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For multi-center clinical research, how to ensure the quality of ethical review and improve the efficiency of ethical review through cooperation among centers is an important direction for clinical research management departments and research parties to explore. By combing and analyzing the existing pattern of multi-center ethical review at home and abroad, combining the current situation of the ethical review and management development in China, taking cancer clinical research as the breakthrough point, it was advocated to establish a cooperative review led by professional institute in domestic, on the basis of extensive and in-depth training exchanges and effective communication on the same platform, collaborative review, ensure quality and efficiency, so as to promote and implement the "mutual recognition" of ethical review. Then, this paper further put forward the concept of "whole-process linkage" in the ethical management process of multi-center clinical research, and pointed out that all research parties should clarify their responsibilities, enhance their awareness and ability, and jointly and comprehensively implement the protection of subjects among clinical researchers.
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In recent years， with the gradual maturity of achievable remote collection of digital health technology， more and more clinical research have applied this technology to improve the quality of data collection and reduce the burden on subjects. However， its technological characteristics of detachment from the diagnostic and treatment environment and real-time transmission of sensitive information also pose corresponding risks to the protection of subjects’ rights and interests and data standardization management， among which personal information protection and data control permissions are more prominent issues. Based on risk analysis and regulatory review， this paper explored the responsibilities of multiple parties， including the sponsors， researchers， clinical trial institutions， and ethics committee， as well as proposed five elements of special concern for ethical review， with a view to providing a reference for promoting the standardized development of digital health technology in clinical research.
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Strengthening the capacity building of clinical researchers is an important way to achieve high-quality clinical research, ethics training is an important part of it. However, laws and regulations do not specify the requirements for ethical training, many researchers’ cognition of ethics often remain in the form of "passing ethical review", and the content of ethical training often lacks ethical principles, ethical considerations and choices, etc. In view of this, this paper proposed to build a clinical research ethics training system based on the researchers’ ethical decision ability, design and implement ethical concepts, ethical principles grasp, and ethical decision practices from each link of the whole process ethical review, organically integrate them into the training system of clinical research institutions, and promote the conscious infiltration of bioethical awareness that focused on the subjects’ health rights and interests to internalize into the behavior of researchers, accumulate to the ethical decision ability of researchers.
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【Objective:】 Third-party research participants recruitment companies and their recruitment businesses are in the ascendant. To analyze the current situation of company construction, clinical trial application, and ethical review, and discuss and propose ethical management suggestions based on work experience. 【Methods:】 The recruitment of research participants related to the projects approved by the ethics committee in our hospital in the past two years was investigated by questionnaire to comprehend and analyze the data of the third-party recruitment company in construction, application, and ethical review. 【Results:】 This paper found the problems of the third-party recruitment company in the application of clinical trials, the company’s own construction, and the standardization of ethical review, and analyzed the phenomenon and causes of the problems based on work experience. 【Conclusion:】 Although the application of third-party recruitment companies is becoming more and more extensive, it is still in a mixed state of pros and cons. It is necessary for all parties to work together to further standardize and constrain them, so as to protect the rights and interests of research participants and effectively support clinical trial research.
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With the rapid development of clinical trials, the relevant medical research and molecular detection based on biological samples are closely related to the progress of clinical trials, making the role of biological samples in clinical trials increasingly obvious. The standardized supervision mode of biological samples is an important prerequisite for carrying out high-quality clinical trials. Although the laws and regulations related to clinical trials are becoming more and more perfect, there are still a large number of adverse events related to biological samples, which seriously affects the progress and results of clinical trials, and is one of the important challenges currently facing. Therefore, it is urgent to enhance the supervision of biological samples and improve the management methods of biological samples in clinical trials at this stage. Through in-depth discussion of the current status of biological sample management in clinical trials at home and abroad, this paper analyzed the issues existed during the supervision of biological samples, and supplemented the biological sample management methods by further combing the existing relevant laws and regulations and the Guidelines for the Ethical Management of Biological Samples in Clinical Trials, with a view to providing suggestions and ideas for optimizing the management mode of biological samples in clinical trials.
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To strengthen the ethical management of blood samples for scientific research in blood collection and supply institutions, promote the effective use of blood sample resources, and protect the rights and interests of blood donors. Drawing on the experience of the Finnish Red Cross Blood Center biobank which has rich experience in management and recruitment, this paper summarized from the aspects of extensive informed consent, management of sample data, application of biological samples and data, and ethical management of research projects, and put forward the enlightenment to improve the ethical management of blood samples in blood collection and supply institutions, including further improving the construction of ethical laws and regulations, strengthening the ethical review norms of the ethics committee, standardizing the use of informed consent, and enhancing the privacy protection of blood donors.
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Objective:To analyze ethical management of subjects′ complaints in drug clinical trials in a cancer hospital.Methods:A retrospective analysis of the complaints of subjects received and properly handled by the ethics committee through telephone, e-mail and on-site reception during the drug clinical trial in our hospital. Case studies were conducted to analyze the reasons for the occurrence of some particular subjects′ complaints, processing procedures and resolution processes.Results:The number of subjects' complaints in clinical trials in our hospital decreased year by year. The ethics committee of our hospital would check it immediately and review it carefully after receiving the subjects′ complaints, and return the review decisions to the subjects and researchers, at the same time, follow up with board meeting report and documentation. Regarding to the reasons of the subject complaint, mainly identified were the failure to participate in clinical trials due to inclusion and exclusion criteria, withdraw by investigators due to safety concerns, and not satisfied with the compensation.Conclusions:When receiving subjects′ complaints, the ethics committee should manage them seriously, verify the reasons in time and follow up properly, act as a communication bridge between subjects, researchers and sponsors, try their best to resolve subjects′ complaints, and protect the rights and interests of subjects.
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For multi-center clinical research, how to ensure the quality of ethical review and improve the efficiency of ethical review through cooperation among centers is an important direction for clinical research management departments and research parties to explore. By combing and analyzing the existing pattern of multi-center ethical review at home and abroad, combining the current situation of the ethical review and management development in China, taking cancer clinical research as the breakthrough point, it was advocated to establish a cooperative review led by professional institute in domestic, on the basis of extensive and in-depth training exchanges and effective communication on the same platform, collaborative review, ensure quality and efficiency, so as to promote and implement the "mutual recognition" of ethical review. Then, this paper further put forward the concept of "whole-process linkage" in the ethical management process of multi-center clinical research, and pointed out that all research parties should clarify their responsibilities, enhance their awareness and ability, and jointly and comprehensively implement the protection of subjects among clinical researchers.
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【Objective:】 To investigate the construction status of biomedical research ethics committee involving human beings in medical institutions in Guangzhou, and to provide the basis for the standardized management of ethics committee. 【Methods:】 The convenience sampling method was conducted to investigate the construction status of biomedical research ethics committee involving human beings in 58 medical institutions in Guangzhou. The SPSS 21.0 statistical software was used to analyze the data, and the chi-square test was used for difference analysis. 【Results:】 58 medical institutions had set up biomedical research ethics committee involving human beings. 50.00% of the ethics committees hired full-time secretaries, 33.96% of the ethics offices were administratively independent, 52.83% of the ethics offices were equipped with full-time staff, 79.17% of the ethics committees submitted paper documents for review, and 48.61% of ethics committees organized training irregularly. Comparison of the management of ethics committees of drug clinical trials and non-drug clinical trials was statistically significant (P<0.05). 【Conclusion:】 The management of ethics committee is generally good, but the standardization construction still needs to be further strengthened. It is recommended to strengthen the discipline construction and informatization construction of ethics committee, standardize the special training of ethics, improve the supervision systems of ethics committee, unify the construction standards of ethics committee, so as to improve the ability of ethics review, and effectively protect the safety, rights and interests of subjects.
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Objective@#Conduct comprehensive analysis of the regulatory requirement of ethical review regarding to the response of public health emergency, illustrate particular ethical review and ethical administration strategies for COVID-19 Emergency Research.@*Methods@#Theoretical discussion, case study and interpretation of international guidelines were adopted to explore challenges and possible best practices for ethical review of such research.@*Results@#The ethical review of COVID-19 emergency research should comply with regulatory requirement in general, combined with contextual background.@*Conclusions@#The ethical review approval criteria of COVID-19 emergency research should take into full consideration of its urgency to make sure efficient and high quality initial review, meanwhile, more attention should be paid on continuing ethical review and ethical consultation during the whole life-circle of COVID-19 Emergency Research.
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Objective Ethical review is an important safeguard for the development of human subject research.The post approval review during the research process is particularly vital because it is the core method in the ethical review to protect participants' safety and right.In this article,current problems about post approval review were analyzed deeply to explore how to improve the mechanism of post approval review from the combination of management and technical aspect,particularly for the plan of not-for-cause visit.Methods According to the work experiences,literature review,identifying problems,to explore the collaboration to strengthen post approval review with experts,pharmacological institutions and scientific research management department.Results There are more and more frequent ethical issues during the implementation process,besides continuing strengthen the passive continuing review,continuing review guidelines and more detailed active continuing review screening and implementation mechanism should be developed.Conclusions It will prevent the occurrence of injury through establishing more optimal post approval review mechanism and a forehand active prevention strategy,which play an important role in the ethical review of human subject research.
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Objective In recent years,technology and ideology of big data has played an important role in promoting clinical science research and medical management,which has been paid more attention.And relative researches and findings were reported constantly.However,there still exists some problems on how to apply patient-related big data to clinical researches based on ethical principles.Moreover,for ethical management,it is challenging that technology and ideology of big data is introduced to human-involved clinical researches,especially for the management and protection of biological samples,clinical data,identity information and gene data.Therefore,in the present study,the ethical management methods of human-involved clinical researches in the age of big data are explored.Methods Combining work experience and think from researches,we want to make some targeted suggestions on ethical review.Results In the age of big data,following suggestions should be taken into consideration in human-involved clinical researches,which include standardizing management system of biological sample bank,establishing compulsory isolation system for identity information,improving accountability mechanism for data leakage,and defining participating qualification of gene-involved project.Conclusions The suggestions are expected to exert an enlightening and promoting role in the reformation of ethical review system in the age of big data.
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BACKGROUND: In this study, state-owned medical institutes, industrial accident hospitals, veteran hospitals, and private medical clinics including 16 university medical institutes in the Seoul metropolitan area were selected to examine the causality of ethical management, positive psychological capital, and organizational effectiveness. METHODS: The study analyzed 1,056 valid questionnaires to which a total of 1,325 nurses, medical technicians, doctors, and administrative staff in 34 healthcare organizations answered over two months from June to August 2015. The study also utilized a ‘structural equation model,’ and a ‘hierarchical linear model’ to conduct the analysis. RESULTS: It was first found that ethical leadership, ethical management systems, and organizational ethics values, which are the three factors of ethical management, had significant influence on organizational commitment, and behavior. These are the three factors of employee organizational effectiveness. Second, ethical management, ethical leadership, ethical management systems, and organizational ethics values had significant influence on positive psychological capital. Third, positive psychological capital had significant influence on organizational commitment, turnover intention, and organizational citizenship behavior. Positive psychological capital presented an indirect effect on the relationship between the ethical management and organizational effectiveness of employees. The effect of positive psychological capital consisting of self-efficacy, hope, resilience, and optimism was confirmed in the healthcare organizations. Fourth, in relations among ethical management variables, ethical leadership showed a significant impact on ethical management systems, which had significant impacts on organizational ethics values, which had significant impacts on ethical leadership.
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Humans , Academies and Institutes , Accidents, Occupational , Delivery of Health Care , Ethics, Institutional , Hope , Intention , Leadership , Optimism , Seoul , VeteransABSTRACT
Objective:To analyze the status of ethical management of biobanks in Shanghai public hospitals. Methods :A questionnaire survey on ethical management of biobanks was conducted in 9 representative ethics com-mittees, which were established in public hospitals with biobanks in Shanghai. Results: The ethics committees in Shanghai public hospitals had paid relatively high attention to ethical review of protocols were related to biobanks. Nonetheless, the ethical supervision and training on biobanks in Shanghai public hospitals should be enhanced. Con-clusion:The unified ethical guideline on biobanks should be developed in Shanghai for strengthening the standard-ized ethical management and ethics training to promote the development and use of biological samples library re-sources.
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Objective To evaluate the ethical management status quo of Capital Medical Research Fund in 2007.Methods Cross-sectional study was applied to analyze the ethics management and ethics self-evaluation in applications.Results There were 652 applications,covering with 14 districts and 2 counties in Beijing,from 128 Hospitals.Applicants have some knowledge of the ethical issues in clinical research accounted for 88.7％ ; informed consent of subjects considered in 72.5％ ;the potential risk and protection involved in application accounted for 62.0％; personal privacy protection of subject accounted for 49.4％.Unfortunately,the benefit vs risk assessment was only involved in 28.7％ applications.Applicants from general hospitals had more ethical issue knowledge (90.2％) than those from community hospitals (84.6％).Applicants from university hospitals had more ethical issue knowledge (93.9％) than those from military hospitals (80.2％).Applicants aged 55 0r over had less ethical issue knowledge (70.0％) than other applicants (89.2％).The applicants to study on descriptive research and etiological research had less ethical issue knowledge than others.578 applications filled out the approval from ethics committee or research management department.62.6％ of the written were acceptable.Conclusion The applicants for clinical research had preliminary understanding for ethical issues in Beijing in 2007.Hospital ethics committees or research management departments had conducted clinical research ethical review applications for funds management.It has taken place the external conditions to carry out the ethical management in clinical research fund management.
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The book itself is well known in traditional Chinese culture of literature.It contains five chapters: Introspection,Social Intercourse,Deliberation,Leisure and Conspectus.There are 381 observations that lead us through paths as complex,absurd,and grotesque as life itself.Terse,humorous,witty,and above all,timely,this book offers a provocative and personal mix of Taoist,Buddhist,and Confucian understanding.And it embodies the inclusive cultural awareness of social intercourse,the thought of people-oriented educational management and the idea that harmony is above anything,which will lead the management of morality and ethics in higher medical institutions in China.