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Consent and Retrospective Data Collection

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The Law and Ethics of Data Sharing in Health Sciences

Part of the book series: Perspectives in Law, Business and Innovation ((PLBI))

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Abstract

The secondary use of health data offers great potential for health research. Technological developments, for instance the progress in the field of artificial intelligence, have improved the reusability of datasets. However, the GDPR and ethical guidelines regularly restrict the reuse of personal data when the data subject has not given their informed or explicit consent. In retrospective studies, where researchers use personal data and sensitive data from previous medical examinations, the retrospective collection of the patient's consent can be challenging. This chapter will focus on the potential legal and practical hurdles associated with obtaining consent from the data subject for a new processing purpose. In addition, it will present the ethical considerations associated with consent and retrospective data collection in health and medical research. This chapter will discuss several Horizon 2020 funded research projects in the areas of health and medical research. These research projects will be used as practical examples to demonstrate the issues faced with consent as a legal basis in retrospective research.

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Notes

  1. 1.

    European Commission (2021b).

  2. 2.

    European Commission, Why the EU Supports Health Research and Innovation. Available at: https://ec.europa.eu/info/research-and-innovation/research-area/health-research-and-innovation_en. Accessed 27 March 2023.

  3. 3.

    European Commission (2021b).

  4. 4.

    European Data Protection Board, ‘Guidelines 05/2020 on Consent Under Regulation 2016/679’. Adopted on 4 May 2020 7.

  5. 5.

    Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation).

  6. 6.

    Biomap, https://biomap-imi.eu/about/data-portal. Accessed 27 March 2023.

  7. 7.

    InteropEHRate, https://www.interopehrate.eu/. Accessed 27 March 2023.

  8. 8.

    ProCAncer-I, https://www.procancer-i.eu/about/. Accessed 27 March 2023.

  9. 9.

    VBC, https://virtualbraincloud-2020.eu/tvb-cloud-main.html. Accessed 27 March 2023.

  10. 10.

    KATY, https://katy-project.eu/. Accessed 27 March 2023.

  11. 11.

    This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No. 821511.

  12. 12.

    This project has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No. 826106.

  13. 13.

    This project has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement No. 952159.

  14. 14.

    This project has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No. 826421.

  15. 15.

    This project has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No. 101017453.

  16. 16.

    Clinical Trials Regulation (EU) 536/2014.

  17. 17.

    See Talari and Goyal (2020), p. 409.

  18. 18.

    See Talari and Goyal (2020), p. 398.

  19. 19.

    Hess (2004), p. 1171.

  20. 20.

    See Talari and Goyal (2020), p. 398.

  21. 21.

    See Talari and Goyal (2020), p. 401; Euser et al. (2009), p. 215–216.

  22. 22.

    See Euser et al. (2009), p. 216.

  23. 23.

    See Talari and Goyal (2020), p. 399.

  24. 24.

    Hess (2004), p. 1172.

  25. 25.

    Talari and Goyal (2020), p. 399.

  26. 26.

    Doll and Hill (1950), pp. 739–748.

  27. 27.

    Talari and Goyal (2020), p. 401.

  28. 28.

    More information on broad consent is provided in Sect. 4.

  29. 29.

    GDPR, Article 9(2)(j).

  30. 30.

    Donelly and McDonagh (2019), p. 112.

  31. 31.

    Bundesdatenschutzgesetz (BDSG), paragraph 27(1).

  32. 32.

    Article 110-bis (1) D.Lgs 196/2003 (as modified by D.Lgs. 101/2018).

  33. 33.

    This will be described in more detail in Sect. 7.

  34. 34.

    ECJ 11.11.2020, C‑61/19 (ECLI:EU:C:2020:901, Orange România SA) 34 with further case law.

  35. 35.

    ECJ 11.11.2020, C‑61/19 (ECLI:EU:C:2020:901, Orange România SA) 38.

  36. 36.

    ECJ 1.10.2019, C-673/17 (ECLI:EU:C:2019:801, Planet49 GmbH) 74.

  37. 37.

    Article 29 Data Protection Working Party, Guidelines on consent under Regulation 2016/679, 17/EN, WP259 rev.01 (2018) 15 f.

  38. 38.

    On the fundamentals of the broad consent concept see Strech et al. (2016), pp. 295–309.

  39. 39.

    Cepic (2021).

  40. 40.

    Hallinan (2020).

  41. 41.

    European Data Protection Board, “EDPB Document on Response to the Request from the European Commission for Clarifications on the Consistent Application of the GDPR, Focusing on Health Research,” February 2, 2021, https://edpb.europa.eu/sites/default/files/files/file1/edpb_replyec_questionnaireresearch_final.pdf. Accessed 27 March 2023.

  42. 42.

    In this way also Donelly and McDonagh (2019).

  43. 43.

    Likewise tending to reject broad consent: Article 29 Working Party Guidelines on consent under Regulation 2016/679, 17/EN WP259 rev.01 (2017) 28.

  44. 44.

    Datenschutzkonferenz (2020).

  45. 45.

    Medizininformatik-Initiative (2020).

  46. 46.

    Hänold (2020).

  47. 47.

    Quinn (2021).

  48. 48.

    Cepic (2021).

  49. 49.

    European Commission (2021a), p. 58.

  50. 50.

    Article 29 Data Protection Working Party (2014), margin number 15.

    The articles referenced in Opinion 06/2014 are arts 7 and 8 of the Data Protection Directive which are the forerunners of arts 6 and 9 respectively of the GDPR.

  51. 51.

    EDPB, Guidelines 03/2020 on the processing of data concerning health for the purpose of scientific research in the context of the COVID-19 outbreak (2020), margin number 17 and 18.

  52. 52.

    EDPB, Guidelines 05/2020 on consent under Regulation 2016/679, Version 1.1. (2020), margin number 91.

  53. 53.

    See Mester in Taeger/Gabel (2022), margin number 18; Schiff in Ehmann/Selmayr (2017), margin number 30.

  54. 54.

    GDPR, Article 7(3).

  55. 55.

    This interpretation is supported by the European Commission’s GDPR Q&A website, https://ec.europa.eu/info/law/law-topic/data-protection/reform/rules-business-and-organisations/principles-gdpr/purpose-data-processing/can-we-use-data-another-purpose_en. Accessed 27 March 2023.

  56. 56.

    Chico (2018) p. 117.

  57. 57.

    Staunton et al. (2019), p. 1161.

  58. 58.

    GDPR, Article 9(4).

  59. 59.

    European Commission (2021a), p. 76; Austrian Federal Gene Technology Act (Gentechnikgesetz), paragraph 66.

  60. 60.

    European Commission (2021a), p. 77.

  61. 61.

    European Commission (2021a), p. 77.

  62. 62.

    Clarke et al. (2019), p. 1132.

  63. 63.

    GDPR, Article 6(1).

  64. 64.

    GDPR, Article 6(4).

  65. 65.

    GDPR, Recital 50.

  66. 66.

    GDPR, Article 6(4); Recital 50.

  67. 67.

    Article 29 Data Protection Working Party (2013), p. 3.

  68. 68.

    GDPR, Article 5(1)(b).

  69. 69.

    European Commission (2022).

  70. 70.

    Article 29 Data Protection Working Party (2013), p. 28.

  71. 71.

    Albers and Veit in Wolff/Brink (2020), Article 6, margin number 71 ff.

  72. 72.

    Horton (2002), p. 107.

  73. 73.

    World Medical Association (2022).

  74. 74.

    GDPR, Article 4(11).

  75. 75.

    Wu et al. (2019).

  76. 76.

    Declaration of Helsinki, paragraph 26.

  77. 77.

    Article 29 Data Protection Working Party (2017), p. 5.

  78. 78.

    Article 29 Data Protection Working Party (2017), p. 7.

  79. 79.

    Habiba (2000).

  80. 80.

    Chipidza et al. (2015).

  81. 81.

    Helsinki Declaration, paragraph 31.

  82. 82.

    Wendler and Wertheimer (2017).

  83. 83.

    The UK BioBank is a large-scale biomedical database and research resource, which aims to help the research community to improve public health.

  84. 84.

    UK Biobank (n.d.).

  85. 85.

    UK Biobank (2007).

  86. 86.

    InteropEHRate Project (2020).

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Authors and Affiliations

  1. Department of Innovation and Digitalisation in Law, University of Vienna, Schenkenstraße 4/2. Stock, 1010, Wien, Austria

    Tima Otu Anwana, Katarzyna Barud, Michael Cepic, Emily Johnson & Marie-Catherine Wagner

  2. MLL Meyerlustenberger Lachenal Froriep AG, Schiffbaustrasse 2, 8031, Zurich, Switzerland

    Max Königseder

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  1. Tima Otu Anwana
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  2. Katarzyna Barud
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  3. Michael Cepic
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  4. Emily Johnson
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  5. Max Königseder
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Editors and Affiliations

  1. CeBIL, University of Copenhagen, København S, Denmark

    Marcelo Corrales Compagnucci

  2. CeBIL, University of Copenhagen, Copenhagen K, Denmark

    Timo Minssen

  3. Kyushu University, Fukuoka, Japan

    Mark Fenwick

  4. University of Cambridge, Cambridge, UK

    Mateo Aboy

  5. University of Cambridge, Cambridge, UK

    Kathleen Liddell

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© 2024 The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd.

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Anwana, T.O., Barud, K., Cepic, M., Johnson, E., Königseder, M., Wagner, MC. (2024). Consent and Retrospective Data Collection. In: Corrales Compagnucci, M., Minssen, T., Fenwick, M., Aboy, M., Liddell, K. (eds) The Law and Ethics of Data Sharing in Health Sciences. Perspectives in Law, Business and Innovation. Springer, Singapore. https://doi.org/10.1007/978-981-99-6540-3_7

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  • DOI: https://doi.org/10.1007/978-981-99-6540-3_7

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