1 Second International Biobanking Summit (IBS-II): Future Directions Alte Universität, Graz, Austria September 17, 2013 Big Data, Privacy Protection and Ethics Harmonisation Bartha M. Knoppers Director, Centre of Genomics and Policy Canada Research Chair in Law and Medicine McGill University
2 Outline Introduction: Big Data and Privacy Protection A Way Forward: The Global Alliance Towards International Interoperability: IPAC Conclusion: A Safe Harbour for Ethics Harmonisation?
3 Introduction: A World of Big Data What is Big Data? Datasets whose size are beyond the ability of typical database software tools to capture, store, manage and analyse. As technology advances over time, the size of datasets that qualify as Big Data will also increase. - McKinsey Global Institute: Big data: The next frontier for innovation, competition, and productivity (2011)
4 Introduction: A World of Big Data Data is the 21st century s new raw material. - Rt. Hon. Francis Maude - Open Data White Paper: Unleashing the Potential (UK, 2012)
5 Introduction: A World of Big Data A wealth of information creates a poverty of attention and a need to allocate that attention efficiently among the overabundance of information sources that might consume it. - Herbert Simon (1971)
6 Introduction: A World of Big Data Eric E. Schadt, The Changing Privacy Landscape in the Era of Big Data, Molecular Systems Biology 8, 612 (2012).
7 Introduction: A World of Big Data
8 Privacy Protection Big Data: Potential to create significant value for the world (in terms of innovation, productivity, economic benefit, health outcomes, etc.) but what about the risks to privacy and data protection? Big Data creates transparency, but at what cost to privacy?
9 Privacy Protection Privacy protection comes in two main forms 1. Laws, regulations and guidance EU: Data Protection Directive 95/46 EC Canada: PIPEDA, public/private/health sector statutes (prov.) U.S.: FTC s Fair Information Practice Principles OECD: Guidelines on the Protection of Privacy and Transborder Flows of Personal Data 2. Industry self-regulation Privacy Utility
10 Privacy Protection Six areas of concern in the age of Big Data: Informed consent Purpose specification Fair Information Practices Data minimization Binary of personal vs. non-personal data Effective anonymization/de-identification National privacy/data protection laws that unduly restrict transborder data flows Has Big Data changed the nature of risk to privacy?
11 Privacy Protection: Two Open Questions Should policymakers create exceptions in privacy/data protection laws for 1) certain research purposes (or a safe harbour approach application and approval structure administered by a central/federated authority?); and for 2) the use of anonymized or aggregated data? We can aim to ensure that all data is cleaned of identifiers before being transferred into large databases, but how sure are we the data is legally or truly de-identified?
12 Privacy Protection: Four Observations Privacy is an important value, but not an absolute value time to rethink some of the privacy principles listed in the OECD Privacy Guidelines There is a need to harmonize privacy/data protection laws across the globe in the long term, and in the short term, work towards interoperability of privacy/data protection laws, and give more focus to reforming/enacting anti-discrimination protections Recognize the limits of law and regulation (e.g. inflexibility) and embrace more Codes of Conduct We need to continue to support and develop new privacy-enhancing technologies (e.g. DataSHIELD) [W]e now need to understand what information is personally identifiable and to figure out collectively what reasonable expectation of privacy we have regarding such data. I believe education and legislation aimed less at protecting privacy and more at preventing discrimination will be key. Eric Schadt
13 Global Biomedical Research: Suffering from Silos and Insufficiencies
14 A Way Forward: The Global Alliance
15 A Way Forward: The Global Alliance Why? To advance medical knowledge and improve clinical care. How? By encouraging the widespread ability to address genomic and clinical data in an interoperable, secure, and trusted manner that preserves diversity of approach and application, and by enabling comparison of genetic variants and clinical features. Specifically: a global alliance is needed to bring together researchers, health care providers, funders, disease advocacy organizations, life science and technology companies, and informed citizens to enable, support, and promote the responsible sharing of genomic and clinical data.
16 A Way Forward: The Global Alliance Media Coverage across the World
17 A Way Forward: The Global Alliance Partners American Association for Cancer Research (US) American Society of Clinical Oncology (US) American Society of Human Genetics (US) Association for Molecular Pathology (US) A-T Children's Project (US) Beth Israel Deaconess Medical Center (US) BGI-Shenzhen (CN) Boston Children s Hospital (US) Brigham and Women's Hospital (US) Broad Institute of MIT and Harvard (US) California Institute of Technology (US) Canadian Cancer Society (CA) Canadian Institutes for Health Research (CA) Cancer Commons (US) Cancer Research UK (UK) Center for Genomic Regulation (ES) Centre for Comparative Genomics, Murdoch University (AU) Centre for the Advancement of Sustainable Medical Innovation (UK) Centro Nacional de Analisis Genomico (ES) Chinese Academy of Sciences (CN) Coalition of Heritable Disorders of Connective Tissue (US) Community Oncology Research Consortium (US) Dahlem Center for Genome Research and Medical Systems Biology, Max Planck Institute (DE) Dana-Farber Cancer Institute (US) ELIXIR (UK) EMBL- European Bioinformatics Institute (UK) European Molecular Biology Laboratory (DE) European Society of Human Genetics (AT) Genetic Alliance (US) Genetic Alliance UK (UK) Genome Canada (CA) Global Genes RARE Project (US) H3ABioNet Consortium (ZA) Howard Hughes Medical Institute (US) Human Genome Organization (SG) Human Variome Project International (AU) Huntington Society of Canada (CA) Institut National du Cancer (FR) Institute for Systems Biology (US) International Cancer Genome Consortium (CA) International Rare Diseases Research Consortium (FR) Johns Hopkins University School of Medicine (US) King s Health Partners (UK) Knight Cancer Institute, Oregon Health & Science University (US) Lund University (SE) Massachusetts Eye and Ear Infirmary (US) Massachusetts General Hospital (US) McGill University/Université McGill (CA) McLaughlin Centre, Faculty of Medicine, University of Toronto (CA) Memorial Sloan-Kettering Cancer Center (US) National Cancer Center (JP) National Cancer Institute (US) National Human Genome Research Institute (US) National Institute for Health and Welfare (FI) National Institute for Health Research (UK) National Institutes of Health (US) New York Genome Center (US) Ontario Institute for Cancer Research (CA) Ontario Personalized Medicine Network (CA) Partners HealthCare (US) P3G Public Population Project in Genomics and Society (CA) PHG Foundation (UK) PXE International (US) Queen's University Belfast (UK) RD-Connect (UK) RIKEN Center for Integrative Medical Sciences (JP) Sage Bionetworks (US) Samuel Lunenfeld Research Institute, Mount Sinai Hospital (CA) Simons Foundation (US) Spanish Institute of Bioinformatics (ES) Spanish National Cancer Research Center (ES) St. Jude Children's Research Hospital (US) Stanford University (US) Sunnybrook Health Sciences Centre (CA) SIB-Swiss Institute of Bioinformatics (CH) The Hospital for Sick Children (CA) The University of Cape Town (ZA) University Health Network (CA) University of California, Berkeley (US) University of California Health System (US) University of California, San Francisco (US) University of California, Santa Cruz (US) University of Chicago (US) University of Michigan (US) University of Oxford (UK) University of Texas M.D. Anderson Cancer Center (US) University of Toronto (CA) University of Waterloo (CA) Weill Cornell Medical College (US) Wellcome Trust Sanger Institute (UK) The Wellcome Trust (UK)
18 A Way Forward: The Global Alliance
20 ELSI 2.0 Building a Collaboratory A new project whose administrative hub is P 3 G. Mission: to accelerate the translation of ELSI research findings into practice and policy. Jane Kaye et al., ELSI 2.0 for Genomics and Society. Science 336, (2012).
21 P 3 G Mission An international not-for-profit corporation; Dedicated to the development and management of biobanks, research databases and other similar health and social research infrastructures; Through its tools, support and networks, help the international research community with effective strategies to promote the health of individuals, families and communities; Comprises more than 450 individual and institutional members
22 Research Programmes Maelstrom Research Programme (dir. I. Fortier) Paediatric Research Programme (dir. E. Clayton) CGP Policy Research Programme (dir. B.M. Knoppers) HARMONIZATION Research Partnership (ex. BioSHaRE.EU; Qc Harmonization Platform) P 3 G employees working with the harmonization team PAEDIATRICS Research/Services Partnership POLICY Research/Services Partnership IPAC International Policy interoperability and data Access Clearinghouse
23 P3G-IPAC Building an International Policy interoperability and data Access Clearinghouse
24 IPAC Structure C o l l a b o r a t o r s P3G Head Office Exec. Director Op. Director - Comm. Officer Adm. Assistant Domain Expert Research Assistant IPAC Coordinator Domain Expert Research Assistant Domain Expert Research Assistant International Advisory Board Document Coder Domain Expert Research Assistant Archivist ( ) ( )
25 IPAC International Advisory Board International Advisory Board Jane Kaye (UK) Ching-Li Hu (China) Jean McEwen (USA) Jantina de Vries (South Africa) John Wilbanks (USA) Nils Hoppe (Germany) Pedro Rondot Radío (Argentina) Sharon Terry (USA) Zakiya Al-Lamki (Oman-TBC) Ruth Chadwick (UK) Mats Hansson (Sweden) Ellen Wright Clayton (USA) Emmanuelle Rial-Sebbag (France) Kazuto Kato (Japan) Don Chalmers (Australia) Susan Wallace (UK)
27 Problems and Proposals: Ethics Harmonisation
28 Problems with the Current Ethics Oversight System Disproportionate fixation on individual risks See recent discussion in Rosamond Rhodes et al., De Minimis Risk: A Proposal for a New Category of Research Risk, American Journal of Bioethics (2011). Disregard of alternative bioethical lenses that are more suitable for genomics research and respectful of research participants in the modern era (e.g., citizenry and solidarity) Overly politicized & under transparent Ossified
29 Problems with the Current Ethics Oversight System Nuremberg mentality : all research projects face the same level of scrutiny. RECs are reluctant to publish their decisions, share decisions with other RECs, or defer to their colleagues in other institutions. RECs are quasi-judicial entities, yet lack transparent jurisprudence or published procedural norms.
30 Problems with the Current Ethics Oversight System Costly Fragmented Inefficient Inconsistent Most investigators expressed concerns that differing views of risk as well as logistical variations across IRBs discouraged multi-site research at a time when large samples are needed to advance science.
31 Ethics Harmonisation: Where to from Here? "Turn him to any cause of policy, The Gordian Knot of it he will unloose, Familiar as his garter" (Shakespeare, Henry V, Act 1 Scene ) Alexander cuts the Gordian Knot Jean-Simon Berthélemy ( )
32 Ethics Harmonisation: Where to from Here? Some countries have attempted to improve the status quo, but none at a global level. There should be gateways for researchers that ensure high standards and consistent application for noninterventional studies that test neither drugs nor devices, and that work toward the mutual recognition between countries of ethically equivalent approaches.
33 P 3 G 53 Studies Harmonisation Project Europe: 26 studies; 3,4 million participants Asia: 5 studies; 0,7 million participants North America: 17 studies; 2,5 million participants Australia: 5 studies; 0,3 million participants Fortier I, Doiron D, Little J, Ferretti V, L Heureux F, Stolk R, Knoppers BM, Hudson T, Burton PR on behalf of the International Harmonization Initiative: Is Rigorous Retrospective Harmonization Possible? Application of the DataSHaPER Approach across 53 Large Studies :5 Int J Epidemiol
34 Conclusion: A Safe Harbour Approach? In a world of Big Research and Big Data, Big Ethics is needed. View of Delft, Jan Vermeer, 1660