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Commercial Biobanks and Genetic Research

Ethical and Legal Issues

  • Bioethics
  • Published:
American Journal of Pharmacogenomics

Abstract

Human biological material is recognized as an important tool in research, and the demand for collections that combine samples and data is increasing. For-profit companies have assumed a leading role in assembling and managing these collections. The emergence of commercial biobanks has raised significant ethical and legal issues.

The growing awareness of the importance of human biological material in research has been accompanied by a growing awareness of the deficiencies of existing archives of tissue. Commercial biobanks are attempting to position themselves as a, if not the, solution to problems that include a lack of public trust in researchers and lack of financial resources to support the prospective creation of collections that meet the highest scientific and ethical standards in the non-profit sector.

Broad social and policy questions surrounding the operation of commercial biobanks have been raised however. International documents, in particular, suggest discomfort with the idea of gain from the mere transfer or exchange of human genetic material and information. Commercial involvement in the development of useful products from tissue is generally not condemned, so long as there is attention to scientific and social norms. Views on the acceptability of commercial biobanks vary.

Specific issues that arise when commercial biobanks are permitted — in the areas of consent, recruitment, confidentiality, and accountability — are also relevant to the operation of public and private, non-profit biobanks. Although many uncertainties remain, consensus seems to be forming on a number of issues. For example, there appears to be agreement that blanket consent to future unspecified research uses, with no conditions, is unacceptable. Indeed, many of the leading commercial biobanks have been attentive to concerns about consent, recruitment, and confidentiality. Unfortunately, the binding nature of assurances in these areas is unclear, especially given the risk of insolvency. Hence, accountability may be the most important area of concern in relation to commercial biobanks. A few countries have enacted general legislation providing for comprehensive regulation of biobanks, for example, through licensure. Efforts to achieve harmonization of standards at the international level, and cautions against an approach that focuses on biobanking for genetic research alone, are to be applauded.

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Notes

  1. 1 ‘Participant’ is gaining favor as a term to describe those enrolled in research. However, ’subject’ is used in current US research regulations, and the term’s connotation of passivity may be appropriate for individuals whose participation in research is limited to the supply of tissue and information. Also, in this article, ‘donor’ is used rather than the more generic ’source’, although it should be noted that in cases where tissue is used without consent the donor is a conscript.

References

  1. Wade N. Scientist reveals secret of genome: it’s his. New York Times 2002 Apr 27, Sect A: 1

    Google Scholar 

  2. Yeoh E, Ross ME, Shurtleff SA, et al. Classification, subtype discovery, and prediction of outcome in pediatric acute lymphoblastic leukemia by gene expression profiling. Cancer Cell 2002; 1: 133–43

    Article  PubMed  CAS  Google Scholar 

  3. Pomeroy SL, Tamayo P, Gaasenbeek M, et al. Prediction of central nervous system embryonal tumour outcome based on gene expression. Nature 2002; 415: 436–42

    Article  PubMed  CAS  Google Scholar 

  4. van de Vijver MJ, He YD, van’t Veer LJ, et al. A gene-expression signature as a predictor of survival in breast cancer. N Engl J Med 2002; 347: 1999–2009

    Article  PubMed  Google Scholar 

  5. Fellay J, Marzolini C, Meaden ER, et al. Response to antiretroviral treatment in HIV-1-infected individuals with allelic variants of the multidrug resistance transporter 1: a pharmacogenetics study. Lancet 2002; 359: 30–6

    Article  PubMed  CAS  Google Scholar 

  6. Tukey RH, Strassburg CP, Mackenzie PI. Pharmacogenomics of human UDP-glucuronosyltransferases and irinotecan toxicity. Mol Pharmacol 2002; 62: 446–50

    Article  PubMed  CAS  Google Scholar 

  7. Arranz MJ, Collier D, Kerwin RW. Pharmacogenetics for the individualization of psychiatric treatment. Am J Pharmacogenomics 2002; 1: 3–10

    Article  Google Scholar 

  8. Korn D. Contribution of the human tissue archive to the advancement of medical knowledge and the public health. In: National Bioethics Advisory Commission. Research involving human biological materials: ethical issues and policy guidance. Vol. II. Rockville (MD): National Bioethics Advisory Commission, 1999: E1–E30

    Google Scholar 

  9. Cavalli-Sforza LL, Wilson AC, Cantor CR, et al. Call for a world-wide survey of human genetic diversity: a vanishing opportunity for the human genome project. Genomics 1991; 11: 490–1

    Article  PubMed  CAS  Google Scholar 

  10. Greely HT. Human genome diversity: what about the other human genome project? Nat Rev Genet 2001; 2: 222–7

    Article  PubMed  CAS  Google Scholar 

  11. Caspi A, McClay J, Moffitt TE, et al. Role of genotype in the cycle of violence in maltreated children. Science 2002; 297: 851–4

    Article  PubMed  CAS  Google Scholar 

  12. Sauter G, Simon R. Predictive molecular pathology. N Engl J Med 2002; 347: 1995–6

    Article  PubMed  Google Scholar 

  13. Laage-Hellman J. The industrial use of biobanks in Sweden: an overview. In: Hansson MG, editor. The use of human biobanks: ethical, social, economical and legal aspects. Uppsala, Sweden: Uppsala University, 2001: 15–34 [online]. Available from URL: http://www.bioethics.uu.se/biobanks-report.html/ [Accessed 2002 Aug 30]

    Google Scholar 

  14. Clayton EW, Steinberg KK, Khoury MJ, et al. Informed consent for genetic research on stored tissue samples. JAMA 1995; 274: 1786–92

    Article  PubMed  CAS  Google Scholar 

  15. Garver KL, Garver B. The human genome project and eugenic concerns. Am J Hum Genet 1994; 54: 148–58

    PubMed  CAS  Google Scholar 

  16. Duster T. Backdoor to eugenics. New York: Routledge, 1990

    Google Scholar 

  17. Rothstein MA, editor. Pharmacogenomics: social, ethical, and clinical dimensions. Hoboken (NJ): Wiley-Liss, 2003: 3–27

    Google Scholar 

  18. Dalton R. Tribe blasts ‘exploitation’ of blood samples [letter]. Nature 2002; 420: 111

    Article  PubMed  CAS  Google Scholar 

  19. Balancing privacy and biotechnology [editorial]. Business Week 2002 Apr 15; 126

  20. Merz JF, Sankar P, Taube SE, et al. Use of human tissues in research: clarifying clinician and researcher roles and information flows. J Investig Med 1997; 45: 252–7

    PubMed  CAS  Google Scholar 

  21. Ashburn TT, Wilson SK, Eisenstein BI. Human tissue research in the genomic era of medicine. Arch Intern Med 2000; 160: 3377–84

    Article  PubMed  CAS  Google Scholar 

  22. Roche PA, Annas GJ. Protecting genetic privacy. Nat Rev Genet 2001; 2: 392–6

    Article  PubMed  CAS  Google Scholar 

  23. Robertson JA. Consent and privacy in pharmacogenetic testing. Nat Genet 2001; 28: 207–9

    Article  PubMed  CAS  Google Scholar 

  24. Buchanan A, Califano A, Kahn J, et al. Pharmacogenetics: ethical issues and policy options. Kennedy Inst Ethics J 2002; 12: 1–15

    Article  PubMed  Google Scholar 

  25. Rosenberg R. Questions still linger on heart study access. Boston Globe 2001 Apr 21, Sect D: 4

    Google Scholar 

  26. Niiler E. Collapse of Framingham data deal highlights lack of cooperative model. Nat Biotechnol 2001 Feb; 19: 103

    Article  PubMed  CAS  Google Scholar 

  27. Office of Technology Assessment. New developments in biotechnology: 1. Ownership of human tissues and cells. Washington, DC: US Congress, 1987

    Google Scholar 

  28. Moore v. Regents of University of California, 793 P.2d 479 (Cal. 1990), cert. denied, 499 U.S. 936 (1991)

  29. Gorner P. Parents suing over patenting of genetic test. Chicago Tribune 2000 Nov 19, Sect C: 1

    Google Scholar 

  30. United Nations Educational, Scientific, and Cultural Organization (UNESCO). Universal declaration on the human genome and human rights, 1997 Nov 11 [online]. Available from URL: http://www.unesco.org/ibc/en/genome/ [Accessed 2002 Dec 16]

  31. Knoppers BM. Status, sale and patenting of human genetic material: an international survey. Nat Genet 1999; 22: 23–5

    Article  PubMed  CAS  Google Scholar 

  32. Knoppers BM. Biotechnology: sovereignty and sharing. In: Caulfield TA, Williams-Jones B, editors. The commercialization of genetic research: ethical, legal, and policy issues. New York: Kluwer, 1999: 1–11

    Google Scholar 

  33. National Bioethics Advisory Committee. Research involving human biological materials: ethical issues and policy guidance. Vol. I. Rockville (MD): National Bioethics Advisory Commission, 1999

    Google Scholar 

  34. Hirtle M, Knoppers BM, Lormeau S. Banking of human materials, intellectual property rights and ownership isues: emerging trends in the literature and international policy positions. Law Hum Gen Rev 1997; 6: 63–83

    Google Scholar 

  35. Council of Europe. Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine: convention on human rights and biomedicine. Oviedo 1997 Apr 4 [online]. Available from URL: http://conventions.coe.int/treaty/en/treaties/html/164.htm [Accessed 2002 Dec 16]

    Google Scholar 

  36. Hansson M. In the interests of efficiency and integrity. In: Hansson MG, editor. The use of human biobanks: ethical, social, economical and legal aspects. Uppsala, Sweden: Uppsala University, 2001: 35–40 [online]. Available from URL: http://www.bioethics.uu.se/biobanks-report.html/ [Accessed 2002 Aug 30]

    Google Scholar 

  37. Bioethics Advisory Committee, Israel Academy of Sciences and Humanities. Population-based large-scale collections of DNA samples and databases of genetic information, 2002 Oct. In: Matthiessen L, editor. Survey on opinions from national ethics committees or similar bodies, public debate and national legislation in relation to human biobanks. Brussels: European Commission Research Directorate-General, 2002 Oct: 1–25

    Google Scholar 

  38. Nuffield Council on Bioethics. Human tissue: ethical and legal issues. London: Nuffield Council on Bioethics, 1995

    Google Scholar 

  39. Raeburn P. Pieces of you: how the business works. Business Week 2002 Apr 15, 76

    Google Scholar 

  40. Ardais Corporation. What people ask (Q and A) [online]. Available from URL: http://www.ardais.com/qanda.html [Accessed 2001 Nov 7]

  41. Cyranoski D. Share and share alike? Nature 2002; 420: 602–4

    Article  PubMed  CAS  Google Scholar 

  42. Ready T. Teaching hospitals to share tissue with industry. Nat Med 2000; 6: 1072

    Article  PubMed  CAS  Google Scholar 

  43. Human Genome Organization Ethics Committee. Statement on benefit-sharing, 2000 [online]. Available from URL: http://www.gene.ucl.ac.uk/hugo/benefit.html/ [Accessed 2002 Dec 16]

  44. Schissel A, Merz JF, Cho MK. Survey confirms fears about licensing of genetic tests [letter]. Nature 1999; 402: 118

    Article  PubMed  CAS  Google Scholar 

  45. DNA Sciences Gene Trust. The Gene Trust bill of rights [online]. Available from URL: http://www.dna.com/ [Accessed 2002 Jun 24]

  46. Merz JF, Magnus D, Cho MK, et al. Protecting subjects’ interests in genetics research. Am J Hum Genet 2002; 70: 965–71

    Article  PubMed  Google Scholar 

  47. Trials of war criminals before the Nuremberg Military Tribunals under Control Council Law No. 10. Vol. 2. Washington, DC: US Government Printing Office, 1949: 181–2

  48. Grimes v. Kennedy Krieger Institute, 366 Md. 29, 782 A.2d 807 (Md 2001)

  49. Campbell A, Glass KC. The legal status of clinical and ethics policies, codes, and guidelines in medical practice and research. McGill Law J 2001; 46: 473–89

    PubMed  CAS  Google Scholar 

  50. US Department of Health and Human Services. Federal policy for the protection of human subjects (basic DHHS policy for protection of human research subjects). Title 45 Code of Federal Regulations, Part 46, Subpart A, revised 2001 Nov 13

    Google Scholar 

  51. Food and Drug Administration, US Department of Health and Human Services. Protection of human subjects. Title 21 Code of Federal Regulations, Parts 50 and 56, revised 1998 Apr 1998

    Google Scholar 

  52. US Department of Health and Human Services, Basic HHS Policy for Protection of Human Subjects, 45 C.F.R. § 46.101(b)(4)

  53. National Institutes of Health. Research on human specimens: are you conducting research using human subjects?. [online]. Available from URL: http://www-cdp.ims.nci.nih.gov/brochure.html [Accessed 2002 Dec 16]

  54. US Department of Health and Human Services, Basic HHS Policy for Protection of Human Subjects, 45 C.F.R. § 46.116(d)

  55. Spallone P, Wilkie T. The research agenda in pharmacogenetics and biological sample collections: a view from the Wellcome Trust. New Genet Soc 2000; 19: 193–205

    Article  Google Scholar 

  56. Dahl v. HEM Pharmaceuticals Corp, 7 F.3d 1399 (9th Cir. 1993)

  57. Deschenes M, Cardinal G, Knoppers BM, et al. Human genetic research, DNA banking and consent: a question of ‘form’? Clin Genet 2001; 59: 221–39

    Article  PubMed  CAS  Google Scholar 

  58. Office for Human Research Protections. Guidance topics by subject [online]. Available from URL: http://ohrp.osophs.dhhs.gov/g-topics.htm/ [Accessed 2002 Dec 16]

  59. OPRR guidance concerning operation of human cell repositories under Department of Health and Human Service regulations for the protection of human subjects, 1996 Aug 19 [online]. Available from URL: http://ohrp.osophs.dhhs.gov/humansubjects/guidance/reposit.htm/ [Accessed 2002 Dec 16]

  60. Pentz RD, Young LN, Amos CI, et al. Informed consent for tissue research [letter]. JAMA 1999; 282: 1625

    Article  PubMed  CAS  Google Scholar 

  61. Bohannon J. UK researchers hope for clarity in tissue use. Science 2002; 298: 1867–9

    Article  PubMed  CAS  Google Scholar 

  62. People Science & Policy Ltd. BioBank UK: a question of trust. London: People Science & Policy Ltd, 2002

    Google Scholar 

  63. Dolly firm used woman’s DNA. BBC News 2000 Jul 3. [Formerly available from URL: http://news.bbc.co.uk [Accessed 2000 Jul 4] (copy on file with author)

  64. Wade N. Stem cell mixing may form a human-mouse hybrid. NY Times 2002 Nov 27, Sect A: 21

    Google Scholar 

  65. Wendler D, Emanuel E. The debate over research on stored biological samples: what do sources think? Arch Intern Med 2002; 162: 1457–62

    Article  PubMed  Google Scholar 

  66. Greely HT. Breaking the stalemate: a prospective regulatory framework for unforeseen research uses of human tissue samples and health information. Wake Forest Law Rev 1999; 34: 737–66

    PubMed  CAS  Google Scholar 

  67. N.Y. Civil Rights Law § 79-1 Sect 9, effective 2002 Jan 17

  68. Janssen D. Enhancing research with clinical samples. Genomics Proteomics 2002 Apr 1, 24

    Google Scholar 

  69. First Genetic Trust. Dynamic informed consent [online]. Available at URL: http://www.firstgenetic.net/products_icf.html [Accessed 2002 Jun 7]

  70. Huang J. Maine Medical Center to provide tissue samples for gene research. Portland Press Herald 2001 Oct 16, Sect B: 1

    Google Scholar 

  71. Foubister V. Genetics firms seeking wide patient base. Am Med News 2000 Oct 9 [online]. Available at URL: http://www.ama-assn.org/sci-pubs/amnews/pick_00/hlsc1009.htm [Accessed 2001 Nov 7]

    Google Scholar 

  72. DNA Sciences Gene Trust. Welcome to the Gene Trust Project [online]. Available from URL: http://www.dna.com/ [Accessed 2002 Jun 24]

  73. Ardais Corporation. Role of the donor [online]. Available from URL: http://www.ardais.com/donor_role/role_of_donor.html/ [Accessed 2002 Jun 25]

  74. World Medical Association. Declaration of Helsinki: ethical principles for medical research involving human subjects, 2002 [online]. Available at URL: http://www.wma.net/e/policy/17-c_e.html [Accessed 2002 Dec 16]

  75. US Department of Health and Human Services. Standards for Privacy of Individually Identifiable Information, Final Rule, 65 F.R. 82462 (2000 Dec 28)

  76. US Department of Health and Human Services, Standards for Privacy of Individually Identifiable Information; Final Rule, 67 F.R. 53182 (2002 Aug 14) (codified at Title 45 Code of Federal Regulations, Parts 160 and 164)

  77. US Department of Health and Human Services, Privacy of Individually Identifiable Health Information, 45 C.F.R. § 164.512(i)

  78. Office for Civil Rights, US Department of Health and Human Services, OCR Guidance Explaining Significant Aspects of the Privacy Rule: Research, 2002 Dec 4 [online]. Available from URL: http://www.hhs.gov/ocr/hipaa/priva-cy.html [Accessed 2002 Dec 12]

  79. US Department of Health and Human Services, Privacy of Individually Identifiable Health Information, 45 C.F.R. § 164.514

  80. US Department of Health and Human Services, Privacy of Individually Identifiable Health Information, 45 C.F.R. § 164.532

  81. Krasner J. More than tissue samples collection may become key tool for researchers of disease, drugs. Boston Globe 2001 Oct 24, Sect D: 4

    Google Scholar 

  82. First Genetic Trust. Internal security, internet, third-party audits [online]. Available from URL: http://www.firstgenetic.net/products_internal.html [Accessed 2002 Jun 7]

  83. NIH Office of Extramural Research. Frequently asked questions on Certificates of Confidentiality, 2002 Mar 15 [online]. Available from URL: http://grant-s1.nih.gov/grants/policy/coc/faqs.htm [Accessed 2002 Dec 16]

  84. Silber J. Fremont, Calif.-based genetics research firm withdraws IP. Contra Costa Times 2001 Jul 20

    Google Scholar 

  85. Wells JA, Karr D. Mini-hearings on tissue samples and informed consent. In: National Bioethics Advisory Commission. Research involving human biological materials: ethical issues and policy guidance. Vol. II. Rockville (MD): National Bioethics Advisory Commission, 1999: G1–G53

    Google Scholar 

  86. Rothstein MA. The role of IRBs in research involving commercial biobanks. J Law Med Ethics 2002; 30: 105–8

    Article  PubMed  Google Scholar 

  87. US Department of Health and Human Services, Basic HHS Policy for Protection of Human Subjects, 45 C.F.R. § 46.116

  88. OPRR, Cooperative Oncology Group Chairpersons. “Exculpatory language” in informed consent, 1996 Nov 15 [online]. Available from URL: http://ohrp.osophs.dhhs.gov/humansubjects/guidance/exculp.htm [Accessed 2002 Jun 24]

  89. European Parliament and European Council. Directive on the legal protection of biotechnological inventions [online]. Official J Eur Communities 1998: L213/13. Available from URL: http://europa.eu.int/eurlex/pri/en/oj/dat/1998/l_213/1_21319980730en00130021.pdf [Accessed 2002 Jun 6]

    Google Scholar 

  90. Human cell lines auctioned in Japan by court. Eubios Ethics Institute Daily News 2001 Oct 26 [online]. Formerly available from URL: http://www.biol.t-sukuba.ac.jp/~macer/DAILY/eeid54.htm [Accessed 2001 Oct 31] (on file with author)

  91. Hawkins D. Keeping secrets. US News World Report 2002 Dec 2; 133: 58–60

    Google Scholar 

  92. Genaisse snaps up DNA Sciences. GenomiKa 2003 Apr 9, 1

  93. Dickerson M. From jeans to genes: the evolving nature of property of the estate. Bank Dev J 1999; 15: 285–319

    Google Scholar 

  94. Robertson J. Ethical and legal issues in genetic biobanking. In: Knoppers BM, editor. Population and genetics: legal socio-ethical perspectives. New York: Kluwer. In press

  95. Ad Hoc Committee on Individual Identification by DNA Analysis, American Society of Human Genetics. Individual identification by DNA analysis: points to consider. Am J Hum Genet 1991; 46: 631–4

    Google Scholar 

  96. Parliament of Iceland. Act on Biobanks no. 110/2000, passed 2000 May 13, effective 2001 Jan 1 [online]. Available at URL: http://brunnur.stjr.is/interpro/htr/htr.nsf/pages/Act-biobanks [Accessed 2002 Dec 16]

  97. Parliament of Sweden. Act on Biobanks in Health Care bill no. 2001/02: 04, passed 2002 May 16, effective 2003 Jan 1

  98. Winickoff D. The Icelandic healthcare database [letter]. N Engl J Med 2000; 343: 1734

    Article  PubMed  CAS  Google Scholar 

  99. Working Party on Biotechnology, Directorate for Science, Technology and Industry Committee for Scientific and Technological Policy, Organisation for Economic Co-operation and Development. Biological resource centers: underpinning the future of life sciences and biotechnology [online]. Available from URL: http://www.oecd.org/pdf/M00037000/M00037892.pdf [Accessed 2002 Dec 23]

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Acknowledgements

This research was supported by the Office of Science (BER), US Department of Energy, Grant No. DE-FG02-01ER63169. The views expressed are the author’s own and do not represent the opinions or policies of the US Department of Energy.

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  1. Institute for Bioethics, Health Policy and Law, School of Medicine, University of Louisville, 501 E. Broadway, Suite 310, Louisville, Kentucky, 40202, USA

    Mary R. Anderlik

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Anderlik, M.R. Commercial Biobanks and Genetic Research. Am J Pharmacogenomics 3, 203–215 (2003). https://doi.org/10.2165/00129785-200303030-00006

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