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.
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.
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.
Objective To explore whether the placebo-controlled trials in traditional Chinese medicine (TCM) were scientific and ethical. Method An electronic search concerned with placebo-controlled trials of TCM was performed at Chinese Journal Full-text Database, Chinese Scientific and Technological Periodical Database (VIP), Wanfang Database and Chinese Bio-medicine Database (CBM) from January 1979 to April 2008. In addition, we handsearched the trials in specialized journals of TCM. The trials were assessed regard with their scientificalness, ethic and traits of TCM of placebo-controlled trials. Results A total of 231 trials were included, occupying about 2.09% of all the randomized controlled trials (RCTs) of TCM; among which there were 79 (34.20%) with sequence generation, 10 (4.33%) with allocation concealment, 129 (55.84%) with blind methods; 106 (45.89%)with basic intervention, 13 (5.63%) with criteria of intervention quality control, 139 (60.17%) with preparation of placebo, 10 (10.33%) with aggravating scheme, 70 (30.30%) with syndrome type of TCM, 48 (20.78%) with the outcome measurement of TCM. There were 48 RCTs (20.78%) were not scientific. There were 221 RCTs without institutional review board and 187 RCTs without informed consent. Conclusion Placebo-controlled trials of TCM are not applied extensively, and some of them are not scientific. Most of than do not meet the ethical requirements.
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.
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.
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.
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.
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.