Genomics & Informatics

Korea Genome Organization (한국유전체학회)
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Current Status, Challenges, Policies, and Bioethics of Biobanks

  • Kang, Byunghak (Division of Biobank for Health Sciences, Korea National Institute of Health) ;
  • Park, Jaesun (Division of Biobank for Health Sciences, Korea National Institute of Health) ;
  • Cho, Sangyun (Division of Biobank for Health Sciences, Korea National Institute of Health) ;
  • Lee, Meehee (Division of Biobank for Health Sciences, Korea National Institute of Health) ;
  • Kim, Namhee (Division of Biobank for Health Sciences, Korea National Institute of Health) ;
  • Min, Haesook (Division of Biobank for Health Sciences, Korea National Institute of Health) ;
  • Lee, Sooyoun (Division of Biobank for Health Sciences, Korea National Institute of Health) ;
  • Park, Ok (Division of Vaccine Preventable Diseases, Korea Centers for Disease Control and Prevention) ;
  • Han, Bokghee (Center for Genome Science, Korea National Institute of Health)
  • Received : 2013.10.15
  • Accepted : 2013.11.13
  • Published : 2013.12.31
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Abstract

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.

Keywords

References

  1. Ministry of Health, Welfare and Family Affairs. The Bioethics and Safety Act. No. 9100. Seoul: Ministry of Health, Welfare and Family Affairs, 2013.
  2. Norwegian Institute of Public Health. Norwegian Act Relating to Biobank. Oslo: Norwegian Institute of Public Health, 2005.
  3. Dawber TR, Kannel WB. The Framingham Study, An epidemiologic approach to coronary heat diseas. Circulation 1966;34:553-555. https://doi.org/10.1161/01.CIR.34.4.553
  4. Greely HT. The uneasy ethical and legal underpinnings of large-scale genomic biobanks. Annu Rev Genomics Hum Genet 2007;8:343-364. https://doi.org/10.1146/annurev.genom.7.080505.115721
  5. GBI Research. Biobanks: 2011 Yearbook. Survey Report. GBI Research, 2011.
  6. Minamikumo M. Current status and future of biobanks. Policy Inst News 2012;36:15-21.
  7. Watts G. UK Biobank opens it data vaults to researchers. BMJ 2012;344:e2459. https://doi.org/10.1136/bmj.e2459
  8. UK Biobank. The UK Biobank project. Biobank, 2013. UK Biobank. Accessed 2013 Oct 15. Available from: http:// www.ukbiobank.ac.uk.
  9. Haga SB, Beskow LM. Ethical, legal, and social implications of biobanks for genetics research. Adv Genet 2008;60:505-544. https://doi.org/10.1016/S0065-2660(07)00418-X
  10. Park A. 10 ideas changing the world right now. Biobanks. TIME 2009 Mar 12:Part 8.
  11. Elger BS, Caplan AL. Consent and anonymization in research involving biobanks: differing terms and norms present serious barriers to an international framework. EMBO Rep 2006; 7:661-666. https://doi.org/10.1038/sj.embor.7400740
  12. Korea Centers for Disease Control and Prevention. An Internal Report of Project Implementation from Regional Biobanks. Cheongwon: Korea Centers for Disease Control and Prevention, 2012.
  13. Cho SY, Hong EJ, Nam JM, Han B, Chu C, Park O. Opening of the national biobank of Korea as the infrastructure of future biomedical science in Korea. Osong Public Health Res Perspect 2012;3:177-184. https://doi.org/10.1016/j.phrp.2012.07.004
  14. Park O, Cho SY, Shin SY, Park JS, Kim JW, Han BG. A strategic plan for the second phase (2013-2015) of the Korea Biobank Project. Osong Public Health Res Perspect 2013;4:107-116. https://doi.org/10.1016/j.phrp.2013.03.006
  15. Organisation for Economic Co-operation and Development. OECD Guidelines on Human Biobanks and Genetic Research Databases. Paris: OECD, 2009.
  16. International Society for Biological and Environmental Repositories. 2012 best practices for repositories: collection, storage, retrieval, and distribution of biological materials for research. Biopreserv Biobank 2012;10:79-161. https://doi.org/10.1089/bio.2012.1022
  17. Betsou F, Lehmann S, Ashton G, Barnes M, Benson EE, Coppola D, et al. Standard preanalytical coding for biospecimens: defining the sample PREanalytical code. Cancer Epidemiol Biomarkers Prev 2010;19:1004-1011. https://doi.org/10.1158/1055-9965.EPI-09-1268
  18. Bredenoord AL, Kroes HY, Cuppen E, Parker M, van Delden JJ. Disclosure of individual genetic data to research participants: the debate reconsidered. Trends Genet 2011;27:41-47. https://doi.org/10.1016/j.tig.2010.11.004
  19. Rotimi CN, Marshall PA. Tailoring the process of informed consent in genetic and genomic research. Genome Med 2010;2:20. https://doi.org/10.1186/gm141
  20. Kaye J, Boddington P, de Vries J, Hawkins N, Melham K. Ethical implications of the use of whole genome methods in medical research. Eur J Hum Genet 2010;18:398-403. https://doi.org/10.1038/ejhg.2009.191
  21. Otlowski M. Developing an appropriate consent model for biobanks: in defence of "broad" consent. In: Principles and Practice in Biobank Governance (Kaye J, Stranger M, eds.). Aldershot: Ashgate, 2009. pp. 79-92.
  22. McGuire AL, Caulfield T, Cho MK. Research ethics and the challenge of whole-genome sequencing. Nat Rev Genet 2008;9: 152-156. https://doi.org/10.1038/nrg2302
  23. NCI Best practices for biospecimen resources. Bethesda: National Cancer Institue, National Institutes of Health, U.S. Department of Health and Human Services. Accessed 2013 Oct 4. Available from: http://biospecimens.cancer.gov/bestpractices/ 2011-NCIBestPractices.pdf.
  24. Otlowski M, Nicol D, Stranger M. Biobanks Information Paper. Canberra: Austrailian Government, National Health and Medical Research Council, 2010.
  25. Wellcome Trust Case Control Consortium. Genome-wide association study of 14,000 cases of seven common diseases and 3,000 shared controls. Nature 2007;447:661-678. https://doi.org/10.1038/nature05911
  26. Austin MA, Harding S, McElroy C. Genebanks: a comparison of eight proposed international genetic databases. Community Genet 2003;6:37-45. https://doi.org/10.1159/000069544
  27. Knoppers BM, Abdul-Rahman MH. Biobanks in the literature. In: Ethical Issues in Governing Biobanks: Global Perspectives (Elger B, Biller-Andorno N, Mauron A, Capron AM, eds.). Aldershot: Ashgate, 2008. pp. 13-22.
  28. Day-Williams AG, Zeggini E. The effect of next-generation sequencing technology on complex trait research. Eur J Clin Invest 2011;41:561-567. https://doi.org/10.1111/j.1365-2362.2010.02437.x
  29. Diamandis EP. Next-generation sequencing: a new revolution in molecular diagnostics? Clin Chem 2009;55:2088-2092. https://doi.org/10.1373/clinchem.2009.133389
  30. Zolg W. The proteomic search for diagnostic biomarkers: lost in translation? Mol Cell Proteomics 2006;5:1720-1726. https://doi.org/10.1074/mcp.R600001-MCP200
  31. Scudellari M. Biobank managers bemoan underuse of collected samples. Nat Med 2013;19:253.
  32. Henderson GE, Cadigan RJ, Edwards TP, Conlon I, Nelson AG, Evans JP, et al. Characterizing biobank organizations in the U.S.: results from a national survey. Genome Med 2013;5:3. https://doi.org/10.1186/gm407
  33. Betsou F, Rimm DL, Watson PH, Womack C, Hubel A, Coleman RA, et al. What are the biggest challenges and opportunities for biorepositories in the next three to five years? Biopreserv Biobank 2010;8:81-88. https://doi.org/10.1089/bio.2010.8210

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