Abstract
Requirement for informed, express, and specific consent is one of the key principles of research ethics that evolved as a reaction to the atrocities of the Nazi medicine as well as a response to the unethical human experimentation revealed during the post World War II period. Such consent is thought to be the default position in clinical research and any softening of the requirement is usually perceived as an exception which requires justification. However, in some areas of human research the requirement is more and more often both weakened in practice and criticised by the members of the research community and ethicists. In this chapter we discuss circumstances under which research on human biological materials is in fact conducted without specific consent or re-consent of a donor. First, we explore the research use of materials that were collected for broadly-defined research purposes for which broad consent was initially secured. Second, we discuss the possibility to waive consent in research use of biological materials that were initially collected for non-research purposes without consent for research use. Third, we address three alternative regulatory regimes allowing turning residual biological materials into research collections during the collection procedure. These alternatives that justify the so-called research storage of biological materials collected for non-research purposes can be based on precautionary consent, presumed consent, and no consent.
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Bathe, O. F., and A. L. McGuire. 2009. “The Ethical Use of Existing Samples for Genome Research.” Genetics in Medicine 11: 712–15.
Belgium Federal Parliament. 2008. “Kingdom of Belgium: Law on Procurement and Use of Human Bodily Material for Medical Application to Humans and for Scientific Research.” Accessed 08 March 2011. Available in French at: http://www.ejustice.just.fgov.be/cgi/article_body.pl?language=fr&caller=summary&pub_date=2008-12-30&numac=2008018385#top
Bioethics Commission at the Federal Chancellery. 2007. “Biobanks for Medical Research.” Accessed 08 March 2011. http://www.bka.gv.at/DocView.axd?CobId=25510
Chadwick, R., and K. Bere. 2001. “Solidarity and Equity: New Ethical Frameworks for Genetic Databases.” Nature Reviews Genetics 2 (4): 318–21.
Coebergh, J. W. W., E. B. van Veen, J. P. Vandenbroucke et al. 2006. “One-Time General Consent for Research on Biological Samples – Opt Out System for Patients is Optimal and Endorsed in Many Countries.” British Medical Journal 332 (7542): 665.
Council of Europe. 2006a. “Recommendation Rec(2006)4 of the Committee of Ministers to Member States on Research on Biological Materials of Human Origin.” Accessed 08 March 2011. http://wcd.coe.int/ViewDoc.jsp?id=977859
Council of Europe. 2006b. “Draft Explanatory Memorandum to the Draft Recommendation Rec(2006) of the Committee of Ministers to Member States on Research on Biological Materials of Human Origin.” Accessed 08 March 2011. http://wcd.coe.int/ViewDoc.jsp?id=961161&Site=COE
Danish National Committee on Biomedical Research Ethics. 2009. “Guidelines About Notification etc. of a Biomedical Research Project to the Committee System on Biomedical Research Ethics.” Accessed 08 March 2011. http://www.cvk.sum.dk/English/guidelinesaboutnotification.aspx.
Elger, B. S., and A. L. Caplan. 2006. “Consent and Anonymization in Research Involving Biobanks: Differing Terms and Norms Present Serious Barriers to an International Framework.” EMBO Report 7: 661–66.
Estonian Ministry of Social Affairs. 2007. “Republic of Estonia. Annex 1 to the Decree No 36 of the Ministry of Social Affairs of Estonia: Gene Donor Consent Form.” Accessed 08 March 2011. http://www.geenivaramu.ee/index.php?id=100
Federation of Medical Scientific Societies. 2003. “Code for Proper Secondary Use of Human Tissue in the Netherlands.” Accessed 08 March 2011. http://www.federa.org/?s=1&m=82
French National Consultative Ethics Committee for Health and Life Sciences. 2003. “Opinion n° 77 – Ethical Issues Raised by Collections of Biological Material and Associated Information Data: ‘Biobanks’, ‘Biolibraries’.” Accessed 08 March 2011. http://ec.europa.eu/research/biosociety/pdf/opinion_77.pdf
Furness, P. N., and M. L. Nicholson. 2004. “Obtaining Explicit Consent for the Use of Archival Tissue Samples: Practical Issues.” Journal of Medical Ethics 30: 561–64.
German National Ethics Council. 2004. “Opinion on Biobanks for Research.” Accessed 08 March 2011. http://www.ethikrat.org/_english/publications/Opinion_Biobanks-for-research.pdf
Hansson, M., J. Dillner, C. Bartram et al. 2006. “Should Donors Be Allowed to Give Broad Consent to Future Biobank Research?” The Lancet Oncology 7: 266–69.
Hartlev, M., and U. Lind. 2006. “Use of Blood Samples from the Danish PKU-Biobank – A Study of the Conceptualization of Research in Law and Action.” Accessed 08 March 2011. http://www.eureca.manchester.ac.uk/newsletters/cases/thefile,116174,en.pdf
Helgesson, G., J. Dillner, J. Carlson et al. 2007. “Ethical Framework for Previously Collected Biobank Samples.” Nature Biotechnology 25: 973–76.
Hoeyer, K. 2008. “An Opt Out System for Tissue Storage: Lessons from Denmark.” British Medical Journal. Accessed 08 March 2011. http://www.bmj.com/content/337/bmj.a345.abstract/reply
Human Tissue Authority. 2009. “Code of Practice 9: Research.” Accessed 08 March 2011. http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice/code9research.cfm?FaArea1=customwidgets.content_view_1&cit_id=764&cit_parent_cit_id=757
Hunter, D. (Unpublished manuscript) Tis but a Scratch:The Human Tissue Act and the Use of Tissue for Research, Issues for Research Ethics Committees.
Irish Council for Bioethics. 2005. “Human Biological Material: Recommendations for Collection, Use and Storage in Research.” Accessed 08 March 2011: http://www.bioethics.ie/uploads/docs/BiologicalMaterial.pdf.
Junod, V., and B. Elger. 2010. “Retrospective Research: What Are the Ethical and Legal Requirements?” Swiss Medical Weekly 140: w13041.
Knoppers, B. M. 2005. “Biobanking: International Norms.” Journal of Law Medicine and Ethics 33 (1): 7–14.
Knoppers, B. M., and M. Saginur. 2005. “The Babel of Genetic Data Terminology.” Nature Biotechnology 23: 925–27.
Knoppers, B. M., and M. Saginur. 2008. “Bio-Banking.” In The Cambridge Textbook of Bioethics, edited by P. A. Singer and A. M. Viens, 166–73. Cambridge: Cambridge University Press.
Organisation for Economic Co-operation and Development. 2009. “OECD Guidelines on Human Biobanks and Genetic Research Databases.” Accessed 08 March 2011. http://www.oecd.org/dataoecd/41/47/44054609.pdf
Parliament of Estonia. 2005. “Republic of Estonia. Law No. 821 Regarding the Determination of Death’s Cause.” Accessed 08 March 2011. Available in Estonian: http://www.riigiteataja.ee/ert/act.jsp?id=895466
Parliament of Finland. 2001. “Republic of Finland. Act No 101/2001 on the Medical Use of Human Organs and Tissues.” Accessed 08 March 2011. http://www.finlex.fi/pdf/saadkaan/E0010101.PDF
Parliament of Latvia. 1992. “Republic of Latvia: Law on the Protection of the Body of Deceased Human Beings and the Use of Human Tissues and Organs in Medicine.” Accessed 08 March 2011. http://www.vvc.gov.lv/advantagecms/LV/tulkojumi/dokumenti.html?currentPage=11
Parliament of Norway. 2008. “Kingdom of Norway: Act No 44 on Medical and Health Research.” Accessed 08 March 2011. http://www.ub.uio.no/ujur/ulovdata/lov-20080620-044-eng.pdf
Parliament of the United Kingdom. 2004. “The United Kingdom: The Human Tissue Act.” Accessed 08 March 2011. http://www.legislation.gov.uk/ukpga/2004/30/contents?view=plain
Porteri, C., and P. Borry. 2008. “A Proposal for a Model of Informed Consent for the Collection, Storage and Use of Biological Materials for Research Purposes.” Patient Education and Counseling 71: 136–42.
Petrini, C. 2010. “ ‘Broad’ Consent, Exceptions to Consent and the Question of Using Biological Samples for Research Purposes Different from the Initial Collection Purpose.” Social Science & Medicine 70: 217–20.
Price, D. 2005. “The Human Tissue Act 2004.” Modern Law Review 68 (5): 798–821.
Salvaterra, E., Lecchi, L., Giovanelli, S., et al. 2008. “Banking Together: A Unified Model of Informed Consent for Biobanking.” EMBO Report 9 (4): 307–13.
Seimas of the Republic of Lithuania. 2000. “Republic of Lithuania: Law on Ethics of Biomedical Research.” Accessed 08 March 2011. http://www3.lrs.lt/pls/inter3/dokpaieska.showdoc_e?p_id=148740
Stegmayr, B., and K. Asplund. 2002. “Informed Consent for Genetic Research on Blood Stored for More than a Decade: A Population Based Study.” British Medical Journal 325: 634–35.
Swiss Parliament. 2009. “Swiss Confederation: The Draft of Swiss Federal Law on Human Research.” Accessed 08 March 2011. Available in German at: http://www.bag.admin.ch/themen/medizin/00701/00702/07558/index.html?lang=de
Tarini, B. A., W. Burke, C. R. Scott et al. 2008. “Waiving Informed Consent in Newborn Screening Research: Balancing Social Value and Respect.” American Journal of Medical Genetics Part C (Seminars in Medical Genetics) 148C: 23–30.
UK Biobank. 2010. “Information Leaflet.” Accessed 08 March 2011. http://www.ukbiobank.ac.uk/docs/BIOINFOBK14920410.pdf
UNESCO. 2008. “Report of the International Bioethics Committee of UNESCO (IBC) ON CONSENT.” Accessed 08 March 2011. http://unesdoc.unesco.org/images/0017/001781/178124e.pdf
Uranga, A. M., M. C. Martín-Arribas, J. H. di Donato et al. 2005. “Outstanding Legal and Ethical Issues on Biobanks: An Overview on the Regulations of Member States of the EuroBioBank Project.” Accessed 08 March 2011. http://www.eurobiobank.org/en/intranet/workflow/uploadDir/PDFmarcadoresEUROBIOBANK-ING.pdf
van Veen, E. B. 2006. “Human Tissue Bank Regulations.” Nature Biotechnology 24: 496–97.
van Veen, E. B., P. H. J. Riegman, W. N. M. Dinjens et al. 2006. “TuBaFrost 3: Regulatory and Ethical Issues on the Exchange of Residual Tissue for Research Across Europe.” European Journal of Cancer 42: 2914–23.
Vermeulen, E., M. K. Schmidt, N. K. Aaronson et al. 2009. “Obtaining ‘Fresh’ Consent for Genetic Research with Biological Samples Archived 10 Years Ago.” European Journal of Cancer 45: 1168–74.
Wendler, D. 2006. “One Time General Consent for Research on Biological Samples.” British Medical Journal 332: 544–47.
World Medical Association. 2008. “Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects (Helsinki: 1964; amended Tokyo: 1975; Venice: 1983; Hong Kong: 1989; Republic of South Africa: 1996; Edinburgh: 2000; Washington: 2002; Tokyo: 2004; Seoul: 2008).” Accessed 08 March 2011. http://www.wma.net/en/30publications/10policies/b3/index.html
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Gefenas, E., Dranseika, V., Cekanauskaite, A., Serepkaite, J. (2011). Research on Human Biological Materials: What Consent Is Needed, and When. In: Lenk, C., Sándor, J., Gordijn, B. (eds) Biobanks and Tissue Research. The International Library of Ethics, Law and Technology, vol 8. Springer, Dordrecht. https://doi.org/10.1007/978-94-007-1673-5_7
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DOI: https://doi.org/10.1007/978-94-007-1673-5_7
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