The objective of the SYNCHROS project is to establish a sustainable European strategy for the development of the next generation of integrated cohorts studies (contributing to an international agenda for enhanced coordination of cohorts globally) in order to address the practical, ethical and legal, and the methodological challenges to optimising the exploitation of current and future cohort data, towards the development of stratified and personalised medicine as well as facilitating health policy. Specifically, Work package 3 aims to identify solutions for addressing practical, ethical and legal challenges in integrating data across cohort studies. The focus of this strategy brief, therefore, is to identify ethical and legal obstacles to data integration, and, based on the evidence collected, describe solutions to overcome these obstacles. The strategy brief (alternatively evidence brief or policy brief) is an internationally-recognized strategic tool of modern implementation science – which itself has developed from evidence-based medicine and knowledge-transfer methodologies to become the foundation for promoting the adoption and integration of practices and policies for individual clinical care, public health and health research. SYNCHROS is a coordination and support action with the overall objective of addressing the practical, ethical and legal, and methodological challenges to optimising the exploitation of current and future cohort study data. Because of this aim, it is essential that SYNCHROS rely on implementation science to transfer what tends to be abstract and theoretical issues into practical solutions that can be accomplished in the context of existing research infrastructures and practice. Strategy briefs are the essential first step in implementation, as they provide both the scientific basis and agenda focus for the consensus-based, sustainable and strategic resolution by means of stakeholder dialogues. The current strategy brief follows a well-established format. We begin to describe and contextualize the central issues and a case is made, both for their relationship to the overall objective of the project but also their significance and priority. This is followed by an identification and prioritization of the key issues involved, in this case the leading ethical and legal obstacles to optimisation of data harmonization. Relying on the evidence that is set out in previous deliverables D3.1 (submitted August 2020) and D4.3 (submitted June 2020), each issue is presented in terms of potential options for realistic and feasible solution. Each option is motivated and evidence and argument presented. Finally, a recommendation for the best option is provided. Although for reasons provided below, it is often difficult to distinguish between ethical and legal issues in the context of cohort data integration (e.g. preservation of confidentiality is both an ethical requirement and a legal duty), we have chosen to describe these issues separately in what follows.

This document is produced in the context of the SYNCHROS project. SYNCHROS (SYNergies for Cohorts in Health: integrating the Role of all Stakeholders) is an EU-funded Coordination and Support Action (H2020, ref. no. 825884), aimed at developing a sustainable strategy for the integration and harmonisation of health cohort initiatives and networks across Europe and internationally. Through intensive collaboration with stakeholders (e.g. researchers, funding bodies, coordinators of cohort harmonisation and integration initiatives, policy-makers), SYNCHROS aims to create a strategic agenda for an enhanced international coordination and sustainable recommendations for better collaboration of cohorts globally, towards the development of stratified or personalised medicine.