{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T13:24:33Z","timestamp":1789046673893,"version":"build-2803163510"},"reference-count":65,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2025,2,25]],"date-time":"2025-02-25T00:00:00Z","timestamp":1740441600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Med."],"abstract":"<jats:sec><jats:title>Introduction<\/jats:title><jats:p>The General Data Protection Regulation (\u201cGDPR\u201d) 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\u2019s 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 \u201cinformed consent\u201d, 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 \u201cinformed\u201d 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 \u2018data altruism\u2019, as stipulated within Article 2 (10) of the Data Governance Act (\u201cDGA\u201d), addresses the gaps left behind by the application of the legal basis of \u2018consent\u2019, 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 \u2018data altruism\u2019 can add any value and work as a cohesive solution that the research community can use.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objectives<\/jats:title><jats:p>The article, through its research, intends to answer the following questions:<\/jats:p><jats:list><jats:list-item><jats:p>What gaps has the GDPR left when it comes to the interpretation and practical application of \u201cconsent\u201d towards the secondary use of health data;<\/jats:p><\/jats:list-item><jats:list-item><jats:p>Can the DGA, through the mechanism of \u2018data altruism\u2019, address these issues and provide a solution;<\/jats:p><\/jats:list-item><jats:list-item><jats:p>What solutions have been used so far in practice to address this issue.<\/jats:p><\/jats:list-item><\/jats:list><\/jats:sec><jats:sec><jats:title>Methodology<\/jats:title><jats:p>To address the above-mentioned questions, the Arskey and O\u2019Malley scoping review methodology and best practice, as outlined in the Joanna Briggs scoping review guidelines, have been applied. The research questions have been identified through an extensive literature review and consultation with subject matter experts. The search was conducted using six search engines and utilising a tailored search strategy, with the application of both MESH and non-MESH based search terms. From the identified relevant publications, 148 abstracts were kept to be read and 60 of those publications were kept as relevant. A PRISMA chart showcases the process in which the publications were reviewed and the process which led to the final papers kept as relevant. The title-abstract and full text screening and charting the data were concluded independently by two reviewers. Discrepancies were then resolved by a third reviewer. Results are summarised in both chart and narrative form below.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The final 60 publications were then split into three subcategories: (i) GDPR critique (23 publications listed); (ii) iterations of consent and data altruism (21 publications listed); and (iii) proposed solutions and current practices (31 publications). Certain of the publications fell into more than one of the above subcategories, given the interdisciplinary element of the subject and theme of each paper. Throughout the research, 5 of the publications discuss the Data Governance Act and data altruism, with 4 of those providing a critique over the text used in the DGA and the concept of \u2018data altruism\u2019 in relation to \u2018consent\u2019 as defined within the GDPR and the overall legislative framework for the secondary uses of data.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fmed.2024.1489925","type":"journal-article","created":{"date-parts":[[2025,2,25]],"date-time":"2025-02-25T11:50:06Z","timestamp":1740484206000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":5,"title":["Data altruism and the \u201cconsent\u201d question: a study into the \u201cconsent\u201d models used under the GDPR and how the data altruism mechanism can act as a potential solution for the research community in the reuse of health data"],"prefix":"10.3389","volume":"11","author":[{"given":"Maria","family":"Christofidou","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Theodoros N.","family":"Arvanitis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dipak","family":"Kalra","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nathan","family":"Lea","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mahsa","family":"Shabani","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pascal","family":"Coorevits","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2025,2,25]]},"reference":[{"key":"ref1","year":"1978"},{"key":"ref2","doi-asserted-by":"publisher","first-page":"205395171986259","DOI":"10.1177\/2053951719862594","article-title":"Negotiating the reuse of health-data: research, big data, and the European general data protection regulation","volume":"6","author":"Starkbaum","year":"2019","journal-title":"Big Data Soc"},{"key":"ref3","year":""},{"key":"ref4","doi-asserted-by":"publisher","first-page":"2191","DOI":"10.1001\/jama.2013.281053","article-title":"World medical association declaration of Helsinki: ethical principles for medical research involving human subjects","volume":"310","year":"2013","journal-title":"JAMA"},{"key":"ref5","year":""},{"key":"ref6","volume-title":"Regulation (EU) 2016\/679 Of the European Parliament and of the council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing directive 95\/46\/EC","year":"2016"},{"key":"ref7","doi-asserted-by":"publisher","first-page":"23","DOI":"10.1007\/s11019-021-10060-1","article-title":"Controversies between regulations of research ethics and protection of personal data: informed consent at a cross-road","volume":"25","author":"Gefenas","year":"2022","journal-title":"Med Health Care Philos"},{"key":"ref8","year":""},{"key":"ref9","doi-asserted-by":"publisher","first-page":"85","DOI":"10.1177\/096853320901000201","article-title":"Broad consent in biobanking: reflections on seemingly insurmountable dilemmas","volume":"10","author":"Caulfield","year":"2009","journal-title":"Med Law Int"},{"key":"ref10","first-page":"481","article-title":"Research ethics committees and clinical research in Italy: where are we going?","volume":"19","author":"Minacori","year":"2015","journal-title":"Eur Rev Med Pharmacol Sci"},{"key":"ref11","doi-asserted-by":"publisher","first-page":"16","DOI":"10.1186\/s12910-016-0099-z","article-title":"Ethical analysis in HTA of complex health interventions","volume":"17","author":"Lysdahl","year":"2016","journal-title":"BMC Med Ethics"},{"key":"ref12","year":""},{"key":"ref13","year":""},{"key":"ref14","year":""},{"key":"ref15","doi-asserted-by":"publisher","first-page":"897","DOI":"10.1038\/ejhg.2012.282","article-title":"Broad consent versus dynamic consent in biobank research: is passive participation an ethical problem?","volume":"21","author":"Steinsbekk","year":"2013","journal-title":"Eur J Hum Genet"},{"key":"ref16","doi-asserted-by":"publisher","first-page":"168","DOI":"10.1177\/0968533213508974","article-title":"Delivering proportionate governance in the era of eHealth: making linkage and privacy work together","volume":"13","author":"Sethi","year":"2013","journal-title":"Med Law Int"},{"key":"ref17","doi-asserted-by":"publisher","first-page":"117","DOI":"10.1093\/idpl\/ipz023","article-title":"Should consent for data processing be privileged in health research? 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