Abstract
Several recent biomedical research initiatives have sought to make their data freely accessible to others to stimulate innovation. Many of these initiatives have adopted the “open source” model that has achieved prominence in the computing industry. With respect to genomics research, open access models of data release have become common and most large funding bodies now require researchers to deposit their data in centralized repositories. In particular, biobanks, which are organised collections of biological samples and corresponding data, benefit from the implementation of open source principles. Several obstacles loom, however, as barriers to widespread implementation of open source principles in the field of biomedical research. These include the reluctance among researchers to share their data; the challenge of crafting appropriate publication and intellectual property policies; the difficulties in affording informed consent, privacy, and confidentiality to research participants when data is shared so widely; controversy surrounding the issues of commercialization and benefit-sharing; and the complexity of establishing a suitable infrastructure. This article examines each of these and considers an alternative approach, “fair access” biobanks.
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Notes
- 1.
See International Consortium Announces the 1000 Genomes Project, http://www.1000genomes.org/docs/1000Genomes-NewsRelease.pdf (22 January 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”); The International HapMap Consortium (2003) (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”).
- 2.
Among the life sciences initiatives that have consciously adopted one or more open source principles are Science Commons, see About Science Commons, http://sciencecommons.org/about/ (last visited March 16, 2010); the International HapMap Project, see generally Gitter (2007), p. 1475; the Biobricks Foundation, see Endy (2005), p. 449; the Tropical Diseases Initiative (TDI), see Maurer et al. (2004), p. 183, http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0010056; and the Biological Innovation for Open Society (BIOS), see Dennis (2004), p. 494.
- 3.
See Lerner and Tirole (2005), available at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=620904 (describing computer software as “the most prominent example of open source production”).
- 4.
Source code is a computer program in its original form, written and readable by human beings. Hope (2004), available at http://opensource.mit.edu/papers/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”. Ibidem.
- 5.
See Hope (2004), supra note 4, p. 68 (explaining the copyleft licensing scheme developed in the software community and describing it as “an ingenious twist on the conventional copyright licence”); see also Lerner and Tirole (2005), supra note 3, p. 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 under these same conditions”).
- 6.
See Feldman and Nelson (2008), http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1127571 (May 2008) (using the terms “Open Source Biotechnology” 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”); see also Gitter (2007), supra note 2, pp. 1482–1485 (describing the former International HapMap Project data access policy, which was modeled upon an open source software licensing approach and aimed to ensure that basic data remained widely accessible).
- 7.
The Bermuda Statement is an international agreement favoring release into the public domain of genetic databases achieved through public funding. See Human Genome Project, US Department of Energy Office of Science, Summary of Principles Agreed at the First International Strategy Meeting on Human Genome Sequencing, http://www.ornl.gov/sci/techresources/Human_Genome/research/bermuda.shtml#1 (February 25–28, 1996).
- 8.
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, http://www.genome.gov/10506537 (February 2003).
- 9.
See, e.g., National Institutes of Health, Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-wide Association Studies (GWAS), http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html (January 25, 2008) (“All investigators who receive NIH support to conduct genome-wide analysis of genetic variation in a study population 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”) (hereinafter NIH GWAS Data Sharing Policy). In the UK as well, 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, http://www.wellcome.ac.uk/About-us/Policy/Policy-and-position-statements/WTX035043.htm (January 2007).
- 10.
National Institutes of Health, Final NIH Statement on Sharing Research Data, NOT-OD-03-032, http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html (February 26, 2003).
- 11.
See Rai (1999), p. 95 (describing how Congressional enactment of the Bayh-Dole Act in 1980 stimulated the commercialisation of academic research).
- 12.
Reichman and Uhlir (2003), p. 322.
- 13.
Ibid., pp. 322–323.
- 14.
Cambon-Thomsen (2004), p. 866.
- 15.
Boggio (2008), p. 231.
- 16.
Cambon-Thomsen et al. (2007), p. 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 US biobanks, such as the Framingham Heart Study and the Marshfield Clinic’s Personalized Medicine Research Project. See Elger and Caplan (2006), p. 661.
- 17.
- 18.
Cambon-Thomsen et al. (2003), p. 629.
- 19.
Lowrance (2006), available at http://www.wellcome.ac.uk/stellent/groups/corporatesite/@msh_grants/documents/web_document/wtx030842.pdf.
- 20.
The terms “data producers” and “data users” are not mutually exclusive, since scientists may in some situations be data producers, yet be data users in others.
- 21.
See Nelson (2009), p. 163. Indeed, one expert has noted that certain researchers may in fact 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, 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) (September 11, 2009). However, he noted that in reality researchers typically contact a colleague personally to clarify their questions, as opposed to publicly challenging the work. Ibidem.
- 22.
See Singleton (2007), http://www.genome.gov/Multimedia/OD/GWAS_Boston_07/11-Singleton_Professional.ppt#4 (June 22, 2007) (hereinafter Singleton).
- 23.
See Singleton (2007), supra note 22.
- 24.
Ibidem. It should be noted that while open source sharing of data is possible, open source sharing of actual tissue samples is not, because of the limited amount of tissue that can be collected and stored. Data producers must husband this resource carefully to ensure optimal allocation. See Boggio (2008), supra note 15, p. 231.
- 25.
Singleton (2007), supra note 22.
- 26.
- 27.
Creative Commons is a nonprofit corporation that aims to facilitate content-sharing in accordance with the law of copyright. Creative Commons, About, http://creativecommons.org/about/ (last visited March 18, 2010).
- 28.
See Nelson (2009), supra note 21, p. 163 (citing Professor James Boyle of Duke Law School).
- 29.
See ccMixter, About, http://ccmixter.org/about (last visited March 18, 2010).
- 30.
See Nelson (2009), supra note 21, p. 163.
- 31.
Cambon-Thomsen (2003), p. 26.
- 32.
Boggio (2008), supra note 15, p. 234.
- 33.
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 UK and use this data for research into the prevention, diagnosis and treatment of human disease. UK Biobank, UK Biobank—What Is It?, http://www.ukbiobank.ac.uk/about/what.php (last visited April 11, 2010).
- 34.
UK Biobank (2007), Ethics and Governance Framework 12–13, http://www.ukbiobank.ac.uk/docs/EGFlatestJan20082.pdf (October 2007).
- 35.
UK Biobank (2007), Ethics and Governance Framework 12–13, http://www.ukbiobank.ac.uk/docs/EGFlatestJan20082.pdf (October 2007).
- 36.
See Gitter (2007), supra note 2, pp. 1493–1494 (describing the grantback requirement imposed by Incyte Genomics, Inc.).
- 37.
See Boggio (2008), supra note 15, p. 235.
- 38.
Cf. Gitter (2007), supra note 2, pp. 1489–1490 (explaining the obstacles to achieving the open source model with respect to the International HapMap Project without an adequate enforcement mechanism).
- 39.
See Boggio (2008), supra note 15, p. 235.
- 40.
Ibidem.
- 41.
See Gitter (2007), supra note 2, pp. 1478 and 1508–1509 (citing the example of the SNP Consortium, a group of pharmaceutical firms and a nonprofit organisation 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). See also Hope ( 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”).
- 42.
See Rai (1999), supra note 11, pp. 95–96 (describing how the enactment of the Bayh-Dole Act in 1980 stimulated the commercialisation of academic research).
- 43.
Post (2007), http://www.genome.gov/Multimedia/OD/GWAS_Boston_07/02-Post_Challenges.ppt#1 (June 22, 2007).
- 44.
Press Release, http://www.nlm.nih.gov/news/press_releases/dbgap_launchPR06.html (December 12, 2006). 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. Ibidem.
- 45.
NIH GWAS Data Sharing Policy, supra note 9.
- 46.
Ibidem. See also The GAIN Collaborative Research Group (2007) (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–phenotype associations identified through GAIN to remain unencumbered by intellectual property claims” in order to maximise the benefit provided by these “community resources”).
- 47.
See Nelson (2009), supra note 21, pp. 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).
- 48.
Reichman and Uhlir (2003), supra note 12, pp. 322–323.
- 49.
Ibid., p. 346.
- 50.
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, 461 Nature 168, 170 (2009).
- 51.
Medical Research Council, About Us, http://www.mrc.ac.uk/About/Structure/index.htm (last visited March 19, 2010).
- 52.
NIH GWAS Data Sharing Policy, supra note 9.
- 53.
Lowrance (2006), supra note 19, p. 36.
- 54.
Medical Research Council, Medical Research Council Policy on Data Sharing and Preservation Policy, http://www.mrc.ac.uk/Ourresearch/Ethicsresearchguidance/Datasharinginitiative/Policy/index.htm#P16_1349 (last visited March 20, 2010).
- 55.
See Lowrance (2006), supra note 19, p. 36.
- 56.
See Reichman and Uhlir (2003), supra note 12, p. 355. The NIH provides a freely accessible GWAS database, where the UK Biobank permits access via an application system. See supra note 34 and accompanying text.
- 57.
PLoS One, PLoS One Editorial and Publishing Policies, http://www.plosone.org/static/policies.action#sharing (last visited March 20, 2010).
- 58.
Nature.com, Authors & Referees @npg, http://www.nature.com/authors/editorial_policies/availability.html (last visited March 20, 2010).
- 59.
Schofield et al. (2009), p. 171.
- 60.
Hernán and Wilcox (2009), p. 168.
- 61.
Nelson (2009), supra note 21, p. 163.
- 62.
See, e.g., 2 Trials of War Criminals Before the Nuremberg Military Tribunals Under Control Council Law No. 10, pp. 181–182 (US Gov’t Printing Office, 1946–1949) (The Nuremberg Code is an international agreement that prohibits countries from conducting experimental medical treatments on patients without their express informed consent.); World Medical Association (1997), p. 925 (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”); 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, http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm (April 18, 1979) (The Belmont Report is a set of national recommendations in the US regarding research on human subjects); 45 C.F.R. part 46 (2007) (The Common Rule) (The Common Rule is a US 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).
- 63.
Swede et al. (2007), p. 145 (citations omitted).
- 64.
See Cambon-Thomsen (2004), supra note 14, p. 869.
- 65.
See Burger (2009), p. 56.
- 66.
Ibid., pp. 69–74 (citing numerous examples of research participants who expressed preferences as to the specific research uses to be made of their tissue samples).
- 67.
See Cambon-Thomsen (2004), supra note 14, p. 869 (citations omitted).
- 68.
Blanket consent suggests that there are no restrictions placed on the scope and duration of the consent, and “can never be fully informed”. Lunshof et al. (2008), p. 408 (citation omitted).
- 69.
Cambon-Thomsen (2004), supra note 14, p. 869.
- 70.
Ibidem.
- 71.
See Lunshof et al. (2008), supra note 68, p. 408.
- 72.
See Elger and Caplan (2006), supra note 16, p. 662.
- 73.
See Cambon-Thomsen (2004), supra note 14, p. 869 (citation omitted).
- 74.
Ibidem.
- 75.
Ibid., p. 871.
- 76.
Ibid., p. 869.
- 77.
Ibid., p. 871.
- 78.
See supra note 44 for a definition of a GWAS.
- 79.
Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS), 72 Fed. Reg. p. 49, 294 (August 28, 2007).
- 80.
Ibid., p. 291.
- 81.
Ibid., p. 295.
- 82.
Ibidem.
- 83.
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 (August 28, 2008).
- 84.
Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS), 72 Fed. Reg. p. 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 (2007), supra note 46, p. 1049.
- 85.
Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS), 72 Fed. Reg. at 49, 296; Nat'l Insts. 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) 7, available at http://grants.nih.gov/grants/gwas/gwas_ptc.pdf (2007).
- 86.
Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS), 72 Fed. Reg. at 49, 295.
- 87.
Ibidem. De-identification “means that the identities of data subjects cannot be readily ascertained or otherwise associated with the data by the repository staff or secondary data users []; 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 combination with other information to identify the subject of the data”. Ibidem. The 18 identifiers that must be removed pursuant to HIPAA include 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; email 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 C.F.R. para 164.514(b)(2)(i) (2007).
- 88.
See Lin et al. (2004), p. 183 (“If someone has access to individual 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 Lowrance and Collins (2007), p. 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”).
- 89.
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, http://grants.nih.gov/grants/gwas/gwas_ptc.pdf (November 12, 2007) (citation omitted).
- 90.
See National Institutes of Health, Modifications to Genome-Wide Association Studies (GWAS) Data Access 1, http://grants.nih.gov/grants/gwas/data_sharing_policy_modifications_20080828.pdf (August 28, 2008).
- 91.
See Homer et al. (2008), http://www.plosgenetics.org/article/info%3Adoi%2F10.1371%2Fjournal.pgen.1000167.
- 92.
See Felch (2008), p. 31.
- 93.
Malin et al. (2010), p. 15.
- 94.
See supra notes 42–43 and accompanying text.
- 95.
See Bregman-Eschet (2006), supra note 17, p. 11.
- 96.
See Haddow et al. (2007), p. 274.
- 97.
- 98.
- 99.
See UK Biobank, Ethics and Governance Framework 3, http://www.ukbiobank.ac.uk/docs/EGFlatestJan20082.pdf (October 2007).
- 100.
See UK Biobank, Ethics and Governance Framework 18, http://www.ukbiobank.ac.uk/docs/EGFlatestJan20082.pdf (October 2007).
- 101.
See Moore v. Regents of the Univ. of Cal., 51 Cal. 3d 120, 134–47 (Cal. 1990), cert. denied, 499 U.S. 936 (1991); Greenberg v. Miami Children’s Hosp. Research Inst., Inc., 264 F. Supp. 2d 1064, 1074–76 (S.D. Fla. 2003); 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 to the research subject. See Moore, 51 Ca. 3d at 131–33.
- 102.
See Moore, 51 Cal. 3d at 143–47.
- 103.
See Gitter (2004), p. 298.
- 104.
Cf. ibid., p. 260 (noting that the plaintiff parents in Greenberg v. Miami Children’s Hosp. Research Inst., Inc. has premised their research participation on the belief that their contributions would promote widely affordable and accessible carrier and prenatal testing for Canavan disease).
- 105.
See ibid., pp. 262–263 and 320; see also Terry et al. (2007), p. 157.
- 106.
Ibid., p. 162.
- 107.
See Coriell Personalized Medicine Collaborative, Technical Paper, http://cpmc.coriell.org/Docs/PDF/cpmc_technical_paper.pdf (April 22, 2009).
- 108.
See Coriell Personalized Medicine Collaborative, Consent to Participate in a Research Study 7, http://cpmc.coriell.org/Docs/PDF/Informed_Consent.pdf (last visited March 21, 2010).
- 109.
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, http://74.125.93.132/search?q=cache:LaOd73ZxxGYJ:www.navigenics.com/visitor/what_we_offer/our_policies/gene_patents/+navigenics+universal+royalty&cd=1&hl=en&ct=clnk&gl=us (last visited March 21, 2010).
- 110.
See Simon (2009), supra note 97, p. 78.
- 111.
Nelson (2009), supra note 21, p. 162.
- 112.
Ibidem.
- 113.
See Gibbons (2009), p. 313.
- 114.
Nelson (2009), supra note 21, p. 162 (quoting Professor Boyle of Duke University School of Law).
- 115.
European Life Science Infrastructure for Biological Information, ELIXIR: Data for Life, http://www.elixir-europe.org/bcms/elixir/Documents/Elixir_brochure.pdf (last visited March 22, 2010).
- 116.
See Lowrance (2006), supra note 19, p. 35.
- 117.
EMBL-EBI is a European nonprofit bioinformatics research centre which aims to “provide freely available data and bioinformatics services to all facets of the scientific community in ways that promote scientific progress”. EMBL-EBI, Welcome to the EBI, http://www.ebi.ac.uk/Information/ (last visited March 23, 2010).
- 118.
ELIXIR, Project Information, http://www.elixir-europe.org/page.php?page=information (last visited March 23, 2010).
- 119.
Biobanking and Biomolecular Resources Research Infrastructure, Background, http://bbmri.eu/index.php/about-bbmri/background (last visited March 23, 2010).
- 120.
National Center for Biotechnology Information, NCBI at a Glance, http://www.ncbi.nlm.nih.gov/About/glance/ourmission.html (revised 21 May 2004).
- 121.
Nature Opinion Forum: Prepublication Data Sharing: The Toronto Statement, 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) (September 11, 2009).
- 122.
Foster and Sharp (2007), p. 635.
- 123.
Ibid., pp. 635–636.
- 124.
See Yuille et al. (2009), http://www.springerlink.com/content/l1082h68g0645517/fulltext.pdf; see also Reichman and Uhlir (2003), supra note 12, p. 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).
- 125.
See Yuille et al. (2009), supra note 124, p. 2.
- 126.
See supra note 51 and accompanying text.
- 127.
Yuille et al. (2009), supra note 124, p. 3.
- 128.
Ibidem. 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 http://www.oncoreuk.org/downloads/CCB%20Ethics%20Governance%20Workshop%20monograph.pdf (January 2009).
- 129.
See Yuille et al. (2009), supra note 124, p. 6.
- 130.
Ibid., p. 4.
- 131.
Ibidem.
- 132.
Ibidem. See also Reichman and Uhlir (2003), supra note 12, p. 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).
- 133.
Caulfield et al. (2008), http://www.plosbiology.org/article/info:doi/10.1371/journal.pbio.0060073. See also supra note 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 formalisation of liability rules for misuse of data, all of which are particularly compatible with a restricted access approach).
- 134.
Samet (2009), p. 174.
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Acknowledgements
I wish to thank my host Professor Umberto Izzo and the entire Law and Technology Research Group, Department of Legal Sciences at the University of Trento in Italy for inviting me to contribute this work to their May 2010 conference on “Comparative Issues in the Governance of Research Biobanks: Property, Privacy, Intellectual Property, and the Role of Technology.” This work also benefited from the comments of participants at the 2010 International Data Sharing Conference at the University of Oxford, Centre for Health, Law and Emerging Technologies, as well as the 2010 Intellectual Property Scholars Roundtable at the Intellectual Property Law Center, Drake University Law School in Des Moines, Iowa. Professor Robert Bohrer of California Western School of Law in particular contributed valuable suggestions. Thanks are also due to Professor Jason Mazzone of Brooklyn Law School, who invited me to present this work to his intellectual property law seminar. This work originally appeared in Biotechnology Law Report, December 2010, Vol. 29, No. 6:623–635.
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Gitter, D.M. (2013). The Challenges of Achieving Open Source Sharing of Biobank Data. In: Pascuzzi, G., Izzo, U., Macilotti, M. (eds) Comparative Issues in the Governance of Research Biobanks. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-33116-9_10
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