that this article will provide thoughts and references for the research and development of ethics of the medical application of implantable BCI.
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.
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.