Biobanking and Disclosure of Research Results: Addressing the Tension Between Professional Boundaries and Moral Intuition

  • Lynn G. Dressler


The role of biobanks is changing to accommodate the expanding needs of the research enterprise. In addition to collecting human specimens, many biobanks also collect research results derived from those specimens.With the advent of technologies to screen the whole genome and the inter-relatedness of multiple genes with multiple diseases, research results will increasingly reveal information with health implications for the contributor of the specimen. What is the responsibility of the biobank to communicate these research findings? What are the benchmarks to guide decision-making on a daily basis? Although there is an emerging ethical imperative from international guidelines to communicate research results to the individual, how should these be implemented in practice? The answers to these questions are highly contextual and currently lack standards of reference. This creates tensions between the traditional boundaries of a biobank, as a resource to store specimens, and the moral intuition of the biobank personnel, as gatekeepers to potentially beneficial health information. This chapter explores these tensions and issues of disclosure of research results in the context of biobanking and provides practice recommendations and next steps for policy development.


Research Result Moral Intuition Individual Research Ethical Argument Ethical Duty 
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  1. Annas GJ et al. (1995) Drafting the genetic privacy act: science, policy, and practical considerations. J Law Med Ethics 23:360–366PubMedCrossRefGoogle Scholar
  2. ASHG (1998) ASHG statement. Professional disclosure of familial genetic information. The American Society of Human Genetics Social Issues Subcommittee on Familial Disclosure. Am J Hum Genet 62:474–483Google Scholar
  3. Banks TM (2000) Misusing informed consent: a critique of limitations on research subjects’ access to genetic research results. Sask Law Rev 63:539–580PubMedGoogle Scholar
  4. Bookman EB et al. (2006) Reporting genetic results in research studies: summary and recommendations of an NHLBI working group. Am J Med Genet A 140:1033–1040PubMedGoogle Scholar
  5. CIOMS International Ethical Guidelines for Biomedical Research involving human subjects (2002): nov 2002.htm
  6. CLIA (1988) Public Law No. 100–578, C.R.V. Clinical Laboratory Improvement Amendments Stat. 102 (October 31, 1988). Available from: [Accessed 5-515-2008]
  7. Council of Europe (2005) Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research:
  8. Dressler L (1998) Genetic testing for the BRCA1 gene and the need for protection from discrimination: an evolving legislative and social issue. Int J Breast Dis 10:127–135Google Scholar
  9. Dressler L (2005) Human specimens, cancer research and drug development: How science policy can promote progress and protect research participants. Commissioned paper prepared for the National Cancer Policy Board, Institute of Medicine and Research Council of the National Academies:
  10. Dressler LG (2007) Disclosure of genetic research results: ethical and regulatory perspective. Meeting abstract. Public Responsibility in Medicine and Research (PRIM&R). (October, 2007).Google Scholar
  11. Dressler L, Juengst E (2006) Thresholds and Boundaries in the disclosure of individual genetic research results. Am J Bioethics 6:18–20CrossRefGoogle Scholar
  12. Dressler L et al. (1999) Policy guidelines for the utilization of formalin-fixed, paraffin-embedded tissue sections. The UNC SPORE experience. Breast Cancer Res Treat 58:31–39CrossRefGoogle Scholar
  13. Dugan RB et al. (2003) Duty to warn at-risk relatives for genetic disease: genetic counselors’ clinical experience. Am J Med Genet 119:27–34CrossRefGoogle Scholar
  14. Falk MJ et al. (2003) Medical geneticists’ duty to warn at-risk relatives for genetic disease. Am J Med Genet 120:374–380CrossRefGoogle Scholar
  15. Gert B (2004) Common Morality: Deciding What To Do. Oxford University Press, OxfordCrossRefGoogle Scholar
  16. Grizzle W, Groday W (1999) Recommended policies for uses of human tissue in research, education, and quality control. Arch Pathol Lab Med 123:296–300PubMedGoogle Scholar
  17. Hippocrates. The Hippocratic Oath. National Institutes of Health [cited 5–14–2008]:
  18. Jewell S et al. (2006) Biospecimen banking, standardization and lessons learned from the Cancer and Leukemia Group B Pathology Coordinating Office. Sem Breast Dis 8:93–99CrossRefGoogle Scholar
  19. Knoppers BM et al. (2006) The emergence of an ethical duty to disclose genetic research results: international perspectives. Eur J Hum Genet 14:1170–1178PubMedCrossRefGoogle Scholar
  20. Lugogo NL et al. (2007) Genetic profiling and tailored therapy in asthma: are we there yet? Curr Opin Mol Ther 9:528–537PubMedGoogle Scholar
  21. Lynch HT et al. (1997) A descriptive study of BRCA1 testing and reactions to disclosure of test results. Cancer 79:2219–2228PubMedCrossRefGoogle Scholar
  22. Manolio TA (2006) Taking our obligations to research participants seriously: disclosing individual results of genetic research. Am J Bioethics 6:32–34Google Scholar
  23. MRC (2001) Human tissue and biological samples for use in research – operational and ethical guidelines:
  24. MRC (2004) Human tissue and biological samples for use in research – operational and ethical guidelines:
  25. NAPBC (1997) Model Consent Forms and Related Information on Tissue Banking and Routine Biopsies,With comments by the PRIM&R and ARENA Tissue BankingWorking Group. Letter to Directors/chairpersons and Members, Institutional Review Boards. Public Responsibility in Medicine and Research. National Action Plan on Breast Cancer, National Cancer Institute. Available at:
  26. NBAC (1999) Research involving human biological materials: ethical issues and policy guidance. Vol. 1: Report and Recommendations of the National Bioethics Advisory Commission:
  27. NCI (2007) NCI best practices for biospecimen resources:
  28. NIH (2008) National Institutes of Health. Public Access Frequently Asked Questions. Available at:
  29. Offit K et al. (2004) The “duty to warn” a patient’s family members about hereditary disease risks. JAMA 292:1469–1473PubMedCrossRefGoogle Scholar
  30. OPPR (1993) Human genetic research: issues to consider:
  31. Ossorio PN (2006) Letting the gene out of the bottle: a comment on returning individual research results to participants. Am J Bioethics 6:24–25CrossRefGoogle Scholar
  32. Parker LS (2006) Best laid plans for offering results go awry. Am J Bioethics 6:22–23CrossRefGoogle Scholar
  33. Parker M, Lucassen A (2003) Concern for families and individuals in clinical genetics. J Med Ethics 29:70–73PubMedCrossRefGoogle Scholar
  34. Pate v. Threlkel (1995) 661 So.2d 278 (Fla.), rehearing denied (October 10, 1995)Google Scholar
  35. Pelias MK (2005) Research in human genetics: the tension between doing no harm and personal autonomy. Clin Genet 67:1–5PubMedCrossRefGoogle Scholar
  36. Pullman D, Hodgkinson K (2006) Genetic knowledge and moral responsibility: ambiguity at the interface of genetic research and clinical practice. Clin Genet 69:199–203PubMedCrossRefGoogle Scholar
  37. Ravitsky V, Wilfond BS (2006) Disclosing individual genetic results to research participants. Am J Bioethics 6:8–17CrossRefGoogle Scholar
  38. Renegar G et al. (2006) Returning genetic research results to individuals: points-to-consider. Bioethics 20:24–36PubMedCrossRefGoogle Scholar
  39. Safer v. Estate of Pack (1996) 291 N.J. Super. 619, 677 A.2d 1188 (N.J. Super.App.Div.)Google Scholar
  40. Schilsky R et al. (2002) Cooperative Group Tissue Bank as Research Resources: The Cancer and Leukemia Group B Tissue Repositories. Clinical Cancer Research 8:943–948PubMedGoogle Scholar
  41. UNESCO (2003) International Declaration on Human Genetic Data: UNESCO-the United Nationl Educational, Scientific and Cultural Organization (October 16, 2003). Available at:
  42. Wachbroit R (1998) The question not asked: the challenge of pleiotropic genetic tests. Kennedy Inst Ethics J 8:131–144PubMedCrossRefGoogle Scholar
  43. WHO (2003) Genetic databases: assessing the benefits and impact on human and patient rights [Report]:

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© Springer Science + Business Media, LLC 2009

Authors and Affiliations

  • Lynn G. Dressler
    • 1
  1. 1.Eshelman School of PharmacyUniversity of North Carolina at Chapel HillChapel Hill, NCUSA

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