ABSTRACT
The artificial intelligence products such as diagnostic expert system and medical robot are constantly applied to medical field, which improve efficiency and benefit, and reduce the amount of labor of medical personnel, but also inevitably bring many ethical issues. The ethical challenges of artificial intelligence applying in medical field include fair benefits, unemployment, patient privacy, medical safety, division of responsibilities and supervision. The reasons may include failure to comply with basic ethical principles, technical defects, lack of legislation and supervision, implicit algorithm bias, poor data quality, insufficient public literacy and so on. The solutions proposed for the reasons included the definition of human priority, fault transparency and traceability, representative samples and researchers to avoid prejudice, the whole process supervision of research and development, production and sales, regulation to clarify moral and ethical boundaries, the legislation to improve the supervision and management system, the restriction of monopoly data, and the promotion of public awareness through education, and global governance to deal with challenges. It should ensure the application of artificial intelligence products in the medical field take "serving the interests of the human being and never harming human" as principle, under the premise of alleviating the repeated labor of medical staff to improve the efficiency and reducing the misdiagnosis and missed diagnosis, effectively improve the medical service quality.
ABSTRACT
Objective: To standardize the capacity construction of medical ethics committee,improve the quali-ty of ethical review of clinical scientific research projects,and better protect the rights and interests of subjects.Methods: This paper reviewed the literature about standardization construction of ethical review of clinical scientif-ic research projects and analyzed them comprehensively.Results: Based on the problems of regulatory system,re-view standards,education training,ethic awareness and tracking review facing in the practice of ethical review,this paper put forward some reflections and suggestions for the ethical development trend and solving strategies of clinical scientific research projects in future.Conclusion: It should standardize the construction of ethical review system of clinical scientific research projects,strengthen education and training,promote the construction capacity of medical ethics committee of our country,and promote the scientificity and standardization of the ethical review of clinical scientific research projects.
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Objective:To standardize the present situation of informed consent in China' s clinical research projects, and to better play the role of protecting the rights and interests of subjects, in order to improve the ethicality of research. Methods:According to the actual work,this paper reviewed literatures about the existing problems and solutions in the informed consent process in clinical research to carry out comprehensive analysis and discussion. Results:Combining with the problems about researchers, subjects and ethical committees faced in informed conent process in clinical research, this paper put forward thinking and suggestions on standardizing the informed consent for future medical clinical research. Conclusion:We should standardize the informed consent form and carry out the training of the subjects and researchers about medical ethics knowledge, so as to improve the status of informed consent, reflect the scientificity and ethicality of clinical research project, and to contribute to the development and progress of clinical medicine.
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Objective:To summarize the opportunities,challenges and countermeasures that China Food and Drug Administration (CFDA) joining ICH-GCP will bring to the construction of ethics committee,so as to provide reference for the standardization construction and review ability of ethical committee in China.Methods:We reviewed and comprehensively analyzed the domestic literatures about the requirement for ethics committee after CF-DA join ICH-GCP.Results:CFDA joining ICH-GCP was conducive to speeding up the construction of Chinese ethics committee.Aiming at the challenge of the standardization construction of ethics committee,it could use the revised policy regulations and guidelines to integrate with ICH-GCP,establish ethics certification system in line with the national condition,clear the composition of members,standardize operational procedures,and establish regional ethics committee and leader the review of the unit system;to improve the review ability,it could strengthen reviewing requirement from the aspects of sponsor responsibilities,researchers qualification,research protocols,informed consent,researcher brochures and documents management.Conclusion:CFDA joining ICH-GCP brings a rapid development opportunity for the ethics committee as well as challenges.We can solve problems from standardization construction and the improvement of review ability,to speed up the construction of ethics committee that meets the requirements of ICH-GCP.
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Objective:To explore the ethical review questions of CRISPR/Cas9 gene editing technology caused in clinical research,and thus to provide a reference for matters needing attention of the ethical review involved in this technology in clinical.Methods:This paper summarized the ethical problems of CRISPR/Cas9 gene editing technology at home and abroad,analyzed the reasons and put forward some suggestions for the application of new technology in line with China's national conditions.Results:It should allow CRISPR/Cas9 gene editing technology to be applied in somatic cell gene therapy,forbidden for genital gene therapy and not considered to enhance.Since CRISPR/Cas9 lack clear subject of responsibility ethics,it brings security,conflict of rights and social equality issues.The measures that need to be taken include the strengthening of cultural communication,the formation of ethic forms of gene editing technology,the establishment of independent ethical review body at national's level,the improvement of legal norms,the formulating of technical standards and ethical principles and the major support to gene editing research field at the national level.Conclusion:In view of the potential clinical application of CRISPR/Cas9,our country should progressively restrictively develop the embryonic gene editing techniques from the prohibition.The ethics committee is responsible for the ethical review and supervision of clinical research.Members of the ethics committee and ethical staff should strengthen the study of new knowledge,strictly docking policies and regulations from accepting the clinical research projects involving CRISPR / Cas9 to ethical review,and thus to ensure the effectively review the ethical problems of genetic editing technology project.
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Objective:To summarize the existing problems and countermeasures of informed consent when children,one of the vulnerable groups in China,participate in clinical research,and further to provide reference for ethical review.Methods:We reviewed and comprehensively analyzed the domestic literatures that involved children and required informed consent.Results:Aiming at the unique physiological and psychological cognitive characteristics of children,this paper expounded the rationality of children's participation in clinical research and the timing of choice.It emphasized the existing problems in the process of informed consent such as inadequate informing,verbal acknowledgement,too long or too short time informed by the doctor-in-charge,as well as overspecialization of informed consent,inductive language,not describing potential risks and other incomplete information disclosure.According to these problems,the paper put forward some countermeasures.Conclusions:Informed consent of children's participation in clinical research should follow the general principles,consider children's characteristics,respect their willingness,and avoid unnecessary harm.