Current Status, Challenges, Policies, and Bioethics of Biobanks

강병학,박재선,조상연,이미희,김남희,민해숙,이수연,박옥,한복기 한국유전체학회 2013 Genomics & informatics Vol.11 No.4

Many biobanks were established as biorepositories for biomedical research, and a number of biobanks were founded in the1990s. The main aim of the biobank is to store and to maintain biomaterials for studying chronic disease, identifying riskfactors of specific diseases, and applying personalized drug therapies. This report provides a review of biobanks, includingKorean biobanks and an analysis of sample volumes, regulations, policies, and ethical issues of the biobank. Until now, thetop 6 countries according to the number of large-scale biobanks are the United Kingdom, United States, Sweden, France, theNetherlands, and Italy, and there is one major National Biobank of Korea (NBK) and 17 regional biobanks in Korea. Manycountries have regulations and guidelines for the biobanks, and the importance of good management of biobanks isincreasing. Meanwhile, according to a first survey of 456 biobank managers in the United States, biobankers are concernedwith 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 iscontinuously introducing for researchers to use biospecimens in the biobank. An accreditation process can also beintroduced for biobanks to harmonize collections and encourage use of biospecimens in the biobanks. KBN is preparing anon-line application system for the distribution of biospecimens and a biobank accreditation program and is trying toharmonize the biobanks.

Current Status, Challenges, Policies, and Bioethics of Biobanks

Kang, Byunghak,Park, Jaesun,Cho, Sangyun,Lee, Meehee,Kim, Namhee,Min, Haesook,Lee, Sooyoun,Park, Ok,Han, Bokghee Korea Genome Organization 2013 Genomics & informatics Vol.11 No.4

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.

국내외 바이오모니터링 프로그램 및 생체시료 활용 현황

김다해(Da Hae Kim),김성균(Sungkyoon Kim),이승호(Seungho Lee),최윤형(Yoon-Hyeong Choi),김진희(Jin Hee Kim) 한국환경보건학회 2021 한국환경보건학회지 Vol.47 No.3

Objectives: Biomonitoring programs have been widely implemented in the field of environmental health, both in Korea and worldwide. Recently, it has been suggested that the storage, management, and utilization of bio-samples collected from biomonitoring programs should be organized based on a biobank system. Therefore, we attempted to review the current status of representative biomonitoring programs and biobank systems that have been implemented in Korea and in other countries. Methods: We searched for bio-samples collected in domestic and foreign biomonitoring programs and their applications. For this, we referred to research papers, homepages hosted by biomonitoring programs, and project reports. We also checked information for biobanks related with biomonitoring programs, including the operating systems, facilities, technologies, and regulations of biobanks. Results: We summarized six domestic and 32 foreign biomonitoring programs. These biomonitoring programs collected bio-samples to determine the relationship between environmental chemicals and diseases. Domestically, bio-samples from KoNEHS, KorSEP, MOCEH, KoCHENS, and KorEHS-C were stored at −80℃ in a deep freezer at the National Institute of Environmental Research, while KNHANES samples were stored at Korea Biobank, which has a stabilized biobanking system with a well-established database. Nine foreign biomonitoring programs (JECS, China-NHBP, CKB, CHMS, NHANES, GerES, Germaan ESB, MoBa, and UK Biobank) were ongoing for large populations. Among them, CKB, GermanESB, and UK biobank have been maintained for at least 10 years with their own biomonitoring programs as well as advanced systems for the safe storage of bio-samples. Conclusion: Currently on-going biobanks have devoted considerable efforts to managing bio-samples for public purposes. The preceding domestic and foreign biomonitoring programs and biobanks will be great references for constructing biobank facilities and systems for environmental public health in Korea in the future.

공공 유전자은행에 관한 시민인식 특성 연구

조성겸(Cho Sung Kyum),조은희(Cho Eun Hee),박성철(Park Seong-Cheol) 한국생명윤리학회 2010 생명윤리 Vol.11 No.1

본 연구는 공공 유전자은행 설립과 유전자 정보제공에 대한 한국인의 인식 특성을 살펴보기 위한 것이다. 이를 위해 2009년에 708명의 성인을 대상으로 전화를 이용한 전국여론조사를 실시했다. 분석결과 유전자은행에 대한 시민인식은 다섯 가지 특성으로 정리되었다. 첫째, 유전자은행에 대한 인지도가 낮게 형성되어 있는 것으로 나타났다. 응답자의 13.9% 정도만이 유전자은행에 대해 알고 있는 것으로 분석됐다. 둘째 공공 유전자은행 설립에 대한 태도는 긍정적인 경향이 높았다. 셋째 자신의 개인정보 제공에 대해서 유보적인 입장을 갖고 있는 것으로 나타났다. 개인정보를 연구목적에 제공할 의사가 있는 응답자는 46.7%로 절반 이하였다. 넷째, 유전자은행의 설립 및 운영에 대하여 공공성과 참여성을 강조하는 경향이 나타났다. 다섯째, 유전자은행 설립에 대하여 위험과 혜택의 측면을 동시에 인식하고 있는 경향이 나타났다. 즉 시민들은 프라이버시 침해 가능성을 우려하면서도 유전자은행 설립의 혜택을 높게 인식하고 있었다. 전반적으로 시민들은 판단에 사용할 수 있는 정보가 부족한 상황에서 배아복제에 대해 갖고 있는 지식과 태도를 이용해 공공유전자은행에 대한 판단을 내리는 경향이 있다고 해석할 수 있다. This study aimed to analyze the public's perception and attitude toward a national biobank. Using a telephone survey, researchers collected data from 708 completed interviews conducted throughout 2009. These interviews revealed 5 major trends regarding the public's opinion of a national biobank. First, awareness of national biobanks were very low with only 13.9% of respondents indicating that they had heard of a biobank. Secondly, the public's attitude toward biobanks was an optimistic one. Another, this survey also suggested that less than 50% of respondents were reluctant to provide their personal genetic information. Additionally, respondents emphasized "public service" and "citizen participation" as the primary principles for making a national biobank. Lastly, citizens were aware of both the risks and benefits associated with the creation of a biobank. Lastly, citizens were aware of both the risks and benefits associated with the creation of a biobank. While many people were wary of the government's ability to maintain their privacy, they also recognized the research benefits of compiling such a wide array of genetic data. Overall, the public's perception of national biobanks was consistent with that of stem cell research and other biotech issues.

ManBIF: a Program for Mining and Managing Biobank Impact Factor Data

유기진,남정민,허윤,추민석,서형석,김준우,전재필,박혜경,박기정 한국유전체학회 2011 Genomics & informatics Vol.9 No.1

Biobank Impact Factor (BIF), which is a very effective criterion to evaluate the activity of biobanks, can be estimated by the citation information of biobanks from scientific papers. We have developed a program, ManBIF, to investigate the citation information from PDF files in the literature. The program manages a dictionary for expressions to represent biobanks and their resources, mines the citation information by converting PDF files to text files and searching with a dictionary, and produces a statistical report file. It can be used as an important tool by biobanks.

ManBIF: a Program for Mining and Managing Biobank Impact Factor Data

Yu, Ki-Jin,Nam, Jung-Min,Her, Yun,Chu, Min-Seock,Seo, Hyung-Seok,Kim, Jun-Woo,Jeon, Jae-Pil,Park, Hye-Kyung,Park, Kie-Jung Korea Genome Organization 2011 Genomics & informatics Vol.9 No.1

Biobank Impact Factor (BIF), which is a very effective criterion to evaluate the activity of biobanks, can be estimated by the citation information of biobanks from scientific papers. We have developed a program, ManBIF, to investigate the citation information from PDF files in the literature. The program manages a dictionary for expressions to represent biobanks and their resources, mines the citation information by converting PDF files to text files and searching with a dictionary, and produces a statistical report file. It can be used as an important tool by biobanks.

Biobank for Multidrug-resistant Tuberculosis Research: Importance of Sequential Samples

( Jiyeon Kim ),( Yoohyun Hwang ),( Jihye Kang ),( Junghee Lee ),( Seungkyu Park ),( Sungweon Ryoo ) 대한결핵 및 호흡기학회 2021 대한결핵 및 호흡기학회 추계학술대회 초록집 Vol.129 No.-

Purpose Since 2013, Masan National Tuberculosis Hospital (MNTH) has collected standardized specimens from its tuberculosis patients, which include a large number of multidrug-resistant strains. The repository collects matched participants and their bacilli samples, compiling sequential samples from the beginning of treatment. The repository aims to provide resources for in-depth international research. Method The MNTH biobank emphasizes on collecting and maintaining specimens from various types of disease-progress in its TB patients. Sputum, serum, urine, and bacterial strains are collected from each patient sequentially, the intervals depending on the condition of each patient. Strains are collected and stored under standardized protocols and stringent biosafety guidelines. Result The majority of specimens collected at MNTH for the past ten years are mostly made up of sputum and blood serum, with 13,196 and 10,905 samples respectively. A total of 1,354 distributions for the internal research institute and 1,022 distributions to external organizations were made as of 2021. The Results and related information are stored in the biobank database, helping form the groundwork in monitoring inpatients’ future treatment outcomes as well as providing future research resources. Analysis of sequential samples has shown a difference in the antibiotic and molecular profiles of the same patient. Currently, the MNTH biobank database stores the Results in the patterns of resistance of TB strains as pDST, molecular diagnosis, and WGS data. Conclusion MNTH presents this unique biobank and its protocols in the hopes that it will be taken as an example of a biorepository operation that may model the future management of TB biobanks. We always welcome infectious sample contributions and distribution requests and hope that our institute’s specimens and our database will allow research projects and clinical trials to become more accessible to all types of pharmaceuticals and medical technology development in our pursuit of the eradication of TB.

'책임'에 근거한 바이오뱅크의 윤리적 토대 모색: 한스 요나스의 책임윤리를 중심으로

김진경 한국의료윤리학회 2012 한국의료윤리학회지 Vol.15 No.2

In the era of personalized medicine, in which human biological materials are becoming more important,the demand for biobanks is increasing. However, as the research potential of biological materials made available through biobanks increases, concerns are growing over the processes and consequences of biobank technology. Accordingly, there are calls for the establishment of biobanks and the setting of ethical criteria for research involving biobanks. This article examines new ethical criteria for research involving biobanks using the concept of ethical responsibility presented by Hans Jonas.

Development of Indicators to Assess the Stability of Remnant Blood Samples Stored in a Biobank: Experience at One Institution

김세환,강영은,홍영준,장윤환,홍석일,오애진,이진경 대한진단검사의학회 2010 Annals of Laboratory Medicine Vol.30 No.6

Background : One of the major concerns with biobanking is the absence of standard operating procedures to eliminate pre-analytical variation arising from sample collection, preparation, and storage. Currently, there is a lack of tools to carry out quality control procedures for stored blood samples. The aim of this study is to assess the quality of stored blood samples in our biobank and to suggest appropriate indicators for their quality control. Methods : The stored blood samples that we tested have been registered into our biobank since 2003. These were transferred to our biobank after carrying out routine requested tests, because the samples would have otherwise been discarded. For the purpose of quality control, we analyzed the concentrations and the integrity of DNA and RNA extracted from the stored samples and tested the levels of several serum proteins; the results were compared with the corresponding pre-storage levels. Results : A total of 19 samples were stored from 2006 to 2009. Of the 22 samples stored between 2003 and 2005, 50% showed complete DNA integrity. However, sufficient RNA integrity was noted in only 1 sample stored as recently as 2009. High blood urea nitrogen levels were also noted in the stored sera, but the increase did not correlate to the duration of storage. Conclusions : The amount and integrity of nucleic acids extracted from stored blood samples are potential indicators that can be used for quality control. A guideline for the quality assessment of stored blood samples in a biobank is urgently needed. (Korean J Lab Med 2010;30:718-25)

바이오뱅크와 포괄적 동의(Broad Consent)

김문정 한국의료윤리학회 2012 한국의료윤리학회지 Vol.15 No.1

The biobank, which is recently pursued by many countries, is supposed to play an important role for the development of the Biomedical science. Thus, I argue that there are a number of important ethical issues needed to be examined for the successful operation of the biobank. Especially, I've focused on “informed consent”, which is fundamental ethical norm in protecting donors' safety and right. But the informed consent for the biobank has to be quite “broad” due to the intrinsically uncertain nature of the future research related to it, and social, for the unique characteristics of genetic information. Therefore the focus of this study is to examine “broad consent” as an alternative approach for protecting of sujects safety and right in using human biological materials and personal medical information.