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How traditional informed consent impairs inclusivity in a learning healthcare system: lessons learned from the Utrecht Cardiovascular Cohort

      In a Learning Healthcare System (LHS), research and care are intertwined in such a way that learning is embedded in the context of care. Its aim by using routine care data (own practice) is to provide evidence with optimal inclusivity of the patient population. Using the example of the Utrecht Cardiovascular Cohort, we show that a traditional informed consent procedure may undermine inclusivity and thus the LHS approach.
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      References

        • Institute of Medicine
        Olsen L. Aisner D. McGinnis J.M. The learning healthcare system: workshop summary. Roundtabel on Evidence-Based Medicine. The National Academies Press, Washington, DC2007 (Available at)
        • Wouters R.H.P.
        • van der Graaf R.
        • Voest E.E.
        • Bredenoord A.L.
        Learning health care systems: Highly needed but challenging.
        Learn Health Syst. 2020; 4: e10211
        • World Medical Association
        Declaration of Helsinki - ethical principles for medical research involving human subjects.
        64th WMA General Assembly, Fortaleza, Brazil2013
        • Asselbergs F.W.
        • Visseren F.L.
        • Bots M.L.
        • de Borst G.J.
        • Buijsrogge M.P.
        • Dieleman J.M.
        • et al.
        Uniform data collection in routine clinical practice in cardiovascular patients for optimal care, quality control and research: the Utrecht Cardiovascular Cohort.
        Eur J Prev Cardiol. 2017; 24: 840-847
        • Budrionis A.
        • Bellika J.G.
        The Learning Healthcare System: where are we now? A systematic review.
        J Biomed Inform. 2016; 64: 87-92
        • Kass N.E.
        • Faden R.R.
        • Goodman S.N.
        • Pronovost P.
        • Tunis S.
        • Beauchamp T.L.
        The research-treatment distinction: a problematic approach for determining which activities should have ethical oversight.
        Hastings Cent Rep. 2013; Spec No: S4-S15
      1. Dutch Civil Code Article 7:458. Available at https://wetten.overheid.nl/BWBR0005290/2022-04-27.

      2. Dutch GDPR Implementation Act, Article 24 (2018). Available at https://wetten.overheid.nl/BWBR0040940/2021-07-01

        • Mostert M.
        • Koomen B.M.
        • van Delden J.J.M.
        • Bredenoord A.L.
        Privacy in Big Data psychiatric and behavioural research: a multiple-case study.
        Int J Law Psychiatry. 2018; 60: 40-44
        • Sethi N.
        • Laurie G.T.
        Delivering proportionate governance in the era of eHealth: Making linkage and privacy work together.
        Med Law Int. 2013; 13: 168-204
        • Koops B.J.
        The evolution of privacy law and policy in The Netherlands.
        J Comp Policy Anal. 2011; 13: 165-179
        • Negrouk A.
        • Lacombe D.
        Does GDPR harm or benefit research participants? An EORTC point of view.
        Lancet Oncol. 2018; 19: 1278-1280
      3. 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), (2018). Available at https://eur-lex.europa.eu/eli/reg/2016/679/oj.

      4. Regulation (EU) 2016/679 of the European Parliament and of the Council of April 27, 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). Article 6. Available at https://eur-lex.europa.eu/eli/reg/2016/679/oj.

      5. Regulation (EU) 2016/679 of the European Parliament and of the Council of April 27, 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). Article 9. Available at https://eur-lex.europa.eu/eli/reg/2016/679/oj.

        • Dove E.S.
        The EU general data protection regulation: implications for international scientific research in the digital era.
        J Law Med Ethics. 2019; 46: 1013-1030
        • Cumyn A.
        • Barton A.
        • Dault R.
        • Cloutier A.M.
        • Jalbert R.
        • Ethier J.F.
        Informed consent within a learning health system: A scoping review.
        Learn Health Syst. 2019; 4: e10206
        • Faden R.R.
        • Kass N.E.
        • Goodman S.N.
        • Pronovost P.
        • Tunis S.
        • Beauchamp T.L.
        An ethics framework for a learning health care system: a departure from traditional research ethics and clinical ethics.
        Hastings Cent Rep. 2013; Spec No: S16-S27
        • Carter P.
        • Laurie G.T.
        • Dixon-Woods M.
        The social licence for research: why care.data ran into trouble.
        J Med Ethics. 2015; 41: 404-409
        • Lafeber M.
        • Grobbee D.E.
        • Bots M.L.
        • Thom S.
        • Webster R.
        • Rodgers A.
        • et al.
        The evening versus morning polypill utilization study: the TEMPUS rationale and design.
        Eur J Prev Cardiol. 2014; 21: 425-433
        • Bioethics NCo
        The collection, linking and use of data in biomedical research and health care: ethical issues.
        Nuffield Council on Bioethics, London2015 (Available at)
        • Taylor M.J.
        Health research, data protection, and the public interest in notification.
        Med Law Rev. 2011; 19: 267-303