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Incorporating Exclusion Clauses into Informed Consent for Biobanking

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1 Weir RF, Olick RS. The Stored Tissue Issue. New York: Oxford University Press; 2004.

2 Johnsson L, Hansson MG, Eriksson S, Helgesson G. Patients’ refusal to consent to storage and use of samples in Swedish biobanks: Cross sectional study. British Medical Journal 2008;337:a345. Forsberg JS, Eriksson S, Hansson MG. Changing defaults in biobank research could save lives too. European Journal of Epidemiology2010;25(2):65–8.

3 Annas G. Rules for research on human genetic variation—Lessons from Iceland. New England Journal of Medicine2000;342(24):1830–3.

4 Murphy J, Scott J, Kaufman D, Geller G, LeRoy L, Hudson K. Public perspectives on informed consent for biobanking. American Journal of Public Health 2009;99(12):2128–34. Vermeulen E, Schmidt MK, Aaronson NK, Kuenen M, van Leeuwen FE. Obtaining “fresh” consent for genetic research with biological samples archived 10 years ago. European Journal of Cancer 2009;45(7):1168–74. Kaufman DJ, Murphy-Bollinger J, Scott J, Hudson KL. Public opinion about the importance of privacy in biobank research. The American Journal of Human Genetics2009;85(5):643–54.

5 Anderson R, O’Hare M, Balls M, Brady M, Brahams D, Burt A, et al. The availability of human tissue for biomedical research: The report and recommendations of the ECVAM workshop 32. Alternatives to Laboratory Animals 1998;26(6):763–77. Knoppers BM. Biobanks: Simplifying consent. Nature Reviews Genetics 2004;5(7):485. Elger BS, Caplan AL. Consent and anonymization in research involving biobanks: Differing terms and norms present serious barriers to an international framework. EMBO Reports2006;7(7):661–6.

6 Knoppers BM. Consent revisited: Points to consider. Health Law Review 2005;13(2–3):33–8. Hansson MG, Dillner J, Bartram CR, Carlson JA, Helgesson G. Should donors be allowed to give broad consent to future biobank research? Lancet Oncology 2006;7(3):266–9. Petrini C. “Broad” consent, exceptions to consent and the question of using biological samples for research purposes different from the initial collection purpose. Social Sciences and Medicine2010;70(2):217–20.

7 Lilleyman J. Consent in the practice of haematology. British Journal of Haematology 2001;115(4):782–5. Malone T, Catalano P, O’Dwyer P, Giantonio B. High rate of consent to bank biologic samples for future research: The eastern cooperative oncology group experience. Journal of the National Cancer Institute 2002;94(10):769–71. Furness PN, Nicholson ML. Obtaining explicit consent for the use of archival tissue samples: Practical issues. Journal of Medical Ethics 2004;30(60):561–4. Williams G, Schroeder D. Human genetic banking: Altruism, benefit and consent. New Genetics and Society 2004;23(1):89–103. Chen D, Rosenstein D, Muthappan P, Hilsenbeck S, Miller F, Emanuel E, et al. Research with stored biological samples: What do research participants want? Archives of Internal Medicine 2005;165(6):652–5. Pentz RD, Billot L, Wendler D. Research on stored biological samples: Views of African American and White American cancer patients. American Journal of Medical Genetics Part A 2006;140(7):733–9. Wendler D. One-time general consent for research on biological samples. British Medical Journal 2006;332(7540):544–7. Hansson MG. For the safety and benefit of current and future patients. Pathobiology 2007;74(4):198–205. Macilotti M, Izzo U, Pascuzzi G, Barbareschi M. Legal aspects of biobanks. Pathologica 2008;100(2):86–115. Lipworth W, Morrell B, Irvine R, Kerridge I. An empirical reappraisal of public trust in biobanking research: Rethinking restrictive consent requirements. Journal of Law and Medicine 2009;17(1):119–32. Treweek S, Doney A, Leiman D. Public attitudes to the storage of blood left over from routine general practice tests and its use in research. Journal of Health Services Research and Policy 2009;14(1):13–9. Hansson MG. Building on relationships of trust in biobank research. Journal of Medical Ethics 2005;31(7):415–8. Helgesson G, Dillner J, Carlson J, Bartram CR, Hansson MG. Ethical framework for previously collected biobank samples. Nature Biotechnology2007;25(9):973–6.

8 Greely HT. Breaking the stalemate: A prospective regulatory framework for unforeseen research uses of human tissue samples and health information. Wake Forest Law Review 1999;34(3):737–66. Caulfield T, Upshur R, Daar A. DNA databanks and consent: A suggested policy option involving an authorization model. BMC Medical Ethics 2003;4:E1. Andrews LB. Harnessing the benefits of biobanks. Journal of Law, Medicine and Ethics 2005;33(1):22–30. Caulfield T. Biobanks and blanket consent: The proper place of the public good and public perception rationales. King’s Law Journal 2007;18(2):209–26. Hofmann B. Broadening consent—and diluting ethics? Journal of Medical Ethics 2009;35(2):125–9. Greely HT. To the barricades! American Journal of Bioethics 2010;10(9):1–2. Caulfield T, Ries NM. Consent, privacy and confidentiality in longitudinal, population health research: The Canadian legal context. Health Law Journal2003;11:1–59.

9 National Bioethics Advisory Commission. Research Involving Human Biological Materials: Ethical Issues and Policy Guidance. Vol. 1. Rockville, MD: National Bioethics Advisory Committee; 1999. Hansson SO. The ethics of biobanks. Cambridge Quarterly of Healthcare Ethics 2004;13(4):319–26. Salvaterra E, Lecchi L, Giovanelli S, Butti B, Bardella MT, Bertazzi PA, et al. Banking together: A unified model of informed consent for biobanking. EMBO Reports2008;9(4):307–13.

10 Shickle D. The consent problem within DNA biobanks. Studies in History and Philosophy of Biological and Biomedical Sciences2006;37(3):503–19.

11 Wertz DC. Archived specimens: A platform for discussion. Community Genetics 1999;2(2–3):51–60. Sharp RR, Foster MW. An analysis of research guidelines on the collection and use of human biological materials from American Indian and Alaskan Native communities. Jurimetrics 2002;42(2):165–86. Helft PR, Champion VL, Eckles R, Johnson CS, Meslin EM. Cancer patients’ attitudes toward future research uses of stored human biological materials. Journal of Empirical Research on Human Research Ethics2007;2(3):15–22. See note 9, National Bioethics Advisory Commission 1999. See also note 9, Salvaterra et al. 2008.

12 Botkin JR. Informed consent for genetic research. Current Protocols in Human Genetics Chapter 2010;1:Unit 1.16.

13 Schwartz B. The Paradox of Choice. New York: Harper Collins; 2004.

14 Skene L. Patients’ rights or family responsibilities? Two approaches to genetic testing. Medical Law Review 1998;6(1):1–41. Winickoff DE, Winicoff RN. The charitable trust as a model for genomic biobanks. New England Journal of Medicine 2003;349(12):1180–4. Thasler WE, Schlott T, Kalkuhl A, Plän T, Irrgang B, Jauch KW, et al. Human tissue for in vitro research as an alternative to animal experiments: A charitable “honest broker” model to fulfil ethical and legal regulations and to protect research participants. Alternatives to Laboratory Animals 2006;34(4):387–92. Harmon SHE. Semantic, pedantic or paradigm shift? Recruitment, retention and property in modern population biobanking. European Journal of Health Law2009;16(1):27–43.

15 See note 12, Botkin 2010.

16 Godard B, Ozdemir V, Fortin M, Égalité N. Ethnocultural community leaders’ views and perceptions on biobanks and population specific genomic research: A qualitative research study. Public Understanding of Science 2010;19(4):469–85. Lemke A, Wolf WA, Hebert-Beirne J, Smith ME. Public and biobank participant attitudes toward genetic research participation and data sharing. Public Health Genomics 2010;13(6):368–77. Trinidad SB, Fullerton SM, Bares JM, Jarvik GP, Larson EB, Burke W. Genomic research and wide data sharing: Views of prospective participants. Genetics in Medicine2010;12(8):486–95.

17 Fong M, Braun KL, Chang R. Native Hawaiian preferences for informed consent and disclosure of results from research using stored biological specimens. Pacific Health Dialogue 2004;11(2):154–9. Mello MM, Wolf LE. The Havasupai Indian tribe case—lessons for research involving stored biologic samples. New England Journal of Medicine2010;363(3):204–7.

18 Caulfield T, Rachul C, Nelson E. Biobanking, consent, and control: A survey of Albertans on key research ethics issues. Biopreservation and Biobanking2012;10(5):433–8. See note 16, Lemke et al. 2010. See also note 16, Trinidad et al. 2010.

19 See note 17, Mello, Wolf 2010.

20 Doerr A. Newborn bloodspot litigation: 70 days to destroy 5+ million samples. Genomics Law Report 2010; available at http://www.genomicslawreport.com/index.php/2010/02/02/newborn-blood-spot-litigation-70-days-to-destroy-5-million-samples(last accessed 1 Oct 2011).

21 Texas Civil Rights Project. Parents Sue Texas Health Dept. and Texas A&M over Infant Blood Databank; 2009; available at http://www.texascivilrightsproject.org/?p=1096(last accessed 1 Oct 2011).

22 Master Z, Nelson E, Murdoch B, Caulfield T. Biobanks, consent and claims of consensus. Nature Methods2012;9(9):885–8.

23 Allen C, Foulkes WD. Qualitative thematic analysis of consent forms used in cancer genomic sequencing. BMC Medical Ethics2011;12:14.

24 See note 8, Greely 2010.

We are grateful to Professor Timothy Caulfield, Drs. Bill Schrader and Bruce Androphy, and the anonymous reviewer for insightful comments on the manuscript. This research was supported in part by a generous grant from the Cancer Stem Cell Consortium, the AllerGen Network, the Interdisciplinary Chronic Disease Collaboration, and the Stem Cell Network. The majority of the work for this paper was done while ZM was at the Health Law and Science Policy Group at the University of Alberta. This research is also the work product of an employee or group of employees of the National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH); however, the statements, opinions, or conclusions contained herein do not necessarily represent those of NIEHS, NIH, or the U.S. government.

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Cambridge Quarterly of Healthcare Ethics
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