Learning from Clinical Data. Ethical, Social and Legal Aspects (LinCDat)

Funded by the German Research Foundation (Deutsche Forschungsgemeinschaft)
Term: 2019-2022

The project “Learning from Clinical Data. Ethical, Social and Legal Aspects (LinCDat)” investigates the possibility and desirability of a paradigm shift in the usage of clinical data. Systematic usage of clinical data (data derived from patient care) for learning and research purposes has the potential to significantly benefit the delivery of health services for patients, the public health system, and, ultimately, the common welfare.

Several national and international medical research programs, such as the German Medical Informatics Initiatives or the US CancerLinQ enterprise, are designed to systematically collect clinical data for secondary analyses. However, to date, the re-use (or secondary use) of clinical data for learning and research activities is rather the exception than the rule.

Data from clinical routine can contribute to different kinds of data gathering and non-interventional studies or learning activities (DaNIS) that may improve quality, safety and effectiveness of health care and promote scientific knowledge. Also, the set-up of Learning Health Care Systems builds on the systematic use and analysis of clinical data.

As opposed to interventional clinical studies, the secondary use of clinical data for learning and research activities is associated with low risks for patients. At the same time, clinical data are very sensitive data and at the core of patients’ rights to privacy and confidentiality. In addition, the systematic use of clinical data is challenged by serious practical obstacles.

To address ethical, legal and social questions and to elaborate recommendations for data governance and policies, the interdisciplinary LinCDat project aims to address the following research questions:

  • What risks and burdens does DaNIS pose for patients, physicians and institutions?
  • What are the potential benefits of DaNIS?
  • What rights, duties and expectations do physicians and health care institutions, patients, and the public have with respect to DaNIS?
  • What recommendations and frameworks should be followed in the governance of DaNIS?

Ethical and Socio-empirical Analysis

University of Heidelberg
Medical Faculty and Heidelberg University Hospital
National Center for Tumor Diseases
Head: Prof. Dr. med. Dr. phil. Eva Winkler
Phone: +49 6221 56-36049

 

The ethical and socio-empirical parts of the project aim at delivering an assessment of risks and benefits as well as evaluating moral rights, duties and responsibilities of stakeholders. The overall methodological approach is inspired by the concept of empirical ethics. This approach improves context-sensitivity of ethical evaluations through descriptive information from socio-empirical investigations. The socio-empirical part of the project focuses on gaining in-depth knowledge and views about risks and benefits of DANIS from the perspective of the stakeholder groups that are relevant for legitimacy, acceptability, and implementation of the systematic usage of clinical data. The ethical part focusses on the questions whether and to what extent patients and physicians may be morally expected to support DANIS and/or need to be protected against implied risks and concerns.

To achieve this, we first establish a typology of DaNIS processed in daily clinical routine. We then retrieve expert knowledge along these DaNIS types concerning risks and benefits through qualitative interviews. Based on these insights, a qualitative content analysis will identify themes and support the generation of hypotheses. In the next step, a quantitative survey among physicians and patients tests these hypotheses. The ethical part of the project will use the results of this empirical work as one foundation of its analysis. Arguments from qualitative, quantitative and literature research will be assessed against the background of an approach based on the concepts of minimal risk, autonomy, and solidarity within an overall liberal and rights-based ethical framework.

Legal Analysis

University of Heidelberg
Law Faculty
Head: Prof. Dr. Kai Cornelius, LL.M.
Phone: +49 6221 547480

 

This part of the project investigates opportunities and requirements of a paradigm shift in the secondary usage of clinical data from a legal perspective. A prima vista the antinomies of freedom of research and protection of personal data are almost irreconcilable at their extreme edges. Freedom of research seeks to increase knowledge and may infringe general personal rights when using personal data, while increased protection of personal data might hamper research purposes to an intolerable extend. It is the assignment of the legislator to adjust both fundamental rights.

As part of the legal analysis, we evaluate how this assignment is carried out at the national and European level, especially by the General Data Protection Regulation and domestic Data Protection Law. The safeguards for personal data protection such as consent, technical and organisational measures and medical confidentiality must be weighed against privileges and justifications of medical research. Based on this, we strive to answer the question whether responsibilities and interests in using existing clinical data for research purposes are properly reflected in the current legal system and which necessary shifts should be taken into account in the future.

Funding

DFG
Term: 2019-2022
Run-time: 36 months
Project number: 406103282

Team

Publications

  • Jungkunz M, Köngeter A, Winkler EC, Schickhardt C (2024): Do physicians have a duty to support secondary use of clinical data in biomedical research? An inquiry into the professional ethics of physicians. J Law Med Ethics 52(1): 101-117  https://doi.org/10.1017/jme.2023.146

  • Schickhardt C, Mehlis K, Winkler EC, Jungkunz M (2024): Zur Ethik der Forschungsnutzung von Patientendaten. Rollen der Patienten und Ärzte. Onkologie, 30: 25-30. https://doi.org/10.1007/s00761-023-01433-7

  • Schickhardt C, Winkler E (2023): Ethische Aspekte mit Blick auf Patienten und Ärzte. Patientendaten für die Forschung. Ärzteblatt Baden-Württemberg, 78(6): 380-383.

  • Jungkunz M, Köngeter A, Spitz M, Mehlis K, Cornelius K, Schickhardt C, Winkler EC (2022): Stellungnahme zur Etablierung der sekundären Forschungsnutzung von Behandlungsdaten in Deutschland. Ergebnisse des Verbundprojekts LinCDat: „Learning from Clinical Data. Ethical, Social and Legal Aspects". Forum Marsilius Kolleg, 21: 1-123. https://doi.org/10.11588/fmk.2022.1.91697

  • Köngeter A, Schickhardt C, Jungkunz M, Bergbold S, Mehlis K, Winkler EC (2022): Patients’ Willingness to Provide Their Clinical Data for Research Purposes and Acceptance of Different Consent Models: Findings From a Representative Survey of Patients With Cancer. J Med Internet Res, 24(8), e37665. https://doi.org/10.2196/37665

  • Jungkunz M, Köngeter A, Mehlis K, Spitz M, Winkler EC, Schickhardt C (2022): Haben Patient*innen die moralische Pflicht, ihre klinischen Daten für Forschung bereitzustellen? Eine kritische Prüfung möglicher Gründe. Ethik Med 34, 195–220. https://doi.org/10.1007/s00481-022-00684-z

  • Spitz M, Cornelius K (2022) Einwilligung und gesetzliche Forschungsklausel als Rechtsgrundlagen für die Sekundärnutzung klinischer Daten zu Forschungszwecken. MedR, 40:191–198. https://doi.org/10.1007/s00350-022-6136-7

  • Jungkunz M, Köngeter A, Mehlis K, Winkler E, Schickhardt C (2022): Sekundärnutzung klinischer Daten für Forschungs- und Lernaktivitäten – Begriff, Studientypen und ethische Herausforderungen. In: Richter G, Loh W, Buyx A, von Kielmansegg S: Datenreiche Medizin und das Problem der Einwilligung Ethische, rechtliche und sozialwissenschaftliche Perspektiven. Heidelberg: Springer. https://doi.org/10.1007/978-3-662-62987-1_5

  • Köngeter A, Jungkunz M, Schickhardt C, Winkler E, Mehlis K (2022): Sekundärnutzung klinischer Daten aus der Patientenversorgung für Forschungszwecke – Eine qualitative Interviewstudie zu Nutzen- und Risikopotenzialen aus Sicht von Expertinnen und Experten für den deutschen Forschungskontext. In: Richter G, Loh W, Buyx A, von Kielmansegg S: Datenreiche Medizin und das Problem der Einwilligung Ethische, rechtliche und sozialwissenschaftliche Perspektiven. Heidelberg: Springer. https://doi.org/10.1007/978-3-662-62987-1_10

  • Spitz M, Cornelius K (2022): Personenbezogene Daten im Kontext biomedizinischer Sekundärforschungsnutzung. In: Richter G, Loh W, Buyx A, von Kielmansegg S: Datenreiche Medizin und das Problem der Einwilligung Ethische, rechtliche und sozialwissenschaftliche Perspektiven. Heidelberg: Springer. https://doi.org/10.1007/978-3-662-62987-1_6

  • Spitz M, Jungkunz M, Schickhardt C, Cornelius K (2021): Rechtlicher Rahmen für eine privilegierte Nutzung klinischer Daten zu Forschungszwecken, Medizinrecht, 39:499-504. https://doi.org/10.1007/s00350-021-5898-7

  • Jungkunz M, Köngeter A, Mehlis K, Winkler EC, Schickhardt C (2021): Secondary Use of Clinical Data in Data-Gathering, Non-Interventional Research or Learning Activities: Definition, Types, and a Framework for Risk Assessment. Journal of Medical Internet Research; 23(6):e26631. https://www.jmir.org/2021/6/e26631

Lectures

  • Jungkunz M: Secondary Use of Clinical Data in Data-Gathering, Non-Interventional Research or Learning Activities: Definition, Types, and a Framework for Risk Assessment. Vortrag zur Verleihung des Forschungspreises 2022 des Arbeitskreises medizinischer Ethikkommissionen (AKEK), 23.6.2022, Berlin.

  • Köngeter A, Schickhardt C, Jungkunz M, Bergbold S, Mehlis K/Winkler EC: Patients’ willingness to provide their clinical data for research purposes and acceptance of different consent models. Findings from a representative survey of cancer patients in Germany. Internationales Zentrum für Ethik in den Wissenschaften (IZEW), 15. März 2022, Virtuell.

  • Köngeter A, Jungkunz M, Schickhardt C, Winkler EC, Mehlis K: Sekundärnutzung klinischer Daten aus der Patientenversorgung für Forschungszwecke - Eine Mixed-Method-Studie zu Nutzen- und Risikopotenzialen für den deutschen Forschungskontext. DaDuHealth - Datenzugang und Datennutzung in der medizinischen Versorgung und im Bereich Gesundheit und Freizeit, 14. September 2021, Virtuell

  • Köngeter A, Jungkunz M, Schickhardt C, Mehlis K, Winkler EC: Sekundärnutzung klinischer Daten aus der Patientenversorgung für Forschungszwecke -  Eine quantitative Studie zur Bereitschaft von Tumorpatient:innen ihre klinischen Daten für Forschungszwecke zur Verfügung zu stellen. Krebsregister Baden-Württemberg, 10. November 2021, Virtuell



The "69th Heidelberg Grand Rounds - Responsible Use of Clinical Data for Research Purposes" were held online on June 15 2021:

  • Thorogood A: Sharing healthcare data across borders: Connecting national initiatives through governance and standards. 69th Heidelberg Grand Rounds - Responsible Use of Clinical Data for Research Purposes, 15. Juni 2021, Virtuell.
  • Jungkunz M, Köngeter A, Mehlis K, Winkler E, Schickhardt C: To share or not to share? Moral responsibilities of patients and physicians to support secondary use of clinical data for biomedical research. 69th Heidelberg Grand Rounds - Responsible Use of Clinical Data for Research Purposes, 15. Juni 2021, Virtuell.
  • Köngeter A, Jungkunz M, Schickhardt C, Winkler E, Mehlis K: Expert opinions on the potential and risks of secondary use of clinical data for biomedical research, 69th Heidelberg Grand Rounds - Responsible Use of Clinical Data for Research Purposes, 15. Juni 2021, Virtuell.
  • Spitz M, Cornelius K: Is patient consent always necessary to use clinical data for biomedical research? 69th Heidelberg Grand Rounds - Responsible Use of Clinical Data for Research Purposes, 15. Juni 2021, Virtuell.


  • Jungkunz M, Köngeter A, Mehlis K, Winkler E, Schickhardt C (2020): Risikoanalyse für die Sekundärnutzung klinischer Daten. Modell zur Bewertung von Risiken für Patienten im Rahmen medizinischer Forschung mit Behandlungsdaten, AEM Jahrestagung, 23.-24. September 2020, Virtuell.
  • Jungkunz M, Köngeter A, Winkler E, Mehlis K, Schickhardt C (2019): From Categorization to Evaluation of Secondary Data Use. Learning and Research Uses of Clinical Data - Ethical Aspects, BMFB Workshop: New ethical challenges in data-rich biomedical research: a country comparison of consent in UK, Austria and Germany,16.-20. Oktober 2019, München.
  • Köngeter A, Jungkunz M, Winkler E, Schickhardt C, Mehlis K (2019): From Categorization to Evaluation of Secondary Data Use. Learning and Research Uses of Clinical Data - Social Aspects, BMFB Workshop: New ethical challenges in data-rich biomedical research: a country comparison of consent in UK, Austria and Germany,16.-20. Oktober 2019, München.
  • Spitz M: Learning from Clinical Data – Legal perspective on risks and opportunities of secondary use of clinical data in different research contexts, BMFB Workshop: New ethical challenges in data-rich biomedical research: a country comparison of consent in UK, Austria and Germany, 16.-20. Oktober 2019, München.
  • Spitz M: Learning from Clinical Data – Sekundärnutzung medizinischer Daten für Forschungszwecke, Vortragsveranstaltung des Vereins zur Förderung des Deutschen, Europäischen und Internationalen Medizinrechts, Gesundheitsrechts und der Bioethik in Heidelberg und Mannheim: Compliance im Krankenhaus, 12. Dezember 2019, Mannheim