Maria Christofidou ^1* Theodoros N Arvanitis ² Dipak Kalra ^3,4 Nathan Lea ³ Mahsa Shabani ^5,6 Pascal Coorevits ¹

• ¹ Department of Public Health and Primary Care, Faculty of Medicine and Health Sciences, Ghent University, Ghent, East Flanders, Belgium
• ² Department of Electronic, Electrical and Systems Engineering, University of Birmingham, Birmingham, England, United Kingdom
• ³ The European Institute for Innovation through Health Data, Gent, Belgium
• ⁴ Ghent University, Ghent, East Flanders, Belgium
• ⁵ Faculty of Law and Criminology, Ghent University, Ghent, East Flanders, Belgium
• ⁶ Law Centre for Health and Life, Amsterdam Law School, University of Amsterdam, Amsterdam, Netherlands

The General Data Protection Regulation ('GDPR') legal basis for obtaining consent for the processing of personal data for research purposes, where those purposes cannot be fully specified in advance, is provided for in Articles 6, 7 and Recital 33. However, GDPR's requirements for obtaining consent, as to the secondary use and sharing of data in research, have been argued to have generated confusion, whilst the conflicts between the Regulation itself, its practical application and research ethics are well-documented. 1 The requirements for 'informed consent', as defined within the GDPR, have not been well defined in the context of genome research or clinical trials, 2 which has in turn led to the implementation and interpretation of the lawful basis to span into different idiosyncratic models. This naturally has fed into the uncertainty of how the legal basis can be applied in practice and calls for an investigation into the requirements for consent to be "informed" in the context of health research. This work aims to provide a scoping review and analysis of relevant publications with ultimate purpose to examine whether the concept of 'data altruism', as stipulated within Article 2(10) of the Data Governance Act ('DGA'), addresses the gaps left behind by the application of the legal basis of 'consent', under the GDPR (Art. 6(1) and 7), in so far as the secondary uses of data for research are concerned. In this light the article, by exploring available solutions found in relevant literature and used in practice in national and European projects, examines how 'data altruism' can add any value and work as a cohesive solution that the research community can use.The article, through its research, intends to answer the following questions: 1. What gaps has the GDPR left when it comes to the interpretation and practical application of 'consent' towards the secondary use of health data; 2. Can the DGA, through the mechanism of 'data altruism', address these issues and provide a solution;