gms | German Medical Science

Introduction: Enabling the secondary research use of patient data is a prerequisite for the efficient and sustainable promotion of translation and personalisation in medicine, and for the advancement of public health. However, balancing the legitimate scientific interests in unrestricted data access and the demand for individual autonomy, privacy and social justice is a great challenge for patient-based medical research.

Methods: We conducted two questionnaire-based surveys in a representative random sample of North-German outpatients (n=650) to determine their attitude towards data donation for medical research, implemented as an opt-out process (i.e. legal permission of data-use unless actively denied by data subject).

Results: We observed a high level of acceptance of such a model (75.0%), mainly due to the conviction that every citizen has a duty to contribute to medical research (>80% of participants approving data donation). Patients distinguished sharply between research inside and outside the EU. Despite general awareness that academic institutions cooperate with commercial companies, willingness to allow data use by the latter was low (depending upon company location; outside EU: 7.1%, Germany: 29.1%). The most popular measure to counteract such reservations was regulation by law (61.4%), stipulating that data are not sold (84.6%). Additionally, a majority of patients requested control of data use (46.8%) and data protection (41.5%) by independent bodies.

Discussion: Recent surveys undertaken against the backdrop of the SARS-CoV-2 pandemic revealed that a majority of German citizens would be prepared to make personal health data available for research, including research by private companies. Even before the pandemic, studies in various countries demonstrated high willingness of patients and members of the general population to contribute personal data to medical research (e.g. [1], [2], [3]). Not surprisingly, initial considerations have gotten under way since then to create a legal basis in Germany for data donation [4], [5], [6]. In fact, previous studies in Germany have suggested robust acceptance of data donation if understood as one of many possible forms of patient consent [7], but the envisaged legal and organizational concept has not been differentiated in much detail yet.

Patient willingness to contribute data from routine clinical care to research was likely motivated by a ‘reciprocity’ position implying that patients who benefit from medical research should contribute to research themselves. The most prominent beneficiaries were universities and public research institutions in Germany whereas use of the donated data by commercial companies was very unpopular. We therefore tried to identify reasons for the latter reservations and to find out how they could be counteracted when designing a data donation process. Most frequent concerns were insufficient data protection by commercial users and an objection of their profit making through the use of the data, explaining the great demand of participants for legal regulations stipulating that the data were not commercialised.

Conclusion: Data donation for medical research, implemented as a combination of legal entitlement and easy-to-exercise opt-out, was found to be widely supported by German patients and therefore warrants further consideration for a transposition into national law.

The authors declare that they have no competing interests.

The authors declare that a positive ethics committee vote has been obtained.