Biobanking and Privacy Laws in Australia

Amalgamated Society of Engineers v. Adelaide Steamship Co. Ltd. (1920) 28 CLR 129 and Commonwealth v. Tasmania (1983) 158 CLR 1.

See Australian Government, Australian Institute of Health and Welfare (AIHW) Australia's Health 2014, available at <http://www.aihw.gov.au/australias-health/2014/health-system/> (last visited October 20, 2015).

S.128 Commonwealth of Australia Constitution Act, 1900.

Id., at S.51 (xxiiiA).

See <http://www.health.gov.au/internet/main/publishing.nsf/Content/work-nras> (last visited October 20, 2015).

See Australian Government, Department of Human Services, Medicare Benefits Schedule (MBS) <http://www.medicareaustralia.gov.au/provider/medicare/mbs.jsp> (last visited April 24, 2015).

See NHMRC, Research Funding Facts Book for 2013 , available at <https://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/nh167_funding_facts_book_2013.pdf> (last visited October 20, 2015).

These are figures for 2010 to 2011, available at <http://www.researchaustralia.org/health-medical-research/funding-hmr> (last visited October 20, 2015).

See Research Australia, “Major Australia Health & Medical Research,” available at <http://www.researchaustralia.org/health-medical-research/major-australian-health-medical-research-achievements> (last visited October 20, 2015).

See Strategic Review of Health & Medical Research, available at <http://www.mckeonreview.org.au/downloads/Strategic_Review_of_Health_and_Medical_Research_Feb_2013-Summary_Report.pdf> (last visited Feb. 25, 2015).

See The Virtuous Cycle - Working Together for Health and Medical Research, 2000 available at <https://www.nhmrc.gov.au/guidelines-publications/nh28> (last visited October 20, 2015).

Chalmers D. Nicolm D. , “Human Genetic Research Databases and Biobanks -Towards Uniform Terminology and Australian Best Practice,” Journal of Law and Medicine 15, no. 4 (2008): 538–554.

Green E. D. Guyer M. , “Charting a Course for Genomic Medicine from Base Pairs to Bedside,” Nature 470, no. 7333 (2011): 204–213.

Greely H. quoted in Longtin R. “Canadian Province Seeks Control of Its Genes,” Journal of the National Cancer Institute 96, no. 21 (2004): 1567–1569.

See ABNA, available at <http://abna.org.au/> (last visited October 20, 2015).

The Australian Biospecimen Network provides a list of links to Australasian biobanks at <http://abrn.net/contact/links/> (last visited October 20, 2015): Australian Ovarian Cancer Study; Australian Brain Bank Network; Australian Breast Cancer Tissue Bank-NSW; Australasian Leukaemia & Lymphoma Group; Queensland Institute Medical Research Cell Line Bank; Brisbane Breast Bank; Australian Leukaemia and Lymphoma TB-QLD; Qld Children's Tumour Bank; Wesley Tissue Bank part of the Wesley Private Hospital-Qld; Australian Prostate Cancer Bioresource (APCC)-Qld; Cart-Wheel; Lifepool; Peter Mac Tissue Bank; Victorian Cancer Biobank (VCB); Australian Brain Bank Network; Australian Breast Cancer Tissue Bank-NSW; Cancer Lifestyle & Evaluation of Risk (CLEAR); New South Wales Pancreatic Cancer Network (NSWPCN); Genetic Repositories Australia; Gynecological Oncology Biobank at Westmead; Paediatric Tissue bank; Cellbank Australia; Harry Perkins Institute of Medical Research (formerly Western Australia Institute of Medical Research); Western Australian DNA Bank; Western Australian Research Tissue Network- St. John of God Pathology; Australian Mesothelioma Tissue Bank.

COSA Submission to the Cancer Research Leadership Forum on “Towards a National Cancer Research Plan,” April 2012, available at <https://www.cosa.org.au/media/1075/cosa_submission_towards-a-national-cancer-research-plan_april2012.pdf> (last visited October 20, 2015).

Australasian Biospecimen Network-Oncology (ABN-Onc): (with Peter MacCallum Cancer Centre, kConFab, Westmead Children's Hospital, Westmead Gynaecological Oncology Biobank, WARTN, QEII Mesothelioma Bank, the Cell Bank at QIMR and Breast Tissue Bank, QIMR), <www.abrn.net>; <http://www1.petermac.org/allg/NewSite/>; Australian Ovarian Cancer Study (AOCS), <www.aocstudy.org>; Australian Prostate Cancer Consortium (APCC), <www.apccbioresource.org.au>; Australian Breast Cancer Tissue Bank (ABCTB), <www.abctb.org.au>; The Kathleen Cuningham Consortium for Research into Familial Breast Cancer (kConFab), <www.kconfab.org> (all last visited October 20, 2015).

NHMRC, Biobanks Information Paper (2010), available at <https://www.nhmrc.gov.au/_files_nhmrc/file/your_health/egenetics/practioners/biobanks_information_paper.pdf> (last visited October 20, 2015).

Department of Innovation, Industry, Science and Research, Strategic Roadmap for Australian Research Infrastructure (2011), available at <http://www.industry.gov.au/science/Documents/2011StrategicRoadmapforAustralianResearchInfrastructure.pdf> (last visited October 20, 2015).

See list at supra note 18.

The NHMRC Cancer Biobank Working group presented 5 key advantages for a national network applicable not only to a cancer biobank network but that of other diseases: (1) closer interactions with clinicians, surgeons and other health professionals to open the way for Medicare number and/or the electronic medical record to facilitate the linking of clinical information and follow-up data to banked specimens; (2) a common approaches to governance, infrastructure and operational aspects of biobanking, particularly in IT; (3) high quality biospecimens; (4) rapid response for collecting tumour types or specific data; and (5) continuing support for biobanking, training and accreditation/certification.

OECD Council Recommendation on Human Biobanks and Genetic Research Databases October 22, 2009, available at <http://acts.oecd.org/Instruments/ShowInstrumentView.aspx?InstrumentID=218&InstrumentPID=214&Lang=en&Book=> (last visited October 20, 2015).

Chalmers D. Nicol D. , “Human Genetic Research Databases and Biobanks: Towards Uniform Terminology and Australian Best Practice,” Journal of Law and Medicine 15, no. 4 (2008): 538–555.

See Coriell Personalized Medicine Collaborative, available at <https://cpmc.coriell.org/> (last visited October 20, 2015).

See <http://biospecimens.cancer.gov/programs/cahub/default.asp> (last visited 29 October 2015).

See Early Detection Research Network, available at <http://edrn.nci.nih.gov> (last visited October 20, 2015).

See <http://cancergenome.nih.gov/> (last visited October 20, 2015).

See <www.redbiobancos.es> (last visited October 21, 2015).

See <www.eurobiobank.org> (last visited October 21, 2015).

See <www.ctrnet.ca/> (last visited October 21, 2015).

Hudson T. , “International Network of Cancer Genome Projects,” Nature 464, no. 7291 (2010): 993–998.

Vaught J. , “Biobankonomics: Developing a Sustainable Business Model Approach for the Formation of a Human Tissue Bank,” Journal of the National Cancer Institute Monograph no. 42 (2011): 24–31.

See <www.hupo.org/> (last visited October 21, 2015).

Karapetis C. , “K-ras Mutations and Benefit from Cetuximab in Advanced Colorectal Cancer,” New England Journal of Medicine 359, no. 17 (2008): 1757–1765.

See <http://www.p3gconsortium.org/> (P3G motto is “transparency and collaboration”) (last visited October 21, 2015).

Norwegian Institute of Public Health, “Promoting Harmonisation of Epidemiological Biobanks in Europe,” available at <http://www.fhi.no/artikler/?id=73793> (last visited October 21, 2015).

The principles of Collection Limitation; Data Quality; Purpose Specification; Use Limitation; Openness; Individual Participation; Accountability.

95/46/EC, see also Directive on Telecommunications privacy (97/66/EC now 2002/58/EC).

See <http://www.oaic.gov.au/privacy/privacy-act/the-privacy-act> (last visited October 21, 2015).

Combined APP guidelines were published on April 1, 2015; see <https://www.oaic.gov.au/agencies-and-organisations/appguidelines/> (last visited December 14, 2015).

This legislation goes under a range of titles and can be accessed at <http://www.oaic.gov.au/privacy/other-privacy-jurisdictions/state-and-territory-privacy-law> (last visited October 21, 2015).

Gibbons S. M. Kaye J. , “Governing Genetic Databases: Collection, Storage and Use,” King's Law Journal 18, no. 2 (2007): 201–208.

For Your Information: Australian Privacy Law and Practice (ALRC Report 108) recommended that IPPs or NPPs be replaced by model Unified Privacy principles (UPPs). This recommendation was accepted with the nomenclature of Australian Privacy Principles (APPs).

See OECD, OECD Guidelines on Human Biobanks and Genetic Research Databases, available at <http://www.oecd.org/science/biotech/44054609.pdf> (last visited October 21, 2015).

Australasian Biospecimen Network Biorepository Protocols, 2012, available at <http://abrn.net/what-we-do/protocols/> (last visited October 21, 2015).

See ISBER, Best Practices for Repositories: Collection, Storage, Retrieval and Distribution of Biological Materials for Research (2011), available at <http://c.ymcdn.com/sites/www.isber.org/resource/resmgr/Files/ISBER_Best_Practices_3rd_Edi.pdf> (last visited October 21, 2015).

National Cancer Institute, NCI Best Practices for Biospecimen Resources , updated in 2011, at page 1, available at <http://biospecimens.cancer.gov/bestpractices/2011-NCIBestPractices.pdf> (last visited October 21, 2015).

The term is not precise, as has been noted by Knoppers B. M. Saginur M. , “The Babel of Genetic Data Terminology,” Nature Biotechnology 23, no. 8 (2005): 925–927.

The National Statement states that human tissue samples should always be regarded as, in principle, re-identifiable. See National Health and Medical Research Council, Australian Research Council and Australian Vice-Chancellors' Committee, National Statement on Ethical Conduct in Human Research (2007).

Milius D. , “The International Cancer Genome Consortium's Evolving Data-sharing Policies,” Nature Biotechnology 32, no. 6 (2014): 519–523.

See <http://www.abctb.org.au/abctbNew2/ApplicationProcedures.aspx> (last visited March 2, 2015).

Chalmers D. , “Marking Shifts in Human Research Ethics in the Development of Biobanking,” Public Health Ethics (2014).

The National Statement defines “unspecified” consent as “given for the use of data or tissue in any future research,” National Statement on Ethical Conduct in Human Research (2007), Paragraph 2.2.14 (c).

See Otlowski M. F. , “Tackling Legal Challenges Posed by Population Biobanks: Reconceptualising Consent Requirements,” Medical Law Review 20, no. 2 (2012): 191.

Schofield , “Post-Publication Sharing of Data and Tools,” Nature 461, no. 7261 (2009): 171–173.)

Petherick A. , “Biobanks Look to Software Solutions to Handle Data Deluge,” Nature Medicine 18, no. 7 (2012): 992.

Stein L. , “The Case for Cloud Computing in Genome Informatics,” Genome Biology 11, no. 5 (2010): 207–213.

CHeReL operates in NSW and the ACT, available at <http://www.cherel.org.au/about-us> (last visited October 21, 2015).

The Australian Privacy Principles were introduced in March 2014 and are: APP 1: Open and transparent management of personal information; APP 2: Anonymity and pseudonymity; APP 3: Collection of solicited personal information; APP 4: Dealing with unsolicited personal information; APP 5: Notification of the collection of personal information; APP 6: Use or disclosure of personal information; APP 7: Direct marketing; APP 8: Cross-border disclosure of personal information; APP 9: Adoption, use or disclosure of government related identifiers; APP 10: Quality of personal information; APP 11: Security of personal information; APP 12: Access to personal information; and, APP 13: Correction of personal information. These APPs replaced the former Information Privacy Principles (IPPs) for the public sector and the National Privacy Principles (NPPs) for the private sector.

In considering this balance, HRECs should to consider matters including: The degree to which the personal information is necessary for the research; the public importance of the research and the likely contribution to the community; any likely benefits to individuals or groups; whether the research could be achieved within the terms of the IPPs and NPPs and the degree to which this would impact on the scientific value of the research; whether the risk of harm to the individual whose personal information is to be used is minimal; the study design and scientific credentials of those involved in the research; whether access to the information is restricted to appropriate personnel; the procedures to be followed to ensure that the information is permanently de-identified before the publication of results; and, the procedures to be followed at the completion of the study to protect or destroy the information.

Wolf S. M. , “Managing Incidental Findings and Research Results in Genomic Research Involving Biobanks and Archived Data,” Genetics in Medicine 14, no. 4 (2012): 361–384; Wolf S. M. , “The Role of Law in the Debate over Return of Research Results and Incidental Findings: The Challenge of Developing Law for Translational Science,” Minnesota Journal of Law, Science & Technology 13, no. 1 (2012): 435–448; Levesque E. , “Return of Research Results: General Principles and International Perspectives,” Journal of Law, Medicine & Ethics 39, no. 4 (2011): 583–592.

Green R. C. , “ACMG Recommendations for Reporting of Incidental Findings in Clinical Exome and Genome Sequencing,” Genetics in Medicine 15, no. 7 (2013): 565–574.

Berg J. S. Khoury M. J. Evans J. P. , “Deploying Whole Genome Sequencing in Clinical Practice and Public Health: Meeting the Challenge One Bin at a Time,” Genetics in Medicine 13, no. 6 (2011): 499–503.

Health Council of the Netherlands, “The ‘Thousand-Dollar Genome’: An Ethical Exploration,” Monitoring Report Ethics and Health 2010/2 (2010): 21.

Essentially Yours: The Protection of Human Genetic Information in Australia Report 96 2003 Recs 18–1 to 18–3 and 14–1 to 14–5. Dr. Francis Collins, then Head, US National Human Genome Research Institute, described the Report as “a truly phenomenal job, placing Australia ahead of what the rest of the world is doing, described this Report,” News release during the XIX International Congress of Genetics Melbourne July 5–9 2003.

National Health and Medical Research Council, Use and Disclosure of Genetic Information to a Patient's Genetic Relative under Section 95AA of the Privacy Act 1988 (Cth): Guidelines for Health Practitioners in the Private Sector (October 27, 2009).

Due to jurisdictional issues, these Guidelines are stated to only apply to medical practitioners who work in the private sector: The ALRC/AHEC report Essentially Yours had recommended that States and Territories enact parallel amendments to their privacy legislation to ensure uniform coverage.

Notably, the legislation and guidelines do not provide protection from breach of the common law duty of confidentiality. However, by indicating that disclosure should, where possible, be made without identifying the patient (see Guideline 7), the guidelines seek to minimise the risk of a breach of confidentiality.

See National Health and Medical Research Council, Guidelines Approved under Section 95AA of the Privacy Act 1988 (Cth), available at <https://www.nhmrc.gov.au/guidelines-publications/pr3> (last visited October 21, 2015).

Rogers A. Durand de Bousingen D. , Bioethics in Europe (Council of Europe Press 1995): At 64–67 citing Professor Alain Pompidou Souviens-toi de l'Homme Paris, 1990.

This has been a central focus for the Tasmania Biobank planning, McWhirter R. , “Community Engagement for Big Epidemiology: Deliberative Democracy as a Tool,” Journal of Personalized Medicine 4, no. 4 (2014): 459–474. See also Chalmers D. Nicol D. , “Commercialisation of Biotechnology: Public Trust and Research,” International Journal of Biotechnology 6, no. 2/3 (2004): 116–133.

Australian Law Reform Commission, Essentially Yours report 96, 2003 at para 5.2.

In Australia and New Zealand, the voluntary, not-for-profit Australasian Biospecimen Network is developing standardization advice. See the website at <http://www.abrn.net/> (last visited October 21, 2015).

Australasian Biospecimen Network Biorepository Protocols, 2012, available at <http://abrn.net/what-we-do/protocols/> (last visited October 21, 2015).

Beyleveld D. , “Data Protection and Genetics: Medical Research and the Public Good,” King's Law Journal 18, no. 2 (2007): 275–289; Campbell A. V. , “The Ethical Challenges of Genetic Databases: Safeguarding Altruism and Trust,” King's Law Journal 18, no. 2 (2007): 227–245; Brownsword R. , “Genetic Databases: One for All and All for One?” King's Law Journal 18, no. 2 (2007): 247–273.

See, for example, GA4GH, “Framework for Responsible Sharing of Genomic and Health-Related Data,” available at <http://genomicsandhealth.org/about-the-global-alliance/key-documents/framework-responsible-sharing-genomic-and-health-related-data> (last visited October 21, 2015).