Abstract
The number of population-based and disease-based biobanks being created for research purposes is increasing. These collections of samples and associated data are being used to discover the links between genes and disease, and the genetic, lifestyle and environmental factors behind common complex diseases. In order to make a decision as to whether or not to provide their consent, potential participants in both types of biobanks need to be informed of the requirements and implications of participation. This comparative examination of clauses contained in consent materials from disease biobanks and population biobanks points to the factors that are specific to each type of biobank and highlights the issues that should be taken into consideration when creating consent materials for biobanking activities.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
Literatur
Beskow LM, Burke W, Merz JF et al (2001) Informed consent for population-based research involving genetics. JAMA 286: 2315-2321
Beyleveld D, Longley D (1998) Informing potential participants of local research ethics committee approval of research protocols. Med Law Int 3: 209-222
Cambon-Thomsen A (2004) The social and ethical issues of post-genomic human biobanks. Nat Rev Genet 5:866-873
Cambon-Thomsen A, Rial-Sebbag E, Knoppers BM (2007) Trends in ethical and legal frameworks for the use of human biobanks. Eur Respir J 30: 373-382
Cambon-Thomsen A, Sallée C, Rial-Sebbag E et al (2005) Population genetic databases: Is a specific ethical and legal framework necessary? GenEdit 3:1-13 www.humgen.umontreal.ca/int/genedit.cfm?idsel=1312. Accessed 22 February 2008
Council of Europe (2006) Recommendation of the Committee of Ministers to member states on research on biological materials of human origin https://wcd.coe.int/ViewDoc.jsp? id=977859&Site=COE. Accessed 12 September 2007
Deschênes M, Cardinal G, Knoppers BM et al (2001) Human genetic research, DNA banking and consent: a question of ’form’? Clin Genet 59: 211-239
Eiseman E, Bloom G, Brower J et al (2003) Case Studies of Existing Human Tissue Repositories: “Best Practices” for a Biospecimen Resource for the Genomic and Proteomic Era. RAND, Santa Monica
Eriksson S, Helgesson G (2005) Potential harms, anonymization, and the right to withdraw consent to biobank research. Eur J Hum Genet 13: 1071-1076
European Union (2003) European Union Workshop on Optimisation of Biobanks: Biobanks for Health: Optimising the Use of European Biobanks and Health Registries for Research Relevant to Public Health and Combating Disease. http://www.fhi.no/dav/1F1C30AB2C.pdf. Accessed 12 Sep 2007
Flory J, Emanuel E (2004) Interventions to improve research participants’ understanding in informed consent for research: a systematic review. JAMA 292: 1593-1601
Greely HT (2007) The uneasy ethical and legal underpinnings of large-scale genomic biobanks. Annu Rev Genomics Hum Genet 8: 343-364
Hamilton S, Hepper J, Hanby A et al (2007) Consent gained from patients after breast surgery for the use of surplus tissue in research: an exploration. J Med Ethics 33: 229-233
Hampton T (2006) Rare Disease Research Gets Boost. JAMA 295: 2836-2838
Hirtzlin I, Dubreuil C, Preaubert N et al (2003) An empirical survey on biobanking of human genetic material and data in six EU countries. Eur J Hum Genet 11: 475-488
ICH (2007) International Conference on Harmonisation Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories (E15). http://www.ich.org/LOB/media/MEDIA3383.pdf. Accessed 20 February 2008
Kaye J (2006) Do we need a uniform regulatory system for biobanks across Europe? Eur J Hum Genet 14: 245-248
Kelley K, Stone C, Manning A et al (2007) Population-based biobanks and genetics research in Connecticut. http://www.ct.gov/dph/LIB/dph/genomics/BiobanksPolicyBrief.pdf. Accessed 21 February 2008
Kettis-Lindblad A, Ring L, Viberth E et al (2006) Genetic research and donation of tissue samples to biobanks. What do potential sample donors in the Swedish general public think? Eur J Public Health 16: 433-440
Khoury MJ (2001) Informed consent for population research involving genetics: a public health perspective. http://www.cdc.gov/genomics/population/publications/editorial.htm. Accessed 7 September 2007
Knoppers BM, Joly Y, Simard J et al (2006) The emergence of an ethical duty to disclose genetic research results: international perspectives. Eur J Hum Genet 14: 1322-1322
Lowrance WW (2002) Learning from Experience: Privacy and the Secondary Use of Data in Health Research. The Nuffield Trust, London
Marcus AD (2006) Patients with rare diseases work to jump-start research. The Wall Street Journal Online 11 July 2006
Merz JF, Magnus D, Cho MK et al (2002) Protecting subjects’ interests in genetics research. Am J Hum Genet 70: 965-971
Pullman D, Hodgkinson K (2006) Genetic knowledge and moral responsibility: ambiguity at the interface of genetic research and clinical practice. Clin Genet 69: 199-203
Rothstein MA (2005) Expanding the ethical analysis of biobanks. J Law Med Ethics 33: 89 – 101
Shickle D (2006) The consent problem within DNA biobanks. Stud Hist Philos Sci Part C: Stud Hist Philos Biol Biomed Sci 37: 503-519
Smith GD, Ebrahim S, Lewis S et al (2005) Genetic epidemiology and public health: hope, hype and future prospects. Lancet 366: 1484-1498
TCGA (2006) The Cancer Genome Atlas Data Release Workshop Summary Report. http://cancergenome.nih.gov/components/TCGA_101706.pdf. Accessed 20 February 2008
Terry SF, Terry PF, Rauen KA et al (2007) Advocacy groups as research organizations: the PXE International example. Nat Rev Genet 8: 157-164
Towie N (2007) London hospital launches infectious disease ’biobank’. Nat Med 13:653
UK Biobank (2007) UK Biobank Information Leaflet. www.ukbiobank.ac.uk/docs/infoleaflet 0607.pdf. Accessed 13 Sep 2007
Wallace S, Lazor S, Knoppers BM (2008) Consent and population genomics: The creation of generic tools. Submitted
Williams G, Schroeder D (2004) Human genetic banking: altruism, benefit and consent. New Genet Soc 23: 89-103
Zeitlin PL (2007) Emerging drug treatments for cystic fibrosis. Expert Opin Emerg Drugs 12: 329-336
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2012 Springer-Verlag Berlin Heidelberg
About this paper
Cite this paper
Wallace, S., Lazor, S., Knoppers, B.M. (2012). What is in a Clause?. In: Dabrock, P., Taupitz, J., Ried, J. (eds) Trust in Biobanking. Veröffentlichungen des Instituts für Deutsches, Europäisches und Internationales Medizinrecht, Gesundheitsrecht und Bioethik der Universitäten Heidelberg und Mannheim, vol 33. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-540-78845-4_7
Download citation
DOI: https://doi.org/10.1007/978-3-540-78845-4_7
Published:
Publisher Name: Springer, Berlin, Heidelberg
Print ISBN: 978-3-540-78844-7
Online ISBN: 978-3-540-78845-4
eBook Packages: Humanities, Social Sciences and LawLaw and Criminology (R0)