Nayha Sethi

Delivering proportionate governance in the era of eHealth: Making linkage and privacy work together.

This article advances a principled proportionate governance model (PPGM) that overcomes key impediments to using health records for research. Despite increasing initiatives for maximising benefits of data linkage, significant challenges remain, including a culture of caution around data sharing and linkage, failure to make use of flexibilities within the law and failure to incorporate intelligent iterative design. The article identifies key issues for consideration and posits a flexible and accessible governance model that provides a robust and efficient means of paying due regard to both privacy and the public interests in research. We argue that proportionate governance based on clear guiding principles accurately gauges risks associated with data uses and assigns safeguards accordingly. This requires a clear articulation of roles and responsibilities at all levels of decision-making and effective training for researchers and data custodians. Accordingly, the PPGM encourages and supports defensible judgements about data linkage in the public interest.

Towards Principles-Based Approaches to Governance of Health-related Research using Personal Data.

Technological advances in the quality, availability and linkage potential of health data for research make the need to develop robust and effective information governance mechanisms more pressing than ever before; they also lead us to question the utility of governance devices used hitherto such as consent and anonymisation. This article assesses and advocates a principles-based approach, contrasting this with traditional rule-based approaches, and proposes a model of principled proportionate governance. It is suggested that the approach not only serves as the basis for good governance in contemporary data linkage but also that it provides a platform to assess legal reforms such as the draft Data Protection Regulation.

On moving targets and magic bullets: Can the UK lead the way with responsible data linkage for health research?

Highlights • We explore key elements of good governance in health linkage.• Adaptive reflexive governance models are essential.• Two examples illustrate how we can achieve standardisation of practice.• Distinct elements of governance compiled in a composite fashion tend to challenges.

Data Safe Havens and Trust: Toward a Common Understanding of Trusted Research Platforms for Governing Secure and Ethical Health Research.

In parallel with the advances in big data-driven clinical research, the data safe haven concept has evolved over the last decade. It has led to the development of a framework to support the secure handling of health care information used for clinical research that balances compliance with legal and regulatory controls and ethical requirements while engaging with the public as a partner in its governance. We describe the evolution of 4 separately developed clinical research platforms into services throughout the United Kingdom-wide Farr Institute and their common deployment features in practice. The Farr Institute is a case study from which we propose a common definition of data safe havens as trusted platforms for clinical academic research. We use this common definition to discuss the challenges and dilemmas faced by the clinical academic research community, to help promote a consistent understanding of them and how they might best be handled in practice. We conclude by questioning whether the common definition represents a safe and trustworthy model for conducting clinical research that can stand the test of time and ongoing technical advances while paying heed to evolving public and professional concerns.

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.

Research during Global Health Emergencies: On the essential role of best practice

Abstract This article addresses an important, overlooked regulatory challenge during global health emergencies (GHEs). It provides novel insights into how, and why, best practice can support decision makers in interpreting and implementing key guidance on conducting research during GHEs. The ability to conduct research before, during and after such events is crucial. The recent West-African Ebola outbreaks and the Zika virus have highlighted considerable room for improvement in meeting the imperative to research and rapidly develop effective therapies. A means of effectively capturing these experiences and folding them into future decision-making is lacking; the need for effective practical translational measures remains. The challenge for the research community lies in extracting meaningful action-guiding content from pre-existing guidelines—which draw upon practical examples of guidelines ‘in action’—that assist in determining how to act in a particular (future) situation. Insights are provided into the role of best practice as a means to do so; such examples can provide invaluable support to decision makers in interpreting high-level guidance; overarching guidelines retain their necessary level of generality and flexibility, whilst corresponding best practice examples—which incorporate important lessons learned—illustrate how such guidelines can be interpreted at a practical level.

International academic conferences: Significance and legacy of the 13th World Congress of the International Association of Bioethics

In June 2016, the University of Edinburgh hosted the 13th World Congress (IAB2016) of the International Association of Bioethics (IAB). It is critical both to reflect on the event past and to consider how we might keep future events relevant and to adequately bridge the periods in-between. In other words, how do we generate and maintain legacy and help to keep communities consistently engaged over time? This brief article undertakes these functions by reflecting on some of the lessons learned from IAB2016 in the hope that it will prove useful to future IAB Congress organizers (and indeed other international conference organizers).