JMIR Publications

ABSTRACT

Background:

In Europe, within the scope of the GDPR, more and more digital infrastructures are created to allow for large-scale access to patients’ health data and its use for research. Where this research is carried out on the basis of patient consent, traditional study-specific consent appears too cumbersome to many researchers. Alternative models of consent are currently discussed and introduced in different contexts.

Objective:

This study explores stakeholder perspectives on ethical, legal and practical concerns regarding models of consent for health data research at German University Medical Centres.

Methods:

Semi-structured focus group interviews were conducted with medical researchers at German University Medical Centres, health IT specialists, data protection officers, and patient representatives. The interviews were analysed using a software-supported structuring qualitative content analysis.

Results:

Stakeholders regard broad consent to be only marginally less laborious to implement and manage than tiered consent. Patient representatives favour specific consent, with tiered consent as a possible alternative. All stakeholders lament that information material is difficult to understand. Oral information and videos are mentioned as means of improvement. Patient representatives doubt that researchers have a sufficient degree of data security expertise to act as sole information providers. They are afraid of undue pressure if obtaining health data research consent is part of medical appointments. IT specialists and other stakeholders regard withdrawal of consent to be a major challenge and call for digital consent management solutions. Transfer of health data to non-European countries and for-profit organisations is, on the one hand, seen as a necessity for research. On the other hand, there are data security concerns with regard to these actors. Research without consent is legally possible under certain conditions, but deemed problematic by all stakeholder groups, albeit for differing reasons and to different degrees.

Conclusions:

More efforts should be made to determine which options of choice should be included in health data research consent. Digital tools could improve patient information and facilitate consent management. A unified and strict regulation for research without consent is required at national and EU level. Obtaining consent for health data research should be independent of medical appointments and additional personnel should be trained in data security to provide information on health data research.