Project Details
Projekt
Learning from Clinical Data: Ethical, Social and Legal Aspects
Subject Area
Public Health, Healthcare Research, Social and Occupational Medicine
Term
from 2018 to 2022
Project identifier
Deutsche Forschungsgemeinschaft (DFG) - Project number 406103282
The project Learning from Clinical Data (LinCDat) aims to investigate if a paradigm shift from exceptional to routine use of medical data for research and learning activities would be desirable and feasible, from an empirical, ethical and legal view Data from clinical care can be used in various innovative, data-gathering, non-interventional studies or learning activities (DaNIS) to generate insights valuable beyond the diagnosis and treatment of the individual patient. These studies are thought to be low-risk, and utilizing clinical data for DaNIS can benefit patients and society through advancing science and improving health care quality. However, there are serious practical difficulties and normative concerns, such as protection of patients’ privacy and data sovereignty, which must be addressed. So far, rights and responsibilities of all stakeholders to contribute to DaNIS within a public health care system like Germany’s have not been explored in depth, and the empirical data needed to include the perspectives of stakeholders in an ethical and legal analysis are missing. The lack of a rigorous investigation of the normative issues related to DaNIS has engendered unease, hindering the systematic provision and use of clinical data for learning and research.In our project, we employ an interdisciplinary approach to address ethical, legal and social questions raised by DaNIS: the first step is to develop a typology of DaNIS and analyze the opportunities, risks and burdens. (Work Package 1: WP1). Building on WP1, we investigate the attitudes, and moral and legal rights and duties of physicians (WP2) and patients (WP3) concerning DaNIS. We also examine whether and to what extent society, particularly in light of public health care systems, is entitled to contributions to DaNIS from patients, physicians and institutions, as well as the responsibilities of public instituions to protect stakeholders and promote DaNIS. Finally, we leverage the insights from WP1-4 to develop a governance framework for DaNIS for 1) policy makers, 2) funding agencies, and 3) health care institutions addressing: a) principles and procedures to inform, involve and protect patients; b) the role of physicians and incentives for physicians to contribute to DaNIS c) patients’, physicians’, and institutions’ roles and responsibilities to contribute to DaNIS. The governance framework aims to develop strategies that encourage the sharing and use of clinical data while maintaining rigorous but proportionate information governance and accountability. Prof. Winkler’s position as attending physician in a university medical center ensures access to the field and readily available opportunities for implementing approaches in clinical practice. International expertise in the ethical and legal governance of health and genomic data and best practices will be provided by Adrian Thorogood as Mercator Fellow.
DFG Programme
Research Grants
Co-Investigator
Christoph Schickhardt, Ph.D.
