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With the rapid development of healthcare big data and artificial intelligence technology, how to utilize the massive medical data generated based on clinical diagnosis and treatment has become an important issue to be solved in the field of clinical research. Clinical diagnosis and treatment data is an essential part of healthcare big data, and also the main field of healthcare big data research. With the continuous deepening and extensive development of informatization, hospitals have accumulated a large number of patient-centered clinical diagnosis and treatment data. Deeply mining and analyzing these data through big data technology can provide reference for precise diagnosis and treatment, and standardized prevention and control of diseases. However, conducting relevant research still faces many difficulties and blockages, such as the increased risk of data leakage or abuse, and the difficulty in implementing informed consent. To safely, legally and efficiently utilize clinical diagnosis and treatment data to conduct clinical research and fully tap into the value of these precious medical resources, a tertiary hospital in Beijing has built a research big data platform and developed relevant systems to effectively solve the problems of blockages and difficulties in the application of rich clinical resources to clinical research, and improve the service quality of medical institutions and the conversion rate of scientific research achievements. By introducing the key points and management methods in the implementation of clinical research based on the scientific research big data platform, analyzing and exploring the existing problems and improvement measures, this paper aimed to provide theoretical basis and system reference for high-quality and efficient health and medical big data clinical research, inspire and promote the continuous improvement of medical research management, and promote the development of medical and health science and technology innovation.
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Objective:This paper aims to promote the standardization of ethics review of horizontal scientific research projects and improve the ethics review quality by analyzing the current ethics review practice in a certain tertiary hospital, identifying common problems during the review process, illustrating relevant causes and proposing corresponding solutions.Methods:Through introducing the current situation of ethics review of horizontal scientific research projects in a tertiary level hospital, the differences between the main points of ethics review of horizontal scientific research projects and government-funded scientific research projects were analyzed, so as to sort out the common problems and possible causes in the process of ethics review of horizontal scientific research projects, and then explore the possible corresponding solutions.Results:Based on the characteristics of horizontal research projects, ethics review should focus on their scientific and social values, potential conflicts of interest, protection of subjects′ rights and interests, and whole-process management and quality assurance. At present, there are still many problems, such as a large number of projects, but not many projects with high research value, inadequate project process management, and ineffective implementation of ethics review opinions.Conclusions:The hospital should further improve the management system of horizontal scientific research project approval, bring in more comprehensive review regarding to both scientific and ethics review, engage more experts at the outset of project funding decision-making, set up ethics specialists, strengthen the process management of horizontal scientific research projects, strengthen ethical publicity and education, and improve the ethical awareness of researchers to fully protect the rights and interests of subjects and promote the high-quality development of clinical research.
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Objective:Improve the quality of clinical research at different stages for better protection of human subject.Methods:Introduce the operational and the administrative experiences of establishing the human research protection program in our hospital.Results:Establish human research protection program can promote the direct communication and cooperation among relevant departments of clinical research, strengthen the whole process management of clinical research.Conclusions:Developing comprehensive human research protection program and related policies play a positive role in promoting the high-quality development of clinical research in hospitals.
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With the constant growth of national investment in science and technology, biomedical scientific and technological achievements keep mushrooming. Hospitals, as a powerful force in high-tech research and development, experimental translation and industrialization of biomedicine research, play an important role in the transfer and translation of scientific and technological achievements. This paper analyzed the conflicts of interest in the achievements translation in hospitals, and considered that conflicts of interest are widespread in practice. Under the background of encouraging innovation and promoting the achievements translation, projects with conflicts of interest should be carried out in hospitals conditionally. While reducing the conflicts of interest, the achievements translation should be done properly.
ABSTRACT
With the constant growth of national investment in science and technology,biomedical scientific and technological achievements keep mushrooming.Hospitals,as a powerful force in high-tech research and development,experimental translation and industrialization of biomedicine research,play an important role in the transfer and translation of scientific and technological achievements.This paper analyzed the conflicts of interest in the achievements translation in hospitals,and considered that conflicts of interest are widespread in practice.Under the background of encouraging innovation and promoting the achievements translation,projects with conflicts of interest should be carried out in hospitals conditionally.While reducing the conflicts of interest,the achievements translation should be done properly.
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The paper introduced the preparations of the hospital in applying for AAHRPP accreditation, and the positive push on improving the human research protection program. This proved that such application can learn from overseas experiences in scientific management and improve our human research protection system in a short timeframe. The accreditation can promote the understanding of both administrators and investigators for the importance of protecting human subjects in research, especially the detailed protection procedures, and promoting clinical researches in world class quality.
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By introducing the stage management of ethics review for medical research protocols,this paper try to explain the submission requirement,the review procedures,the key points for focusing on,and analyze the issues found in ethical reviewing of research protocols,help to guide the procedures of ethical review,as well as improve the supervision of ethical review for research protocols.
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Given the rapid progress in recent years,hospital ethics review remains a weak link.This study started from the nature and role of the hospital ethics committee to probe into setbacks found in hospital ethics review practice.Viewpoints in the paper covered the access system,review system,training system,and the conflicts of interest between researchers and subjects,in an effort to further improve the quality of ethic review,and to better protect the rights and interests of subjects.
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An introduction to the classified management of such trials and clinical application,documents submission for ethical review,operating procedures and review key points,as well as the problems found in the review.These efforts aim to provide guidance to the review of medical technique clinical trials,and to promote ethical supervision for new medical techniques.
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The authors presented in the paper the following subjects: a description of risk exposures commonly found in drug clinical trials; risk types in terms of the personnel organization of ethical review boards, and the composition of the ethical review board members, as well as ethical training, ethical review procedures and supervising of the ethical review. To avoid these risks, an analysis is made on the causes of ethical review risks, and recommendations are proposed on international certification, reform of ethical review board setup, greater efforts on training, introduction of ethical supervision and ethical acceptance procedure.