The challenges of achieving open-source sharing of biobank data

Biotechnology Law Report

Volumn 29, Issue 6, 2010, Pages 623-635

  Gitter, Donna M ^a  

^a UNIVERSITY OF PENNSYLVANIA LAW SCHOOL   (United States)

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[No Author keywords available]

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EID: 78650796570     PISSN: 0730031X     EISSN: None     Source Type: Journal    
DOI: 10.1089/blr.2010.9909     Document Type: Article

References (166)

1. See International Consortium Announces the 1000 Genomes Project; available at www.1000genomes.org/docs/1000Genomes-NewsRelease.pdf (Jan. 22, 2008)("As with other major human genome reference projects, data from the 1000 Genomes Project will be made swiftly available to the worldwide scientific community through freely accessible public databases");
2. The International HapMap Consortium, The International HapMap Project. Nature 2003;426:789, 793 (setting forth the data access policy for the International HapMap Project and describing it as one committed to "rapid and complete data release, and to ensuring that project data remain freely available in the public domain, at no cost to users").
3. Among the life sciences initiatives that have consciously adopted one or more open source principles are Science Commons, see About Science Commons; available at http://sciencecommons.org/about/ (last visited Mar. 16, 2010);
4. The Inter national HapMap Project; see generally Donna M. Gitter, Resolving the open source paradox in biotechnology: a proposal for a revised open source policy for publicly funded genomic databases, 43 Hous L Rev 1475 (2007);
5. The Biobricks Foundation, see Drew Endy, Foundations for engineering biology. Nature 2005;438:449-453 (2005);
6. The Tropical Diseases Initiative (TDI), see Stephen Maurer et al ., Finding cures for tropical disease: is open source an answer? 1 Public Library of Science Medicine e56, at 183; available at www.plosmedicine.org/article/info: doi/10.1371/journal.pmed.0010056 (2004);
7. And the Biological Innovation for Open Society (BIOS), see Carina Dennis, Biologists launch open source movement. Nature 2004;431:494.
8. See Josh Lerner and Jean Tirole, The economics of technology sharing: open source and beyond 2 (Harvard NOM Research Paper No. 04-35, 2004); available at http://papers.ssrn.com/sol3/papers.cfm?abstract-id=620904 (Nov. 2004) (describing computer software as "the most prominent example of open source production").
9. Source code is a computer program in its original form, written and readable by human beings. Janet Elizabeth Hope, OpenSource Biotechnology 66 (Dec. 2004)(Ph.D. thesis, Australian National University); available at http://opensource.mit.edu/pa-pers/hope.pdf. Because computers can execute only instructions coded as a series of binary numbers (ones and zeroes), source code must be "translated by means of another program into binary form, known as machine or object code." Id.
10. See Hope, op. cit. n. 4 at 68 (explaining the copy-left licensing scheme developed in the software community and describing it as "an ingenious twist on the conventional copyright licence")
11. See also Lerner and Tirole, op. cit. n. 3, at 2 ("In an open-source project, . a body of original material is made publicly available for others to use, under certain conditions. In many cases, anyone who makes use of the material must agree to make all enhancements to the original material available un der these same conditions.").
12. See Robin Feldman and Kris Nelson, Open source, open access, and open transfer: market approaches to research bottle necks 17; available at http://papers.ssrn.com/sol3/papers.cfm?abstract-id = 1127571 (May 2008)(using the terms "open sourcebiotechnology" and "open science" interchangeably to describe projects for which "participants agree to either grant licenses or enforce their rights in a way that maintains the availability of the inventions and improvements in the future");
13. See also Gitter, op. cit. note 2, at 1482-1485 (describing the former International HapMap Project data access policy, which was modeled on an open source software licensing approach and aimed to ensure that basic data remained widely accessible).
14. The Bermuda Statement is an international agreement favoring release into the public domain of genetic databases achieved through public funding. See Human Genome Project, U.S. Department of Energy Office of Science, Summary of Principles Agreed at the First International Strategy Meeting on Human Genome Sequencing; available at www.ornl.gov/sci/techresources/Human-Genome/research/ bermuda.shtml#1 (Feb. 25-28, 1996).
15. The Fort Lauderdale Agreement emphatically reaffirmed the Bermuda Statement. See National Human Genome Research Institute, National Institutes of Health, Reaffirmation and Extension of NHGRI Rapid Data Release Policies: Large-scale Sequencing and Other Community Resource Projects; available at www.genome.gov/10506537 (Feb. 2003).
16. See, e.g, National Institutes of Health, Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-wide Association Studies (GWAS); available at http://grants.nih.gov/grants/guide/notic?e-files/NOT-OD-07-088.html (Jan. 25, 2008)
17. "All investigators who receive NIH support to conduct genome-wide analysis of genetic variation in a study pop-ulation are expected to submit to the NIH GWAS data repository descriptive information about their studies for inclusion in an open access portion of the NIH GWAS data repository")
18. Hereinafter "NIH GWAS Data Sharing Policy"). In the U.K., the Wellcome Trust requires researchers "that it funds to maximise the availability of research data with as few restrictions as possible." Wellcome Trust Policy on Data Management and Sharing; available at www.wellcome.ac.uk/About-us/Policy/ Policy-and-position-statements/WTX035043.htm (Jan. 2007).
19. National Institutes of Health, Final NIH Statement on Sharing Research Data, NOT-OD-03-032; available at http://grants.nih.gov/grants/guide/notice- files/NOT-OD-03-032.html (Feb. 26, 2003).
20. See Arti Kaur Rai, Regulating scientific research: intellectual property rights and the norms of science, 94 Northwestern Univ. L. Rev. 77, 95-96 (1999)(describing how Congressional enactment of the Bayh-Dole Act in 1980 stimulated the commercialization of academic research).
21. J.H. Reichman and Paul F. Uhlir, The public domain: a contractually reconstructed research commons for scientific data in a highly protectionist intellectual property environment, 66 Law & Contemp Problems 315, 322 (2003).
22. Id. at 322-323.
23. Anne Cambon-Thomsen, The social and ethical issues of post-genomic biobanks. Nature Rev Genet 2004;5:866.
24. Andrea Boggio, Transfer of samples and sharing of results: requirements imposed on researchers, in Ethical Issues in Governing Biobanks: Global Perspectives 231, 231 (Bernice Elger et al., eds. 2008)(hereinafter "Boggio").
25. Anne Cambon-Thomsen et al., Trends in ethical and legal frameworks for the use of human biobanks. Eur Respir J 2007;30:373. Among the best known national repositories, also known as population biobanks, are the Estonian Genome Project, the Icelandic Health Sector Database, the International HapMap Project, the UK Biobank, and several U.S. biobanks, such as the Framingham Heart Study and the Marshfield Clinic's Personalized Medicine Research Project.
26. See Bernice S. Elger and Arthur L. Caplan, Consent and anonymization in research involving biobanks. Eur Molecular Biol Org Rep 2006;7:661.
27. See Yael Bregman-Eschet, Genetic databases and biobanks: who controls our genetic privacy?, 23 Santa Clara Comp. & High Tech. L.J. 1, 17-18 (2006);
28. Elger and Caplan, op. cit. n. 16 at 661 (stating that three-fourths of U.S. clinical trials by pharmaceutical companies include a provision for storing human tissue for future use).
29. See Anne Cambon-Thomsen et al., Biobanks for genomics and genomics for biobanks, 4 Comp & Functional Genomics 628, 629 (2003).
30. William W. Lowrance, Access to collections of data and materials for health research 35 (2006); available at www.well-come.ac.uk/stellent/groups/ corporatesite/@msh-grants/docu-ments/web-document/wtx030842.pdf (Mar. 2006).
31. The terms "data producers" and "data users" are not mutually exclusive, as scientists may in some situations be data producers, yet be data users in others.
32. See Bryn Nelson. Empty archives. Nature 2009;461:160, 163.
33. Indeed, one expert has noted that certain researchers may infact fear exposing their data to review in case it is found to be wanting in some way. Nature Opinion Forum: Prepublication Data Sharing: The Toronto Statement; available at http://network.nature.com/groups/naturenewsandopinion/forum/topics/ 5433
34. Ewan Birney, Senior Scientist at the European Molecular Biology Laboratory working at the European Bioin-formatics Institute)(Sept. 11, 2009).
35. He noted, however, that in reality, researchers typically contact a colleague personally to clarify their questions, as opposed to publicly challenging the work. Id.
36. See Andrew Singleton, Professional challenges and rewards of open data sharing, Seminar on Genome-Wide Association Studies for the Rest of Us: Adding Genome-Wide Association to Population Studies; available at www.genome.gov/ Multime-dia/OD/GWAS-Boston-07/11-Singleton-Professional.ppt#4 (June 22, 2007)
37. Hereinafter "Singleton").
38. Id.
39. Id. It should be noted that while open source sharing of data is possible, open source sharing of actual tissue samples is not, 2 because of the limited amount of tissue that can be collected and stored. Data producers must husband this resource care fully to ensure optimal allocation. Boggio, op. cit. n. 15 at 231.
40. Singleton, op. cit. n. 22.
41. Eric S. Raymond, The cathedral and the bazaar, at Release Early, Release Often; available at www.catb.org/∼esr/writ-ings/cathedral-bazaar/cathedral- bazaar/ar01s04.html (Aug. 2, 2002).
42. Creative Commons is a nonprofit corporation that aims to facilitate content-sharing in accordance with the law of copyright. See http://creativecommons.org/about/ (last visited Mar. 18, 2010).
43. See Nelson, op. cit. n. 21 at 163 (citing Professor James Boyle of Duke Law School).
44. See ccMixter, About, at http://ccmixter.org/about (last visited Mar. 18, 2010).
45. See Nelson, op. cit. n. 21 at 163.
46. Anne Cambon-Thomsen. Assessing the impact of biobanks. Nature Genet 2003;34:25, 26.
47. Boggio, op. cit. n. 15 at 234.
48. UK Biobank, a research initiative funded by both private and public sources, aims to collect tissue samples and personal data from at least 500,000 individuals in the U.K. and use this data for research into the prevention, diagnosis and treatment of human disease. UK Biobank, UK Biobank-What Is It? Available at www.ukbiobank.ac.uk/about/what.php (last visited Apr. 11, 2010).
49. UK Biobank, Ethics and Governance Framework 12-13;
50. Available at www.ukbiobank.ac.uk/docs/EGFlatestJan20082. pdf (Oct. 2007).
51. Id.
52. See Gitter, op. cit. n. 2 at 1493-1494 (describing the grant-back requirement imposed by Incyte Genomics, Inc.).
53. See Boggio, op. cit. n. 15 at 235.
54. Cf. Gitter, op. cit. n. 2, at 1489-1490 (explaining the obstacles to achieving the open source model with respect to the International HapMap Project without an adequate enforcement mechanism).
55. See Boggio, op. cit. n. 15 at 235.
56. See id.
57. See Gitter, op. cit. n. 2 at 1478 and 1508-1509 (citing the example of the SNP Consortium, a group of pharmaceutical firms and nonprofit organizations that collaborated at great financial expense to place genomic data in the public domain so as to preempt the patenting of such information that could be used to develop patentable pharmaceutical products).
58. See also Janet Hope, Biobazaar: The Open Source Revolution 265 (2008) (noting that "there is a strong motivation for commercial players to support open source development of any technology upstream of their own place in the relevant value chain").
59. See Rai, op. cit. n. 11 at 95-96 (describing how the enactment of the Bayh-Dole Act in 1980 stimulated the commer cialization of academic research).
60. Wendy Post, Challenges of an Epidemiologist Working in Genomics, Seminar on Genome-Wide Association Studies for the Rest of Us: Adding Genome-Wide Association to Population Studies; available at www.genome.gov/Multimedia/OD/ GWAS-Boston-07/02-Post-Challenges.ppt#1 (June 22, 2007).
61. Press release, NIH Launches dbGaP, a Database of Genome Wide Association Studies; available at www.nlm.nih.gov/ news/press-releases/dbgap-launchPR06.html (Dec. 12, 2006).
62. GWA studies "explore the association between specific genes (genotype information) and observable traits, such as blood pressure and weight, or the presence or absence of a disease or condition (phenotype information)," Thereby facilitating the development of new diagnostic methods and treatments.
63. Id.
64. NIH GWAS Data Sharing Policy, op. cit. n. 9.
65. Id. See also The GAIN Collaborative Research Group. New models of collaboration in genome-wide association studies: The Genetic Association Information Network. Nature Genet 2007;39:1045, 1050
66. Describing the NIH's GAIN project, a GWAS, as promoting data access "by rapidly placing data in the public domain and by encouraging the initial genotype-phe-notype associations identified through GAIN to remain unen cumbered by intellectual property claims" in order to maximize the benefit provided by these "community resources.").
67. See Nelson, op. cit. n. 21 at 161-162 (explaining that, in response to an NIH mandate regarding data sharing, researchers chose to delay compliance so as to see whether and how the NIH would enforce its mandate).
68. Reichman and Uhlir, op. cit. n. 12 at 322-323.
69. Id. at 346-346.
70. Attendees at the 2009 Toronto International Data Release Workshop, which gathered data producers and users in the field of genomics to develop best practices for prepublication data sharing, recognized that data producers might "request a protected time period to allow them to be the first to publish the data set" and declared that the period of exclusivity "should be limited to global analyses of the data and ideally expire within one year." Prepublication data sharing. Nature 2009;461:168, 170.
71. Medical Research Council, About Us; available at www.mrc.ac.uk/About/ Structure/index.htm (last visited Mar. 19, 2010).
72. NIH GWAS Data Sharing Policy, op. cit. n. 9.
73. Lowrance, op. cit. n. 19 at 36.
74. Medical Research Council, Policy on Data Sharing and Preservation Policy; available at www.mrc.ac.uk/Ourre-search/Ethicsresearchguidance/ Datasharinginitiative/Policy/in-dex.htm#P16-1349 (last visited Mar. 20, 2010).
75. See Lowrance, op. cit. n. 19 at 36.
76. See Reichman and Uhlir, op. cit. n. 12 at 355. The NIH provides a freely accessible GWAS database, where the U.K. Biobank permits access via an application system. See supra note 34 and accompanying text.
77. PLoS One, Editorial and Publishing Policies; available at www.plosone.org/static/policies.action#sharing (last visited Mar. 20, 2010).
78. Nature.com, Authors & Referees @npg; available at www.nature.com/authors/editorial-policies/availability.html (last visited Mar. 20, 2010).
79. Paul N. Schofield et al. Post-publication sharing of data and tools. Nature 2009;461:171.
80. Miguel A. Hernán and Allen J. Wilcox. Epidemiology, data sharing, and the challenge of scientific replication. Epidemiology 2009;20:167, 168.
81. Nelson, op. cit. n. 21 at 163.
82. See, e.g., 2 Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law NO. 10, at 181-182 (U.S. Gov't Printing Office, 1946-1949)
83. The Nuremberg Code is an international agreement that prohibits countries from conducting experimental medical treatments on patients without their express informed consent.);
84. World Medical Association, Declaration of Helsinki: recommendations guiding physicians in biomedical research involving human subjects. JAMA 1997;277:925, 925-926
85. The Declaration of Helsinki is a "statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. Medical research involving human subjects includes research on identifiable human material or identifiable data");
86. The Nat'l Comm'n for the Protection of Human Subjects of Biomedical & Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research; available at www.hhs.gov/ohrp/ humansubjects/guidance/bel-mont.htm (Apr. 18, 1979)(The Belmont Report is a set of national recommendations in the U.S. regarding research on human subjects.); 45 CFR part 46 (2007)(The Common Rule) (The Common Rule is a U.S. federal policy protecting human subjects of federally funded research, but in practice has been adopted by many other institutions for their non-federally funded research.).
87. Helen Swede et al. National population-based biobanks for genetic research. Genet Med 2007;9:141, 145 (citations omitted).
88. See Cambon-Thomsen, op. cit. n. 14 at 869.
89. See Julie A. Burger, Symposium: What is owed participants in biotechnology research? 84 Chi-Kent L Rev 55, 56 (2009).
90. Id. at 69-74 (citing numerous examples of research participants who expressed preferences as to the specific uses to be made of their tissue samples).
91. See Cambon-Thomsen, op. cit. n. 14 at 869 (citations omitted).
92. Blanket consent suggests that there are no restrictions placed on the scope and duration of the consent and "can never be fully informed." Jeantine E. Lunshof et al. From genetic privacy to open consent. Nature Rev Genet 2008;9:406, 408 (citation omitted).
93. Cambon-Thomsen, op. cit. n. 14 at 869.
94. Id.
95. See Lunshof et al., op. cit. n. 68 at 408.
96. See Elger and Caplan, op. cit. n. 16 at 662.
97. See Cambon-Thomsen, op. cit. n. 14 at 869 (citation omitted).
98. Id.
99. Id. at 871.
100. Id. at 869, Box 2.
101. Id. at 871.
102. See supra note 44 for a definition of a GWAS.
103. Policy for sharing of data obtained in NIH supported or conducted genome-wide association studies (GWAS), 72 FR at 49,294 72 (Aug. 28, 2007).
104. Policy for sharing of data obtained in NIH supported or conducted genome-wide association studies (GWAS), 72 FR at 49,291.
105. Policy for sharing of data obtained in NIH supported or conducted genome-wide association studies (GWAS), 72 FR at 49,295.
106. Id.
107. National Institutes of Health, Modifications to Genome-Wide Association Studies (GWAS) Data Access 1; available at http://grants.nih.gov/grants/gwas/ data-sharing-policy-modifications-20080828.pdf (Aug. 28, 2008).
108. Policy for sharing of data obtained in NIH supported or conducted genome-wide association studies (GWAS), 72 FR at 49,295. One reason for posting the genotype-phenotype association measures, aside from allowing cross-checking of the data, was "to discourage premature patent claims by placing the phenotype and genotype data and first-line analysis in the public domain." The GAIN Collaborative Research Group, op. cit. n. 46 at 1049.
109. Policy for sharing of data obtained in NIH supported or conducted genome-wide association studies (GWAS), 72 FR at 49,296; Nat'l Inst. Health, NIH Points to Consider for IRBs and Institutions in Their Review of Data Submission Plans for Institutional Certifications under NIH's Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS) 7; available at http://grants.nih.gov/grants/gwas/gwas-ptc.pdf (2007).
110. Supra n. 81.
111. Policy for sharing of data obtained in NIH supported or con ducted genome-wide association studies (GWAS), 72 FR at 49,295. De-identification "means that the identities of data sub jects cannot be readily ascertained or otherwise associated with the data by the repository staff or secondary data users [];
112. The 18 identifiers enumerated [in the HIPAA Privacy Rule] are removed; and the submitting institution has no actual knowledge that the remaining information could be used alone or in com bination with other information to identify the subject of the data." Policy for sharing of data obtained in NIH supported or conducted genome-wide association studies (GWAS), 72 Fed. Reg. at 49,295 and n. 6.
113. The eighteen identifiers that must be removed pursuant to HIPAA are names; addresses; dates relating to the individual (such as birth date and date of admission to the hospital), except for the year; Telephone and fax numbers; e-mail addresses; Social Security numbers; medical record numbers; health plan beneficiary numbers; account numbers; certificate/license numbers; vehicle identifiers and serial numbers, including license plate numbers; device identifiers and serial numbers; URLs; Internet Protocol (IP) address numbers; biometric identifiers, including finger and voice prints; full face photographic images and any comparable images; and any other unique identifying number, characteristic, or code. 45 CFR §164.514(b)(2)(i) (2007).
114. See Zhen Lin et al., Genomic research and human subject privacy. Science 2004;305:183
115. ("If someone has access to in dividual genetic data and performs matches to public SNP data, a small set of SNPs could lead to successful matching and identification of the individual."). See also William W. Lowrance and Francis S. Collins. Identifiability in genomic research. Science 2007;317:600, 602 (stating, with respect to protecting information privacy for genomic research subjects, that "[o]nly rarely will a completely open access model be defensible when sufficient amounts of genomic data are present to be unique to the individual").
116. National Institutes of Health, NIH Points to Consider for IRBs and Institutions in Their Review of Data Submission Plans for Institutional Certifications under NIH's Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome- Wide Association Studies (GWAS) 4; available at http://grants.nih.gov/grants/gwas/gwas-ptc.pdf (Nov. 12, 2007)(citation omitted).
117. See National Institutes of Health, Modifications to Genome-Wide Association Studies (GWAS) Data Access 1; available at http://grants.nih.gov/ grants/gwas/data-sharing-policy-modifications-20080828.pdf (Aug. 28, 2008).
118. See Nils Homer et al. Resolving individuals contributing trace amounts of DNA to highly complex mixtures using high-density SNP genotyping microarrays, 4 Public Library of Sci ence Genetics e1000167, 1, 1-2, 7, 9 (Aug. 2008); available at www.plosgenetics.org/article/info%3Adoi%2F10.1371%2Fjournal.pgen. 1000167.
119. See Jason Felch, DNA profiles blocked from public access, L.A. Times, Aug. 29, 2008, at 31.
120. Bradley Malin et al. Technical and policy approaches to balancing patient privacy and data sharing in clinical and translational research. J Invest Med 2010;58:11, 15-17.
121. See supra notes 42-43 and accompanying text.
122. See Bregman-Eschet, op. cit. n. 17 at 11.
123. See Gillian Haddow et al., Tackling community concerns about commercialisation and genetic research: a modest inter disciplinary proposal. Soc Sci Med 2007;64:272, 274.
124. See Brenda Simon, How to get a fair share: IP policies for publicly supported biobanks, Stanford J. L., Sci. & Pol'y 65, 78, Social Science Research Network; available at http://papers.ssrn.com/sol3/papers.cfm?abstract- id = 1413951 (Aug. 13, 2009).
125. Nicholas Wade, A genetics company fails, its research too complex, N.Y. Times, Nov. 18, 2009, at B2.
126. For further discussion of some of the reasons for DeCode's failure, see Michael Tomasson, Legal, ethical, and conceptual bottlenecks to the development of useful genomic tests, 18 Ann Health L 231, 247 (2009).
127. See U.K. Biobank, Ethics and Governance Framework 3; available at www.ukbiobank.ac.uk/docs/EGFlatestJan20082. pdf (Oct. 2007).
128. Id.
129. See Moore v. Regents of the Univ. of Cal., 51 Cal. 3d 120, 134-147 (Cal. 1990), cert. denied, 499 U.S. 936 (1991);
130. Greenberg v. Miami Children's Hosp. Research Inst, Inc., 264 F. Supp. 2d 1064, 1074-1076 (S.D. Fla. 2003);
131. Washington Univ. v. Catalona, 490 F.3d 667, 675 (8th Cir. 2007), cert. denied, 552 U.S. 1166 (2008). Indeed, courts have denied a property right even in the absence of proper informed consent from the research subject. See Moore, 51 Ca. 3d at 131-133.
132. Moore, op. cit. n. 101 at 143-147.
133. See Donna M. Gitter, Ownership of human tissue: a pro posal for federal recognition of human research participants' property rights in their biological material, 61 Wash & Lee L Rev 257, 298 (2004).
134. Cf id. at 260 (noting that the plaintiff parents in Greenberg had premised their research participation in the belief that their contributions would promote widely affordable and accessible carrier and prenatal testing for Canavan disease).
135. See id. at 262-263, 320; see also Sharon F. Terry et al. Ad vocacy groups as research organizations: The PXE international example. Nat Rev Genet 2007;8:157.
136. Terry et al., op cit n 105 at 157, 160, and 162.
137. See Coriell Personalized Medicine Collaborative, Technical Paper; available at http://cpmc.coriell.org/Docs/PDF/cpmc- technical-paper.pdf (Apr. 22, 2009).
138. See Coriell Personalized Medicine Collaborative, Consent to Participate in a Research Study 7; available at http://cpmc.coriell.org/Docs/PDF/Informed- Consent.pdf (last visited Mar. 21, 2010).
139. One commercial genetics company, Navigenics, has declared that it will make patented discoveries available on a "non exclusive, non-discriminatory basis" and "[s]ubject to commercially reasonable financial and other terms" as an inducement to research participants to contribute to its work. Navigenics, Our Policy Regarding Gene Patents; available at http://74.125.93.132/search?q=cache:LaOd73ZxxGYJ:www.navigenics.com/visitor/ what-we-offer/our-policies/gene-patents/[+t]navigenics[+t]universal[+t] royalty&cd = 1&hl=en&ct=clnk&gl=us (last visited Mar. 21, 2010).
140. See Simon, op. cit. n. 97 at 78.
141. Nelson, op. cit. n. 21 at 162.
142. Id.
143. See Susan M.C. Gibbons, Regulating biobanks: a twelve-point typological tool, 17 Med L Rev 313 (2009).
144. Nelson, op. cit. n. 21 at 162 (quoting Professor Boyle of Duke University School of Law).
145. European Life Science Infrastructure for Biological Information, ELIXIR: Data for Life; available at www.elixir-europe.org/bcms/elixir/Documents/Elixir- brochure.pdf (last visited Mar. 22, 2010).
146. Lowrance, op. cit. n. 19 at 35.
147. EMBL-EBI is a European nonprofit bioinformatics research center which aims to "provide freely available data and bioin formatics services to all facets of the scientific community in ways that promote scientific progress." EMBL-EBI, Welcome to the EBI; available at www.ebi.ac.uk/ Information/ (last visited Mar. 23, 2010).
148. ELIXIR, Project Information; available at www.elixir-europe.org/page.php? page=information (last visited Mar. 23, 2010).
149. Biobanking and Biomolecular Resources Research Infrastructure, Background; available at http://bbmri.eu/index.php/about-bbmri/background (last visited Mar. 23, 2010).
150. National Center for Biotechnology Information, NCBI at a Glance; available at www.ncbi.nlm.nih.gov/About/glance/our-mission.html (revised May 21, 2004).
151. Nature Opinion Forum: Prepublication Data Sharing: The Toronto Statement; available at http://network.nature.com/groups/naturenewsandopinion/forum/ topics/5433 (Ewan Birney, Senior Scientist at the European Molecular Biology Laboratory working at the European Bioinformatics Institute)(Sept. 11, 2009).
152. Morris W. Foster and Richard R. Sharp, Share and share alike. Nature Rev Genet 2007;8:633, 635.
153. Id. at 635-636.
154. See Martin Yuille et al., The U.K. DNA Banking Network: a "fair access" biobank. Cell Tissue Bank; available at www.springerlink.com/ content/l1082h68g0645517/fulltext.pdf (Aug. 12, 2009);
155. see also Reichman and Uhlir, op. cit. n. 12 at 433 (stating their view that "the possibilities for maximizing access to scientific data for the public nonprofit research will not be fully realized in a highly protectionist legal and economic environment unless the scientific community agrees to experiment with suitably regulated conditional deposits")(citation omitted).
156. See Yuille, op. cit. n. 124 at 2.
157. See supra note 51 and accompanying text.
158. Yuille, op. cit. n. 124 at 3.
159. 128 Id. According to this Declaration, "States should regulate the cross-border flow of data and samples so as to foster international . . . cooperation and ensure fair access." Workshop on Ethics and Governance in Biobanking 16; available at www.oncore uk.org/downloads/ CCB%20Ethics%20Governance%20Work shop%20monograph.pdf (Jan. 2009).
160. See Yuille, op. cit. n. 124 at 6.
161. Id. at 4.
162. Id.
163. Id. See also Reichman and Uhlir, op. cit. n. 12 at 438 (noting that an external entity operating under the guidance of the affected funding agencies and academic institutions can help with negotiation, mediation, and even dispute resolution with respect to data sharing).
164. Timothy Caulfield et al., Research ethics recommendations for whole-genome research: consensus statement, 6 Public Library of Science Biology e73, 430, 434; available at www.plos-biology.org/article/info:doi/10.1371/ journal.pbio.0060073 (2008).
165. See also supra n. 93 and accompanying text (describing one expert's suggestions to preserve research participant privacy via the establishment of policies to assess credentials of data users; The execution of clear contracts with data users that define the appropriate use of data; and formalization of liability rules for misuse of data, all of which are particularly compatible with a restricted access approach).
166. Jonathan M. Samet, Data: to share or not to share? Epidemiology 2009;20:172, 174.