The Unique and the Universal: Analyzing the Interplay Between Regulatory Frameworks, Researchers and Research Participants in Data Making
Contemporary health research is becoming increasingly data intensive with a dependency on more data, of different types, and on more people. Multiple measures are therefore taken to ensure a variety of data, for example by re-appropriating data collected for purposes other than research. In genetic research, there is a general aim of more personalized diagnostics and treatments. Personalization in many ways depends on access to a universal data pool to gain statistical strength when identifying rare variants affecting unique individuals. If the aim of identifying the unique depends on access to the universal, how are we then to understand the dialectic between these two concepts? Further, if data-intensive research thrives on repurposing data, how does the repurposing affect the interests of the people from whom the data derive? In this article, we explore these questions by comparing two Danish initiatives aimed at making more data available for research through repurposing: one from a screening program of newborns at the beginning of life; and the other through an educational program collecting bodies after death. They both involve reinventing the original collection practices and they illustrate how regulatory frameworks, researchers and research participants reason differently about what can be considered as unique and as universal, as well as the risks and benefits involved in participating in data-intensive research.
Amelang, Katrin, and Susanne Bauer. 2019. “Following the Algorithm: How Epidemiological Risk-Scores Do Accountability.” Social Studies of Science 49(4): 476–502.
Attride-Stirling, Jennifer. 2001. “Thematic Networks: An Analytic Tool for Qualitative Research.” Qualitative Research 1(3): 385–405.
Bauer, Susanne. 2014. “From Administrative Infrastructure to Biomedical Resource: Danish Population Registries, the ‘Scandinavian Laboratory,’ and the ‘Epidemiologist’s Dream.’” Science in Context 27(2): 187–213. Cambridge: Cambridge University Press.
Birch, Kean, and David Tyfield. 2012. “Theorizing the Bioeconomy: Biovalue, Biocapital, Bioeconomics or . . . What?” Science, Technology, & Human Values 38(3): 299–327.
Borgman, Christine L. 2015. Big Data, Little Data, No Data: Scholarship in the Networked World. Cambridge: MIT Press.
Cheney-Lippold, John. 2018. We Are Data: Algorithms and the Making of Our Digital Selves. New York: NYU Press.
Cool, Alison. 2019. “Impossible, Unknowable, Accountable: Dramas and Dilemmas of Data Law.” Social Studies of Science 49(4): 503–30.
Cruz, Taylor M. 2017. “The Making of a Population: Challenges, Implications, and Consequences of the Quantification of Social Difference.” Social Science and Medicine 174: 79–85.
European Commission. 2020a. Europe’s Moment: Repair and Prepare for the Next Generation. Brussels: European Commission.
⸻. 2020b. Proposal for a Regulation of the European Parliament and of the Council on European Data Governance (Data Governance Act). Brussels: European Commission.
Felt, Ulrike, Milena D. Bister, Michael Strassnig, and Ursula Wagner. 2009. “Refusing the Information Paradigm: Informed Consent, Medical Research, and Patient Participation.” Health 13(1): 87-106.
Fischer, Astrid, and Mathias Friis. 2020a. “Blood Samples from Danish Pregnant Women was Flown to the US Contrary to the Rules: The Government will Examine Reviled Research Project at the State Serum Institute” [Blodprøver fra danske gravide blev fløjet til USA i strid med reglerne: Nu vil myndighed undersøge udskældt forskningsprojekt på SSI], trans. DR.DK. Accessed January 29, 2021.
⸻. 2020b. “Documents Reveal: The State Serum Institute Have Passed on Danish Samples for Six Years, Without Permission” [Dokumenter afslører: Statens Serum Institut har i seks år videregivet danskeres blodprøver uden tilladelse], trans. DR.DK, December 1, 2020. Accessed January 29, 2021.
Folketinget 2018. Law on Supplementary Provisions to the Regulation on Protection of Physical People when Handling Personal Information and on Free Exchange of Such Information (Data Protection Law) [Lov om supplerende bestemmelser til forordning om beskyttelse af fysiske personer i forbindelse med behandling af personoplysninger og om fri udveksling af sådanne oplysninger (Databeskyttelsesloven), trans. Copenhagen.
⸻. 2020. The Legal Act on Scientific Ethical Handling of Health-Related Research Projects and Health-Data Research Projects [Bekendtgørelse af lov om videnskabsetisk behandling af sundhedsvidenskabelige forskningsprojekter og sundhedsdatavidenskabelige forskningsprojekter], trans. Copenhagen.
Frank, Lone. 2000. “When an Entire Country Is a Cohort.” Science 287(5462): 2398–99.
⸻. 2003. “The Epidemiologist’s Dream: Denmark.” Science 301(5630): 163.
General Secretariat of the Council. 2015. Council Conclusions on Personalised Medicine for Patients. Brussels: Council of the European Union. (2015/C 421/03).
GOV.UK. 2020. “UK Caldicott Guardian Council.” UK Caldicott Guardian Council. Accessed January 29, 2021.
Green, Sara, Annamaria Carusi, and Klaus Høyer. 2019. “Plastic Diagnostics: The Remaking of Disease and Evidence in Personalized Medicine.” Social Science & Medicine 112318.
⸻, and Henrik Vogt. 2016. “Personalizing Medicine: Disease Prevention in Silico and in Socio.” Humana.Mente Journal of Philosophical Studies 9 (30): 105–45.
Harman, Gilbert. 1976. “Practical Reasoning.” The Review of Metaphysics 29(3): 431–63.
Hartlev, Mette. 2015. “Genomic Databases and Biobanks in Denmark.” The Journal of Law, Medicine & Ethics 43(4): 743–53.
Hildebrandt, Sabine. 2017. The Anatomy of Murder: Ethical Transgressions and Anatomical Science During the Third Reich. New York: Berghahn Books.
Høyer, Klaus, and Linda F. Hogle. 2014. “Informed Consent: The Politics of Intent and Practice in Medical Research Ethics.” Annual Review of Anthropology 43(1): 347–62.
⸻, and Niels Lynöe. 2006. “Motivating Donors to Genetic Research? Anthropological Reasons to Rethink the Role of Informed Consent.” Medicine, Health Care and Philosophy 9(1): 13–23.
Holm, Soren, Thomas Birk Kristiansen, and Thomas Ploug. 2020. “Control, Trust and the Sharing of Health Information: The Limits of Trust.” Journal of Medical Ethics. 25 August 2020.
Holmberg, Christine, Christine Bischof, and Susanne Bauer. 2012. “Making Predictions: Computing Populations.” Science, Technology & Human Values 38(3): 398–420.
Hurlbut, J. Benjamin, Sheila Jasanoff, and Krishanu Saha. 2020. “Constitutionalism at the Nexus of Life and Law.” Science, Technology, & Human Values 45(6): 979–1000.
Kaye, Jane, Edgar A Whitley, David Lund, Michael Morrison, et al. 2015. “Dynamic Consent: A Patient Interface for Twenty-First Century Research Networks.” European Journal of Human Genetics 23: 141–46.
Khoury, Muin J., M. Scott Bowen, Mindy Clyne, W. David Dotson, et al. 2018. “From Public Health Genomics to Precision Public Health: A 20-Year Journey.” Genetics in Medicine 20(6): 574–82.
Krieger, Nancy. 2012. “Who and What Is a ‘Population’? Historical Debates, Current Controversies, and Implications for Understanding ‘Population Health’ and Rectifying Health Inequities.” Milbank Quarterly 90(4): 634–81.
Lupton, Deborah. 2019. Data Selves: More-Than-Human Perspectives. Cambridge: Polity Press.
Lury, Celia, and Sophie Day. 2019. “Algorithmic Personalization as a Mode of Individuation.” Theory, Culture & Society 36(2): 17–37. https://doi.org/10.1177/0263276418818888.
Madden, Raymond. 2010. Being Ethnographic: A Guide to the Theory and Practice of Ethnography. Sage Publications.
McMahon, Aisling, Alena Buyx, and Barbara Prainsack. 2020. “Big Data Governance Needs More Collective Responsibility: The Role of Harm Mitigation in the Governance of Data Use in Medicine and Beyond.” Medical Law Review 28(1): 155–82.
Mercier, Hugo. 2020. Not Born Yesterday: The Science of Who We Trust and What We Believe. Princeton, NJ: Princeton University Press.
Merriam-Webster. 2021. “Merriam-Webster Dictionary.” Accessed January 29, 2021.
Mol, Annemarie. 2002. The Body Multiple: Ontology in Medical Practice. Dunham, NC & London: Duke University Press.
Nordfalk, Francisca, and Claus Thorn Ekstrøm. 2019. “Newborn Dried Blood Spot Samples in Denmark: The Hidden Figures of Secondary Use and Research Participation.” European Journal of Human Genetics 27: 203–210.
Nørgaard-Pedersen, Bent, and Henrik Simonsen. 1999. “Biological Specimen Banks in Neonatal Screening.” Acta Paediatrica (Oslo, Norway: 1992). Supplement 88(432): 106–9.
⸻. 2016. “The NDBS Sample and the Biobank” In The Collected Human: The Raw Material of Medical Science from Cadaver to DNA” [“PKU-Prøven og Biobanken.” In Det indsamlede menneske: Lægevidenskabens råmateriale fra kadaver til DNA], trans. edited by Karin Tybjerg 106–7. Copenhagen: Medical Museion, University of Copenhagen.
⸻, and David M. Hougaard. 2007. “Storage Policies and Use of the Danish Newborn Screening Biobank.” Journal of Inherited Metabolic Disease 30(4): 530–36.
O’Doherty, Kieran C., Emily Christofides, Jeffery Yen, Heidi Beate Bentzen, et al. 2016. “If You Build It, They Will Come: Unintended Future Uses of Organised Health Data Collections.” BMC Medical Ethics 17: 1–16.
Olejaz, Maria. 2015. “The Anatomy of Bioavailability. Making Sense of Donation and Dissection of Bodies for Medical Purposes in Denmark.” PhD Thesis. Faculty of Health and Medical Sciences. University of Copenhagen.
⸻. 2017. “When the Dead Teach: Exploring the Postvital Life of Cadavers in Danish Dissection Labs.” Medicine Anthropology Theory 4(4): 125–149.
⸻, and Klaus Høyer. 2016. “Meet the Donors: A Qualitative Analysis of What Donation Means to Danish Whole Body Donors.” European Journal of Anatomy 20(1): 19–29.
Pasquale, Frank. 2015. The Black Box Society: The Secret Algorithms That Control Money and Information. Harvard, USA: Harvard University Press.
Pedersen, Carsten Boecker, Jonas Bybjerg-Grauholm, Marianne Gioertz Pedersen, Jakob Grove, et al. 2017. “The IPSYCH2012 Case–Cohort Sample: New Directions for Unravelling Genetic and Environmental Architectures of Severe Mental Disorders.” Molecular Psychiatry 23(1): 6–14.
Pinel, Clémence. 2020. “Renting Valuable Assets: Knowledge and Value Production in Academic Science.” Science, Technology, & Human Values 46(2) 275–297.
Ploug, Thomas, and Søren Holm. 2017. “Eliciting Meta Consent for Future Secondary Research Use of Health Data Using a Smartphone Application—A Proof of Concept Study in the Danish Population.” BMC Medical Ethics 18(51): 1–8.
POLICYAID. 2021. “Policy, Practice and Patient Experience in the Age of Intensified Data Sourcing (POLICYAID).” Accessed Nov 2, 2021. Available at: www.policyaid.ku.dk.
Prainsack, Barbara, and Alena Buyx. 2017. Solidarity in Biomedicine and Beyond. Cambridge: Cambridge University Press.
Richardson, Ruth. 2000. Death, Dissection and the Destitute. Chicago: University of Chicago Press.
Skolbekken, John-Arne. 2019. “Online Risk Numbers—Helpful, Meaningless or Simply Wrong? Reflections on Online Risk Calculators.” Health 23(4): 401–17.
Statens Serum Institut. 2020a. To Parents: Blood Samples from Newborn Babies. Copenhagen: Statens Serum Institut.
⸻. 2020b. “Screening for Medfødte Sygdomme.” Statens Serum Institut. Accessed November 29, 2021.
Stefánsson, Kolbeinn. 2012. “What Is in a Word? Universalism, Ideology and Practice.” In Welfare State, Universalism and Diversity, edited by Anneli Anttonen, Liisa Häikiö, and Kolbeinn Stefánsson. Cheltenham: Edward Elgar Publishing Limited.
Sundhedsdatastyrelsen 2020. “Vævsanvendelsesregisteret.” [“The Use-of-Tissue-Register.” The Danish Health Data Authority.] Accessed January 18, 2021.
Svendsen, Mette N., Laura E. Navne, Iben M. Gjødsbøl, and Mie S. Dam. 2018. “A Life Worth Living: Temporality, Care, and Personhood in the Danish Welfare State.” American Ethnologist 45(1): 20–33.
Taylor, Linnet. 2017. “Introduction: A New Perspective on Privacy.” and “Safety in Numbers? Group Privacy and Big Data Analytics in the Developing World.” In Group Privacy: New Challenges of Data Technologies, edited by Linnet Taylor, Luciano Floridi, and Bart van der Sloot, 1–36. Cham, Switzerland: Springer.
The Danish National Committee on Health Research Ethics. 2021. “The Danish National Committee on Health Research Ethics.” NVK. Accessed January 28, 2021. https://en.nvk.dk.
University of Copenhagen. 2021. “Kropsdonation Til Gavn for Videnskab Og Uddannelse.” Department of Cellular and Molecular Medicine, University of Copenhagen. Accessed January 28, 2021.
Vogt, Henrik, Bjørn Hofmann, and Linn Getz. 2016. “Personalized Medicine: Evidence of Normativity in Its Quantitative Definition of Health.” Theoretical Medicine and Bioethics 37: 401–16.
Wachter, Robert M. 2015. The Digital Doctor: Hope, Hype, and Harm at the Dawn of Medicine’s Computer Age. New York: McGraw-Hill Education.
Copyright (c) 2022 Francisca Nordfalk, Maria Olejaz, Klaus Høyer
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
Authors of all content published in ESTS retain the copyright to their work, and agree to license them under one of the following Creative Commons licenses CC BY-NC-SA 4.0, CC BY 4.0, CC BY-SA 4.0, and refer to the individual article footer for specific licensing data. Please read our open access policy for more information.