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Incorporating Exclusion Clauses into Informed Consent for Biobanking

Published online by Cambridge University Press:  14 March 2013

ZUBIN MASTER  and
DAVID B. RESNIK
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Abstract

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Type
Bioethics and Biotechnology
Information
Cambridge Quarterly of Healthcare Ethics , Volume 22 , Issue 2 , April 2013 , pp. 203 - 212
Copyright
Copyright © Cambridge University Press 2013

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References

Notes

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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.