The European health data space: Too big to succeed?

In May 2022, the European Commission issued the Proposal for a Regulation on the European Health Data Space (EHDS), with the aims of granting citizens increased access to and control of their (electronic) health data across the EU, and facilitating health data re-use for research, innovation, and policymaking. As the first in a series of European domain-specific "data spaces", the EHDS is a high-stakes development that will transform health data governance in the EU region. As an international consortium of experts from health policy, law, ethics and the social sciences, we are concerned that the EHDS Proposal will detract from, rather than lead to the achievement of, its stated aims. We are in no doubt on the benefits of using health data for secondary purposes, and we appreciate attempts to facilitate such uses across borders in a carefully curated manner. Based on the current draft Regulation, however, the EHDS risks undermining rather than enhancing patient control over data; hindering rather than facilitating the work of health professionals and researchers; and eroding rather than increasing the public value generated through health data sharing. Therefore, significant adjustments are needed if the EHDS is to realize its promised benefits. Besides analyzing the implications for key groups and European societies at large who will be affected by the implementation of the EHDS, this contribution advances targeted policy recommendations to address the identified shortcomings of the EHDS Proposal.

Ethics review of decentralized clinical trials (DCTs): Results of a mock ethics review.

Decentralized clinical trials (DCTs) can be a valuable addition to the clinical trial landscape. However, the practice of DCTs is dependent on a regulatory system designed for conventional (site-based) trials. This study provides insight into the ethics review of DCTs. A 'mock ethics review' was performed in which members of European ethics committees (ECs) and national competent authorities (NCAs) discussed and reviewed a DCT protocol. Respondents expressed hesitancy toward DCTs and focused on potential risks and burdens. We advise to address these aspects explicitly when submitting a DCT protocol. We propose that both the benefits and risks of DCTs should be carefully monitored to advance the review and practice of this innovative approach to ethically optimize drug development.

Joint controllers in large research consortia: a funnel model to distinguish controllers in the sense of the GDPR from other partners in the consortium.

Large European research consortia in the health sciences face challenges regarding the governance of personal data collected, generated and/or shared during their collective research. A controller in the sense of the GDPR is the entity which decides about purposes and means of the data processing. Case law of the Court of Justice of the European Union (CJEU) and Guidelines of the European Data Protection Board (EDPB) indicate that all partners in the consortium would be joint controllers. This paper summarises the case law, the Guidelines and literature on joint controllership, gives a brief account of a webinar organised on the issue by Lygature and the MLC Foundation. Participants at the webinar agreed in large majority that it would be extreme if all partners in the consortium would become joint controllers. There was less agreement how to disentangle partners who are controllers of a study from those who are not. In order to disentangle responsibilities, we propose a funnel model with consecutive steps acting as sieves in the funnel. It differentiates between two types of partners: all partners who are involved in shaping the project as a whole versus those specific partners who are more closely involved in a sub-study following from the DoA or the use of the data Platform. If the role of the partner would be comparable to that of an outside advisor, that partner would not be a data controller even though the partner is part of the consortium. We propose further nuances for the disentanglement which takes place in various steps. Uncertainty about formal controllership under the GDPR can stifle collaboration in consortia due to concerns over (shared) responsibility and liability. Data subjects' ability to exercise their right can also be affected by this. The funnel model proposes a way out of this conundrum.

Human exposome assessment platform.

The Human Exposome Assessment Platform (HEAP) is a research resource for the integrated and efficient management and analysis of human exposome data. The project will provide the complete workflow for obtaining exposome actionable knowledge from population-based cohorts. HEAP is a state-of-the-science service composed of computational resources from partner institutions, accessed through a software framework that provides the world's fastest Hadoop platform for data warehousing and applied artificial intelligence (AI). The software, will provide a decision support system for researchers and policymakers. All the data managed and processed by HEAP, together with the analysis pipelines, will be available for future research. In addition, the platform enables adding new data and analysis pipelines. HEAP's final product can be deployed in multiple instances to create a network of shareable and reusable knowledge on the impact of exposures on public health.

Correction: Data in question: A survey of European biobank professionals on ethical, legal and societal challenges of biobank research.

[This corrects the article DOI: 10.1371/journal.pone.0221496.].

Data in question: A survey of European biobank professionals on ethical, legal and societal challenges of biobank research.

Biobanks have evolved, and their governance procedures have undergone important transformations. Our paper examines this issue by focusing on the perspective of the professionals working in management or scientific roles in research-based biobanks, who have an important impact on shaping these transformations. In particular, it highlights that recent advances in molecular medicine and genomic research have raised a range of ethical, legal and societal implications (ELSI) related to biobank-based research, impacting directly on regulations and local practices of informed consent (IC), private-public partnerships (PPPs), and engagement of participants. In our study, we investigate the ways that these concerns influence biobanking practices and assess the level of satisfaction of the cross-national biobanking research communities with the ELSI related procedures that are currently in place. We conducted an online survey among biobankers and researchers to investigate secondary use of data, informing and/or re-contacting participants, sharing of data with third parties from industry, participant engagement, and collaboration with industrial partners. Findings highlight the need for a more inclusive and transparent biobanking practice where biobanks are seen in a more active role in providing information and communicating with participants; the need to improve the current IC procedures and the role of biobanks in sharing of samples and data with industry partners and different countries, and the need for practical, tangible and hands-on ethical and legal guidance.

The FAIR guiding principles for data stewardship: fair enough?

The FAIR guiding principles for research data stewardship (findability, accessibility, interoperability, and reusability) look set to become a cornerstone of research in the life sciences. A critical appraisal of these principles in light of ongoing discussions and developments about data sharing is in order. The FAIR principles point the way forward for facilitating data sharing more systematically-provided that a number of ethical, methodological, and organisational challenges are addressed as well.

Patients to learn from: on the need for systematic integration of research and care in academic health care.

Patients suffering from rare, extreme or extremely complex sets of symptoms have something to expect from efforts to improve care through research. Biomedical research and care have often been approached as distinct worlds which are and should be only loosely connected. For observational research focusing on data drawn from real-world settings, however, that approach is found wanting. Integrating research and care responsibly is the main challenge instead. Integrated IT infrastructures facilitating Personalized medicine and Big Data are crucial components of a learning health care system, in which patients regularly play a double role: as individuals to be treated and as cases to learn from. Drawing on the example of the Dutch Parelsnoer Institute (PSI), a national biobanking and IT infrastructure integrated with clinical care procedures, this article outlines the reforms that are needed. Systematic integration of research and care offers a promising avenue, provided that a number of conditions are met: data and IT infrastructures will require overhauls in order to facilitate secure, high-quality data integration between research and care; institutional focus is needed to bring patient populations and expertise together; ethical frameworks and approaches for integrating research and care responsibly require further elaboration; clinical procedures and professional responsibilities may need to be adapted in order to accommodate research requirements in clinical processes; and involvement of patients and other stakeholders in design and research priority setting is needed to further the goals of real-world and patient relevance. RELEVANCE FOR PATIENTS: Integrating research and care in academic medicine in a more systematic fashion offers a promising perspective to current and future patients. In order to live up to these promises, research and care should be integrated more systematically in academic health science, with patients being included as research participants by default. Data and tissue infrastructures and facilities can provide a platform for doing so. At the same time, many issues remain to be settled. New ethical ways and means for protecting and respecting patient-participants in such a double role are also needed in this respect. In this way a deeper transformation is at stake as well: a change towards a setting in which patients fully take center stage in debate and action on the future of biomedicine.

Governing the research-care divide in clinical biobanking: Dutch perspectives.

Biobanking, the large-scale, systematic collection of data and tissue for open-ended research purposes, is on the rise, particularly in clinical research. The infrastructures for the systematic procurement, management and eventual use of human tissue and data are positioned between healthcare and research. However, the positioning of biobanking infrastructures and transfer of tissue and data between research and care is not an innocuous go-between. Instead, it involves changes in both domains and raises issues about how distinctions between research and care are drawn and policed. Based on an analysis of the emergence and development of clinical biobanking in the Netherlands, this article explores how processes of bio-objectification associated with biobanking arise, redefining the ways in which distinctions between research and clinical care are governed.

[Biobanks and the return of results to donors]. / Biobanken en de terugkoppeling van onderzoeksbevindingen aan donoren.

Biobanks should return clinically significant and actionable research findings to donors who have given physical material to the biobank. Because the clinical significance of a research finding is hard to determine for the individual donor, a procedure to decide on clinical significance should be incorporated into a structure for the actual feedback of research results. Most published studies show that donors expect return of individual research results, but there is almost no experience with it. Explorative questionnaire-based research among Dutch biobanks from the BioBanking Medical Research Infrastructure (BBMRI.NL) shows that a substantial group of biobanks can return individual research findings from data analysis. On the basis of these experiences a return of results policy may be drafted that answers to the interests of donors and the possibilities of biobanks.

[Ethical review of biobanks in The Netherlands: lessons from the String of Pearls Initiative]. / Toetsing van biobanken: lessen uit het Parelsnoer Initiatief.

Ethical and legal aspects of biobanking continue to be a topic of concern. The String of Pearls Initiative (PSI) helped establish new norms for biobank governance in The Netherlands. This article gives an overview of issues that emerged from the medical-ethical review processes of PSI. The criteria applied to biobanking projects by Ethical Review Boards were derived from the legally prescribed criteria for medical research. However, these criteria were interpreted in radically diverging ways. Key issues included the legal status of prospective research-dedicated biobanks, informed consent, monitoring of the use of biobanks, and alignment of biobanking policies both within and between research departments. The article calls on all actors involved in biobanking to continue to strive for the harmonization of biobanking policies. A certain degree of central coordination is crucial in order to improve on collaborative biobanking initiatives.