What can data trusts for health research learn from participatory governance in biobanks?

New models of data governance for health data are a focus of growing interest in an era of challenge to the social licence. In this article, we reflect on what the data trust model, which is founded on principles of participatory governance, can learn from experiences of involving and engagement of members of the public and participants in the governance of large-scale biobanks. We distinguish between upstream and ongoing governance models, showing how they require careful design and operation if they are to deliver on aspirations for deliberation and participation. Drawing on this learning, we identify a set of considerations important to future design for data trusts as they seek to ensure just, proportionate and fair governance. These considerations relate to the timing of involvement of participants, patterns of inclusion and exclusion, and responsiveness to stakeholder involvement and engagement. We emphasise that the evolution of governance models for data should be matched by a commitment to evaluation.

Beyond categorisation: refining the relationship between subjects and objects in health research regulation.

In this article, we argue that the relationship between 'subject' and 'object' is poorly understood in health research regulation (HRR), and that it is a fallacy to suppose that they can operate in separate, fixed silos. By seeking to perpetuate this fallacy, HRR risks, among other things, objectifying persons by paying insufficient attention to human subjectivity, and the experiences and interests related to being involved in research. We deploy the anthropological concept of liminality - concerned with processes of transformation and change over time - to emphasise the enduring connectedness between subject and object in these contexts. By these means, we posit that regulatory frameworks based on processual regulation can better recognise and encompass the fluidity and significance of these relationships, and so ground more securely the moral legitimacy and social licence for human health research.

Examining the power of the social imaginary through competing narratives of data ownership in health research.

This article explores the social imaginary in the context of data ownership and the (non-)delivery of the data sharing revolution in biomedicine. We contribute to this special issue on imaginaries by developing a method and paradigm of 'competing narratives'. Despite multiple initiatives to encourage health data sharing, and a strong 'open access' agenda, the data sharing revolution is not yet delivered. Ownership is persistently (though inconsistently) presented as a barrier to data sharing. However, existing literature does not reveal how far appeals to ownership are part of the problem. This paper reports original, interdisciplinary research asking: in health research, in what ways, if at all, do notions of ownership (broadly conceived) of health-related data impact on sharing practices? Doctrinal and empirical research methods are used to expose evidence of drivers behind appeals to ownership in health data sharing. The findings speak to how funders and data custodians can better tailor existing and potential data sharing initiatives to perspectives and behaviors. The concept of 'my data' is important: notions of reward, opportunity, control, and safeguarding establish legitimate, potentially competing 'ownership' interests in data. In particular, this research raises questions about the long-term effectiveness of an open access ideology that ignores these subtleties. In conclusion we find power in the social imaginary of ownership with respect to biomedical data; however, that power emerges and is enacted in unexpected ways by multiple actors within the ecosystem, often driven by competing narratives about what is at stake. Importantly, formal legal property-type appeals to ownership appear to have far less power in the narratives about data than the ethical and social concerns that underpin responsible biomedical research.

Public involvement in the governance of population-level biomedical research: unresolved questions and future directions.

Population-level biomedical research offers new opportunities to improve population health, but also raises new challenges to traditional systems of research governance and ethical oversight. Partly in response to these challenges, various models of public involvement in research are being introduced. Yet, the ways in which public involvement should meet governance challenges are not well understood. We conducted a qualitative study with 36 experts and stakeholders using the World Café method to identify key governance challenges and explore how public involvement can meet these challenges. This brief report discusses four cross-cutting themes from the study: the need to move beyond individual consent; issues in benefit and data sharing; the challenge of delineating and understanding publics; and the goal of clarifying justifications for public involvement. The report aims to provide a starting point for making sense of the relationship between public involvement and the governance of population-level biomedical research, showing connections, potential solutions and issues arising at their intersection. We suggest that, in population-level biomedical research, there is a pressing need for a shift away from conventional governance frameworks focused on the individual and towards a focus on collectives, as well as to foreground ethical issues around social justice and develop ways to address cultural diversity, value pluralism and competing stakeholder interests. There are many unresolved questions around how this shift could be realised, but these unresolved questions should form the basis for developing justificatory accounts and frameworks for suitable collective models of public involvement in population-level biomedical research governance.

Co-production and Managing Uncertainty in Health Research Regulation: A Delphi Study.

European and international regulation of human health research is typified by a morass of interconnecting laws, diverse and divergent ethical frameworks, and national and transnational standards. There is also a tendency for legislators to regulate in silos-that is, in discrete fields of scientific activity without due regard to the need to make new knowledge as generalisable as possible. There are myriad challenges for the stakeholders-researchers and regulators alike-who attempt to navigate these landscapes. This Delphi study was undertaken in order to provide the first interdisciplinary and crosscutting analysis of health research regulation, as it is experienced by such stakeholders in the UK context. As well as reinforcing existing understandings of the regulatory environment, Delphi participants called for greater collaboration, and even co-production, of processes involved in health research regulation. On the basis of this research, we offer insights about how health research regulation can become a matter with which a wider range of stakeholders-including researchers, regulators, publics and research sponsors-can engage. The evidence supports the normative claim that health research regulation should continue to move away from strict, prescriptive rules-based approaches, and towards flexible principle-based regimes that allow researchers, regulators and publics to co-produce regulatory systems serving core principles. By unpacking thorny concepts and practices at the heart of health research regulation-including the public interest and public engagement-our results have the potential to situate and breathe life into them. The results also demonstrate that while proportionality is well-recognised as a crucial element of flexible regulatory systems, more must be done to operationalise this as an ethical assessment of the values and risks at stake at multiple junctures in the research trajectory. This is required if we are to move beyond proportionality as a mere risk-management tool. Compliance culture no longer accurately reflects the needs and expectations of researchers or regulators, nor does it necessarily produce the best research. Embracing uncertainty-both as a human practice and a regulatory objective-may represent the brighter future for health research.

Charting Regulatory Stewardship in Health Research: Making the Invisible Visible.

This section focuses on the ethical, legal, social, and policy questions arising from research involving human and animal subjects.

Impact of the Directive 2011/24/EU in the United Kingdom National Legal System

Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients' rights in cross-border healthcare is aimed at ensuring patient mobility, establishing some rules for facilitating access to safe and high-quality healthcare and promoting cooperation on healthcare between Member States, whilst fully respecting their responsibilities in the organisation and delivery of such healthcare. In this report the impact of the aforementioned Directive in the United Kingdom National Legal System is analyzed

La Directiva 2011/24/UE del Parlamento Europeo y del Consejo, de 9 de marzo de 2011, relativa a la aplicación de los derechos de los pacientes en la asistencia sanitaria transfronteriza, tiene como objetivos garantizar la movilidad de los pacientes, establecer unas reglas para facilitar su acceso a una asistencia sanitaria segura y de alta calidad en la Unión Europea, y promover la cooperación en materia de asistencia sanitaria entre los Estados miembros, respetando plenamente las responsabilidades de éstos en la organización y prestación de dicha asistencia. En este informe se analiza el impacto de dicha Directiva en el sistema jurídico de Reino Unido