Informed Consent to Collect, Store and Use Human Biological Materials for Research Purposes

An International Framework
  • Mariaelena Salvaterra
Conference paper
Part of the Veröffentlichungen des Instituts für Deutsches, Europäisches und Internationales Medizinrecht, Gesundheitsrecht und Bioethik der Universitäten Heidelberg und Mannheim book series (IMGB, volume 33)


The increased buildup of human biobanks developed out a need for rethinking traditional research ethics. In particular, the advancement of research using samples of human origin (namely body fluids, cells, tissues, intra-cellular substance, DNA) calls for the definition of a new model of informed consent appropriate to biobank research.

Even though some recent studies doubt the importance attributed to informed consent, the international debate on ethical and legal aspects of research using human biospecimens and associated data focuses on consent as the priority issue of biobanking research.

This paper contains a review of the international ethical and legal framework of consent requisites for retrospective and prospective research using biobank samples. Critical terms and definitions are examined to show that different standards and recommendations concerning informed consent are present at regional, national and international levels. Additionally, different contexts in which a waiver of informed consent can be accepted are discussed and the question of criteria for future regulations is raised. The ultimate aim of this paper is to highlight that there is no unified recommendation concerning the type of consent that should be sought among patients interested in biobanking research at present. Accordingly, the review concludes by calling for a specific biobanking research ethics to deal with the meta-ethical questions raised by informed consent appropriately.


International Debate Broad Consent Consent Model Human Biological Material Human Genome Organisation 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.


  1. Bernice, SE., Caplan, AL. (2006). Consent and anonymization in research involving biobanks. EMBO Reports, 7, 1-6Google Scholar
  2. Council for International Organisations of Medical Sciences (2002). International Ethical Guidelines for Biomedical Research Involving Human Subjects. Accessed 12 June 2007Google Scholar
  3. Council of Europe (2005). Additional Protocol to the Convention on Human Rights and Biomedicine Concerning Biomedical Research. Accessed 21 May 2007Google Scholar
  4. Council of Europe (2006). Recommendation Rec (2006) 4 on research on biological materials of human origin. Accessed 20 June 2007Google Scholar
  5. Deschenes, M., Cardinal, G., Knoppers, BM., et al. (2001). Human Genetic Research, DNA banking and consent: a question of ‘form’?. Clin Genet59, 221-239Google Scholar
  6. Engelhardt, HT. (1996). The Foundations of Bioethics. New York: Oxford University PressGoogle Scholar
  7. Hoeyer, K., Olofsson, BO., Mjorndal T et al. (2005). The Ethics of research using biobanks. Reason to question the importance attributed to informed consent,. Arch Intern Med. 165, 97-100Google Scholar
  8. EMEA CHMP (2005). Concept paper on the development of a guideline on biobank issues relevant to pharmacogenetics. Accessed 23 April 2007Google Scholar
  9. Knoppers, BM. (2005). Consent Revisited: Points to Consider. Health Law Review2/3, 33-38Google Scholar
  10. Loft, S., Poulsen, He. (1996). Cancer risk and oxidative DNA damage in man. J Mol Med. 74, 297-312Google Scholar
  11. Maschke, KJ. (2005). Navigating an ethical patchwork – human gene banks. Nature Biotechnology. 5, 539-545Google Scholar
  12. Merz, JF. (2003). On the intersection of privacy, consent, commerce and genetics research, in: BM Knoppers, ed., Populations and genetics: Legal Socio-Ethical Perspectives. New York: Kluwer Legal Int’l, 2003, 257-268Google Scholar
  13. National Bioethics Advisory Commission. (1999). Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, in: Vol. I. Rockville, MD, USAGoogle Scholar
  14. The Human Genome Organisation. (1998). The HUGO Ethics Committee, Statement on Dna Sampling Accessed 11 September 2007Google Scholar
  15. Thomas, HM. (2006). Key issues and questions in research with human biological materials. Accessed 1 September 1 2007Google Scholar
  16. United Nations Educational, Scientific and Cultural Organization. (1997). The Universal Declaration on the Human Genome and Human Rights. Accessed 12 September 2007Google Scholar
  17. World Health Organisation. (1998). Proposed International Guidelines on Ethical Issues in Medical Genetics and Genetic Services. Accessed 24 June 2007Google Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 2012

Authors and Affiliations

  • Mariaelena Salvaterra
    • 1
  1. 1.University of MilanoMilanoItaly

Personalised recommendations