Optimising cohort data in Europe

1. Introduction SYNCHROS (SYNergies for Cohorts in Health: integrating the Role of all Stakeholders) is an EU-funded project that aims to establish a sustainable European strategy for the development of the next generation of integrated population, patient and clinical trial cohorts, thereby contributing to an international strategic agenda for enhanced coordination of cohorts globally. Significant ethical and legal practical challenges for researchers, practitioners, governments and the general public are addressed within the framework of the SYNCHROS project in pursuit of its main objective, namely optimising the exploitation of current and future cohort data, toward the development of stratified and personalised medicine as well as facilitating health policy. Practical, ethical and legal issues can be substantial obstacles to an optimal exploitation of cohort data, including data harmonisation and integration across cohort studies. In the context of cohort research, it is important to note that the distinction between ethical and legal obstacles can at times be fluid: the key legal issues of consent, confidentiality, and social justice, for example, are at the same instant key ethical issues. The legal sphere is distinguished from ethics primarily in terms of authoritative enforceability. Unless ethical concerns are codified and given legal status, these concerns are persuasive only. Legal requirements, such as those set out in the EU General Data Protection Regulation (GDPR), can be enforced in a manner consistent with and subject to the provisions of the regulation and jurisdictional considerations. Moreover, some research tools such as biobanks and other repositories can be involved in cohort studies and may raise quite distinct ethical and legal problems. Similarly, genomic research or research involving very large datasets (“big data” studies) using machine learning and other sophisticated techniques can overlap with cohort studies and be associated with specific ethical and legal issues that are nonetheless distinct from those found in cohort studies. 2. Domain-related challenges to cohort research 2.1. Research practices: collection, processing, access and sharing of data 2.1.1. Data collection One of the first stages of data collection is the identification of the target population. A crucial component of this research process is the principle of beneficence: researchers have to ensure that there are no blind spots in the population category it purports to help (Winter et al., 2018). For research with digital health data, for instance, it is necessary to ensure research access for those communities that either lack the technical means for participation (e.g. no Internet connection) or lack digital literacy (Gold et al., 2018). In this