The Chinese medical ethics committee and the ethical review system have made the following achievements： （1） enabled the institutionalization of medical ethics, （2） carried out the ethics review of Chinese medici...The Chinese medical ethics committee and the ethical review system have made the following achievements： （1） enabled the institutionalization of medical ethics, （2） carried out the ethics review of Chinese medicine （CM） and integrative medicine extensively, （3） trained a large number of ethical professionals, （4） supported and protected the interests of patients and subjects, and （5） ensured the correct direction of biological research and provided ethical defense for the publication of its results. However, at the same time, they are also faced with some new problems and difficulties that need to be resolved in the following ways： （1） to refine the relevant rules of ethical review, （2） to develop the relevant standards of the CM and integrative medicine ethical review, （3） to enhance the independence and authority of ethics committee, （4） to emphasize innovation and to discover and solve new problems, and （5） to increase international exchanges and improve relevant research.展开更多
Three features of ethics review in Chinese medicine（CM） and integrative medicine（IM） were put forward in this paper. It is consistent with the principles of ethical review in Western medicine; it has to be complia...Three features of ethics review in Chinese medicine（CM） and integrative medicine（IM） were put forward in this paper. It is consistent with the principles of ethical review in Western medicine; it has to be compliant with the laws of CM and IM; emphasis should be laid on the review of clinical practice facts and experience. Three problems were pointed out. The characteristics of CM and IM are not distinctive enough, operation procedures need to be refined and effectiveness remains to be improved. Based on the mentioned above, seven measures were proposed to improve the level and quality of ethics review in CM and IM, including better brand awareness, considerable tolerance, treatment based on disease differentiation and syndrome differentiation, scientific review and toxicity and side effects of CM, perfection of the ethics review system, reasonable procedures of ethics review and more specialized ethics review workers.展开更多
As one of the significant parts of medical science research in China,the research on Chinese medicine（CM） reflects the essence of healthcare tradition in the country both theoretically and clinically, and embodies t...As one of the significant parts of medical science research in China,the research on Chinese medicine（CM） reflects the essence of healthcare tradition in the country both theoretically and clinically, and embodies the values of Chinese culture.Therefore,in the practice of ethics review on CM research protocols,besides abiding by the contemporary prevalent international principles and guidelines on bioethics, which emphasizes the scientific and bioethical value of the study,we should also stress the CM theoretical background and relevant clinical experience in the framework of Chinese culture and values.In this paper, we went over the traits of CM clinical research and the experience from the practice of ethics review by the institution review board for bioethics,and then attempted to summarize the key points for the bioethics review to CM researches in China,so as to serve as reference for the bioethics review to traditional and alternative medicine researches.展开更多
Brain-computer interface(BCI)technology is rapidly advancing in medical research and application.As an emerging biomedical engineering technology,it has garnered significant attention in the clinical research of brain...Brain-computer interface(BCI)technology is rapidly advancing in medical research and application.As an emerging biomedical engineering technology,it has garnered significant attention in the clinical research of brain disease diagnosis and treatment,neurological rehabilitation,and mental health.However,BCI also raises several challenges and ethical concerns in clinical research.In this article,the authors investigate and discuss three aspects of BCI in medicine and healthcare:the state of international ethical governance,multidimensional ethical challenges pertaining to BCI in clinical research,and suggestive concerns for ethical review.Despite the great potential of frontier BCI research and development in the field of medical care,the ethical challenges induced by itself and the complexities of clinical research and brain function have put forward new special fields for ethics in BCI.To ensure"responsible innovation"in BCI research in healthcare and medicine,the creation of an ethical global governance framework and system,along with special guidelines for cutting-edge BCI research in medicine,is suggested.展开更多
With the continuous advancement of medical research,the number of multi-center clinical studies has been stead-ily increasing,bringing about significant challenges to ethical review.Improving the efficiency and qualit...With the continuous advancement of medical research,the number of multi-center clinical studies has been stead-ily increasing,bringing about significant challenges to ethical review.Improving the efficiency and quality of ethical review has become a necessity driven by national policies and the development of the industry.Mutual recognition of ethical reviews is one of the most effective ways to enhance the efficiency of ethical review in multi-center clinical trials.The promotion of mutual recognition of ethical reviews is both feasible and practically significant;however,pro-gress has been less than ideal.Through conducting surveys,this study attempts to understand the status of mutual recognition of ethical reviews in Jiangsu Province,identify the reasons hindering the implementation of mutual recognition,and propose possible solutions.The results indicate that while most medical and health institutions are aware of the policies related to mutual recognition of ethical reviews,the majority remain in a wait-and-see attitude.Ensuring policy guarantees and the high quality and homogeneity of ethical review across institutions are considered necessary conditions for achieving mutual recognition of ethical reviews.展开更多
Introduction: The Research Ethical Committee (REC) is responsible for the ethical evaluation of the projects presented by the scientific community to inform and train the members and researchers. Objective: To describ...Introduction: The Research Ethical Committee (REC) is responsible for the ethical evaluation of the projects presented by the scientific community to inform and train the members and researchers. Objective: To describe the purpose, composition and function of the REC of the Association of Social Pioneers (APS) located in the Sarah Rehabilitation’s Hospital (Brasilia, Brazil). Methodology: Descriptive analysis of the REC/APS based on 2013’s collected data was done. Results: The REC/APS is an independent collegiate body, which was established in 1998 in accordance with Brazilian regulation. The main objective is promoting the application of ethical principles and human rights in research involving humans. The REC was composed by chairperson and a substitute;secretary, fourteen regular members and five substitutes. We analyzed 164 projects submitted. The minimum time to a committee member who came up with the first opinion has been estimated as 14 days and the insurance of the consolidation occurred in 30 days. We approved 64 projects, of which 25 had pendencies in the first analysis, one project failed and 99 were excluded. The main problems were related to the writing of informed consent and the multicenter projects that did not include aspects such as costs, schedule and methodological limitations. We observed that the researcher could provide assistance. We considered the important role of the REC/APS to ensure trust between researchers and participants in the research. Conclusion: Despite the purpose, composition and function of the APS research ethical committee, there were encountered many obstacles in its formation, considering monitoring the progress of the research, national normative, international researches and others. The ethical committee does a vital public service with the variety of the specialized views on the meeting. We need to strike a balance and we must weigh up risks and benefits related to knowledge, in its essence, to research’s participant and its relevant social participation.展开更多
The rapid developments of science and technology in China over recent decades, particularly in biomedical research, have brought forward serious challenges regarding ethical governance. Recently, Jian-kui HE, a Chines...The rapid developments of science and technology in China over recent decades, particularly in biomedical research, have brought forward serious challenges regarding ethical governance. Recently, Jian-kui HE, a Chinese scientist, claimed to have "created" the first gene-edited babies, designed to be naturally immune to the human immunodeficiency virus(HIV). The news immediately triggered widespread criticism, denouncement, and debate over the scientific and ethical legitimacy of HE’s genetic experiments. China’s guidelines and regulations have banned germline genome editing on human embryos for clinical use because of scientific and ethical concerns, in accordance with the international consensus. HE’s human experimentation has not only violated these Chinese regulations, but also breached other ethical and regulatory norms. These include questionable scientific value, unreasonable risk-benefit ratio, illegitimate ethics review, invalid informed consent, and regulatory misconduct. This series of ethical failings of HE and his team reveal the institutional failure of the current ethics governance system which largely depends on scientist’s self-regulation. The incident highlights the need for urgent improvement of ethics governance at all levels, the enforcement of technical and ethical guidelines, and the establishment of laws relating to such bioethical issues.展开更多
Objective： To construct a quantitative ethical evaluation index system for the clinical approval of medical technology in China. Methods： Exploratory factor analysis （EFA） and first-order confirmatory factor analy...Objective： To construct a quantitative ethical evaluation index system for the clinical approval of medical technology in China. Methods： Exploratory factor analysis （EFA） and first-order confirmatory factor analysis （CFA） based on a structure equation model （SEM）, higher-order CFA and normalisation were used to establish an ethical evaluation index system for the clinical approval of medical technology. Data were processed in SPSS 13.0 and Lisre 15.3. Results： There were 52 third class indices, 15 second class indices, and 3 first class indices in this ethical evaluation index system. The weight of each index was calculated by normalisation. Conclusion： This study developed a three-level ethical evaluation index system, comprising 70 indices, for the clinical approval of medical technology.展开更多
Purpose With the rapid development of Phase I clinical trials for anticancer drugs in China,addressing ethical con-cerns is imperative.In order to safeguard the rights,interests,and well-being of research participants...Purpose With the rapid development of Phase I clinical trials for anticancer drugs in China,addressing ethical con-cerns is imperative.In order to safeguard the rights,interests,and well-being of research participants,this paper aims to illustrate vital ethical issues that should not be neglected by institutional review boards as well as other relevant stakeholders for Phase I clinical trials of anticancer drugs.Methods This study retrospectively collects documents on Phase I clinical trials for anticancer drugs that were sub-mitted to the Institutional Review Board at Zhejiang Cancer Hospital from 2021 to 2023.Based on Chinese and inter-national research regulations and guidelines,these documents,as well as initial and follow-up review resolutions,have been classified and analyzed.Results Given the additional risks of potentially toxic effects in Phase I clinical trials for anticancer drugs and the vul-nerability of participants enrolled with advanced cancer status,it is important to review investigator qualifica-tions,preliminary findings,research methods,inclusion and exclusion criteria in the protocol,as well as the validity and readability of informed consent.Additionally,attention should be given to follow-up reviews,particularly regard-ing safety reports and protocol deviations.Conclusion To effectively protect the rights,interests and safety of research participants.Relevant stakeholders,including sponsors,researchers,and regulatory bodies,should diligently evaluate potential risks and provision contin-gency plan to minimize the latent risk.展开更多
文摘The Chinese medical ethics committee and the ethical review system have made the following achievements： （1） enabled the institutionalization of medical ethics, （2） carried out the ethics review of Chinese medicine （CM） and integrative medicine extensively, （3） trained a large number of ethical professionals, （4） supported and protected the interests of patients and subjects, and （5） ensured the correct direction of biological research and provided ethical defense for the publication of its results. However, at the same time, they are also faced with some new problems and difficulties that need to be resolved in the following ways： （1） to refine the relevant rules of ethical review, （2） to develop the relevant standards of the CM and integrative medicine ethical review, （3） to enhance the independence and authority of ethics committee, （4） to emphasize innovation and to discover and solve new problems, and （5） to increase international exchanges and improve relevant research.
基金Supported by the Project of Philosophy and Social Planning of Zhejiang in 2017(No.17NDJC160BY)
文摘Three features of ethics review in Chinese medicine（CM） and integrative medicine（IM） were put forward in this paper. It is consistent with the principles of ethical review in Western medicine; it has to be compliant with the laws of CM and IM; emphasis should be laid on the review of clinical practice facts and experience. Three problems were pointed out. The characteristics of CM and IM are not distinctive enough, operation procedures need to be refined and effectiveness remains to be improved. Based on the mentioned above, seven measures were proposed to improve the level and quality of ethics review in CM and IM, including better brand awareness, considerable tolerance, treatment based on disease differentiation and syndrome differentiation, scientific review and toxicity and side effects of CM, perfection of the ethics review system, reasonable procedures of ethics review and more specialized ethics review workers.
基金Supported by the Major Projects of National Science and Technology"Research Project Technology Platform for Clinical Evaluation of New Drugs of Chinese Medicine"(No. 2008ZX09312-021)
文摘As one of the significant parts of medical science research in China,the research on Chinese medicine（CM） reflects the essence of healthcare tradition in the country both theoretically and clinically, and embodies the values of Chinese culture.Therefore,in the practice of ethics review on CM research protocols,besides abiding by the contemporary prevalent international principles and guidelines on bioethics, which emphasizes the scientific and bioethical value of the study,we should also stress the CM theoretical background and relevant clinical experience in the framework of Chinese culture and values.In this paper, we went over the traits of CM clinical research and the experience from the practice of ethics review by the institution review board for bioethics,and then attempted to summarize the key points for the bioethics review to CM researches in China,so as to serve as reference for the bioethics review to traditional and alternative medicine researches.
基金supported by the Ministry of Science and Tech-nology of the People's Republic of China(2021ZD0201900),Project 5(2021ZD0201905).
文摘Brain-computer interface(BCI)technology is rapidly advancing in medical research and application.As an emerging biomedical engineering technology,it has garnered significant attention in the clinical research of brain disease diagnosis and treatment,neurological rehabilitation,and mental health.However,BCI also raises several challenges and ethical concerns in clinical research.In this article,the authors investigate and discuss three aspects of BCI in medicine and healthcare:the state of international ethical governance,multidimensional ethical challenges pertaining to BCI in clinical research,and suggestive concerns for ethical review.Despite the great potential of frontier BCI research and development in the field of medical care,the ethical challenges induced by itself and the complexities of clinical research and brain function have put forward new special fields for ethics in BCI.To ensure"responsible innovation"in BCI research in healthcare and medicine,the creation of an ethical global governance framework and system,along with special guidelines for cutting-edge BCI research in medicine,is suggested.
文摘With the continuous advancement of medical research,the number of multi-center clinical studies has been stead-ily increasing,bringing about significant challenges to ethical review.Improving the efficiency and quality of ethical review has become a necessity driven by national policies and the development of the industry.Mutual recognition of ethical reviews is one of the most effective ways to enhance the efficiency of ethical review in multi-center clinical trials.The promotion of mutual recognition of ethical reviews is both feasible and practically significant;however,pro-gress has been less than ideal.Through conducting surveys,this study attempts to understand the status of mutual recognition of ethical reviews in Jiangsu Province,identify the reasons hindering the implementation of mutual recognition,and propose possible solutions.The results indicate that while most medical and health institutions are aware of the policies related to mutual recognition of ethical reviews,the majority remain in a wait-and-see attitude.Ensuring policy guarantees and the high quality and homogeneity of ethical review across institutions are considered necessary conditions for achieving mutual recognition of ethical reviews.
文摘Introduction: The Research Ethical Committee (REC) is responsible for the ethical evaluation of the projects presented by the scientific community to inform and train the members and researchers. Objective: To describe the purpose, composition and function of the REC of the Association of Social Pioneers (APS) located in the Sarah Rehabilitation’s Hospital (Brasilia, Brazil). Methodology: Descriptive analysis of the REC/APS based on 2013’s collected data was done. Results: The REC/APS is an independent collegiate body, which was established in 1998 in accordance with Brazilian regulation. The main objective is promoting the application of ethical principles and human rights in research involving humans. The REC was composed by chairperson and a substitute;secretary, fourteen regular members and five substitutes. We analyzed 164 projects submitted. The minimum time to a committee member who came up with the first opinion has been estimated as 14 days and the insurance of the consolidation occurred in 30 days. We approved 64 projects, of which 25 had pendencies in the first analysis, one project failed and 99 were excluded. The main problems were related to the writing of informed consent and the multicenter projects that did not include aspects such as costs, schedule and methodological limitations. We observed that the researcher could provide assistance. We considered the important role of the REC/APS to ensure trust between researchers and participants in the research. Conclusion: Despite the purpose, composition and function of the APS research ethical committee, there were encountered many obstacles in its formation, considering monitoring the progress of the research, national normative, international researches and others. The ethical committee does a vital public service with the variety of the specialized views on the meeting. We need to strike a balance and we must weigh up risks and benefits related to knowledge, in its essence, to research’s participant and its relevant social participation.
基金Project supported by the National Natural Science Foundation of China(No.L1824000)
文摘The rapid developments of science and technology in China over recent decades, particularly in biomedical research, have brought forward serious challenges regarding ethical governance. Recently, Jian-kui HE, a Chinese scientist, claimed to have "created" the first gene-edited babies, designed to be naturally immune to the human immunodeficiency virus(HIV). The news immediately triggered widespread criticism, denouncement, and debate over the scientific and ethical legitimacy of HE’s genetic experiments. China’s guidelines and regulations have banned germline genome editing on human embryos for clinical use because of scientific and ethical concerns, in accordance with the international consensus. HE’s human experimentation has not only violated these Chinese regulations, but also breached other ethical and regulatory norms. These include questionable scientific value, unreasonable risk-benefit ratio, illegitimate ethics review, invalid informed consent, and regulatory misconduct. This series of ethical failings of HE and his team reveal the institutional failure of the current ethics governance system which largely depends on scientist’s self-regulation. The incident highlights the need for urgent improvement of ethics governance at all levels, the enforcement of technical and ethical guidelines, and the establishment of laws relating to such bioethical issues.
基金Supported by National Natural Science Fundation of China(No.71173054)Guangdong Province Physiology and Social Science Fund(No.GD10CZX02)
文摘Objective： To construct a quantitative ethical evaluation index system for the clinical approval of medical technology in China. Methods： Exploratory factor analysis （EFA） and first-order confirmatory factor analysis （CFA） based on a structure equation model （SEM）, higher-order CFA and normalisation were used to establish an ethical evaluation index system for the clinical approval of medical technology. Data were processed in SPSS 13.0 and Lisre 15.3. Results： There were 52 third class indices, 15 second class indices, and 3 first class indices in this ethical evaluation index system. The weight of each index was calculated by normalisation. Conclusion： This study developed a three-level ethical evaluation index system, comprising 70 indices, for the clinical approval of medical technology.
基金The research belongs to the project“influencing factors and countermeasures of clinical research ethical cognition implementation of medical researchers in the context of scientific research innovation”,financed by Zhejiang Provincial Medical Health Science and Technology Project 2022,No.2022KY643.
文摘Purpose With the rapid development of Phase I clinical trials for anticancer drugs in China,addressing ethical con-cerns is imperative.In order to safeguard the rights,interests,and well-being of research participants,this paper aims to illustrate vital ethical issues that should not be neglected by institutional review boards as well as other relevant stakeholders for Phase I clinical trials of anticancer drugs.Methods This study retrospectively collects documents on Phase I clinical trials for anticancer drugs that were sub-mitted to the Institutional Review Board at Zhejiang Cancer Hospital from 2021 to 2023.Based on Chinese and inter-national research regulations and guidelines,these documents,as well as initial and follow-up review resolutions,have been classified and analyzed.Results Given the additional risks of potentially toxic effects in Phase I clinical trials for anticancer drugs and the vul-nerability of participants enrolled with advanced cancer status,it is important to review investigator qualifica-tions,preliminary findings,research methods,inclusion and exclusion criteria in the protocol,as well as the validity and readability of informed consent.Additionally,attention should be given to follow-up reviews,particularly regard-ing safety reports and protocol deviations.Conclusion To effectively protect the rights,interests and safety of research participants.Relevant stakeholders,including sponsors,researchers,and regulatory bodies,should diligently evaluate potential risks and provision contin-gency plan to minimize the latent risk.
