Park Ok, Cho Sang Yun, Shin So Youn, Park Jae-Sun, Kim Jun Woo, Han Bok-Ghee
Division of Biobank for Health Sciences, Korea National Institute of Health, Osong, Korea.
Osong Public Health Res Perspect. 2013 Apr;4(2):107-16. doi: 10.1016/j.phrp.2013.03.006.
The Korea Biobank Project (KBP) was led by the Ministry of Health and Welfare to establish a network between the National Biobank of Korea and biobanks run by university-affiliated general hospitals (regional biobanks). The Ministry of Health and Welfare started the project to enhance medical and health technology by collecting, managing, and providing researchers with high-quality human bioresources. The National Biobank of Korea, under the leadership of the Ministry of Health and Welfare, collects specimens through various cohorts and regional biobanks within university hospitals gather specimens from patients. The project began in 2008, and the first phase ended in 2012, which meant that there needed to be a plan for the second phase that begins in 2013. Consequently, professionals from within and outside the project were gathered to develop a plan for the second phase. Under the leadership of the planning committee, six working groups were formed to formulate a practical plan. By conducting two workshops with experts in the six working groups and the planning committee and three forums in 2011 and 2012, they have developed a strategic plan for the second phase of the KBP. This document presents a brief report of the second phase of the project based on a discussion with them. During the first phase of the project (2008-2012), a network was set up between the National Biobank of Korea and 17 biobanks at university-affiliated hospitals in an effort to unify informatics and governance among the participating biobanks. The biobanks within the network manage data on their biospecimens with a unified Biobank Information Management System. Continuous efforts are being made to develop a common standard operating procedure for resource collection, management, distribution, and personal information security, and currently, management of these data is carried out in a somewhat unified manner. In addition, the KBP has trained and educated professionals to work within the biobanks, and has also carried out various publicity promotions to the public and researchers. During the first phase, biospecimens from more than 300,000 participants through various cohorts and biospecimens from more than 200,000 patients from hospitals were collected, which were distributed to approximately 600 research projects. The planning committee for the second phase evaluated that the first phase of the KBP was successful. However, the first phase of the project was meant to allow autonomy to the individual biobanks. The biobanks were able to choose the kind of specimens they were going to collect and the amount of specimen they would set as a goal, as well as being allowed to choose their own methods to manage their biobanks (autonomy). Therefore, some biobanks collected resources that were easy to collect and the resources needed by researchers were not strategically collected. In addition, there was also a low distribution rate to researchers outside of hospitals, who do not have as much access to specimens and cases as those in hospitals. There were also many cases in which researchers were not aware of the KBP, and the distribution processes were not set up to be convenient to the demands of researchers. Accordingly, the second phase of the KBP will be focused on increasing the integration and cooperation between the biobanks within the network. The KBP plans to set goals for the strategic collection of the needed human bioresources. Although the main principle of the first phase was to establish infrastructure and resource collection, the key objective of the second phase is the efficient utilization of gathered resources. In order to fully utilize the gathered resources in an efficient way, distribution systems and policies must be improved. Vitalization of distribution, securing of high-value resource and related clinical and laboratory information, international standardization of resource management systems, and establishment of a virtuous cycle between research and development (R&D) and biobanks are the four main strategies. Based on these strategies, 12 related objectives have been set and are planned to be executed.
韩国生物样本库项目(KBP)由卫生与福利部牵头,旨在在韩国国家生物样本库与大学附属医院运营的生物样本库(地区生物样本库)之间建立网络。卫生与福利部启动该项目,通过收集、管理高质量人类生物资源并向研究人员提供这些资源,以提升医疗和健康技术。在卫生与福利部的领导下,韩国国家生物样本库通过各种队列收集样本,大学医院内的地区生物样本库则从患者身上采集样本。该项目始于2008年,第一阶段于2012年结束,这意味着需要为始于2013年的第二阶段制定计划。因此,项目内外的专业人员齐聚一堂,共同制定第二阶段的计划。在规划委员会的领导下,成立了六个工作组来制定切实可行的计划。通过在2011年和2012年与六个工作组及规划委员会的专家举办两次研讨会和三次论坛,他们制定了KBP第二阶段的战略计划。本文基于与他们的讨论,简要报告了该项目的第二阶段。在项目的第一阶段(2008 - 2012年),在韩国国家生物样本库与17家大学附属医院的生物样本库之间建立了网络,旨在统一参与生物样本库之间的信息学和管理。网络内的生物样本库使用统一的生物样本库信息管理系统来管理其生物样本数据。目前正在持续努力制定资源收集、管理、分发和个人信息安全的通用标准操作程序,并且这些数据的管理目前在一定程度上是统一进行的。此外,KBP对在生物样本库工作的专业人员进行了培训和教育,还针对公众和研究人员开展了各种宣传推广活动。在第一阶段,通过各种队列收集了来自30多万参与者的生物样本,以及来自医院20多万患者的生物样本,并将这些样本分发给了大约600个研究项目。第二阶段的规划委员会评估认为KBP的第一阶段是成功的。然而,项目的第一阶段旨在给予各个生物样本库自主权。生物样本库能够选择要收集的样本种类和设定为目标的样本量,还可以选择自己管理生物样本库的方法(自主权)。因此,一些生物样本库收集了易于收集的资源,而研究人员所需的资源并未得到战略性收集。此外,向医院以外研究人员的分发率也很低,他们获取样本和病例的机会不如医院内的研究人员多。还有很多情况是研究人员并不了解KBP,并且分发流程的设置也不符合研究人员的需求便利性。因此,KBP的第二阶段将专注于加强网络内生物样本库之间的整合与合作。KBP计划为所需人类生物资源的战略收集设定目标。虽然第一阶段的主要原则是建立基础设施和资源收集,但第二阶段的关键目标是高效利用所收集的资源。为了以高效的方式充分利用所收集的资源,则必须改进分发系统和政策。促进分发、获取高价值资源及相关临床和实验室信息、资源管理系统的国际标准化以及在研发与生物样本库之间建立良性循环是四个主要战略。基于这些战略,已设定了12个相关目标并计划予以执行。