From consent to institutions: Designing adaptive governance for genomic biobanks

Social Science and Medicine

Volumn 73, Issue 3, 2011, Pages 367-374

  O'Doherty, Kieran C ^a   Burgess, Michael M ^b   Edwards, Kelly ^c   Gallagher, Richard P ^d   Hawkins, Alice K ^b   Kaye, Jane ^e   McCaffrey, Veronica ^f   Winickoff, David E ^g  

^a UNIVERSITY OF GUELPH   (Canada)

^b UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^c UNIVERSITY OF WASHINGTON   (United States)

^d BRITISH COLUMBIA CANCER AGENCY   (Canada)

^e UNIVERSITY OF OXFORD   (United Kingdom)

^f HEALTH CANADA   (Canada)

^g UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

Biobanks; British Columbia; Canada; Governance; Health research; Public engagement; Publics; Research participants; Trust

Indexed keywords

GOVERNANCE APPROACH; HEALTH CARE; PUBLIC HEALTH; RESEARCH;

ADAPTIVE ENVIRONMENTAL MANAGEMENT; ARTICLE; BIOBANKS; GENOMICS; HEALTH CARE FACILITY; HEALTH CARE QUALITY; HEALTH PROMOTION; HUMAN; INFORMED CONSENT; PATTERN RECOGNITION; TRUST;

BRITISH COLUMBIA; CANADA;

EID: 79960699766     PISSN: 02779536     EISSN: 18735347     Source Type: Journal    
DOI: 10.1016/j.socscimed.2011.05.046     Document Type: Article

References (59)

1. Anderlik M. Commercial biobanks and genetic research: ethical and legal issues. American Journal of Pharmacogenomics 2003, 3:203-215.
2. Asslaber M., Zatloukal K. Biobanks: transnational, European and global networks. Briefings in Functional Genomics and Proteomics 2007, 6:193-201.
3. Avard D., Bucci L.M., Burgess M.M., Kaye J., Heeney C., Cambon-Thomsen A. Public health genomics (PHG) and public participation: points to consider. Journal of Public Deliberation 2009, 5:2-21.
4. Bjorn G. Barriers set up to protect genome databases. Nature Medicine 2008, 14:996.
5. Borugian M.J., Robson P., Fortier I., Parker L., McLaughlin J., Knoppers B.M., et al. The Canadian partnership for tomorrow project: building a pan-Canadian research platform for disease prevention. Canadian Medical Association Journal (CMAJ) 2010, Advance Online Publication. 10.1503/cmaj.091540.
6. Buchanan D., Sifunda S., Naidoo N., James S., Reddy P. Assuring adequate protections in international health research: a principled justification and practical recommendations for the role of community oversight. Public Health Ethics 2008, 1:246-257.
7. Burgess M.M., Brunger F. Negotiating collective acceptability of health research. The governance of health research involving human subjects 2000, 117-151. Law Commission of Canada, Ottawa. M. McDonald (Ed.).
8. Burgess M., O'Doherty K., Secko D. Biobanking in British Columbia: discussions of the future of personalized medicine through deliberative public engagement. Personalized Medicine 2008, 5:285-296.
9. Cambon-Thomsen A. The social and ethical issues of post-genomic human biobanks. Nature Genetics 2004, 5:866-873.
10. Cambon-Thomsen A., Rial-Sebbag E., Knoppers B.M. Trends in ethical and legal frameworks for the use of human biobanks. European Respiratory Journal 2007, 30:373-382.
11. Castle D., Culver K. Public engagement, public consultation, innovation and the market. The Integrated Assessment Journal 2006, 6(2):137-152.
12. Caulfield T., McGuire A.L., Cho M., Buchanan J.A., Burgess M.M., Danilczyk U., et al. Research ethics recommendations for whole-genome research: consensus statement. PLOS Biology 2008, 6:73.
13. Collins F.S., Green E.D., Guttmacher A.E., Guyer M.S. A vision for the future of genomics research. Nature 2003, 422:835-847.
14. Emanuel E.J., Wendler D., Grady C. What makes clinical research ethical?. Journal of the American Medical Association (JAMA) 2000, 283(20):2701-2711.
15. Foster M.W., Sharp R.R., Freeman W.L., Chino M., Bernsten D., Carter T.H. The role of community review in evaluating the risks of human genetic variation research. American Journal of Human Genetics 1999, 64:1719-1727.
16. Graham J., Amos B., Plumptre T. Principles for good governance in the 21st century 2003, Policy Brief No. 15, Institute On Governance, Ottawa.
17. Haddow G., Laurie G., Cunningham-Burley S., Hunter K.G. Tackling community concerns about commercialisation and genetic research: a modest interdisciplinary proposal. Social Science & Medicine 2007, 64:272-282.
18. Hansson M.G., Dillner J., Bartram C.R., Carlson J.A., Helgesson G. Should donors be allowed to give broad consent to future biobank research?. Lancet Oncology 2006, 7:266-269.
19. Hansson M.G. Ethics and biobanks. British Journal of Cancer 2009, 100:8-12.
20. Hawkins A.K., O'Doherty K.C. Biobank governance: a lesson in trust. New Genetics and Society 2010, 29(3):311-327.
21. Hofmann B. Broadening consent and diluting ethics?. Journal of Medical Ethics 2009, 35:125-129.
22. Hofmann B., Solbakk J.H., Holm S. Consent to biobank research: one size fits all?. Ethics of research biobanking 2009, 3-23. Springer, New York. J.H. Solbakk, S. Holm, B. Hofmann (Eds.).
23. Homer N., Szelinger S., Redman M., Duggan D., Tembe W., Muehling J., et al. Resolving individuals contributing trace amounts of DNA to highly complex mixtures using high-density SNP genotyping microarrays. PLoS Genetics 2008, 4:e1000167.
24. Statement on benefit-sharing. Clinical Genetics 2002, 58:364-366. HUGO Ethics Committee.
25. Hunter K.G., Laurie G. Involving publics in biobank governance: Moving beyond existing approaches. The governance of genetic information: Who decides? 2009, 151-177. Cambridge University Press, Cambridge. H. Widdows (Ed.).
26. Integrating ethics and science in the international HapMap project. Nature Review Genetics 2004, 5:467-475. International HapMap Consortium.
27. Irwin A. Constructing the scientific citizen: science and democracy in the biosciences. Public Understanding of Science 2001, 10:1-18.
28. Juengst E.T. Commentary: what community review can and cannot do. The Journal of Law, Medicine & Ethics 2000, 28:52-54.
29. Kaiser J. Biobanks. Population databases boom, from Iceland to the U.S. Science 2002, 298:1158-1161.
30. Kass N.E. Public health ethics: from foundations and frameworks to justice and global public health. Journal of Law and Medical Ethics 2004, 32:232-242.
31. Kaye J., Stranger M. Principles and practice in biobank governance 2009, Ashgate, Farnham, UK.
32. Lowrance W.W., Collins F.S. Identifiability in genomic research. Science 2007, 317:600-602.
33. Lemke A.A., Wolf W.A., Hebert-Beirne J., Smith M.E. Public and biobank participant attitudes toward genetic research participation and data sharing. Public Health Genomics 2010, 13(6):368-377.
34. Ludman E.J., Fullerton S.M., Spangler L., Trinidad S.B., Fujii M.M., Jarvik G.P., et al. Glad you asked: participants' opinions of re-consent for dbGap data submission. Journal of Empirical Research on Human Research Ethics 2010, 5(3):9-16.
35. Luhmann N. Familiarity, confidence, trust: Problems and alternatives. Trust: Making and breaking cooperative relations 2000, 94-107. Oxford University Press, Oxford. D. Gambetta (Ed.).
36. Lunshof J.E., Chadwick R., Vorhaus D.B., Church G.M. From genetic privacy to open consent. Nature Reviews Genetics 2008, 9(5):406-411.
37. Maschke K.J. Navigating an ethical patchwork-human gene banks. Nature Biotechnology 2005, 23:539-545.
38. McGuire A.L., Beskow L.M. Informed consent in genomics and genetic research. Annual Review of Genomics and Human Genetics 2010, 11:361-381.
39. McGuire A.L., Burke W. An unwelcome side effect of direct-to-consumer personal genome testing: raiding the medical commons. Journal of the American Medical Association (JAMA) 2008, 300:2669-2671.
40. Mello M.M., Wolf L.E. The Havasupai Indian Tribe case - Lessons for research involving stored biologic samples. New England Journal of Medicine 2010, 363:204-207.
41. O'Doherty K., Burgess M. Engaging the public on biobanks: outcomes of the BC biobank deliberation. Public Health Genomics 2009, 12:203-215.
42. O'Doherty, K., Hawkins, A., & Burgess, M. (Unpublished results). Involving citizens in the ethics of biobank research: informing policy through structured public deliberation. Manuscript in preparation.
43. O'Doherty K.C., Hawkins A. Structuring public engagement for effective input in policy development on human tissue biobanking. Public Health Genomics 2010, 13:197-206.
44. Ohm P. Broken promises of privacy: responding to the surprising failure of anonymization. University of Colorado Law Legal Studies Research Paper 2009, No. 09:12.
45. Oosterhuis J.W., Coebergh J.W., van Veen E.B. Tumour banks: well-guarded treasures in the interest of patients. Nature Reviews Cancer 2003, 3(1):73-77.
46. Ormond K.E., Cirino A.L., Helenowski I.B., Chisholm R.L., Wolf W.A. Assessing the understanding of biobank participants. American Journal of Medical Genetics A 2009, 149A(2):188-198.
47. Pullman D., Arbour L. Genetic research and culture: Where does the offense lie?. The ethics of cultural appropriation 2009, 115-139. Blackwell, Hoboken, NJ. J.O. Young, C.G. Brunke (Eds.).
48. Reardon J. ). Race to the finish: Identity and governance in an age of genomics 2005, Princeton University Press, Princeton.
49. Riegman P.H.J., Morente M.M., Betsou F., de Blasio P., Geary P. Biobanking for better healthcare. Molecular Oncology 2008, 2(3):213-222.
50. Rowe G., Frewer L.J. A typology of public engagement mechanisms. Science, Technology & Human Values 2005, 30(2):251-290.
51. Rynning E. Legal challenges and strategies in the regulation of research biobanking. Ethics of research biobanking 2009, 277-313. Springer, New York. J.H. Solbakk, S. Holm, B. Hofmann (Eds.).
52. Solbakk J.H., Holm S., Hofmann B. Ethics of research biobanking 2009, Springer, New York.
53. Swede H., Stone C.L., Norwood B.A. National population-based biobanks for genetic research. Genetics in Medicine 2007, 9:141-149.
54. Terry S. Learning genetics. Health Affairs 2003, 22:166-171.
55. Trinidad S.B., Fullerton S.M., Ludman E.J., Jarvik G.P., Larson E.B., Burke W. Research ethics. Research practice and participant preferences: the growing gulf. Science 2011, 331(6015):287-288.
56. Genetic databases: Socio-ethical issues in the collection and use of DNA 2004, Routledge, London. R. Tutton, O. Corrigan (Eds.).
57. Winickoff D.E. Partnership in U.K. biobank: a third way for genomic property?. Journal of Law, Medicine & Ethics 2007, 35(3):440-456.
58. Winickoff D. From benefit sharing to power sharing: Partnership governance in population genomics research. Principles and practice in biobank governance 2009, 53-66. Ashgate, Farnham. J. Kaye, M. Stranger (Eds.).
59. Yarborough M., Fryer-Edwards K., Geller G., Sharp R.R. Transforming the culture of biomedical research from compliance to trustworthiness: insights from nonmedical sectors. Academic Medicine 2009, 84(4):472-477.