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.

DFG
Term: 2019-2022
Run-time: 36 months