Hostname: page-component-8448b6f56d-m8qmq Total loading time: 0 Render date: 2024-04-19T20:18:48.226Z Has data issue: false hasContentIssue false

Health Research with Big Data: Time for Systemic Oversight

Published online by Cambridge University Press:  01 January 2021

Abstract

To address the ethical challenges in big data health research we propose the concept of systemic oversight. This approach is based on six defining features (adaptivity, flexibility, monitoring, responsiveness, reflexivity, and inclusiveness) and aims at creating a common ground across the oversight pipeline of biomedical big data research. Current trends towards enhancing granularity of informed consent and specifying legal provisions to address informational privacy and discrimination concerns in data-driven health research are laudable. However, these solutions alone cannot have the desired impact unless oversight activities by different stakeholders acquire a common substantive orientation.

Type
Symposium Articles
Copyright
Copyright © American Society of Law, Medicine and Ethics 2018

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Collins, F. S. and Varmus, H., “A New Initiative on Precision Medicine,” New England Journal of Medicine 372, no. 9 (2015): 793795; E. Elenko, L. Underwood, and D. Zohar, “Defining Digital Medicine,” Nature Biotechnology 33, no. 5 (2015): 456–461; S. Hawgood, I. G. Hook-Barnard, T. C. O'Brien, and K. R. Yamamoto, “Precision Medicine: Beyond the Inflection Point,” Science Translational Medicine 7, no. 300 (2015): 300ps17; A. Blasimme and E. Vayena, “‘Tailored-to-You’: Public Engagement and the Political Legitimation of Precision Medicine,” Perspectives in Biology and Medicine 59, no. 2 (2017): 172–188.CrossRefGoogle Scholar
National Research Council, Toward Precision Medicine: Building a Knowledge Network for Biomedical Research and a New Taxonomy of Disease (Washington, D.C.: National Academies Press, 2011).Google Scholar
Blasimme and Vayena, supra note 1; Blasimme, A. and Vayena, E., “Becoming Partners, Retaining Autonomy: Ethical Considerations on the Development of Precision Medicine,” BMC Medical Ethics 17, no. 1 (2016): 67.CrossRefGoogle Scholar
Brownstein, J. S., Freifeld, C. C., and Madoff, L. C., “Digital Disease Detection — Harnessing the Web for Public Health Surveillance,” New England Journal of Medicine 360, no. 21 (2009): 21532157; M. Salathé et al., “Digital Epidemiology,” PLOS Computational Biology 8, no. 7 (2012): e1002616; E. Vayena, M. Salathé, L. C. Madoff, J. S. Brownstein, “Ethical Challenges of Big Data in Public Health,” PLoS Computational Biology 11, no. 2 (2015): e1003904, doi:10.1371/journal.pcbi.1003904; M. J. Khoury, M. F. Iademarco, and W. T. Riley, “Precision Public Health for the Era of Precision Medicine,” American Journal of Preventive Medicine 50, no. 3 (2016): 398–401; A. Flahault, A. Geissbuhler, I. Guessous, P. Guérin, I. Bolon, M. Salathé, and G. Escher, “Precision Global Health in the Digital Age,” Swiss Medical Weekly 147 (2017): w14423.CrossRefGoogle Scholar
Blasimme, A., Haüserman, T., Adjekum, A., and Vayena, E., “Digital Health: Meeting the Ethical and Policy Challenges,” Swiss Medical Weekly (in press); E. Underwood and D. Zohar, “Defining Digital Medicine,” Nature Biotechnology 33, no. 5 (2015): 456461.Google Scholar
Floridi, L., ed., The Onlife Manifesto: Being Human in a Hyperconnected Era (New York: Springer, 2014): at 7.Google Scholar
World Health Organization, The Health Data Ecosystem and Big Data, available at <http://www.who.int/ehealth/resources/ecosystem/en/> (last visited January 24, 2018); E. Vayena, J. Dzenowagis, J.S. Brownstein, and A. Sheikh, “Policy Implications of Big Data in the Health Sector,” Bulletin of the World Health Organization 96, no. 1 (2018): 66-68.CrossRef+(last+visited+January+24,+2018);+E.+Vayena,+J.+Dzenowagis,+J.S.+Brownstein,+and+A.+Sheikh,+“Policy+Implications+of+Big+Data+in+the+Health+Sector,”+Bulletin+of+the+World+Health+Organization+96,+no.+1+(2018):+66-68.>Google Scholar
Jain, S. H., Powers, B. W., Hawkins, J. B., and Brown-stein, J. S., “The Digital Phenotype,” Nature Biotechnology 33, no. 5 (2015): 462463; E. Vayena and U. Gasser, “Strictly Biomedical? Sketching the Ethics of the Big Data Ecosystem in Biomedicine,” in B. D. Mittelstadt and L. Floridi, eds., The Ethics of Biomedical Big Data (Cham, Switzerland: Springer International Publishing, 2016): 17-39.CrossRefGoogle Scholar
Freifeld, C. C., Brownstein, J. S., Menone, C. M., Bao, W., Filice, R., and Kass-Hout, T., “Digital Drug Safety Surveillance: Monitoring Pharmaceutical Products in Twitter,” Drug Safety 37, no. 5 (2014): 343350.Google Scholar
O'Brien, D., Ulman, J., Altman, M., Gasser, U., Bar-Sinai, M., Nissim, K., Vadhan, S., Wocik, M. J., and Wood, A., “Integrating Approaches to Privacy Across the Research Lifecycle: When Is Information Purely Public?” Berkman Center Research Publication, Paper no. 2015-7 (2015), available at <https://papers.ssrn.com/abstract=2586158> (last visited December 27, 2017).Google Scholar
Organisation for Economic Co-operation and Development, “Recommendation on Health Data Governance,” (2017), available at <http://www.oecd.org/els/health-systems/health-data-governance.htm> (last visited January 24, 2018).+(last+visited+January+24,+2018).>Google Scholar
Cohen, I. G., Amarasingham, R., Shah, A., Xie, B., and Lo, B., “The Legal And Ethical Concerns That Arise From Using Complex Predictive Analytics In Health Care,” Health Affairs 33, no. 7 (2014): 11391147; W. Nicholson Price II, “Black-Box Medicine,” Harvard Journal of Law & Technology 28, no. 2 (2015): 419-467.CrossRefGoogle Scholar
Anonymous, “A Digital Revolution in Health Care Is Speeding up,” The Economist, March 2, 2017, available at <https://www.economist.com/news/business/21717990-telemedicine-predictive-diagnostics-wearable-sensors-and-host-new-apps-will-transform-how> (last visited January 24, 2018).+(last+visited+January+24,+2018).>Google Scholar
Nafus, D., ed., Quantified: Biosensing Technologies in Everyday Life (Cambridge, MA: MIT Press, 2016): at ix.CrossRefGoogle Scholar
Roberts, J. L., Pereira, S., and McGuire, A. L., “Should You Profit from Your Genome?” Nature Biotechnology 35, no. 1 (2017): 1820.Google Scholar
Weber, G. M., Mandl, K. D., and Kohane, I. S., “Finding the Missing Link for Big Biomedical Data,” JAMA 311, no. 24 (2014): 24792480.Google Scholar
Hafen, E., “Midata Cooperatives — Citizen-Controlled Use of Health Data Is a Prerequisite for Big Data Analysis, Economic Success and a Democratization of the Personal Data Economy,” Abstract presented at 9th European Congress on Tropical Medicine and International Health, September 6-10, 2015, Basel, Switzerland, in Tropical Medicine & International Health 20, Suppl. 1 (2015): 129.Google Scholar
Vayena, E., Mastroianni, A., and Kahn, J., “Caught in the Web: Informed Consent for Online Health Research,” Science Translational Medicine 5, no. 173 (2013): 173fs6.CrossRefGoogle Scholar
Hayden, E. C., “A Broken Contract,” Nature 486, no. 7403 (2012): 312314.Google Scholar
Henderson, G. E., “Is Informed Consent Broken?” American Journal of the Medical Sciences 342, no. 4 (2011): 267272.Google Scholar
Sekeres, M. A. and Gilligan, T. D., “Informed Patient? Don't Bet On It,” New York Times, March 1, 2017, available at <https://www.nytimes.com/2017/03/01/well/live/informed-patient-dont-bet-on-it.html?_r=0> (last visited January 24, 2018).Google Scholar
Koenig, B. A., “Have We Asked Too Much of Consent?” Hastings Center Report 44, no. 4 (2014): 3334.CrossRefGoogle Scholar
The Precision Medicine Initiative Cohort Program – Building a Research Foundation for 21st Century Medicine, available at <https://www.nih.gov/sites/default/files/research-training/initiatives/pmi/pmi-working-group-report-20150917-2.pdf> at 81 (last visited January 24, 2018).+at+81+(last+visited+January+24,+2018).>Google Scholar
Elger, B. S. and Caplan, A. L., “Consent and Anonymization in Research Involving Biobanks: Differing Terms and Norms Present Serious Barriers to an International Framework,” EMBO Reports 7, no. 7 (2006): 661666.CrossRefGoogle Scholar
National Institutes of Health, Genomic Data Sharing Policy, NOT-OD-14-124 (August, 27, 2014), available at <https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html> (last visited December 27, 2017).+(last+visited+December+27,+2017).>Google Scholar
Blasimme, A., Moret, C., Hurst, S. A., and Vayena, E., “Informed Consent and the Disclosure of Clinical Results to Research Participants,” American Journal of Bioethics 17, no. 7 (2017): 5860.CrossRefGoogle Scholar
Grady, C., Eckstein, L., Berkman, B., Brock, D., Cook-Deegan, R., Fullerton, S. M., Greely, H., Hansson, M. G., Hull, S., Lo, B., Pentz, R., Rodriguez, L., Weil, C., Wilfond, B. S., and Wendler, D., “Broad Consent for Research With Biological Samples: Workshop Conclusions,” American Journal of Bioethics 15, no. 9 (2015): 3442.CrossRefGoogle Scholar
Wendler, D. and Emanuel, E., “The Debate over Research on Stored Biological Samples: What Do Sources Think?” Archives of Internal Medicine 162, no. 13 (2002): 14571462.Google Scholar
Wendler, D., “Broad versus Blanket Consent for Research with Human Biological Samples,” Hastings Center Report 43, no. 5 (2013): 34; T. Tomlinson, “Respecting Donors to Biobank Research,” Hastings Center Report 43, no. 1 (2013): 41–47.CrossRefGoogle Scholar
Lunshof, J. E., Chadwick, R., Vorhaus, D. B., and Church, G. M., “From Genetic Privacy to Open Consent,” Nature Reviews Genetics 9, no. 5 (2008): 406411.CrossRefGoogle Scholar
See Vayena et al., supra note 18.Google Scholar
Árnason, V., “Coding and Consent: Moral Challenges of the Database Project in Iceland,” Bioethics 18, no. 1 (2004): 2749; B. Hofmann, “Broadening Consent — and Diluting Ethics?,” Journal of Medical Ethics 35, no. 2 (2009): 125–129; J. R. Karlsen, J. H. Solbakk, and S. Holm, “Ethical Endgames: Broad Consent for Narrow Interests; Open Consent for Closed Minds,” Cambridge Quarterly of Healthcare Ethics 20, no. 4 (2011): 572–583.Google Scholar
Helgesson, G., “In Defense of Broad Consent,” Cambridge Quarterly of Healthcare Ethics 21, no. 1 (2012): 4050.Google Scholar
Food and Drugs Administration, “Use of Electronic Informed Consent: Questions and Answers. Guidance for Institutional Review Boards, Investigators and Sponsors” available at <https://www.fda.gov/downloads/drugs/guidances/ucm436811.pdf> (last visited January 24, 2018); J. Kaye, E. A. Whitley, D. Lund, M. Morrison, H. Teare, and K. Melham, “Dynamic Consent: A Patient Interface for Twenty-First Century Research Networks,” European Journal of Human Genetics 23, no. 2 (2015): 141-146.+(last+visited+January+24,+2018);+J.+Kaye,+E.+A.+Whitley,+D.+Lund,+M.+Morrison,+H.+Teare,+and+K.+Melham,+“Dynamic+Consent:+A+Patient+Interface+for+Twenty-First+Century+Research+Networks,”+European+Journal+of+Human+Genetics+23,+no.+2+(2015):+141-146.>Google Scholar
Cate, F. H. and Mayer-Schönberger, V., “Notice and Consent in a World of Big Data,” International Data Privacy Law 3, no. 2 (2013): 6773.CrossRefGoogle Scholar
See Vayena et al., supra note 18.Google Scholar
See Nafus, supra note 14.Google Scholar
Kahn, J. P., Vayena, E., and Mastroianni, A. C., “Opinion: Learning as We Go: Lessons from the Publication of Facebook's Social-Computing Research,” Proceedings of the National Academy of Sciences 111, no. 38 (2014): 1367713679.CrossRefGoogle Scholar
Vayena, E. and Blasimme, A., “Biomedical Big Data: New Models of Control over Access, Use and Governance,” Journal of Bioethical Inquiry 14, no. 4 (2017): 113.CrossRefGoogle Scholar
Blasimme et al., supra note 26; Blassime, A., Soulier, A., Julia, S., Leonard, S., and Cambon-Thomsen, A., “Disclosing Results to Genomic Research Participants: Differences That Matter,” American Journal of Bioethics 12, no. 10 (2012): 2022; E. Vayena and J. Tasioulas, “Genetic Incidental Findings: Autonomy Regained?” Genetics in Medicine 15, no. 11 (2013): 868-870.CrossRefGoogle Scholar
Anastasova, V., Blasimme, A., Julia, S., and Cambon-Thomsen, A., “Genomic Incidental Findings: Reducing the Burden to Be Fair,” American Journal of Bioethics 13, no. 2 (2013): 5254.Google Scholar
Caulfield, T., Upshur, R. E. G., and Daar, A., “DNA Databanks and Consent: A Suggested Policy Option Involving an Authorization Model,” BMC Medical Ethics 4, no. 1 (2003): E1.CrossRefGoogle Scholar
Bunnik, E. M., Cecile, A., Janssens, J. W., and Schermer, M. H. N., “A Tiered-Layered-Staged Model for Informed Consent in Personal Genome Testing,” European Journal of Human Genetics 21, no. 6 (2013): 596601.Google Scholar
McGuire, A. L. and Beskow, L. M., “Informed Consent in Genomics and Genetic Research,” Annual Review of Genomics and Human Genetics 11 (2010): 361381.CrossRefGoogle Scholar
Kaye, J., Whitley, E. A., Lund, D., Morrison, M., Teare, H., and Melham, K., “Dynamic Consent: A Patient Interface for Twenty-First Century Research Networks,” European Journal of Human Genetics 23, no. 2 (2015): 141146; I. Budin-Ljøsne, H. J. A. Teare, J. Kaye, S. Beck, H. B. Bentzen, L. Caenazzo, C. Collett, F. D. Abramo, H. Felzmann, T. Finlay, M. K. Javaid, E. Jones, V. Katic, A. Simpson, and D. Mascalzoni, “Dynamic Consent: A Potential Solution to Some of the Challenges of Modern Biomedical Research,” BMC Medical Ethics 18, no. 1 (2017): 4Google Scholar
See Kahn et al., supra note 38.Google Scholar
Jones, K. H., Laurie, G., Stevens, L., Dobbs, C., Ford, D. V., and Lea, N., “The Other Side of the Coin: Harm due to the Non-Use of Health-Related Data,” International Journal of Medical Informatics 97, no. 1 (2017): 4351.CrossRefGoogle Scholar
See Kahn et al., supra note 38.Google Scholar
Sugarman, J., “Examining Provisions Related to Consent in the Revised Common Rule,” American Journal of Bioethics 17, no. 7 (2017): 2226.CrossRefGoogle Scholar
“Governance” has been defined by the Club of Rome as “the command mechanism of a social system and its actions that endeavor to provide security, prosperity, coherence, order and continuity to the system.… Taken broadly, the concept of governance should not be restricted to the national and international systems but should be used in relation to regional, provincial and local governments as well as to other social systems.” King, A. and Schneider, B., The First Global Revolution. A Report of the Council of the Club of Rome (New York: Pantheon Books, 1991): at 114. Other definitions aptly tone down the hierarchical and directive sense conveyed by the expression “command mechanisms” and emphasize — as we also propose — the centrality of steering and control mechanisms to the idea of governance. See, e.g., J. N. Rosenau, “Governance in the Twenty-First Century,” Global Governance 1, no. 1 (1995): 13–43.Google Scholar
Macnaghten, P., Kearnes, M. B., and Wynne, B., “Nanotechnology, Governance, and Public Deliberation: What Role for the Social Sciences?” Science Communication 27, no. 2 (2005): 268291.Google Scholar
Laurie, G., “Reflexive Governance in Biobanking: On the Value of Policy Led Approaches and the Need to Recognise the Limits of Law,” Human Genetics 130, no. 3 (2011): 347356.Google Scholar
Polonetsky, J., Tene, O., and Jerome, J., “Benefit-Risk Analysis for Big Data Projects,” Future of Privacy Forum (September, 2014), available at <https://fpf.org/wp-content/uploads/FPF_DataBenefitAnalysis_FINAL.pdf> (last visited August 18, 2017).Google Scholar
Pasquale, F., The Black Box Society: The Secret Algorithms That Control Money and Information (Cambridge: Harvard University Press, 2015): at 51; Price, supra note 12.Google Scholar
Macnaghten, P. M., Kearnes, M. B., and Wynne, B., “Nanotechnology, Governance, and Public Deliberation,” Science Communication 27, no. 2 (2005): 268291.CrossRefGoogle Scholar
Voß, J.-P. and Bornemann, B., “The Politics of Reflexive Governance: Challenges for Designing Adaptive Management and Transition Management,” Ecology and Society 16, no. 2 (2011): 9.Google Scholar
Hendriks, C. M. and Grin, J., “Contextualizing Reflexive Governance: The Politics of Dutch Transitions to Sustainability,” Journal of Environmental Policy & Planning 9, no. 3 (2007): 333350.Google Scholar
Collingridge, D., The Social Control of Technology (New York: St. Martin's Press, 1980): at 47.Google Scholar
Rhodes, R. A. W., “The New Governance: Governing without Government,” Political Studies 44, no. 4 (1996): 652667; J. Scott and D. M. Trubek, “Mind the Gap: Law and New Approaches to Governance in the European Union,” European Law Journal 8, no. 1 (2002): 1–18.CrossRefGoogle Scholar
Macnaghten, P., Kearnes, M. B., and Wynne, B., “Nanotechnology, Governance and Public Deliberation: What Role for the Social Sciences?” Science Communication 27, no. 2 (2005): 268291.CrossRefGoogle Scholar
Ramachandran, G., Wolf, S. M., Paradise, J., Kuzma, J., Hall, R., Kokkoli, E., and Fatehi, L., “Recommendations for Oversight of Nanobiotechnology: Dynamic Oversight for Complex and Convergent Technology,” Journal of Nanoparticle Research 13, no. 4 (2011): 13451371.Google Scholar
Voß and Bornemann, supra note 56.Google Scholar
Rip, A., Schot, J., and Misa, T. J., “Constructive Technology Assessment: A New Paradigm for Managing Technology in Society”, in Rip, A., Schot, J., and Misa, T. J. (eds.), Managing Technology in Society. The Approach of Constructive Technology Assessment (New York: Pinter Publishers, 1995): 114; D. H. Guston and D. Sarewitz, “Real-Time Technology Assessment,” Technology in Society 24, nos. 1–2 (2002): 93–109; J. Grin and H. van de Graaf, “Technology Assessment as Learning,” Science, Technology & Human Values 21, no. 1 (1996): 72–99; A. Genus, “Rethinking Constructive Technology Assessment as Democratic, Reflective, Discourse,” Technological Forecasting and Social Change 73, no. 1 (2006): 13–26.Google Scholar
Voß and Bornemann, supra note 56.Google Scholar
Stilgoe, J., Owen, R., and Macnaghten, P., “Developing a Framework for Responsible Innovation,” Research Policy 42, no. 9 (2013): 15681580.CrossRefGoogle Scholar
O'Doherty, K. C., Burgess, M. M., Edwards, K., Gallagher, R. P., Hawkins, A. K., Kaye, J., McCaffrey, V., and Winckoff, D. E., “From Consent to Institutions: Designing Adaptive Governance for Genomic Biobanks,” Social Science & Medicine 73, no. 3 (2011): 367374.Google Scholar
See Sekeres and Gilligan, supra note 21.Google Scholar
Garrett, S. B., Dohan, D., and Koenig, B. A., “Linking Broad Consent to Biobank Governance: Support From a Deliberative Public Engagement in California,” American Journal of Bioethics 15, no. 9 (2015): 5657; E. Vayena, R. Brownsword, S. J. Edwards, B. Greshake, J. P. Kahn, N. Ladher, J. Montgomery, D. O'Connor, M. P. Richards, A. Rid, M. Sheehan, P Wicks, and J Tasioulas, “Research Led by Participants: A New Social Contract for a New Kind of Research,” Journal of Medical Ethics 42, no. 4 (2016): 216–219.Google Scholar
Evans, B. J., “Barbarians at the Gate: Consumer-Driven Health Data Commons and the Transformation of Citizen Science,” American Journal of Law & Medicine 42, no. 4 (2016): 651658; B. J. Evans, “Power to the People: Data Citizens in the Age of Precision Medicine,” Vanderbilt Journal of Entertainment & Technology Law 19, no. 2 (2017): 243-265.Google Scholar
Hansson, M. G., Dillner, J., Bartram, C. R., Carlson, J. A., and Helgesson, G., “Should Donors Be Allowed to Give Broad Consent to Future Biobank Research?” The Lancet Oncology 7, no. 3 (2006): 266269.Google Scholar
Shabani, M., Knoppers, B. M., and Borry, P., “From the Principles of Genomic Data Sharing to the Practices of Data Access Committees,” EMBO Molecular Medicine 7, no. 5 (2015): 507509.Google Scholar
Grady, C., Eckstein, L., Berkman, B., Brock, D., Cook-Deegan, R., Fullerton, S. M., Greely, H., et al., “Broad Consent for Research With Biological Samples: Workshop Conclusions,” American Journal of Bioethics 15, no. 9 (2015): 3442.Google Scholar
European General Data Protection Regulation, available at <https://www.eugdpr.org/> (last visited January 24, 2018).+(last+visited+January+24,+2018).>Google Scholar
Swiss Federal Department of Justice and Police “Den Datenschutz verbessern und den Wirtschaftsstandort stärken” available at <https://www.ejpd.admin.ch/ejpd/de/home/aktuell/news/2017/2017-09-150.html> (last visited January 24, 2018).+(last+visited+January+24,+2018).>Google Scholar
KPMG, “EU General Data Protection Regulation Ratified,” (2016), available at <https://assets.kpmg.com/content/dam/kpmg/pdf/2016/05/EU-General-Data-Protection-Regulation-ratified-18-04-2016.pdf> (last visited January 24, 2018).+(last+visited+January+24,+2018).>Google Scholar
Laurie, supra note 52.Google Scholar
Vayena, E., Gasser, U., Wood, A., O'Brien, D. R., and Altman, M., “Elements of a New Ethical Framework for Big Data Research,” Washington & Lee Law Review 72, no. 3 (2016): 420441, available at <http://scholarlycommons.law.wlu.edu/wlulr-online/vol72/iss3/5/> (last visited January 24, 2018).Google Scholar