Science and Engineering Ethics

, Volume 20, Issue 4, pp 1079–1093 | Cite as

‚Mirroring‘ the Ethics of Biobanking: What Analysis of Consent Documents Can Tell Us?

  • Serepkaite JurateEmail author
  • Valuckiene Zivile
  • Gefenas Eugenijus
Original Paper


Biobanks have been recognized as a key research infrastructure and how to approach ethical questions has been a topic of discussion for at least a decade by now. This article explores the characteristics of donors’ participation in European biobanks as reflected in the consent documents of a selection of different biobanks from various European countries. The primary aim of this study is to understand how donors are informed about their participation in biobanking. Also the paper discusses what the most important thematic issues of information are to be given to the biobank participants and how this information should be presented in the consent documents. For these purposes, we analyse consent documents from 14 biobanks in 11 countries for six ethically relevant issues: (1) model of consent, (2) scope of future research, (3) access to medical data, (4) feedback to the participants, (5) consent withdrawal, and (6) role of research ethics committee. In order to compare different trends of informing donors of human biological material and medical data, we interpret the six analysed issues in the context of respect to donor’s autonomy paradigm. Although the results of the paper reflect the heterogeneity of biobank consent document policies applied in different European countries, we uncovered some trends and suggested several examples of good practices to balance the interests of the donors with those of the researchers and future patients.


Europe Biobanking Consent documents Ethics 



This project was supported in part by Grant Number R25 TW007085 from the US National Institutes of Health (NIH) Fogarty International Center. Its contents are solely the responsibility of the authors and do not necessarily represent the official view of the Fogarty International Center or the NIH. We would like to thank the following people from the field of biobanking for sharing their informed consent documents and replying to our questions, without this work would not have been possible: Maria Grazia Diadone (Istituto dei Nazionale Tumori, Milan), Luciana Caenazzo (University Hospital of Padova), Peter Riegman (Erasmus MC, Rotterdam), Wenche Reed (Oslo University Hospital, Oslo), Peter Collins (University of Cambridge, Addenbrooks Hospital, Cambridge), Roberto Salgado (Institute Jules Bordet, Brussels), Manfred Schmitt (Frauenklinik MRI TU München, Munich), Fatima Carneiro (Serviço de Anatomia Patológica do H.S. João, Porto), Dominic Allen (Integrated Biobank of Luxemburg, Luxemburg), Signe Mezinska (University of Latvia), Aime Keis (University of Tartu). For valuable comments and suggestions we would also like to thank Jacqueline Hall (EORTC).


  1. Austrian Bioethics Commission at the Federal Chancellery. (2007). Biobanks for medical research. May 9, 2007. Accessed 12 Nov 2012.
  2. Belgian Advisory Committee on Bioethics. (2009). Opinion no. 45 of 19 January 2009 on human biological material banks intended for research. Accessed 12 Nov 2012.
  3. Bredenoord, A. L., Kroes, H. Y., Cuppen, E., Parker, M., & van Delden, J. J. M. (2011). Disclosure of individual genetic data to research participants: The debate reconsidered. Trends in Genetics, 27(2), 41–47.CrossRefGoogle Scholar
  4. Brothers, K. B. (2011). Biobanking in pediatrics: The human nonsubjects approach. Personalised Medicine, 8(1), 71–79.CrossRefGoogle Scholar
  5. Chadwick, R., & Bere, K. (2001). Solidarity and equity: New ethical frameworks for genetic databases. Nature Reviews Genetics, 2(4), 318–321.CrossRefGoogle Scholar
  6. EnCoRe—Ensuring Consent and Revocation. (2012). Accessed 12 Nov 2012.
  7. European Commission. (2010). Europeans and biotechnology in 2010.Winds of change? Accessed 25 Nov 2012.
  8. European Commission. (2012). Biobanks for Europe. A challenge for governance. Accessed 12 Nov 2012.
  9. Federation of Medical Scientific Societies. (2003). Code for proper secondary use of human tissue in the Netherlands. Accessed 12 Sept 2013.
  10. Gefenas, E., Dranseika, V., Cekanauskaite, A., Serepkaite, J. (2011). Research on human biological materials: What consent is needed and when. In: C. Lenk, J. Sandor, & B. Gordijn (Eds.), Biobanks and tissue research (pp. 95–110). New York: Springer, Series: The international library of ethics, law and technology.Google Scholar
  11. Helgesson, G., Ludvigsson, J., & Gustafsson Stolt, U. (2005). How to handle informed consent in longitudinal studies when participants have a limited understanding of the study. Journal of Medical Ethics, 31(11), 670–673.CrossRefGoogle Scholar
  12. Hoeyer, K. (2010). Donors perceptions of consent to and feedback from biobank research: time to acknowledge diversity? Public Health Genomics., 13(6), 345–352.CrossRefGoogle Scholar
  13. Irish Council for Bioethics. (2005). Human biological material: Recommendations for collection, use and storage in research. Accessed 12 Nov 2012.
  14. Knoppers, B. M., & Chadwick, R. (2005). Human genetic research: Emerging trends in ethics. Nature Reviews Genetics, 6(1), 75–79.CrossRefGoogle Scholar
  15. Knoppers, B. M., Joly, Y., Simard, J., & Durocher, F. (2006). The emergence of an ethical duty to disclose genetic research results: International perspectives. European Journal of Human Genetics, 14(11), 1170–1178.CrossRefGoogle Scholar
  16. Miller, F. A., Christensen, R., Giacomini, M., & Robert, J. S. (2008). Duty to disclose what? Querying the putative obligation to return research results to participants. Journal of Medical Ethics, 34(3), 210–213.CrossRefGoogle Scholar
  17. Nuffield Council on Bioethics. (2011). In B. Prainsack & A. Buyx (Eds.), Solidarity: Reflections on an emerging concept in bioethics. London. Accessed 12 Nov 2012.
  18. Park, A. (2009). 10 Ideas changing the world right now. Time.,28804,1884779_1884782_1884766,00.html. Accessed 12 Nov 2012.
  19. Riegman, P. H., Morente, M. M., Betsou, F., de Blasio, P., Geary, P., & International Working Group on Biobanking for Biomedical Research. (2008). Biobanking for better healthcare. Molecular Oncology, 2(3), 213.Google Scholar

Copyright information

© Springer Science+Business Media Dordrecht 2013

Authors and Affiliations

  • Serepkaite Jurate
    • 1
    Email author
  • Valuckiene Zivile
    • 2
  • Gefenas Eugenijus
    • 1
  1. 1.Department of Medical History and EthicsVilnius UniversityVilniusLithuania
  2. 2.Department of CardiologyHospital of Lithuanian, University of Health SciencesKaunasLithuania

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