Data sharing, both within and outside the consortium, is a common feature of many IMI and IHI projects. However, sharing data can raise legal, technical, data protection, ethical, and intellectual property questions. Now, a new Data Sharing Playbook is set to help new and existing consortia to understand the challenges and rapidly develop solutions, so that they can focus their efforts on what really matters: advancing collaborative and impactful research to improve health outcomes. Designed for everyone involved in data sharing in IMI/IHI projects, the playbook sets out the main concepts and roles/ functions involved in data sharing; the key decisions that need to be taken during the project; the root causes of data sharing issues; and strategies to prevent and address these challenges, together with best and worst-case scenarios. Finally, the playbook provides links to a wide range of resources on data sharing, including examples, templates, guidelines, standards, and other resources.
- Download the Data Sharing Playbook
In a nutshell, you must ensure open access (free, online access for any user) to all peer-reviewed publications relating to your results. You can find details of your obligations relating to the provision of open access to peer-reviewed publications in the relevant parts of the annotated grant agreements:
- IHI projects: Annex 5 of the Annotated Grant Agreement for EU Funding Programmes 2021-2027
- IMI2 projects: Article 29.2 of the IMI2 JU Annotated Model Grant Agreement
We support the ‘FAIR data principles’, i.e. findable, accessible, interoperable and re-usable. This means that research data should be:
- identified in a persistent manner using community conventions, and described using sufficiently rich meta-data;
- stored in such a way that they can be accessed by humans and machines;
- structured in such a way that they can be combined with other data sets;
- licensed or have terms-of-use that spell out how they can be used by others.
You can find details of your obligations relating to research data management in the relevant parts of the annotated grant agreements:
- IHI projects: Annex 5 of the Annotated Grant Agreement for EU Funding Programmes 2021-2027
- IMI2 projects: Article 29.2 of the IMI2 JU Annotated Model Grant Agreement
Transparency and public access to the results of clinical studies and trials are fundamental for the protection and promotion of public health. It assures people participating in research that their involvement is useful and that the results have been collated and reported for the benefit of all. In addition, it allows patients and healthcare professionals, or any other citizen, to find out more information about medicines they might be taking or prescribing. Transparency also enhances scientific knowledge and helps to advance clinical research and support more efficient medicine development programmes.
Clinical trials in the EU and EEA (European Economic Area) are governed by the Clinical Trials Regulation (Regulation (EU) No 536/2014). It is part of a broad initiative to transform the EU/EEA clinical trials environment in support of large clinical trials in multiple European countries, to the benefit of medical innovation and patients.
As of 31 January 2023, all initial clinical trial applications in the EU must be submitted via the Clinical Trials Information System (CTIS). The CTIS is now the single-entry point for sponsors and regulators of clinical trials for the submission and assessment of clinical trial data.
Meanwhile EudraCT (the EU Drug Regulating Authorities Clinical Trials Database) and the associated EU Clinical Trial Register remain active for some trials submitted to EudraCT from 1 May 2004 to 30 January 2023. While some trials can remain in EudraCT, others will have to transition their trials to CTIS; details can be found on the EudraCT website.
Whether a trial is in CTIS or EudraCT, sponsors must post results within one year after the end of a clinical trial (or six months for a paediatric trial). This information is also shared with the World Health Organization’s (WHO) International Clinical Trials Registry Platform (ICTRP).
In addition, IHI projects should take note of the rules described in the Horizon Europe clinical studies template: Irrespective of the successful completion of the clinical study, summary results must be posted in the applicable registry/ies (where the study was registered) even if the timing of posting of results falls outside of the grant period. The report is to be scheduled for the time results posting is expected or for the last months of the project, whichever comes earlier.
To address the outbreak of the coronavirus SARS-CoV-2, which causes COVID-19, we need to ensure that relevant research findings and data be shared as rapidly, openly and effectively as possible. The European Commission prepared specific guidance for Horizon 2020 projects (including IMI2 projects) working on SARS-CoV-2 and topics related to the pandemic. All projects with research outputs that - in any way - may be used to advance research on COVID-19, are encouraged to provide immediate open access to relevant publications, data and any other output possible, in line with the guidance. The guidance includes advice on the FAIR principles; open access to publications; open access to data; data management plans; and other research outputs.
In addition, the European Commission has partnered up with the European Bioinformatics Institute (EBI) of the European Molecular Biology Laboratory (EMBL) and other partners to deliver a European COVID-19 research data platform. The platform provides an open, trusted, and scalable European and global environment where researchers can store and share research datasets, starting initially with DNA sequences, protein structures, and other omics data, and subsequently expanding to data from pre-clinical research and clinical trials, as well as epidemiological data.