Ethical, Legal, and Practical Concerns Surrounding theImplemention of New Forms of Consent for Health Data Research:Qualitative Interview Study

Background: In Europe, within the scope of the General Data Protection Regulation, more and more digital infrastructures arecreated to allow for large-scale access to patients'health data and their use for research. When the research is performed on thebasis of patient consent, traditional study-specific consent appears too cumbersome for many researchers. Alternative models ofconsent are currently being discussed and introduced in different contexts.Objective: This study explores stakeholder perspectives on ethical, legal, and practical concerns regarding models of consentfor health data research at German university medical centers.Methods: Semistructured focus group interviews were conducted with medical researchers at German university medical centers,health IT specialists, data protection officers, and patient representatives. The interviews were analyzed using a software-supportedstructuring qualitative content analysis.Results: Stakeholders regarded broad consent to be only marginally less laborious to implement and manage than tiered consent.Patient representatives favored specific consent, with tiered consent as a possible alternative. All stakeholders lamented thatinformation material was difficult to understand. Oral information and videos were mentioned as a means of improvement. Patientrepresentatives doubted that researchers had a sufficient degree of data security expertise to act as sole information providers.They were afraid of undue pressure if obtaining health data research consent were part of medical appointments. IT specialistsand other stakeholders regarded the withdrawal of consent to be a major challenge and called for digital consent managementsolutions. On the one hand, the transfer of health data to non-European countries and for-profit organizations is seen as a necessityfor research. On the other hand, there are data security concerns with regard to these actors. Research without consent is legallypossible under certain conditions but deemed problematic by all stakeholder groups, albeit for differing reasons and to differentdegrees.Conclusions: More efforts should be made to determine which options of choice should be included in health data researchconsent. Digital tools could improve patient information and facilitate consent management. A unified and strict regulation forresearch without consent is required at the national and European Union level. Obtaining consent for health data research shouldbe independent of medical appointments, and additional personnel should be trained in data security to provide information onhealth data research.