Should donors be allowed to give broad consent to future biobank research?

Large international biobank studies can make substantial contributions to scientific research by validation of the biological importance of previous research and by identification of previously unknown causes of disease. However, regulations for patient consent that are too strict and discrepancies in national policies on informed consent might hinder progress. Therefore, establishment of common ground for ethical review of biobank research is essential. In this essay, broad consent is defined on a scale between strictly specified (eg, for a specific study) and blanket consent (ie, with no restrictions regarding the purpose of the research). Future research includes that which might not be planned or even conceptualised when consent is obtained. In conclusion, broad consent and consent for future research are valid ethically and should be recommended for biobank research provided that: personal information related to research is handled safely; donors of biological samples are granted the right to withdraw consent; and new research studies or changes to the legal or ethical authority of a biobank are approved by an ethics-review board.

[1]  G. Friedman,et al.  Helicobacter pylori infection and the risk of gastric carcinoma. , 1991, The New England journal of medicine.

[2]  M. Lehtinen,et al.  A prospective study of the relationship between prediagnostic Human Papillomavirus seropositivity and HPV DNA in subsequent cervical carcinomas , 2002, British Journal of Cancer.

[3]  D. Spiegelman,et al.  Temporal relationship between elevation of epstein-barr virus antibody titers and initial onset of neurological symptoms in multiple sclerosis. , 2005, JAMA.

[4]  Vilhjalmur Arnason,et al.  Coding and Consent: Moral Challenges of the Database Project in Iceland , 2004, Bioethics.

[5]  M. Ohayon.  Prevalence and risk factors of morning headaches in the general population. , 2004, Archives of internal medicine.

[6]  M. Hansson,et al.  Biobanks as Resources for Health , 2003 .

[7]  T. Beauchamp,et al.  Principles of biomedical ethics , 1991 .

[8]  M. Hansson.  Balancing the quality of consent. , 1998, Journal of medical ethics.

[9]  D. Easton,et al.  Inherited susceptibility to breast cancer. , 1993, Cancer surveys.

[10]  M. Hansson,et al.  Building on relationships of trust in biobank research , 2005, Journal of Medical Ethics.

[11]  B. Stegmayr,et al.  Informed consent for genetic research on blood stored for more than a decade: a population based study , 2002, BMJ : British Medical Journal.

[12]  S. Eriksson,et al.  Potential harms, anonymization, and the right to withdraw consent to biobank research , 2005, European Journal of Human Genetics.

[13]  J. Dillner,et al.  An altered immune response to Epstein-Barr virus in multiple sclerosis , 2004, Neurology.

[14]  K. Hoeyer,et al.  Informed consent and biobanks: a population-based study of attitudes towards tissue donation for genetic research , 2004, Scandinavian journal of public health.

[15]  K. Maschke.  Navigating an ethical patchwork—human gene banks , 2005, Nature Biotechnology.

[16]  Susan Branford,et al.  Frequency of major molecular responses to imatinib or interferon alfa plus cytarabine in newly diagnosed chronic myeloid leukemia. , 2003, The New England journal of medicine.

[17]  R. Kington,et al.  Consent for genetic research in a general population: The NHANES experience , 2003, Genetics in Medicine.

[18]  K. Hoeyer,et al.  The ethics of research using biobanks: reason to question the importance attributed to informed consent. , 2005, Archives of internal medicine.

[19]  E. Emanuel,et al.  Protecting Communities in Biomedical Research , 2000, Science.

[20]  S Holm,et al.  Principles of Biomedical Ethics, 5th edn. , 2002 .

[21]  J. Peto,et al.  Data protection, informed consent, and research , 2004, BMJ : British Medical Journal.

[22]  M. Hansson.  Combining efficiency and concerns about integrity when using human biobanks. , 2006, Studies in history and philosophy of biological and biomedical sciences.

[23]  F. Wiklund,et al.  A population-based seroepidemiological study of cervical cancer. , 1994, Cancer research.

[24]  M. Goodson,et al.  A study of public opinion on the use of tissue samples from living subjects for clinical research , 2004, Journal of Clinical Pathology.