In order to fully implement the ethical principles of biomedical researches and to better safeguard the legitimate rights and interests of the subjects, this paper begins from the research design and closely combines with the ethical practice of biomedical research review, seriously analyzes the key implementation points of the ethical free and compensation principles in biomedical research, including intervention study, random allocation, follow-up research and new medical techniques and so on, also will provide the beneficial reference for comprehensive formulation of enforcement regulation of ethics principle of biomedical research in the future.
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 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.
The worldwide shortage in the supply of donor organs and tissues is becoming more pronounced. Xenotransplantation may probably give the hope to overcome the problem ultimately. However, it gives rise to a number of social and ethical issues, among them, the pig appears to be a likely source for human transplantation because it entails least social and ethical issues than no-human primates or other animals and the pig is similar to human in many aspects. The ethical and economic aspects must also be taken into consideration. Patient and his family’s privacy may be stripped because the patient has received a new or unusual treatment. Xenograftings will squint towards a kind of commodities which are different from human graftings and it is a challenge to human transplantation. Xenotransplantation brings a risk of creating new human disease and pandemic, so, it is necessary to formulate a policy and provide input to draft guidelines on the regulation of xenotransplantation.
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.
Medicine bears the responsibility for human health. Technical competence, service standards, professional ethics and social accountability constitute the soul of this profession. The principles of nonmaleficence, beneficence, respect for autonomy and justice help to establish good doctor-patient relationship and regulate medical services, which has been fixed by international and domestic professional norms. Besides to ensure its truth, effectiveness and safety, medical research also should require certain rendering of subject's autonomy, minimizing risks and maintaining social justice. Some procedures have established for supporting it. Modern medical education furnishes suitable human resources for medical profession, which directly affects the accessibility and outcomes of health services. Its objectives, operations and assessments are increasingly taking shape. Faced with the current issues of healthcare equity, worsening doctor-patient relationship, scandals and ethical controversies in medical research, and the failing of medical education to fully match social needs, evidence-based medical methodology is extending to policy and social sciences for identifying and creating high-quality scientific evidence to improve the quality of decision-making.
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.
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.
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.