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Objective:To establish a standardized information management system (IMS) for preserving, managing, querying, and performing statistics on biospecimens and their clinical data, which is conducive to improving the utilization of biobank.Methods:Under the premise of ensuring operating environment and data security, a database-based data logic relationship model is created and applied to the IMS to manage and analyze biospecimens and their supporting clinical information of patients enrolled in the biobank of our center.Results:To ensure the establishment of the follow-up cohort, biospecimens and clinical information of inpatients and outpatients were continuously collected in the biobank of our center. Since December 2014, more than 270 000 biospecimens from inpatient, outpatient, and scientific research have been preserved. The IMS optimized by this model efficiently completes the basic work of the biobank. At the same time, the data can be queried jointly and in batches, and then converted into a report format for statistical analysis.Conclusions:The IMS of our center is suitable for application and popularization as a construction and management model for the hospital-level biobank, which meets the daily work of the biobank and diverse research needs, and provides a convenient platform and rich resources for the development of precision medicine.
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Objective To explore the strategies of constructing clinical biobank based on the real world study.Methods Biospecimens have been collected since November 2014,as well as continuingly construction of the biobank resources to match the implenmentation of real world study.Related measurements adopted including standardized ethical management,quality control,automated data management,and follow-up management.Results Biospecimens and clinical data information were collected with high quality according to standard SOPs.Sophisticated equipment and data automation management mode were used to make sure the protection of patient privacy and data security.At the same time,biospecimens and data information management system were improved gradually to fulfill the integration and sharing of biospecimen data resources.Conclusions Biorepositories are the key to translational medical research,biospecimens collected in our biobank will link with clinical data information simultaneously,which increase the resource pool that can be applied in real world study.
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The recent revision of the Bioethics and Safety Act has created some confusion as to the appropriate use of biospecimens in research. Here, to avoid misunderstandings, we outline the changes to policies on the use of biospecimens in guidelines provided in a question-and-answer format, citing relevant examples where appropriate.
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BioéticaRESUMEN
Many biobanks were established as biorepositories for biomedical research, and a number of biobanks were founded in the 1990s. The main aim of the biobank is to store and to maintain biomaterials for studying chronic disease, identifying risk factors of specific diseases, and applying personalized drug therapies. This report provides a review of biobanks, including Korean biobanks and an analysis of sample volumes, regulations, policies, and ethical issues of the biobank. Until now, the top 6 countries according to the number of large-scale biobanks are the United Kingdom, United States, Sweden, France, the Netherlands, and Italy, and there is one major National Biobank of Korea (NBK) and 17 regional biobanks in Korea. Many countries have regulations and guidelines for the biobanks, and the importance of good management of biobanks is increasing. Meanwhile, according to a first survey of 456 biobank managers in the United States, biobankers are concerned with the underuse of the samples in their repositories, which need to be advertised for researchers. Korea Biobank Network (KBN) project phase II (2013-2015) was also planned for the promotion to use biospecimens in the KBN. The KBN is continuously introducing for researchers to use biospecimens in the biobank. An accreditation process can also be introduced for biobanks to harmonize collections and encourage use of biospecimens in the biobanks. KBN is preparing an on-line application system for the distribution of biospecimens and a biobank accreditation program and is trying to harmonize the biobanks.