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As an important biological resource of a country or region, human genetic resources (HGR) are increasingly attracting attention and concern from many countries internationally, and even have been elevated to the dimension of national sovereignty by many countries. As a large country with rich and diverse HGR, relevant regulatory work in China started relatively late compared to foreign countries, but has developed rapidly. However, looking around the world, there is still room for further improvement and development of domestic HGR regulation. By reviewing the regulatory legislation of HGR in some countries abroad, this paper sorted out their advanced experience and highlighted measures in detail, and summarized their deep-seated legislative guidance. A detailed analysis and evaluation were conducted from seven aspects:the advanced level of HGR legislation and the enhancement of legal effectiveness, the systematization and systematization of policies and regulations, the unification of platforms and relevant standards, the highlight of the concept of ethics and the rule of law, the strengthening of anti-discrimination protection, the special protection of major human genetic family resources and national special protection areas of HGR, and the establishment of principled consensus or agreement on HGR in international and local regions, to provide reference for the construction of regulatory policies and legal systems for HGR in China.
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Objective:The management system of Investigator Initiated Clinical Trials (IIT) using human genetic resources in large hospitals is still not optimal. The purpose of this study is to sort out the existing problems of human genetic resources management in IIT of large hospitals, analyze the management practices, and provide reference for the standardized management of human genetic resources in IIT.Methods:The existing problems of human genetic resources management in IIT of large hospitals were sorted out by literature analysis, and the management practices since the establishment of human genetic resources management office were analyzed, and suggestions were put forward.Results:The problems of human genetic resources management in IIT of large hospitals mainly focused on the lack of awareness and attention of investigators and managers, the lack of process supervision, and the imbalance between input and output of genetic resources. A large hospital has implemented personnel and system construction, strengthened node management and control, and developed a training system. The approval rate of administrative approval and archival projects of human genetic resources of the Ministry of Science and Technology in 2021 increased by 52.69% compared with the previous year.Conclusions:Large hospitals should proceed from the actual situation, establish the human genetic resource management system jointly through multi-department linkage, improve management process, strengthen quality control, increase training efforts, improve the professional capacity and quality of researchers and managers, promote the high-quality, high-level and well development of IIT.
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Objective:To encourage the innovation of medical science and technology, regulate the Investigator Initiated Clinical Trials (IIT), this paper analyzed the problems faced by the management of human genetic resources in medical institution, and the corresponding management measures.Methods:Existing problems of human genetic resource management in IIT were discussed and summarized, taking into consideration of regulatory requirements and daily practices in the hospital.Results:Problems identified include imperfect supervision mechanism, incomplete policy interpretation, insufficient understanding of human genetic resources management policies by researchers, and how to support innovation with human gentic resources and so on.Conclusions:Medical institutions should establish and improve the supervision system and strengthen the whole process management of IIT. Accurately interpret regulatory requirements to improve application efficiency. Improve researchers′ recognition of human genetic resources to avoid omission and misrepresentation. Build a biobank to encourage legal and compliant use of human genetic resources to carry out high-quality IIT.
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Objective:This paper aims to explore the management of human genetic resources in medical institutions, according to reflections of the management mode of a particular hospital, providing possible reference for other medical institutions.Methods:The management system of human genetic resources was constructed refer to the McKinsey 7S model. Approved projects information includes the types of projects, characteristics of human genetic resources involved and the characteristics of principal investigator are analyzed.Results:A total number of 82 projects were approved Since the implementation of newly updated Regulation of the People′s Republic of China on the Administration of Human Genetic Resources (hereinafter referred to as the regulations), and majority of which are drug clinical trials. The human genetic resources materials and data involved are mainly blood, urine, serum, plasma, clinical data, imaging data, etc. Most of the principal investigators with senior professional title are from key disciplines.Conclusions:McKinsey 7S model provides a new reference path for medical institutions to carry out human genetic resources management.
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Objective:By strengthening the management of external provision of data generated by clinical trials in medical institutions, to improve the effectiveness of supervision of human genetic resource information, and to promote the legal sharing and effective use of data.Methods:Analyzed problems identified in filing human genetic resource information in clinical trials since July 1, 2019, put forward possible solutions and suggestions.Results:Main problems were identified in external provision of human genetic resource information, including the specification and time limit of external provision of information, the information recipient, the storage location and the final disposal method of information.Conclusions:Hospital and regulatory authority need to carry out more tailored training, optimize management systems and procedures in order to strengthen the management of the external provision of human genetic resources information.
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Objective:To analyze the intellectual property risk of international cooperative scientific research involving human genetic resources, explore possible risk control measures regarding to intellectual property.Methods:By means of literature review, this paper analyzes the special attributes and strategic position of human genetic resources, reviews the policies and systems involving human genetic resources in international cooperative scientific research, identifies the intellectual property risk points, and puts forward suggestions on risk management and control from the perspective of intellectual property protection.Results:The management of human genetic resources in China is evolving quickly. However, there is still a lack of practical guidelines on intellectual property protection and development, more substantial engagement and contribution of Chinese investigators in the international collaborative research should be promoted, and the perception and awareness of the significance of human genetic resources should be enhanced.Conclusions:In the international cooperative scientific research involving human genetic resources, we should clarify the operating rules at the level of intellectual property protection, improve the substantive participation of Chinese investigators, enhance the strategic awareness and risk awareness of human genetic resources, and provide support at the level of executive management institutions.
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Objective:To analyze the current situation of human genetic resources management in a tertiary hospital, and propose improvement suggestions for the management of human genetic resources in tertiary hospitals.Methods:According to the review of laws and regulations of human genetic resources management in China, analyze the current situation, challenges and management suggestions of human genetic resources management in this particular tertiary hospital, and further management suggestions are proposed.Results:Main problems were identified in the tertiary hospital, including the knowledge of researchers needs to be improved, and due to lack of supervision and management on process of human genetic resources projects, the management of investigator initiated clinical trials needs to be further strengthened.Conclusions:The tertiary hospital needs to strengthen the researcher training on the management of human genetic resources, establish the whole-process supervision of human genetic resources project and pay more attention to the management of investigator initiated clinical trials.
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Objective To explore the management of human genetic resources in our university,propose relevant suggestions for promoting the appropriate protection and scientific management of human genetic resources.Methods Based on the existing regulations and policies,discuss the potential problems relevant to how to strengthen management of human genetic resources in China at institute level.Results Main problems identified including the management scope of human genetic resources is not clear,the inconsistence of application materials,the informed consent and its process involved in biobank and lack of the management of whole process of human genetic resources exploration.Conclusions With the rapid development of biotechnology,the economic value and strategic significance of human genetic resources have become increasingly prominent.Enhancement of training and whole process management,as well as the improvement of informed consent for biobank play important roles in effectively improve the protection of human genetic resources.
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Objective To strengthen human genetic resource management in clinical trials.Methods This article analyzes the common problems in the process of reviewing human genetic resources application by the drug clinical trial institute in our hospital,and proposes solutions for solving the problems.Results Common questions are also the key points for future review of human genetic resources applications,including the collection of sample and consistency with clinical trial plan,ethical review and informed consent,intellectual property rights etc.Conclusions Strictly reviewing applications of human genetic resources,as well as strengthen the management of human genetic resources in clinical trials,are not only make traceability of human genetic resources traceable,but also have important significance for the authenticity and scientific validity of trial results.
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Objective To summarize the characteristic of projects accepted by human genetic resources management office in 2016 and put forward further measures.Methods Statistic analyses were carried out based on the overall projects application,then Chinese application units and partners were analyzed separately.Results 1 138 international cooperation projects were approved in total,mainly on clinical research.24 countries were involved with increasing trend of globalization.Conclusions The human genetic resources management played a positive role in the development of the biomedical research and industry.
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In this paper,we analyzed 24 international cooperation projects involving human genetic resources from 1999 to 2009 hosted by the Cancer Institute and Hospital,Chinese Academy of Medical Sciences.The analysis concerned the overall situation of the projects,the foreign cooperative units,subject distribution,research content,export planning,actual export and achievement.We also put forward proposals to improve the human genetic resources management.