Optimising cohort data in Europe

the EU has developed a policy framework for data sharing that includes interoperable EHRs for diagnosis and treatment, common data models (e.g. the European Health Data and Evidence Network-EDHEN) and interoperable, semantically coherent classifications for health outcomes (e.g. International Consortium for Health Outcomes Measurement ICHOM) (OECD, 2019). Researchers' perspectives are also helpful in determining data sharing governance. Researchers are mostly committed to data sharing as they consider that it adds social value to databases and EHRs. However, they are warry of collaborations with experts from non-medical disciplines and transparency. For instance, they are reluctant to share data with information scientists because they assume that they are not able to understand and thus translate medical information accurately. Transparency is often considered in terms of its potential for privacy infringements and its contradiction with clinical practices (Müller et al., 2020). There is also a general concern about the potential for data waste and the prospect of not being able to use data to its fullest potential (Rajula et al., 2019; Geneviève et al., 2019). Such attitudes suggest that researchers have an affinity with the fiduciary model of data governance. Namely, the fiduciary model specifies that research institutions determine data sharing and thus take the obligation to protect the best interest of all stakeholders involved (e.g. sample sources and their families, contributing scientists and funding institutions) (Juengst and Meslin, 2019). For researchers, this means that they act as “stewards” for data-sharing decisions on behalf of sample sources (e.g. participants providing genetic data). Although participants consent to their data being shared by the biobank, the researchers (and databank stewards) are the ones who make the data-sharing policy decisions. Nevertheless, such governance scheme is not practicable in international contexts, where decisions about data storage (and consequently data sharing) concern all stakeholders who have sample disposition claims (Juengst and Meslin, 2019). Finally, it should be noted, that no data-sharing arrangement is able to address the interests of all the stakeholders involved (Murtagh et al., 2018). Instead, data sharing is still framed in terms of an opposition between liberal interpretations of autonomy (i.e. individuals voluntarily negotiate how their data are shared in terms of their personalised preferences) and communitarianism principles (i.e. research institutions determine how data are shared within the parameters of individual consent and in accordance with the public good) (Cech, 2019). 2.2. Ethical requirements Ethical requirements for cohort studies (besides respect for persons and justice) include beneficence, non-maleficence, respect of autonomy, respect of confidentiality and privacy, and Informed consent.