Nayha graduated with her LLB (Common and Civil Law with French) from Queens University Belfast in 2008, she then obtained her LLM in Law from the University of Edinburgh in 2009 and was awarded her PhD in 2016. She has taught on several courses including Fundamentals in Medical Jurisprudence and Health Research and Commercialisation.
The over-arching theme of Nayha's research is health research regulation. Since 2016, she has been working as a socio-legal Research Fellow on the Wellcome Trust funded project 'Confronting the Liminal Spaces of Health Research Regulation'. Her fellowship, entitled 'Regulating for Uncertainty' focuses on the relationships between treatment, research and experimentation. Nayha's interests lie primarily within bioethics and in particular, the interface between medicine, ethics and the law. She is particulary interested in interdisciplinary collaborations.
Nayha was appointed Deputy Director of the Mason Institute for Life Sciences, Medicine and the Law in 2012. She was Deputy Chair of the Organising Committee for the 13th World Congress of the International Association of Bioethics in 2016.
Nayha has previously worked as a Research Fellow on the information governance stream of SHIP (Scottish Health Informatics Programme) (2009-2012) under the direction of Professor Graeme Laurie. Her research focused on ethical legal and social issues of secondary uses of data for research purposes, particularly issues of consent, privacy, data protection, data linkage and on a broader level, information governance. Subsequently, she was a Research Fellow on the information governance stream of the Farr Institute (2012-2016), again this project involved exploring key governance issues around data reuse for research.
Fundamental Issues in Medical Jurisprudence (Honours) (Course Organiser)
Books and Reports
Agomoni Ganguli Mitra, Nayha Sethi, Conducting research in the context of global health emergencies: Identifying key ethical and governance issues, (Nuffield Council on Bioethics, 2016)
S. Davidson, C MCLEAN, Steven Treanor, Mhairi Aitken, Sarah Cunningham-Burley, Graeme Laurie, Claudia Pagliari, Nayha Sethi, Public Acceptability of Data Sharing Between the Public, Private and Third Sectors for Research Purposes, (Scottish Government, 2013)
Nayha Sethi, 'Research during Global Health Emergencies: On the essential role of best practice', (2018), Public Health Ethics
Abstract: This paper addresses an important yet overlooked regulatory challenge faced during Global Health Emergencies (GHEs). It provides important and novel insights into how, and why, best practice can provide much needed support to decision-makers in determining how to interpret and implement 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 the 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 and 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 can help them to determine how to act in a particular (future) situation. This paper provides novel insights into the role of best practice as a means to do so, and it is argued that the introduction of best practice examples can provide invaluable support to decision-makers in their interpretations of 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.
Graeme Laurie, Edward S. Dove, Isabel Fletcher, Agomoni Ganguli-Mitra, Catriona McMillan, Nayha Sethi, Annie Sorbie, 'Charting regulatory stewardship in health research: Making the invisible visible?', (2018), Cambridge quarterly of healthcare ethics, Vol 27, pp 333-347
Abstract: This article analyses a hitherto largely obscured feature of regulatory environments in health research, namely, the role of regulatory stewardship. Through examples drawn from research ethics committees, emerging technologies, and governance of research resources, it outlines the essential features of regulatory stewardship, and argues that this concept can demonstrate considerable added value for all parties in delivering and benefiting from efficient and effective navigation of regulatory landscapes. It offers an exposition of the normative principles and associated responsibilities of the concept. The extant invisibility of regulatory stewardship requires fuller recognition and better integration of the approach into the effective functioning of law and regulation in the health research context.
Nayha Sethi, Graeme Laurie, Shawn Harmon, 'International academic conferences: Significance and legacy of the 13th World Congress of the International Association of Bioethics', (2016), Medical Law International, Vol 16, pp 105-114
Abstract: 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).
Graeme Laurie, Nathan Lea, Nicholls Jacqueline, Christine Dobbs, Nayha Sethi, James Cunningham, John Ainsworth, Martin Heaven, Trevor Peacock, Anthony Peacock, Kerina Jones, Dipak Kalra, 'Data safe havens and trust: Toward a common understanding of trusted research platforms for governing secure and ethical health research', (2016), JMIR Medical Informatics, Vol 4, pp e22
Abstract: 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.
Nayha Sethi, 'Reimagining regulatory approaches: On the essential role of principles in health research', (2015), SCRIPTed, Vol 12, pp 91-116
Abstract: This article calls for a reimagining of regulatory approaches to health research. It is argued that an essential first step of such a reimagining involves the development of a deeper understanding of the diverse and indispensable roles which principles can play as regulatory decision-making aids. This topic merits attention given the fact that we perpetually rely upon principles without really considering what it is we are asking principles to do within the regulatory environment. In particular, this paper considers how principles can assist in addressing key challenges which new technologies pose to regulation, as well as the relationships that might exist between principles and rules in such instances. The discussion here takes place against the backdrop of the complex and evolving landscape of the governance of the reuse of data for health research. At the same time, the contributions in this article can be of real value tocontemporary challenges in a far wider array of governance contexts beyond thehealth setting.
Graeme Laurie, J. Ainsworth, J. Cunningham, Christine Dobbs, Kerina H. Jones, D. Kaira, N. C. Lea, Nayha Sethi, 'On Moving Targets and Magic Bullets: Can the UK Lead the Way with Responsible Data Linkage for Health Research?', (2015), International journal of medical informatics, Vol 84, pp 933-940
Abstract: Purpose: To provide an overview of essential elements of good governance of data linkage for health-related research, to consider lessons learned so far and to examine key factors currently impeding the delivery of good governance in this area. Given the considerable hurdles which must be overcome and the changing landscape of health research and data linkage, a principled, proportionate, risk-based approach to governance is advocated.Discussion: In light of the considerable value of data linkage to health and well-being, the United Kingdom aspires to design and deliver good governance in health-related research. A string of projects have been asking: what does good governance look like in data linkage for health research? It is argued here that considerable progress can and must be made in order to develop the UK’s contribution to future health and wealth economies, particularly in light of mis-start initiatives such as care.data in NHS England. Discussion centres around lessons learned from previous successful health research initiatives, identifying those governance mechanisms which are essential to achieving good governance.Conclusion: This article suggests that a crucial element in any step-increase of research capability will be the adoption of adaptive governance models. These must recognise a range of approaches to delivering safe and effective data linkage, while remaining responsive to public and research user expectations and needs as these shift and change with time and experience. The targets are multiple and constantly moving. There is not – nor should we seek – a single magic bullet in delivering good governance in health research.
Nayha Sethi, 'The Promotion of Data Sharing in Pharmacoepidemiology ', (2014), European Journal of Health Law, Vol 21, pp 271-96
Abstract: This article addresses the role of pharmacoepidemiology in patient safety and the crucial role of data sharing in ensuring that such activities occur. Against the backdrop of proposed reforms of European data protection legislation, it considers whether the current legislative landscape adequately facilitates this essential data sharing. It is argued that rather than maximising and promoting the benefits of such activities by facilitating data sharing, current and proposed legislative landscapes hamper these vital activities. The article posits that current and proposed data protection approaches to pharmacoepidemiology — and more broadly, re-uses of data — should be reoriented towards enabling these important safety enhancing activities. Two potential solutions are offered: 1) a dedicated working party on data reuse for health research and 2) the introduction of new, dedicated legislation.
Nayha Sethi, 'Exploiting Existing Data for Health Research: Conference Report', (2013), SCRIPTed, Vol 10, pp 478-479
Nayha Sethi, Graeme Laurie, 'Delivering Proportionate Governance in the Era of eHealth: Making Linkage and Privacy Work Together', (2013), Medical Law International, Vol 13, pp 168-204
Abstract: 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.
Graeme Laurie, Nayha Sethi, 'Towards Principles-Based Approaches to Governance of Health-Related Research Using Personal Data ', (2013), European Journal of Risk Regulation, Vol 2013, pp 43-57
Abstract: 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.
Nayha Sethi, Shawn Harmon, 'Preserving Life and Facilitating Death: What Role for Government after Haas v Switzerland?', (2011), European Journal of Health Law, Vol 18, pp 355-64
Graeme Laurie, Nayha Sethi, 'Information Governance of Use of Health-Related Data in Medical Research in Scotland: Towards a Good Governance Framework' 2012
Abstract: This paper is the second in a series addressing information governance challenges in health-related research involving patient data and it is set against the current legislative and common law landscape within the UK. In Working Paper No.1 we described the diverse actors, regulatory bodies and systems in place within the current framework, and critically examined their roles relative to the different ethical and legal issues at stake and the surrounding literature. In light of this analysis, we advanced a template for good governance: a series of questions relating to benchmarks and standards against which existing and emerging governance models can be assessed. We then evaluated the current governance landscape against these standards, highlighting key areas that required improvement, concluding with recommendations for change.This paper moves one step further and examines more closely what it means to talk of good governance in the health-related research arena. We draw upon our research as part of the SHIP initiative – a consortium working to build the Scottish Health Informatics Platform, funded by the Wellcome Trust and in partnership with NHS Scotland. We build on our academic findings and practical experience of working iteratively with key policy and practice stakeholders in the field to propose a new model of good governance in practice. In particular, we consider how guiding principles and best practice, in tandem with a good governance template, provide not only a good governance framework for SHIP but also an approach that is transformative of the ways in which health-related research is carried out and governed, both in Scotland and elsewhere.The elements of good governance that we advance are set in the context of health data for research. It is important to note, however, that the lessons that can be learned from our work – and the model that we proffer - are applicable to a much broader range of governance settings, such as local authority and other public/private instances of data sharing. Our model adopts an approach of proportionate governance and is unique in this regard. It goes far beyond existing approaches to information governance in the research context while fully respecting relevant ethical and legal norms.
Graeme Laurie, Nayha Sethi, 'Information Governance of Use of Health-Related Data in Medical Research in Scotland: Current Practices and Future Scenarios' 2011
Abstract: This paper has been prepared as part of the governance work stream of the Scottish Health Informatics Programme (SHIP). It is intended as a platform for discussion and further elaboration with colleagues and those interested in issues surrounding the governance of secondary uses of health data for research. The main aims of the paper are two-fold. First, to offer an ethical, legal and social account of the current regulatory framework governing the use of person identifiable information (PII) for medical research in Scotland. It does so by both mapping out the legislation and key actors involved in governance, as well as illustrating how the framework is perceived to work in practice.A second aim of the report is to suggest a template to be used in the assessment of good governance. This template can be used both to evaluate current practices and to test any proposals for change in approaches to governance in Scotland and elsewhere with respect to uses of patient data for research purposes. It is anticipated that this template will be developed and refined with input from SHIP colleagues (particularly those at Information and Statistics Division (ISD) of NHS Scotland and those involved in the SHIP Systematic Review) as well as other stakeholders. This is the first in a series of papers in the governance stream of the SHIP programme, funded by the Welcome Trust. Future papers will address the design challenges of a new system of information governance for health-related medical research in Scotland.