Open Science and Data Protection: Engaging Scientific and Legal Contexts

This paper analyses the relationship between open science policies and data protection. In order to tackle the research data paradox of the contemporary science, i.e., the tension between the pursuit of data-driven scientific research and the crisis of repeatability or reproducibility of science, a theoretical perspective suggests a potential convergence between open science and data protection. Both fields regard governance mechanisms that shall take into account the plurality of interests at stake. The aim is to shed light on the processing of personal data for scientific research purposes in the context of open science. The investigation supports a threefold need: that of broadening the legal debate; of expanding the territorial scope of the analysis, in addition to the extra-territoriality effects of the European Union’s law; and an interdisciplinary discussion. Based on these needs, four perspectives are then identified, that encompass the challenges related to data processing in the context of open science: (i) the contextual and epistemological perspectives; (ii) the legal co-ordination perspectives; (iii) the governance perspectives; and (iv) the technical perspectives

JOAL Special issue on "Open Science and Data Protection" Part I Commentary: On Not Taking Open for Granted

Part I of this special double-issue on "Open Science and Data Protection" from the Journal of Open Access to Law (Vol 11, No 1) presents four papers that grapple with the larger picture of today’s digital-era move to open science

Scientific research processing health data in the European Union: data protection regime vs. open data

Data processing is fundamental for medical and biomedical scientific research. Data access and open sharing foster innovation and knowledge in these fields. However, supporting data-intensive research raises several data protection issues. The legal framework is complex and the proposal recently issued by the European Commission on the European Health Data Space aims at introducing rules to open research data. This paper provides an overview of the relevant data protection laws in the European Union, focusing on the key elements for researchers. It also deals with the policies and legislation on Open Science and Open Data, and discusses the new acts within the Data Strategy that may be relevant for a scientific project to open medical research. Then, the tensions between the data protection regime and the open research data framework are analysed to find the viable solutions for data access and sharing

Enabling Open Science in Medicine Through Data Sharing: An Overview and Assessment of Common Approaches from the European Perspective

Open Science involves the sharing of knowledge and data as well as the exchange of research results. This is particularly important in the biomedical field, as it can foster validation studies in response to the replication crisis and improve resource utilisation. Since medical data is particularly privacy sensitive, its processing is subject to strong data protection requirements. Agencies, institutions, and projects in the European Union are still struggling with the establishment of widely accepted mechanisms supporting the sharing of data for Open Science practices. The goal of this paper is to provide an overview of different methods that have been used for this purpose and to discuss their technical properties and legal challenges. Our assessment is based on well-known conceptualizations, such as the Five Safes Framework. The result shows that different approaches provide different trade-offs between the functionalities and the degree of data protection provided, and that there are open legal issues. Current legislative initiatives in the EU, including regulations for the European Health Data Space and the Data Governance Act, have the potential to address some of the resulting uncertainties

Private and Academic AI Collaboration: Opportunities and Challenges to Open Science in the US

Academic scientific research is undergoing a transformation in many respects. One relevant aspect is that it has become common practice for companies and private actors to fund and support scientific research. The field of scientific research in Artificial Intelligence provides an illustration of this phenomenon. The article, which adopts a US perspective, aims to provide an overview of the advantages and disadvantages of this phenomenon particularly in light of the Open Science approach. A particularly relevant consequence on which the investigation focuses is the handling of personal data and privacy management in academic research projects involving the development of AI systems funded by companies and private actors

(Un)informed consent in Psychological Research: An empirical study on consent in psychological research and the GDPR

In many instances, psychological research requires the collection and processing of personal data collected directly from research subjects. In principle, the General Data Protection Regulation (GDPR) applies to psychological research which involves the collection and processing of personal data in the European Eco- nomic Area (EEA). Further, the GDPR includes provisions elaborating the types of information which should be offered to research subjects when personal data are collected directly from them. Given the general norm that informed consent should be obtained before psychological research involving the collection of personal data directly from research participants should go ahead, the information which should be provided to subjects according to the GDPR will usually be communicated in the context of an informed consent process. Unfortunately, there is reason to believe that the GDPR’s obligations concerning information provision to research subjects may not always be fulfilled. This paper outlines the results of an empirical investigation into the degree to which these information obligations are fulfilled in the context of psychological research consent procedures to which European data protection law applies. Significant discrepancies between the legal obligations to provide information to research subjects, and the information actually provided, are identified

Circulation of personal data and non-personal data within the European Research Area for research and health purposes

The availability and circulation of data, information, knowledge and materials are essential in all fields of research, but they are particularly important in a period in which it is necessary to tackle a global phenomenon like the COVID- 19 pandemic. Awareness of the importance of the circulation of information derived from data, the European Commission has been elaborating a strategy for the circula- tion and sharing of personal and non-personal data. The European strategy needs the data to circulate and be shared in the economic, academic, and social environments. To achieve those objectives, EU documents use the metaphor of building a ‘European Data Area’, that is to say, legal, economic, and cultural frameworks governed at the continental and national levels, such as European Research Area (‘ERA’, see Article 179 TFEU) and the proposed European Health Data Space (‘EHDS’). An analysis of the current legislation seems to indicate several legal constraints on the circulation of data (information, knowledge and material), able to affect the building of an effective European Data Area. These limitations aim at protecting individual rights, such as privacy or other interests. However, such limitations to the circulation of data may affect other relevant rights and interests such as freedom of research and health. For this reason, this paper intends to show what are the legal means to find the points of equilibrium between the different viewpoints and allow the sustainable function of the European Data Area. Because proper global governance of health data and materials is required, the paper tries to the analysis of the main EU instruments which at this moment are able to regulate it, in order to implement an effective system for the exchange of data, in the meantime that the scientific community is waiting for the European Data Protection Board (EDPB) guidance on the processing health data for research purposes, still pending

Citizen-gathered data to support public services under emergencies: promises and perils of openness

Society is experiencing sudden and sometimes unexpected crises mul- tiplying at a fast pace. The emersion of these crises requires a swift intervention under the form of providing public services. However, institutions often struggle to cope with crises. In such confronting situations, local people, networks of non- governmental organizations, and associations mobilize. They do so setting up ini- tiatives and producing (open access) data that could fall within the category of ‘citizen-generated data’. This contribution draws on theoretical notions such as ‘tech- nology appropriation’ and ‘collective intelligence’ in the context of citizen science initiatives to set the scene. It then dives into the analysis of two concrete examples of phenomenon discussed. Subsequently, it explores relevant stakeholders’ position on the matter, relying on insights gathered during a focused workshop. In the discussion, the article explores how the current EU legal framework and international standards for data sharing could ensure that these data flows flourish and are used by the public sector, while preserving potentially conflicting interests

Open? The only way forward for science

This paper aims to set out the reasons underlying the need to foster as much as possible the sharing and re-use of research data as well as their FAIRness, taking into account the various interests at stake. COVID-19 showed that sharing is the only way to go and that to advance science we need data – and every bit of the research process -, not only the final synthesis of the research itself, i.e., the article on a scientific journal. Scientific journals are still at the core of research evaluation, which is being reformed to include any research output and to reward collaboration. To be openly shared, data needs to be FAIR, i.e., Findable, Accessible, Interoperable and Reusable, in order to streamline the workflow, to enable reproducibility, and to booster research integrity. The paper presents the FAIR open data as one of the components of the wider Open Science ecosystem, which we shall discuss here not with the usual “connecting block” approach but with an ecological one, where the web of interactions within the ecosystem defines its elements rather than the opposite and where the focus of Open Science is on co-creating knowledge instead of only disseminating it. The data sharing fostered by the Open Science approach is certainly not indiscriminate, but rather follows the principle “as open as possible, as closed as necessary”. A balancing act is required that takes into account the conflicting interests at stake, such as the right to the protection of personal data, enshrined in Article 8 of the Charter of Fundamental Rights of the European Union

Openness in Scientific Research: A Historical and Philosophical Perspective

Openness is widely regarded as a pillar of scientific ethics because it promotes reproducibility and progress in science and benefits society. However, the sharing of scientific information can sometimes adversely impact the interests of human research participants, human communities or populations, scientists, and private research sponsors; and may threaten national security. Because openness may conflict with other important social values, solutions to ethical and policy dilemmas should include meaningful input from those who are impacted by the sharing and use of scientific information, including research participants, communities, and the public. Data sharing and use policies should be reviewed and revised periodically to account for ongoing changes in science, technology, and society