Active choice but not too active: Public perspectives on biobank consent models

Genetics in Medicine

Volumn 13, Issue 9, 2011, Pages 821-831

  Simon, Christian M ^a   L'Heureux, Jamie ^a   Murray, Jeffrey C ^a   Winokur, Patricia ^a   Weiner, George ^a,b   Newbury, Elizabeth ^c   Shinkunas, Laura ^a   Zimmerman, Bridget ^d  

^a UNIVERSITY OF IOWA   (United States)

^b UNIVERSITY OF IOWA HOSPITALS AND CLINICS   (United States)

^c E11 SSH   (United States)

^d UNIVERSITY OF IOWA   (United States)

Author keywords

biobank; consent models; public perspectives

Indexed keywords

ADULT; AGED; ATTITUDE; BIOBANK CONSENT MODEL; CONTROLLED STUDY; FEMALE; HEALTH CARE FACILITY; HEALTH SURVEY; HUMAN; INFORMATION PROCESSING; INFORMED CONSENT; KNOWLEDGE; MALE; MEDICAL RESEARCH; PUBLIC OPINION; REVIEW;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; BIOLOGICAL SPECIMEN BANKS; FEMALE; FOCUS GROUPS; HUMANS; INFORMED CONSENT; MALE; MENTAL COMPETENCY; MIDDLE AGED; PUBLIC OPINION; UNITED STATES;

EID: 80052573480     PISSN: 10983600     EISSN: 15300366     Source Type: Journal    
DOI: 10.1097/GIM.0b013e31821d2f88     Document Type: Review

References (46)

1. Watson PH, Wilson-McManus JE, Barnes RO, et al. Evolutionary concepts in biobanking-the BC BioLibrary. J Transl Med 2009;7:95.
2. Maschke KJ. Biobanks: DNA and research. In: Crowley M, editor. From birth to death and bench to clinic: the Hastings Center bioethics briefing book for journalists, policymakers, and campaigns. Garrison, NY: The Hastings Center, 2008:11-14.
3. Business Insights Ltd. The future of biobanks: regulation, ethics, investment and the humanization of drug discovery, 2009. Available at: http://www. globalbusinessinsights.com/content/rbdd0026m.pdf. Accessed February 14, 2011.
4. Hoeyer K. Donors perceptions of consent to and feedback from biobank research: time to acknowledge diversity? Public Health Genomics 2010;13: 345-352.
5. Elger BS, Caplan AL. Consent and anonymization in research involving biobanks: differing terms and norms present serious barriers to an international framework. EMBO Rep 2006;7:661-666. (Pubitemid 43986258)
6. U.S. Department of Health and Human Services, 2009. 45 C.F.R. 46.102(f). Available at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html# 46.102. Accessed February 14, 2011.
7. Office for Human Research Protections. 2008. Guidance on research involving coded private information or biological specimens. Available at: http://www.hhs.gov/ohrp/policy/cdebiol.html. Accessed February 14, 2011.
8. Rothwell E, Anderson R, Botkin J. Policy issues and stakeholder concerns regarding the storage and use of residual newborn dried blood samples for research. Policy Polit Nurs Pract 2010;11:5-12.
9. Koontz JI, Haithcock D, Cumbea V, et al. Rationale and design of the Duke Electrophysiology Genetic and Genomic Studies (EPGEN) biorepository. Am Heart J 2009;158:719-725.
10. Goldenberg AJ, Hull SC, Botkin JR, Wilfond BS. Pediatric biobanks: approaching informed consent for continuing research after children grow up. J Pediatr 2009;155:578-583.
11. Pulley J, Clayton E, Bernard GR, Roden DM, Masys DR. Principles of human subjects protections applied in an opt-out, de-identified biobank. Clin Transl Sci 2010;3:42-48.
12. Roden DM, Pulley JM, Basford MA, et al. Development of a large-scale de-identified DNA biobank to enable personalized medicine. Clin Pharmacol Ther 2008;84:362-369.
13. Biobank uses opt-out approach to gathering blood samples. IRB Advisor 2010;10:91-92.
14. Junghans C, Feder G, Hemingway H, Timmis A, Jones M. Recruiting patients to medical research: double blind randomised trial of "opt-in" versus "opt-out" strategies. BMJ 2005;331:940.
15. Rogers CG, Tyson JE, Kennedy KA, Broyles RS, Hickman JF. Conventional consent with opting in versus simplified consent with opting out: an exploratory trial for studies that do not increase patient risk. J Pediatr 1998;132: 606-611. (Pubitemid 28194578)
16. Simon CM, Kodish ED. Step into my zapatos, doc: understanding and reducing communication disparities in the multicultural informed consent setting. Perspect Biol Med 2005;48(suppl 1):S123-S138.
17. Sachs GA, Hougham GW, Sugarman J, et al. Conducting empirical research on informed consent: challenges and questions. IRB 2003;suppl 25:S4-S10.
18. Murphy J, Scott J, Kaufman D, Geller G, LeRoy L, Hudson K. Public perspectives on informed consent for biobanking. Am J Public Health 2009;99:2128-2134.
19. Winickoff DE, Winickoff RN. The charitable trust as a model for genomic biobanks. N Engl J Med 2003;349:1180-1184. (Pubitemid 37122332)
20. Caulfield T, McGuire AL, Cho M, et al. Research ethics recommendations for whole-genome research: consensus statement. PLoS Biol 2008;6:e73.
21. Deschenes M, Cardinal G, Knoppers BM, Glass KC. Human genetic research, DNA banking and consent: a question of 'form'? Clin Genet 2001; 59:221-239. (Pubitemid 32318388)
22. Beleno v. Texas Department of State Health Services, SA-09-CA-188 (U.S. Dist. Ct., W.D. Tex.(2009).
23. Harmon A. Indian tribe wins fight to limit research of its DNA. New York Times, April 21, 2010:A1.
24. Hansson MG, Dillner J, Bartram CR, Carlson JA, Helgesson G. Should donors be allowed to give broad consent to future biobank research? Lancet Oncol 2006;7:266-269. (Pubitemid 43286456)
25. Rumball S, McCall Smith A. Human genetic data: preliminary study by the IBC on its collection, processing, storage and use. Paris: UNESCO, International Bioethics Committee (IBC), 2002. Available at: http://unesdoc. unesco.org/images/0012/001235/123522e.pdf. Accessed February 14, 2011.
26. World Health Organization. Proposed international guidelines on ethical issues in medical genetics and genetic services. Geneva: World Health Organization, Human Genetics Programme 1997. Available at: http://www. who.int/genomics/publications/en/ethicalguidelines1998.pdf. Accessed February 14, 2011.
27. Inside information: balancing interests in the use of personal genetic data. A summary report by the Human Genetics Commission, 2002. Available at: http://www.hgc.gov.uk/UploadDocs/DocPub/Document/insideinformation-summary.pdf. Accessed February 14, 2011.
28. Hohmann E, O'Rourke P, Stayn S. Advanced tissue (biospecimen) banking. Paper presented at Public Responsibility in Medicine and Research (PRIM&R). San Diego, CA, December 6-8, 2010.
29. Haga SB, Beskow LM. Ethical, legal, and social implications of biobanks for genetics research. Adv Genet 2008;60:505-544.
30. McGuire AL, Hamilton JA, Lunstroth R, McCullough LB, Goldman A. DNA data sharing: research participants' perspectives. Genet Med 2008;10: 46-53.
31. Cambon-Thomsen A, Rial-Sebbag E, Knoppers BM. Trends in ethical and legal frameworks for the use of human biobanks. Eur Respir J 2007;30: 373-382. (Pubitemid 47194191)
32. Secko DM, Preto N, Niemeyer S, Burgess MM. Informed consent in biobank research: a deliberative approach to the debate. Soc Sci Med 2009;68:781-789.
33. Ludman EJ, Fullerton SM, Spangler L, et al. Glad you asked: participants' opinions of re-consent for dbGap data submission. J Empir Res Hum Res Ethics 2010;5:9-16.
34. Lemke AA, Wolf WA, Hebert-Beirne J, Smith ME. Public and biobank participant attitudes toward genetic research participation and data sharing. Public Health Genomics 2010;13:368-377.
35. Willison DJ, Swinton M, Schwartz L, et al. Alternatives to project-specific consent for access to personal information for health research: insights from a public dialogue. BMC Med Ethics 2008;9:18.
36. Tupasela A, Sihvo S, Snell K, Jallinoja P, Aro AR, Hemminki E. Attitudes towards biomedical use of tissue sample collections, consent, and biobanks among Finns. Scand J Public Health 2010;38:46-52.
37. McCarty CA, Wilke RA, Giampietro PF, Westbrook SD, Caldwell MD. Marshfield Clinic Personalized Medicine Research Project (PMRP): design, methods and recruitment for a large population-based biobank. Personalized Med 2005;2:49-79.
38. Kitzinger J. Qualitative research. Introducing focus groups. BMJ 1995;311: 299-302.
39. Krueger RA. Focus groups: a practical guide for applied research, 2nd ed. Thousand Oaks, CA: Sage Publications, 1994.
40. Genesys Sampling Systems, 1987-2011. Available at: http://www.genesys- sampling.com/home.aspx. Accessed February 14, 2011
41. The American Association for Public Opinion Research. Standard definitions: final dispositions of case codes and outcome rates for surveys, 4th ed. Ann Arbor, MI: AAPOR, 2006.
42. Allen J, McNamara B. Reconsidering the value of consent in biobank research. Bioethics 2011;25:155-166.
43. Vermeulen E, Schmidt MK, Aaronson NK, et al. A trial of consent procedures for future research with clinically derived biological samples. Br J Cancer 2009;101:1505-1512.
44. Beskow LM, Burke W, Merz JF, et al. Informed consent for population-based research involving genetics. JAMA 2001;286:2315-2321. (Pubitemid 33063154)
45. Beskow LM, Linney KN, Radtke RA, Heinzen EL, Goldstein DB. Ethical challenges in genotype-driven research recruitment. Genome Res 2010;20: 705-709.
46. Fleming JM. Biobanks: professional, donor and public perceptions of tissue banks and the ethical and legal challenges of consent, linkage and the disclosure of research results [PhD thesis]. Institute for Molecular Science, The University of Queensland, 2007.