International Guidelines for Privacy in Genomic Biobanking (or the Unexpected Virtue of Pluralism)

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Id., at 312.

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Id., at Article 4.

Id., at Article 14(a).

UNESCO, Universal Declaration on Bioethics and Human Rights (2005), available at <http://www.unesco.org/new/en/social-and-human-sciences/themes/bioethics/bioethics-and-human-rights/> (last visited October 15, 2015) [hereinafter cited as UDBHR].

Id., at Article 9.

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OECD, OECD Recommendation on Human Biobanks and Genetic Research Databases (2009) [Biobanking Guidelines].

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See Declaration of Helsinki, supra note 32, at Article 9.

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Landau S. , “Control Use of Data to Protect Privacy,” Science 347, no. 6221 (2015): 504–506, at 504.

For samples, see ISBER Best Practices, supra note 41, at L2.200; Forsberg J. S. Hansson M. G. Evers K. , “International Guidelines on Biobank Research Leave Researchers in Ambiguity: Why Is This So?” European Journal of Epidemiology 28, no. 6 (2013): 449–451, at 449 [hereinafter cited as Forsberg].

See Declaration of Helsinki, supra note 32, at Article 26.

See CIOMS Guidelines, supra note 26, at Articles 4, 18.

See UDHGHR, supra note 20, at Article 5(b); See IGHGD, supra note 21, at Article 6(d); see UDBHR, supra note 23, at Article 6(2).

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See Elger , supra note 35.

See UDHGHR, supra note 20, at Article 6(2).

See IGHGD, supra note 21, at Article 2; See UDHGHR, supra note 20, at Article 6(d).

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Steinsbekk K. S. Kåre Myskja B. Solberg B. , “Broad Consent Versus Dynamic Consent in Biobank Research: Is Passive Participation an Ethical Problem?” European Journal of Human Genetics 21, no. 9 (2013): 897–902, at 897.

Fonds de la recherche en santé du Québec, Final Report – Advisory Group on a Governance Framework for Data Banks and Biobanks Used for Health Research (2006), at 59–60, available at <http://www.frsq.gouv.qc.ca/en/ethique/pdfs_ethique/Rapport_groupe_conseil_anglais.pdf> (last visited October 15, 2015).

See Forsberg , supra note 44.

Hofmann B. , “Broadening Consent – and Diluting Ethics?” Journal of Medical Ethics 35, no. 2 (2009): 125–129, at 128.

Greely H. T. , “The Uneasy Ethical and Legal Underpinnings of Large-Scale Genomic Biobanks,” Annual Review of Genomics and Human Genetics 8 (2007): 343–364, at 358.

Caulfield T. Knoppers B. M. , Consent, Privacy & Research Biobanks , Policy Directions Brief Number 1, 2009–2010 Series on Genetic Information, Genome Canada (January 26, 2010): 1–10, at 4–5, available at <http://www.genomecanada.ca/medias/pdf/en/GPS-Policy-Directions-Brief.pdf> (last visited October 15, 2015); Nomper A. , Open Consent: A New Form of Informed Consent for Population Genetic Databases (Tartu: Tartu ülikooli kirjastus, 2005).

Knoppers B. M. Abdul-Rahman (Zawati) M. H. , “Biobanks in the Literature,” in Elger B. , eds., Ethical Issues in Governing Biobanks: Global Perspectives (Aldershot: Ashgate, 2008): At 14 [hereinafter cited as Knoppers].

See Lowrance , supra note 33, at 75–76, 118.

Knoppers B. M. , “Framing Genomics, Public Health Research and Policy: Points to Consider,” Public Health Genomics 13, no. 4 (2010): 224–234, at 231.

See Knoppers Abdul-Rahman , supra note 60.

UNESCO, Report of the International Bioethics Committee of UNESCO (IBC) on Consent, 2008, at para 54 [hereinafter cited as UNESCO IBC].

See OECD Biobanking Guidelines, supra note 30; ISBER Best Practices, supra note 41, at 28; See also ISBER Best Practices, supra note 41, at L2.200.

See 1998 HUGO Statement, supra note 37; 2002 HUGO Statement, supra note 37, at Rec 4(c); UNESCO IBC, supra note 64, at para. 50.

See Biobanking Guidelines, supra note 30, at 4E, F.

See 2002 HUGO Statement, supra note 37, at 4d; Biobanking Guidelines, supra note 30, at 61, Article 4.4.

GA4GH Framework, supra note 35, at “Core Elements”.

See UDBHR, supra note 23, at Article 6(2).

Melham K. , “The Evolution of Withdrawal: Negotiating Research Relationships in Biobanking,” Life Sciences, Society and Policy 10, no. 16 (2014): 1–13; see ISBER Best Practices, supra note 41, at L2.200.

See IDHGD, supra note 21, at Article 9(a); CIOMS Epi Guidelines, supra note 26, at Guideline 5; OECD Biobanking Guidelines, supra note 30, at 42–43.

Kaye J. , “The Tension between Data Sharing and the Protection of Privacy in Genomics Research,” in Mascalzoni , ed., Ethics, Law and Governance of Biobanking (New York: 2015): 101–120, at 105.

Taylor , supra note 42, at 94.

See IDHGD, supra note 21, at Article 16(a–b).

See UNESCO IBC, supra note 64, at para 53.

See OECD Biobanking Guidelines, supra note 30, at Article 33.

See Declaration of Helsinki, supra note 32, at Article 32.

See 1998 HUGO Statement, supra note 37.

See GA4GH Framework, supra note 39, at “Core Elements.”

See CIOMS Epi Guidelines, supra note 26, at Guideline 4 b).

See Kaye , supra note 73, at 112.

Schmidt H. Callier S. , “How Anonymous Is ‘Anonymous’? Some Suggestions towards a Coherent Universal Coding System for Genetic Samples,” Journal of Medical Ethics 38, no. 5 (2012): 304–309, at 304.

See Lowrance , supra note 33, at 87.

Knoppers B. M. Chadwick R. , “Human Genetic Research: Emerging Trends in Ethics,” Nature Reviews Genetics 6, no. 1 (2005): 75–79, at 925.

See 1998 HUGO Statement, supra note 37; International Conference on Harmonisation, ICH Harmonised Tripartite Guideline: Definitions for Genomic Biomarkers, Pharmacogenomics, Phamacogenetics, Genomic Data and Sample Coding Categories E15 (2007), at 3–4, available at <http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E15/Step4/E15_Guideline.pdf> (last visited October 15, 2015).

See IDHGD, supra note 21, at Article 2.

See OECD Biobanking Guidelines, supra note 30, at 14(c-e); 1998 HUGO Statement, supra note 37.

See OECD Biobanking Guidelines, supra note 30, Annotation at 37; OECD Data from Public Funding Guidelines, supra note 29, at D.

Thorogood A. , “An Implementation Framework for the Feedback of Individual Research Results and Incidental Findings in Research,” BMC Medical Ethics 15, no. 88 (2014): 1–13, at 9.

See IDHGD, supra note 21, at Preamble.

See El Emam, supra note 82, at 3.

See Kosseim , supra note 49, at 28.

See Lowrance , supra note 33, at 118.

Gymrek M. , “Identifying Personal Genomes by Surname Inference,” Science 339, no. 6112 (2013): 321–324.

See OECD Biobanking Guidelines, supra note 30, at 6.4.

See ISBER Best Practices, supra note 41, at L2.300.

See, e.g., OECD Data Protection Guidelines, supra note 28, at 24.

See OECD Biobanking Guidelines, supra note 30, at 6.3.

GA4GH Framework, supra note 39, at “Core Elements.”

Id., at 5C, 22.22; ISBER Best Practices supra note 41, at M2.100; GA4GH Framework, supra note 39; Madrid Resolution, supra note 32, at 10.1.

See OECD Biobanking Guidelines, supra note 30, at 7A, 6.8; GA4GH Framework, supra note 39, at “Accountability.”

See OECD Biobanking Guidelines, supra note 30, at 2.3,7.3.

See ISBER Best Practices supra note 41, at M2.200.

See, e.g., OECD Data Protection Guidelines, supra note 28; Madrid Resolution, supra note 32, at 10.2; OECD Biobanking Guidelines, supra note 30, at 66; GA4GH Framework, supra note 39 which imposes some of these as freestanding duties on all of its members; ISBER Best Practices, supra note 41, at M2.610 (sample), M2.620 (data).

See, e.g., OECD Data Protection Guidelines, supra note 28, at 16; Madrid Resolution, supra note 32, at 10.1.

GA4GH Framework, supra note 30, at; GA4GH, “Consent,” available at <http://genomicsandhealth.org/our-work/current-initiatives/consent> (last visited March 6, 2015).

Kaye , supra note 73, at 113.

See Universal Declaration of Human Rights, supra note 14, at Article 27; UN General Assembly, International Covenant on Economic, Social and Cultural Rights, 1966, available at <http://www.ohchr.org/EN/ProfessionalInterest/Pages/CESCR.aspx> (last visited October 15, 2015).

See UDHGHR, supra note 20, at Article 24; See IDHGD, supra note 21, at Article 18.

Wellcome Trust, “Sharing Research Data to Improve Public Health: Full Joint Statement by Funders of Health Research,” available at <http://www.wellcome.ac.uk/About-us/Policy/Spotlight-issues/Data-sharing/Public-health-and-epidemiology/WTDV030690.htm> (last visited October 15, 2015). A list of agency signatories can also be found on the website.

See OECD Data from Public Funding Guidelines, supra note 29, at J; see, e.g., OECD Data Protection Guidelines, supra note 28, at 11.

See OECD Biobanking Guidelines, supra note 30, at 6.5,6.6.

Id., at Articles 7–8.

Global Alliance for Genomics & Health, “Privacy and Security Policy,” available at <http://genomicsandhealth.org/our-work/current-initiatives/privacy-and-security-policy> (last visited March 6, 2015).

See OECD Biobanking Guidelines, supra note 30, at 3A; GA4GH Framework, supra note 39, at “Core Elements.”

See OECD Biobanking Guidelines, supra note 30, at 8C.

Id., at 6.1.

See, e.g., Data Protection Guidelines, supra note 28, at 22.

See Framework , supra note 39, at “Accountability.”

Bamberger K. A. Mulligan D. K. , “Privacy on the Books and on the Ground,” Stanford Law Review 63, no. 2 (2011): 247–316, at 275–276.

OECD Data Protection Guidelines, supra note 28, at 27.

GA4GH, “Accountability Policy,” available at <http://genomicsandhealth.org/our-work/current-initiatives/accountability-policy> (last visited March 6, 2015).

Enderink M. Chin G. , “The End of Privacy: From Big Data to Ubiquitous Internet Connections, Technology Empowers Researchers and the Public – but Makes Traditional Notions of Privacy Obsolete,” Science 347, no. 6221 (2015): 490–491, at 490.

Nuffield Council on Bioethics, The Collection, Linking and Use of Data in Biomedical Research and Health Care (2015), at xi, available at <http://nuffieldbioethics.org/wp-content/uploads/Biological_and_health_data_web.pdf> (last visited October 15, 2015).

Dove E. S. , “Genomic Cloud Computing: Legal and Ethical Points to Consider,” European Journal of Human Genetics (2014).

See Kuner , supra note 10, at 160.

Krisch N. , “The Pluralism of Global Administrative Law,” European Journal of International Law 17, no. 1 (2006): 247–278, at 269–270, 278.

Couzin-Frankel J. , “Trust Me, I'm a Medical Researcher,” Science 347, no. 6221 (2015): 501–503, at 502–503.

Id., at 483–484.