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Incorporating Exclusion Clauses into Informed Consent for Biobanking

Published online by Cambridge University Press:  14 March 2013


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Bioethics and Biotechnology
Copyright © Cambridge University Press 2013

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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.

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

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15 See note 12, Botkin 2010.

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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 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 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.