Tackling legal challenges posed by population biobanks: Reconceptualising consent requirements

Medical Law Review

Volumn 20, Issue 2, 2012, Pages 191-226

  Otlowski, Margaret F A ^a  

^a UNIVERSITY OF TASMANIA   (Australia)

Author keywords

Biobanks; Consent; Governance; Research; Trust

Indexed keywords

ARTICLE; AUSTRALIA; GENETICS; HEALTH CARE FACILITY; HUMAN; INFORMED CONSENT; LEGAL ASPECT; TRUST;

AUSTRALIA; GENETIC RESEARCH; HUMANS; INFORMED CONSENT; TISSUE BANKS; TRUST;

EID: 84862243500     PISSN: 09670742     EISSN: 14643790     Source Type: Journal    
DOI: 10.1093/medlaw/fwr035     Document Type: Article

References (180)

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2. National Health and Medical Research Council (NHMRC), Biobanks Information Paper (NHMRC, 2010) 8-9, http://www.nhmrc.gov.au/_files_nhmrc/file/your_health/egenetics/practioners/biobanks_information_paper.pdf. accessed 12 May 2011.
3. Organisation for Economic Co-operation andDevelopment (OECD), Guidelines for Human Biobanks and Genetic Research Databases (OECD, Paris 2009).
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9. T Caulfield, 'Biobanks and Blanket Consent: The Proper Place of the Public Good and Public Perception Rationales' (2007) 18 Kings LJ 209.
10. T Caulfield, R Brown and E Meslin, 'Challenging a Well Established Consent Norm? One Time Consent for Biobank Research' (2007) 4 JIBL 69.
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14. Note, for example, the Academy of Medical Sciences, Report, Personal Data for Public Good: Using Health Information in Medical Research (AMS, London 2006)
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17. NHMRC, n *, 7
18. See also G Laurie and others, 'Managing Access to Biobanks: How Can We Reconcile Individual Privacy and Public Interests in Genetic Research?' (2010) Med L Int'l 315, 320.
19. G Laurie, Genetic Privacy: A Challenge to Medico-Legal Norms (Cambridge University Press, Cambridge 2002) 108.
20. K Barlow-Stewart and others, 'Verification of Consumers' Experience and Perceptions of Genetics Discrimination and its Impact in Utilization of Genetic Testing' (2009) 11 Genet Med 193.
21. ACambon-Thomsen, 'The Social and Ethical Issues of Post-Genomic Human Biobanks' (2004) 5 Nat Rev Genet 866.
22. H Greely, 'Informed Consent and Other Ethical Issues in Human Population Genetics' (2001) 35 Annu Rev Genet 785
23. See, for example, the US Secretary's Advisory Committee on Genetics, Health and Society, Draft Report on Policy Issues Associated with Undertaking a Large US population Cohort Project on Genes, Environment and Disease (United States Department of Health & Human Services, May 2006)
24. See Art 4. Note also the critical discussion as to the uniqueness of genetic information by Laurie, n 17, 92 ff.
25. Tutton and Corrigan, n 1, 1
26. J McHale, 'Regulating Genetic Databases: Some Legal and Ethical Issues' (2004) 12 Med L Rev 70.
27. S Gibbons and others, 'Governing Genetic Databases: Challenges Facing Research Regulation and Practice'(2007) 34 J L Soc'y 163.
28. P Martin, 'Genetic Governance: The Risks, Oversight and Regulation of Genetic Databases in the UK' (2001) 20 New Genetics and Society 157.
29. OECD, Creation and Governance of Human Genetic Research Databases (OECD, Paris 2006).
30. L Gundermann and U Stockter, 'Co-determination of Donors in Biobanks' in Kaye and Stranger, n *, at 69.
31. Campbell, n 14.
32. H Widdows, 'Constructing Communal Models of Governance: Collective of Individuals or Distinct Ethical Loci?' in H Widdows and C Mullen (eds) The Governance of Genetic Information: Who Decides? (Cambridge University Press, Cambridge 2009) 75.
33. Art 1. For discussion, see M Otlowski, 'Key Themes in the Policy Debate on Human Genetic Research and Genetic Databanks: An Evaluation' (2008) 5 JIBL 143.
34. Cambon-Thomsen, n 18; Greely, n 18.
35. Note Sue Weldon's paper urges attention be shifted from purely individualistic concern with respect to informed consent to a broader social terrain based on 'scientific citizenship': see SWeldon, '" Public Consent" or "Scientific Citizenship" What Counts as Public Participation in Population-based DNA Collections?' in Tutton and Corrigan, n 1, 161-180, at 161.
36. OECD, n 2, 9-10 and 29-30 of the Annotations.
37. Hans Somsen, 'Regulating Biobanks: A Preliminary Analysis of Issues', paper presented at the Genomics and Society International Conference: Towards a Socially Robust Science? Amsterdam, The Netherlands, April 2006.
38. See, for example, A Petersen, 'Biobanks' Engagements: Engendering Trust or Engineering Consent?' (2007) 3 Genomics Society Policy 31.
39. For a case study of community attitudes to biobanking in Tonga, Iceland, and the UK which highlights that the degree of public consultation undertaken can have a significant impact on the success of biobank projects, see NHMRC, n 1, 14. The consequences of failure to properly consult in advance are illustrated by the fate of the proposed Tongan biobank, which was to be developed by AutoGen Limited. It was abandoned in the face of strong opposition from church and human rights groups: OECD Report, n 22, 72.
40. H Greely, 'The Uneasy Ethical and Legal Underpinnings of Large-scale Genomic Biobanks' (2007) 8 Annu Rev Genomics Hum Genet 343, 357.
41. See World Medical Association, Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects, para 24
42. J Kegley, 'Challenges to Informed Consent: New Developments in Biomedical Research and Healthcare May Mark the End of the Traditional Concept of Informed Consent' (2004) 5 EMBO Rep 832
43. It should be noted that there are limited circumstances where the requirement for consent can be waived (see, for example, NHMRC, National Statement on Ethical Conduct in Research (NHMRC, 2007) para 2.3.5-2.3.8); this issue is touched on below; however, detailed discussion is beyond the scope of this paper.
44. As I Kennedy and A Grubb point out (Medical Law: Text with Materials (2nd edn Butterworths, London 1994) at 151).
45. Although 'informed consent' is often treated as synonymous with valid consent, this is strictly speaking not so as the requirement that consent be informed is only one, albeit a very important, ingredient of valid consent. Furthermore, this term begs various questions, including how informed is informed?
46. R Chadwick and K Berg, 'Solidarity and Equity: New Ethical Framework for Genetic Databases' (2001) 2 Nat Rev Genet 318.
47. It should be noted that consent issues also arise with established collections, especially where the original purpose was not for research: see D Chalmers and D Nicol, 'Human Genetic Research Databases and Biobanks: Towards Uniform Terminology and Australian Best Practice' (2008) 15 J Law Med 538, 546.
48. This raises questions regarding waiver of consent which is touched on further below. See also NHMRC, n 1, 37-39.
49. A Caplan, 'What No One Knows Cannot Hurt You: The Limits of Informed Consent in the Emerging World of Biobanking' in J Solbakk, S Holm, and B Hofmann (eds), The Ethics of Research Biobanking (Springer, London 2009) 25.
50. Caulfield, Brown and Meslin, n 7.
51. See also M Burgess, 'Proposing Modesty for Informed Consent' (2007) 65 Soc Sci Med 2284.
52. Chadwick and Berg, n 36.
53. ALRC/AHEC, n 6, Ch 15, 422.
54. D Nicol, M Otlowski and D Chalmers, 'Consent, Commercialisation and Benefit Sharing' (2001) 9 J Law Med 80.
55. M Otlowski, 'Donor Perspectives on Issues Associated with Donation of Genetic Samples and Information: An Australian Viewpoint' (2007) 4 J Bioeth Inq 135.
56. See, for example, J Murphy and others, 'Public Perspectives on Informed Consent for Biobanking' (2009) 99 Am J Public Health 2128.
57. C Auffray and others, 'Genome Medicine: Past, Present and Future' (2011) Genome Med 3:6 doi:10.1186/gm220,,http://genomemedicine.com/content/3/1/6..
58. Caulfield, n 7; Caulfield, Brown and Meslin, n 7.
59. D Nicol and C Critchley, 'What Benefit Sharing Arrangements do People Want from Biobanks? A Survey of Public Opinion in Australia' in Kaye and Stranger, n *, 18-31.
60. K Hoeyer and others, 'Informed Consent and Biobanks: A Population-based Study of Attitudes Towards Tissue Donation for Genetic Research' (2004) 32 Scand J Public Health 224.
61. Caulfield, n 7.
62. DWendler, 'One-Time General Consent for Research on Biological Samples' (2006) 332 Br Med J 544.
63. A Kettis-Linblad, L Ring, E Viberth and M Hansson, 'Genetic Research and Donation of Tissue Samples to Biobanks: What do Potential Samples Donors in the Swedish General Public Think?' (2006) 16 Eur J Public Health 433.
64. G McQuillan and others 'Consent for Genetic Research in a General Population: The NHANES Experience' (2003) 5 Genet Med 35.
65. D Secko and others, 'Informed Consent in Biobanks Research: A Deliberative Approach to the Debate' (2009) 68 Soc Sci Med doi:10.1016/j.socsimed.2008.11.020.
66. D Nicol and C Critchley, n 46, 17-31.
67. J Fleming, 'Issues with Tissues: Perspectives of Tissue Bank Donors and the Public Towards Biobanks and Related Genetic Research' in M Stranger (ed), Human Bioetchnology and Public Trust: Trends, Perceptions and Regulation (Centre for Law and Genetics, Hobart 2007) 184.
68. See text accompanying n 20 above.
69. Wendler, n 49; Fleming, n 50, 187.
70. D Kaufman and others, 'Public Opinion About the Importance of Privacy in Biobank Research'(2009) 85 Am J Hum Genet 643.
71. C Simon and others, 'Active Choice But Not Too Active: Public Perspectives on Biobank Consent Models' (2011) 13 Genet Med 821.
72. Opinion Leader Research, Summary of the UK Biobank Consultation on the Ethics and Governance Framework (2003). www.ukbiobank.ac.uk/docs/ public-stakeholder-olr-report.doc. accessed 1 December 2011.
73. Hoeyer and others, n 47.
74. Otlowski, n 44.
75. Fleming, n 50, 190-2, 197.
76. Kohane and R Altman, 'Health-Information Altruists - A Potentially Critical Resource' (2005) 353 N Eng J Med 2074.
77. Caulfield, n 7.
78. Kaye and Caulfield, n 8, at 96.
79. Eg V Árnason, 'Coding and Consent: Moral Challenges of the Database Project in Iceland' (2004) 18 Bioethics 27.
80. E Salvaterra and others, 'Banking Together: A Unified Model of Informed Consent for Biobanking' (2008) 9 EMBO Rep 307.
81. T Takala, 'Setting a Dangerous Precedent? Ethical Issues in Human Genetic Database Research' (2007) 8 Med L Int'l 105.
82. For example, discussed in Elger, n 6.
83. Kaye, 'Abandoning Informed Consent: The Case of Genetic Research in Population Collections' in Tutton and Corrigan, n 1, at 117.
84. T Ashburn, S Wilson, B Eisenstein, 'Human Tissue Research in the Genomic Era of Medicine: Balancing Individual and Societal Interests' (2000)160 Arch Intern Med 3377.
85. See also arguments canvassed by McHale, n 21, at 84.
86. C Critchley, 'Public Opinion and Trust in Scientists: The Role of the Research Context, and the Perceived Motivation of Stem Cell Researchers' (2008) 17 Public Underst Sci 309.
87. C Critchley and D Nicol, 'Understanding the Impact of Commercialisation on Public Support for Science: Is It about the Funding Source or the Organization Conducting the Research?' (2011) 20 Public Underst Sci 347.
88. J McHale, 'Appropriate Consent and the Use of Human Material for Research Purposes: The Competent Adult' (2006) 1 Clin Ethics 195.
89. World Health Organization (WHO), Genetic Databases: Assessing the Benefits and the Impact on Human and Patient Rights (World Health Organization, Geneva 2003).
90. UNESCO, International Bioethics Committee, International Declaration on Human Genetic Data (2003).
91. See also the UNESCOReport of the International Bioethics Committee of UNESCO (IBC) on Consent, at para 54.
92. HUGO (Human Genome Organisation) Ethics Committee, Statement on Genetic Databases (Hugo, London 2002) which states at Art 4): 'The choices and privacy of individuals, families and communities should be respected. (a) Choices may be with regard to: donation, storage and uses of samples and the information derived therefrom (eg specific, related or other uses subject to authorization by an ethics committee, etc.). Informed consent may include notification of uses (actual or future), or opting out, or, in some cases, blanket consent'.
93. OECD, n 2.
94. See, for example, HUGO, n 70.
95. For discussion, see B Knoppers and C Fecteau, 'Human Genomic Databases: A Global Public Good?' (2003) 10 EJHL 27.
96. M Otlowski, n 25.
97. Eg Council of Europe, Recommendation Rec(2006) 4 of the Committee of Ministers to Member States on Research on Biological Materials of Human Origin (2006).
98. Council of Europe Steering Committee on Bioethics, German National Ethics Council, Opinion on Biobanks for Research (2004).
99. Human Tissue Authority, Code of Practice on Research.
100. UK Biobank, Ethics and Governance Framework (2007),http://www.ukbiobank.ac.uk/docs/EGFlatestJan20082.pdf. accessed 4 May 2011.
101. Tri-Council Policy Statement, Ethical Conduct for Research Involving Humans, 2nd edn (2011),http://www.pre.ethics.gc.ca/eng/policypolitique/ initiatives/tcps2-eptc2/Default/. accessed 29 June 2011.
102. See ch 5.
103. National Bioethics Advisory Commission, Research Involving Human Biological Materials: Ethical Issues and Policy Guidance (U.S. Government Printing Office, Rockville, MD 1999).
104. B Elger and A Caplan, 'Consent and Anonymization in Research Involving Biobanks: Differing Terms and Norms Present Serious Barriers to an International Framework' (2006) 7 EMBO Rep 661.
105. Office for Human Research Protections, Guidance on Research Involving Coded Private Information or Biological Specimens (2004), (2008).
106. B Knoppers and M Saginur, 'The Babel of Genetic Data Terminology' (United States Department of Health & Human Services, 2005) 23 Nat Biotechnol 539.
107. NHMRC, n 34.
108. Paragraph 2.2.14 (c). Note also the middle ground of 'extended' consent dealt with in 2.2.14(b) for the use of data or tissue in future research projects that are: (i) an extension of, or closely related to, the original consent or (ii) in the same general area of research....
109. Paragraph 2.2.15.
110. Paragraph 2.2.16.
111. T Beauchamp and J Childress, Principles of Biomedical Ethics (6th edn Oxford University Press, New York 2009) ch 3.
112. E Clayton, 'Informed Consent and Biobanks' (2007) 33 JLME 15.
113. T Caulfield, and R Brownsword, 'Human Dignity: What Does It Mean in the Biotechnology Era?' (2005) 7 Nat Rev Genet 72.
114. O O'Neill, 'Some Limits of Informed Consent' (2003) 29 J Med Ethics 4.
115. Note also her more recent work, N Manson and O O'Neill, Rethinking Informed Consent in Bioethics (Cambridge University Press, Cambridge 2007).
116. Campbell, n 14.
117. See also G Helgesson and S Eriksson, 'Does Informed Consent Have an Expiry Date? A Critical Appraisal of Informed Consent as a Process' (2011) 20 Cambridge Q Healthc Ethics 85.
118. Irish Council of Bioethics Report, Human Biological Materials: Recommendations for Collection, Use and Storage in Research (Irish Council of Bioethics, Dublin 2005) 34.
119. A McGuire and L Beskow, 'Informed Consent in Genomics and Genomics Research' (2010) 11 Annu Rev Genomics Hum Genet 361.
120. See, for example, NHMRC, n 34, para 2.2.2(g).
121. See also M Hansson and others, 'Should Donors Be Allowed to Give Broad Consent to Future Biobanks Research?' (2006) 7 Lancet Oncol 266.
122. Eg Kaye, n 62. See the Irish Council of Bioethics n 93, 104-5 for sample consent forms. See also the OECD, n 2, Annotation para 28.
123. See above, n 53 and accompanying text.
124. See also Hansson and others, n 95. Note, however, that these terms are not always clearly differentiated (eg Caulfield, n 7, appears to use the term 'blanket' instead of 'broad' or 'general' consent, and the HUGO Statement on Genetic Databases, n 70, also uses the more expansive term 'blanket consent'.
125. Translating this reasoning to the context of a prospective biobank, it could be argued that once samples and information are collected, because only a relatively small proportion of individuals would want to be recontacted for reconsent, consent to future use can be presumed.
126. See discussion in TCaulfield and B Knoppers, 'Consent, Privacy andResearch Biobanks. Policy Brief No 1' (Genome Canada 2010) 5.
127. Elger, n 6, 59.
128. Health Sector Database Act (1998).
129. See Gu{eth}mundsdóttir v The State of Iceland 27 November 2003 (No. 151/2003).
130. For critique, see L Sheremeta, Population Biobanking in Canada: Ethical Legal and Social Issues (Canadian Biotechnology Advisory Committee 2003) 47
131. See, for example, NHMRC, n 34, para 2.3.5-2.3.8.
132. See, for example, the requirements of the NHMRC, n 34, ch 2.3, qualifying or waiving conditions for consent.
133. Hansson and others, n 95.
134. ALRC/AHEC, n 6. New paragraph 2.3.8 states: Given the importance of maintaining public confidence in the research process, it is the responsibility of each institution to make publicly accessible (for example in annual reports) summary descriptions of all its research projects for which consent has been waived under paragraphs 2.3.6 and 2.3.7. Waiver decisions under paragraph 2.3.7 should not be made publicly accessible until the research has been completed.
135. Caplan, n 39.
136. See also R Sade, 'Research on Stored Biological Samples is Still Research' (2002) 162 Arch Int Med 1439.
137. T Caulfield, R Upshur and A Daar, 'DNA Databanks and Consent: A Suggested Policy Option Involving an Authorization Model' (2003) 4 BMC Med Ethics 1.
138. For example, Genetic Interest Group Report, Human Rights, Privacy and Medical Research 2006, 15.
139. O'Neill, n 90.
140. See text accompanying nn 53 and 54.
141. Kaye and Caulfield, n 8, 96. (See text accompanying nn 8-9.).
142. Eg HUGO, n 70.
143. See, for example, K Hoeyer and others, n 47; note also Chadwick and Berg, n 36.
144. Hoeyer and others, n 47
145. K Hoeyer, 'The Ethics of Research Using Biobanks: Is Informed Consent Donors' Main Interest?' (2005) 65 Arch Int Med 97.
146. This evidence is discussed further below
147. Helgesson and Eriksson, n 93. See also Campbell, n 14, 232-233 who supports an argument advanced by O'Neill, n 90, that leaving control to the participants, rather than taking a paternalistic approach, respects participants' autonomy more.
148. Campbell, n 14, 233.
149. See the Deutsche Forschungsgemeinschaft, Senate Commission on Genetic Research Predictive Genetic Diagnosis - Scientific Background, Practical and Social Implementation (2003) referred to in the OECD Report, n 22, 93.
150. O'Neill, n 90, 6.
151. Elger and Caplan, n 80.
152. For a contrasting view, see Caulfield, n 7, 214 and commentators referred to.
153. Declaration of Helsinki (1964) Art 5.
154. Chadwick and Berg, n 36.
155. See WHO, n 68
156. For discussion of the major elements that should be included in consent forms for genetic and genomic research, see McGuire and Beskow, n 93.
157. UK Biobank, n 76.
158. O'Neill, n 90; Burgess, n 40.
159. Somsen, n 29; OECD, n 2, 33 of the Annotations.
160. For discussion of innovative systems to facilitate longitudinal relationships with participants, see McGuire and Beskow, n 93.
161. Kaye, n 62. Note also the possibility raised in the WHO, n 68, Recommendation 8, which suggests the use of sunset clauses, whereby consent will only be valid for a finite period of time.
162. UK Biobank allows staged withdrawal (UK Biobank, n 76, 9-no further contact; no further access; no further use), but for other biobanks it may be an 'all or nothing' approach.
163. UK Biobank, n 76, 6-8.
164. C Johnstone and J Kaye, 'Does the UK Biobank Have a Legal Obligation to Feedback Individual Findings to Participants?' (2004) 12 Med L Rev 239.
165. OECD, n 2, Annotation 46.
166. NHMRC, n 1, 49-50.
167. Note new developments discussed by C Shröder and others, 'Safeguarding Donors' Personal Rights and Biobank Autonomy in Biobank Networks: The CRIP Privacy Regime' (2010) Cell Tissues Bank, Published online 15 July 2010,,http://www.springerlink.com/content/257x56488841215k/fulltext.pdf. accessed 22 November 2011.
168. Discussed in ALRC/AHEC, n 6, 492-5.
169. Caplan, n 39.
170. Gibbons and others, 'Governing Genetic Databases: Challenges Facing Research Regulation and Practice' (2007) 34 J L Soc'y 163
171. See L Austin and T Lemmens, 'Privacy, Consent and Governance' in K Dierickx and P Borry (eds), New Challenges for Biobanks: Ethics, Law and Governance (Intersentia, Oxford 2009) 111, 118.
172. See also Laurie and others, n 16, 328.
173. G Laurie and others, 'The Roles of Values and Interests in the Governance of the Life Sciences: Learning Lessons from the 'Ethics+' Approach of UK Biobank' in C Lyall, T Papaioannou, J Smith (eds), The Limits to Governance: The Challenge of Policy-Making for the New Life Sciences (Ashgate, Aldershot, 2009) 51.
174. D Winickoff, 'From Benefit Sharing to Power Sharing: Partnership Governance in Population Genomic Research' in Kaye and Stranger, n *, at 53
175. See also Laurie and others, n 16, 323.
176. Campbell, n 14
177. J McEwen and P Reilly, 'Setting Standard for DNA Bans: Towards a Model of Conduct' (1996) 1 Microb Comp Genomics 165.
178. Otlowski, n 44.
179. Some matters may be identified as not open to negotiation, for example, the concept of broad consent itself.
180. See text accompanying n 115.