Respecting Autonomy Over Time: Policy and Empirical Evidence on Re-Consent in Longitudinal Biomedical Research

Bioethics

Volumn 30, Issue 3, 2016, Pages 210-217

  Wallace, Susan E ^a   Gourna, Elli G ^a   Laurie, Graeme ^b   Shoush, Osama ^a   Wright, Jessica ^c  

^a UNIVERSITY OF LEICESTER   (United Kingdom)

^b UNIVERSITY OF EDINBURGH   (United Kingdom)

^c UNIVERSITY OF SHEFFIELD   (United Kingdom)

Author keywords

Autonomy; Biobank; Consent; Policy; Re consent

Indexed keywords

BIOBANK; ETHICS; HUMAN; INFORMED CONSENT; MEDICAL RESEARCH; METHODOLOGY; PERSONAL AUTONOMY; PERSONNEL; STANDARDS; TISSUE BANK;

BIOLOGICAL SPECIMEN BANKS; BIOMEDICAL RESEARCH; HUMANS; INFORMED CONSENT; PERSONAL AUTONOMY; RESEARCH DESIGN; RESEARCH PERSONNEL; TISSUE BANKS;

EID: 84958754694     PISSN: 02699702     EISSN: 14678519     Source Type: Journal    
DOI: 10.1111/bioe.12165     Document Type: Article

References (50)

1. European Science Foundation. 2007. Shared Responsibilities in Sharing Research Data: Policies and Partnerships. Available at: http:// www.esf.org/fileadmin/Public_documents/Publications/ SharingData_01.pdf [Cited 2014 May 10].
2. E.J. Ludman, S.M. Fullerton, L. Spangler, S.B. Trinidad, M.M. Fujii, G.P. Jarvik, et al. Glad you Asked: Participants' Opinions of Re-consent for Dbgap Data Submission. J Empir Res Hum Res Ethics 2010; 5: 9-16, p.12.
3. Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada. Tri-Council Policy Statement - Ethical Conduct for Research Involving Humans. 2010, p.33-34.
4. Council for International Organizations of Medical Science. International ethical guidelines for biomedical research involving human subjects. Available at http://www.cioms.ch/publications/layout_guide2002 .pdf [Accessed 20 November 2014].
5. Office for Human Research Protections. Informed Consent. Available at: http://www.hhs.gov/ohrp/policy/consentckls.html [Accessed 10 May 2014].
6. Organization for Economic Cooperation Development. OECD Guidelines on Human Biobanks and Genetic Research Databases. Eur J Health Law 2010; 17: 191-204, p.198.
7. Council of Europe. Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research. 2005 Available at: http://conventions.coe.int/Treaty/en/Treaties/Html/ 195.htm [Accessed 24 November 2014].
8. Gazzetta Ufficiale n. 52 del 2-3-2012. Available at: http:// www.altalex.com/index.php?idnot=17432 [Cited 2014 January 29].
9. Department of Health and Human Services, Federal Policy for the Protection of Human Subjects ('Common Rule'), 45 CFR 46.116(d). 2009 Available at: http://www.hhs.gov/ohrp/humansubjects/ commonrule/ [Cited 2014 May 5].
10. Global Alliance for Genomics and Health. 2014. Available at: http:// www.globalalliancepr.org/ [Cited 2014 June19].
11. M.F.A. Otlowski. Tackling Legal Challenges Posed By Population Biobanks: Reconceptualising Consent Requirements. Med Law Rev 2012; 20: 191-126.
12. G. Laurie & E. Postan. Rhetoric or Reality: What is the Legal Status of the Consent Form in Health-Related Research? Med Law Rev 2013; 21: 371-414, p.371-372.
13. B.E. Ellerin, R.J. Schneider, A. Stern, P.G. Toniolo & S.C. Formenti. Ethical, Legal, and Social Issues Related to Genomics and Cancer Research: the Impending Crisis. J Am Coll Radiol 2005; 2: 919-926.
14. M.A. Igbe & C.A. Adebamowo. Qualitative Study of Knowledge and Attitudes to Biobanking Among Lay Persons in Nigeria. BMC Medical Ethics 2012; 13
15. A.L. McGuire, T. Caulfield & M.K. Cho, Science and Society - Research Ethics and the Challenge of Whole-Genome Sequencing. Nature reviews Genetics 2008; 9: 152-156.
16. J. Murphy, J. Scott, D. Kaufman, G. Geller, L. LeRoy & K. Hudson. Public Perspectives on Informed Consent for Biobanking. Am J Public Health 2009; 99: 2128-2134.
17. S.B. Trinidad, S.M. Fullerton, E.J. Ludman, G.P. Jarvik, E.B. Larson and W. Burke. Research ethics. Research Practice and Participant Preferences: the Growing Gulf. Science 2011; 331: 287-288
18. V. Arnason. Scientific citizenship, benefit, and protection in population-based research. Ethics Res Biob 2009: 131-141.
19. T. Caulfield, A.L. McGuire, M. Cho, et al. Research ethics recommendations for Whole-Genome Research: Consensus Statement. PLoS Biology 2008; 6: 73
20. C.A. McCarty, A. Garber, J.C. Reeser & N.C. Fost. Personalized Med Res P, Ethics Security Advisory B. Study Newsletters, Community and Ethics Advisory Boards, and Focus Group Discussions Provide Ongoing Feedback for a Large Biobank. Am J Med Genet A 2011; 155A: 737-741.
21. O.F. Bathe & A.L. McGuire. The Ethical Use of Existing Samples for Genome Research. Genet Med 2009; 11: 712-715
22. K.L. Edwards, A.A. Lemke, S.B. Trinidad, et al. Attitudes Toward Genetic Research Review: Results from a Survey of Human Genetics Researchers. Public health genomics 2011; 14: 337-345.
23. M.G. Hansson. Building on Relationships of Trust in Biobank Research. J Med Ethics 2005; 31: 415-418
24. International Cancer Genome Consortium. Goals, Structure, Policies and Guidelines 2008. Available at: https://icgc.org/icgc/goals-structure-policies-guidelines [Accessed 15 February 2014].
25. K.S. Steinsbekk & B. Solberg. Biobanks-When is Re-consent Necessary? Public Health Ethics 2011; 4: 236-250.
26. M. DeCamp & J. Sugarman. Ethics in Behavioral Genetics Research. Account Res 2004; 11: 27-47.
27. Z. Master, J.O. Claudio, C. Rachul, J.C. Wang, M.D. Minden & T. Caulfield. Cancer Patient Perceptions on the Ethical and Legal Issues Related to Biobanking. BMC Med Genomics 2013; 6: 8, p.1.
28. T.L. Beauchamp. Informed Consent: its History, Meaning, and Present Challenges. Camb Q Healthc Ethics 2011; 20: 515-523.
29. L. Barnes, F.E. Matthews, B. Barber, L. Davies, D. Lloyd, C. Brayne, et al. Brain Donation For Research: Consent and Re-Consent Post Alder Hey. Bull Med Ethics 2005; 211: 17-21.
30. C. Cooper & R. Eeles. ICGC First Annual Report: Prostate Cancer 2013.
31. E. Vermeulen, M.K. Schmidt, N.K. Aaronson, M. Kuenen & F.E. van Leeuwen. Obtaining 'Fresh' Consent for Genetic Research with Biological Samples Archived 10 Years Ago. Eur J Cancer 2009; 45: 1168-1174.
32. J. Holmen, K. Midthjell, O Krüger, A. Tverdal, T. Claudi, A. Bjorndal, et al. The Nord-Trøndelag Health Study 1995-97 (HUNT 2): Objectives, Contents, Methods and Participation. Norsk Epid 2003; 13: 19-32.
33. B. Stegmayr & K. Asplund. Informed Consent for Genetic Research on Blood Stored for More Than a Decade: a Population Based Study. BMJ 2002; 325: 634-635.
34. J. Kaye, P. Boddington, J. de Vries, N. Hawkins & K. Melham. Ethical implications of the use of whole genome methods in medical research. Eur J Hum Genet 2010; 18: 398-403.
35. H.K. Tabor, T. Brazg, J. Crouch, E.E. Namey, S.M. Fullerton, L.M. Beskow, et al. Parent Perspectives on Pediatric Genetic Research and Implications For Genotype-Driven Research Recruitment. J Empir Res Hum Res Ethics 2011; 6: 41-52.
36. L. Johnsson, M.G. Hansson, S. Eriksson & G. Helgesson. Patients' Refusal to Consent to Storage and Use of Samples in Swedish Biobanks: Cross Sectional Study. BMJ 2008; 337: 345.
37. E. Schadt, S. Woo & K. Hao. Bayesian Method to Predict Individual SNP Genotypes from Gene Expression Data. Nat Genet 2012; 44: 603- 608.
38. D. Beyleveld & D. Townend. When is Personal Data Rendered Anonymous? Interpreting Recital 26 of Directive 95/46/EC. Med Law Int 2004; 6: 73-86.
39. D. Wendler & E. Emanuel. The Debate over Research on Stored Biological Samples: What do Sources Think? Arch Intern Med 2002; 162: 1457-1462
40. G. Haddow, A. Bruce, S. Sathanandam, J.C. Wyatt. 'Nothing is Really Safe': a Focus Group Study on the Processes of Anonymizing and Sharing of Health Data for Research Purposes. J Eval Clin Pract 2010; 17: 1140-1146.
41. T. Caulfield & B.M. Knoppers. Consent, Privacy & Research Biobanks - Policy Brief No. 1. Genome Canada; 2010.
42. G. Gibson & G.P. Copenhaver. Consent and Internet-Enabled Human Genomics. PLoS Genet. 2010; 6.
43. J. Kaye, E.A. Whitley, D. Lund, M. Morrison, H. Teare & K. Melham. Dynamic Consent: a Patient Interface for Twenty-First Century Research Networks. Eur J Hum Genet 2014.
44. S.M. Fullerton, N.R. Anderson, G. Guzauskas, D. Freeman, K. Fryer-Edwards. Meeting the Governance Challenges of Next- Generation Biorepository Research. Science Tran Med 2010; 2: 15cm13
45. N. Anderson, C. Bragg, A. Hartzler & K. Edwards. Participant-Centric Initiatives: Tools to Facilitate Engagement in Research. Appl Transl Genomics 2012; 1: 25-29
46. C.M. Simon, J.K. Williams, L. Shinkunas, D. Brandt, S. Daack-Hirsch & M. Driessnack. Informed Consent and Genomic Incidental Findings: IRB Chair Perspectives. J Empir Res Hum Res Ethics 2011; 6: 53-67.
47. J.M. Oliver, M.J. Slashinski, T. Wang, P.A. Kelly, S.G. Hilsenbeck & A.L. McGuire. Balancing the Risks and Benefits of Genomic Data Sharing: Genome Research Participants' Perspectives. Public Health Genomics 2012; 15: 106-114.
48. A. Tupasela, A. Sihvo, K. Snell, P.A. Jallinoja, A.R. Aro, et al. Attitudes Towards Biomedical Use of Tissue Sample Collections, Consent, and Biobanks Among Finns. Scand J Public Health 2010; 38: 46-52
49. C.M. Halverson & L.F. Ross. Incidental Findings of Therapeutic Misconception in Biobank-Based Research. Genet Med 2012; 14(6): 611-615.
50. M. Dixon-Woods, R.E. Ashcroft, C.J. Jackson, et al. Beyond 'Misunderstanding': Written Information and Decisions about Taking Part in a Genetic Epidemiology Study. Soc Sci Med 2007; 65: 2212-2222.