What No One Knows Cannot Hurt You: The Limits of Informed Consent in the Emerging World of Biobanking

  • Arthur L. Caplan

Abstract

In thinking about the ethics of biobanking many argue that the core protection of individual dignity and privacy is informed consent. But this doctrine will not and cannot be made to handle the ethical load it is being asked to bear in the realm of biobanking. It is time to shift ethical emphasis to general, broad consent to linked-anonymization through trusted third parties as the best way to ensure the ethical practice of biobanking.

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. American College of Medical Genetics Storage of Genetics Materials Committee (ACMG) (1995) Statement on storage and use of genetic materials. www.genetics.faseb.org/genetics/acmg/pol-17.htm
  2. Andrews LB (2005) Harnessing the benefits of biobanks. J Law Med Ethics 33(1):22–30PubMedCrossRefGoogle Scholar
  3. Caplan AL (2006) Smart Mice, Not-So-Smart Humans. Rowman & Littlefield, Lanham, MDGoogle Scholar
  4. Clayton EW (2005) Informed consent and biobanks. J Law Med Ethics 33(1):15–21PubMedCrossRefGoogle Scholar
  5. Comité Consultatif national d’Ethique pour les sciences de la vie et de la santé. Avis No. 77 (2003) Problèmes éthiques posés par les collections de matériel biologique et les données d’information associées: “biobanques”, “biothèques”:www.ccneethique.fr/francais/pdf/avis077.pdf
  6. Commission de l’é thique de la science et de la technologie (2003) Avis. Les enjeux é thiques des banques d’information génétique: pour un encadrement démocratique et responsable. Quebec. www.ethique.gouv.qc.ca/fr/ftp/AvisBanquesGen.pdf
  7. Deschênes M et al. (2001) Human genetic research, DNA banking and consent: a question of “form”? Clin Genet 59:221–239PubMedCrossRefGoogle Scholar
  8. Elger BS, Caplan AL (2006) Consent and anonymization in research. EMBO Rep 7:661–666PubMedCrossRefGoogle Scholar
  9. European Society of Human Genetics (2003) Data storage and DNA banking for biomedical research: technical, social and ethical issues. Recommendations of the European Society of Human Genetics. Eur J Hum Genet 11 (Suppl 2):S8–S10Google Scholar
  10. Greely HT (2007) The uneasy ethical and legal underpinnings of large-sclae genomic biobanks. Annu Rev Genomics Hum Genet 8:343–364PubMedCrossRefGoogle Scholar
  11. Hoeyer K et al. (2005) The ethics of research using biobanks: reason to question the importance attributed to informed consent. Arch Intern Med 165(1):97–100PubMedCrossRefGoogle Scholar
  12. Kaiser J (2002) Population databases boom. From Iceland to the U.S. Science 298:1158–1161Google Scholar
  13. Kaye J et al. (2004) Population genetic databases: a comparative analysis of the law in Iceland, Sweden, Estonia and the UK. TRAMES 8:15–33Google Scholar
  14. Knoppers BM. (2005) Biobanking: international norms. J Law Med Ethics 33:7–14PubMedCrossRefGoogle Scholar
  15. Knoppers BM, Saginur M(2005) The Babel of genetic data terminology. Nat Biotechnol 23:925–7PubMedCrossRefGoogle Scholar
  16. Medical Research Council, UK (2001) Ethics series. Human tissue and biological samples for use in research. Operational and ethical guidelines. www.mrc.ac.uk/pdf-tissueguidefin.pdf
  17. National Bioethics Advisory Commission (NBAC), United States (1999) Research involving human biological materials: Ethical Issues and Policy Guidance, Report and Recommendations, Vol. 1. Rockville. Available at www.georgetown.edu/research/nrcbl/nbac/hbm.pdf
  18. Nationaler Ethikrat, Germany (2004) Biobanken f¨ur die Forschung. Stellungnahme. Berlin. www.ethikrat.org/themen/pdf/StellungnahmeBiobanken04-03-17.pdf
  19. National Health and Medical Research Council – NHMRC, Australia (1999). Guidelines for gene tic registers and associated genetic material. www7.health.gov.au/nhmrc/publications/files/e14.pdf
  20. Office for Human Research Protections – OHRP, Department of Health and Human Services – HHS (2004) Guidance on research involving coded private information or biological specimens. www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf P3G www.p3gconsortium.org/waghp.cfm
  21. Petersen A (2005) Securing our genetic health: engendering trust in UK Biobank. Sociol Health Illness 27(2): 271–292CrossRefGoogle Scholar
  22. PRIM&R (2007) Report of the PRIM&R Human Tissue/Specimen Banking Working GroupGoogle Scholar
  23. Schneider CE (2005) Some realism about informed consent. J Lab Clin Med 145(6):289–291PubMedCrossRefGoogle Scholar
  24. Schweizer Akademie der Medizinischen Wissenschaften (2005) Biobanken: Gewinnung, Aufbewahrung und Nutzung von menschlichem biologischem Material f¨ur Ausbildung und Forschung. Medizinisch-ethische Richtlinien und Empfehlungen. www.samw.ch
  25. Simon J et al. (2007). A legal framework for biobanking: the German experience. Eur J Hum Genet 15:528–532PubMedCrossRefGoogle Scholar
  26. Trouet C (2004) New European guidelines. J Med Ethics 30(1):99–103PubMedCrossRefGoogle Scholar
  27. UNESCO (2003) International declaration on human genetic dataGoogle Scholar
  28. Washington University v. Catalona. See 2007 WL 1758268 (8th Cir. June 20, 2007)Google Scholar
  29. World Medical Association –WMA (2002). TheWorldMedical Association declaration on ethical considerations regarding health databases. www.wma.net/e/policy/d1.htm

Copyright information

© Springer Science + Business Media, LLC 2009

Authors and Affiliations

  • Arthur L. Caplan
    • 1
  1. 1.Center for BioethicsUniversity of PennsylvaniaPhiladelphia, PAUSA

Personalised recommendations