Liminal Spaces
Driving a whole system approach to health research regulation
Liminal Spaces was a six-year Wellcome-funded project at Edinburgh Law School, which ended in March 2021 and scrutinised regulatory systems that support human health research. The vision of the project was to reimagine human health research regulation to deliver the first-ever integrated, interdisciplinary and crosscutting analysis of health research regulation (HRR). The project sought to confront the gaps between documented law, relevant ethical and social theories and concepts, and research practice.
Key findings
- Adopting a whole system approach to health research regulation better promotes the ecosystem as a learning system driven by a commitment to generating social value.
- Lessons can be learned across different sectors of health research regulation about the value and importance of key regulatory tools such as proportionality and public interest and how their roles can be strengthened in the future.
- A processual approach to regulation can generate feedback loops (continuous cycles of learning) to improve learning and efficiency of health research regulation.
- Empirical research confirms the supportive and productive role of key actors in health research regulation – such as research ethics committees – who work closely with researchers to get research done. The value of regulatory stewardship is currently under-recognised and requires further investigation.
- Many stakeholders in the regulatory ecosystem support the co-production of regulation as a form of partnership. This can be promoted by further adopting of principles-based approach to regulation.
- The social value of the research enterprise is currently poorly captured and shared. Social value does not simply refer to scientific outcomes from research. A whole system approach should be oriented more clearly towards realising the full range of social value that human health research can generate.
- The role of best practice is health research regulation is currently under-represented in regulatory ecosystems. More can, and should, be done to make this a central feature of the regulatory landscape.
- The inherent uncertainty of human health research can be seen as an opportunity to improve the responsiveness of the regulatory environment, especially in promoting flexibility and co-production of regulatory responses.
- Trustworthiness of the health research ecosystem is of crucial importance to its success. More can be done by all stakeholders involved to demonstrate trustworthiness of their own actions – and of the system itself – especially in times of crisis and change.
- While engagement with publics and other stakeholders in now commonplace, much remains to be done to demonstrate how this best improves the regulatory environment. Appeals to the public interest can be strengthened and better justified if linked to robust engagement and learning from publics themselves.
The Liminal Spaces Project was based within Edinburgh Law School and involved an interdisciplinary team of researchers examining regulatory spaces across the entire spectrum of health research regulation.
Principal Investigator
Professor Graeme Laurie
Professorial Fellow and Founding Director, Mason Institute (2012-2017)
Research Team
Dr Edward Dove
Lecturer in Health Law and Regulation
Edward Dove began as a Wellcome doctoral candidate on the project as has since transitioned to a full-time lectureship in health law and regulation at Edinburgh Law School.
Dr Isabel Fletcher
Senior Research Fellow
Isabel Fletcher joined the project as a Senior Research Fellow and is currently Senior Research Fellow on the Shaping Interdisciplinary Practices in Europe (SHAPE-ID) project at the University of Edinburgh.
View Isabel Fletcher’s profile
Rhiannon Frowde
Research Fellow
Rhiannon Frowde was a research fellow on the project.
View Rhiannon Frowde's profile
Zahra Jaffer
Research Assistant
Zahra Jaffer was a research assistant on the project.
Dr Agomoni Ganguli Mitra
Lecturer and Chancellor's Fellow in Bioethics and Global Health Ethics
Agomoni Ganguli Mitra began Research Assistant on the project, and in 2017 secured a prestigious Chancellor’s Fellowship in legal and ethical aspects of biomedicine, which led to an offer of a full lectureship at Edinburgh Law School.
View Agomoni Ganguli Mitra’s profile
Ms Kate Harvey
Research Fellow
Kate Harvey joined the Liminal Spaces team in 2020 as a Research Fellow on secondment from the Nuffield Council on Bioethics.
Lynn Kennedy
Research Assistant
Lynn Kennedy was a third year PhD candidate in 2021, conducting research into Medical futility and experimental treatment at Edinburgh Law School. She prepared a briefing policy note for the projects on "How health research regulation can better support access to experimental treatment."
Dr Emily Postan
Senior Research and Teaching Fellow in Bioethics
Emily Postan joined the Liminal Spaces team as an Early Career Fellow in Bioethics, and in April 2021 will begin a prestigious Chancellor’s Fellowship at Edinburgh Law School.
Dr Catriona McMillan
Senior Research Fellow in Medical Law and Ethics
Catriona McMillan started working on the project as a Research Assistant while also studying for her PhD. She went on to hold both a Research Fellowship and Senior Research Fellowship on the project, and in 2020 she was awarded a British Academy Postdoctoral Fellowship for her research into ‘Femtech’ and how law and regulation should respond to health technologies targeted at improving women’s health and well-being.
View Catriona McMillan’s profile
Dr Nayha Sethi
Chancellor’s Fellow, Usher Institute
Nayha Sethi joined the Liminal Spaces project as a Research Fellow and subsequently secured a prestigious Chancellor’s Fellowship in data driven innovation at the Usher Institute, University of Edinburgh.
Ms Annie Sorbie
Lecturer in Law (Medical Law and Ethics)
Annie Sorbie began as a Wellcome doctoral candidate on the project and has since transitioned to a full-time lectureship in medical law and ethics at Edinburgh Law School.
Dr Samuel Taylor-Alexander
Senior Research Fellow
Samuel Taylor-Alexander joined the Liminal Spaces team as a Senior Research Fellow. He was an anthropologist and added vital input to the conceptual foundations of the project. He sadly passed away on 21 August 2019 in Auckland, New Zealand.
On the 40th anniversary of the inaugural of Professor JK Mason, delivered in the University of Edinburgh on 28th February 1974, Professor Graeme Laurie, Chair of Medical Jurisprudence, gave a lecture entitled “Confronting the Liminal Spaces of Health Research Regulation,” which introduced the Liminal Spaces project.
The Liminal Spaces Project ran from October 2014 to March 2021. This Wellcome Trust Senior Investigator Award in Medical Humanities, led by Prof Graeme Laurie, was the first project to consider health research regulation as an holistic enterprise by exploring the regulatory imaginary that influences and can come to influence biomedical research in the UK and Europe.
By revealing and embracing the limits of law, the research contributes to orienting regulation towards the identification and exploitation of flexibilities within liminal regulatory spaces in order to deliver the benefits of biomedicine more effectively and efficiently. The research proceeded in three overlapping phases:
Conceptual (Years 1-2)
Key publications:
- Laurie G. (2016). Liminality and the Limits of Law in Health Research Regulation: What are we Missing in the Spaces in-Between?. Medical Law Review, 25(1), pp. 47-72. View article
- Taylor-Alexander S, Dove ES, Fletcher I, Ganguli Mitra A, McMillan C, Laurie G. (2016). Beyond regulatory compression: confronting the liminal spaces of health research regulation. Law, Innovation and Technology, 8(2), pp. 149-176. View article
- Ganguli Mitra A, Dove ES, Laurie G, Taylor-Alexander S. (2017). Reconfiguring Social Value in Health Research Through the Lens of Liminality. Bioethics, 31(2), pp. 87-96. View article
Empirical (Years 2-4)
Key publications:
- Dove Edward S. (2020). Regulatory Stewardship of Health Research: Navigating Participant Protection and Research Promotion. United Kingdom: Edward Elgar Publishing Ltd. View book
- Fletcher I, Birko S, Dove ES, Laurie GT, McMillan C, Postan E, Sethi, N and Sorbie A. (2020). Co-production and Managing Uncertainty in Health Research Regulation: A Delphi Study. Health Care Analysis: HCA: Journal of Health Philosophy and Policy, 28(2), pp. 99-120. View article
Normative (Years 3-6)
Key publications:
- Laurie, G., Dove, E., Ganguli-Mitra, A., Fletcher, I., McMillan, C., Sethi, N., & Sorbie, A. (2018). Charting Regulatory Stewardship in Health Research: Making the Invisible Visible. Cambridge Quarterly of Healthcare Ethics, 27(2), 333-347. View article
- McMillan, C. (2021). The Human Embryo In Vitro: Breaking the Legal Stalemate. United Kingdom: Cambridge University Press. View book
- Laurie, G., Dove, E., Ganguli-Mitra, A., McMillan, C., Postan, E., Sethi, N., & Sorbie, A. (Eds.). (2021). The Cambridge Handbook of Health Research Regulation (Cambridge Law Handbooks). Cambridge: Cambridge University Press. View book
Research questions
Throughout the project, we considered three questions:
- What insights are revealed when compartmentalisation in health research regulation is dissolved and regulatory space re-conceived as a unitary entity?
- What policy and practice implications flow across areas of health research when we better understand the liminal spaces of regulation?
- What are the benefits for health research of reframing regulation and risk as ethical and co-produced practice, rather than instrumental, techno-rational compliance?
Key findings
- Adopting a whole system approach to health research regulation better promotes the ecosystem as a learning system driven by a commitment to generating social value.
- Lessons can be learned across different sectors of health research regulation about the value and importance of key regulatory tools such as proportionality and public interest and how their roles can be strengthened in the future.
- A processual approach to regulation can generate feedback loops (continuous cycles of learning) to improve learning and efficiency of health research regulation.
- Empirical research confirms the supportive and productive role of key actors in health research regulation – such as research ethics committees – who work closely with researchers to get research done. The value of regulatory stewardship is currently under-recognised and requires further investigation.
- Many stakeholders in the regulatory ecosystem support the co-production of regulation as a form of partnership. This can be promoted by further adopting of principles-based approach to regulation.
- The social value of the research enterprise is currently poorly captured and shared. Social value does not simply refer to scientific outcomes from research. A whole system approach should be oriented more clearly towards realising the full range of social value that human health research can generate.
- The role of best practice is health research regulation is currently under-represented in regulatory ecosystems. More can, and should, be done to make this a central feature of the regulatory landscape.
- The inherent uncertainty of human health research can be seen as an opportunity to improve the responsiveness of the regulatory environment, especially in promoting flexibility and co-production of regulatory responses.
- Trustworthiness of the health research ecosystem is of crucial importance to its success. More can be done by all stakeholders involved to demonstrate trustworthiness of their own actions – and of the system itself – especially in times of crisis and change.
- While engagement with publics and other stakeholders in now commonplace, much remains to be done to demonstrate how this best improves the regulatory environment. Appeals to the public interest can be strengthened and better justified if linked to robust engagement and learning from publics themselves.
The Liminal Spaces team were involved in over 120 engagement activities and produced over 30 policy and practice contributions during the lifecycle of the project. The following examples are some highlights of the work and evidence of the extensive network that was established as a result of this funded research.
Commissioned research
Does data ownership hinder biomedical research?
Liminal Spaces team members Graeme Laurie and Annie Sorbie were commissioned together with Dr Wifak Gueddana (King’s College, London) and Professor David Townend (Maastricht University) by the Wellcome Expert Advisory Group on Data Access (EAGDA) to explore the important question of whether appeals to data ownership hinder biomedical research. The research involved engagement with stakeholders and the findings are reported in an article and as a policy brief.
Conducting research in the context of global health emergencies: identifying key ethical and governance issues
Agomoni Ganguli-Mitra and Nayha Sethi wrote a background paper for the Nuffield Council on Bioethics, which provided an overview of key ethical and governance challenges associated with conducting research and innovation in the context of global health. This fed into the Council’s report on the topic and greatly informed the work of its Working Group.
Read the Nuffield Council's report
Task Team on Privacy and Security for the Global Alliance for Genomics and Health
Graeme Laurie was Chair of this Task Team, with Edward Dove as the Secretary and they led the team to deliver successfully the Privacy and Security policy for this global alliance of over 200 members worldwide committed to international data sharing for human health research.
View the Privacy and Security Policy
Legal Input on a European Ethical Code on Data Donation
Annie Sorbie provided legal input to the Data Donation Project in Oxford, grounding the non-legal perspectives within the realities of law. The project brought diverse disciplines together to examine the theoretical idea of data donation, leading to publications and an ethical code.
Delphi policy study on experiences on stakeholders involved in health research and its regulation
Funds from the Liminal Spaces project were leveraged to commission Dr Stanislav Birko of McGill University, Canada to work with the team to conduct a three-round Delphi policy exercise with researchers and regulators involved in human health research. This was a major objective of the project and generated multiple insights into the lived experience of working with and in a regulatory environment.
Policy-related contributions
Scottish Government: Guthrie Cards collection and its use for research
Graeme Laurie and Edward Dove worked closely with colleagues in the Scottish Government to update their previously-commissioned report on the Scottish Guthrie card collection and to engage with stakeholders on its findings and the need for wider public engagement.
Advisor on public interest to Wellcome
Annie Sorbie acted in an advisory capacity to policy colleagues within Wellcome at a time when the Trust was lobbying over the content of the law designed to give effect to the General Data Protection Regulation (GDPR). In particular, she drew on her research on the role and value of public interest to support the Trust in its arguments for more support for human health research using personal data under the GDPR.
Networking in Latin America on the regulation of biomedicine
The Liminal Spaces project facilitated continued working with Dr Fabiana Arzuaga from the University of Buenos Aires and Chair of the Argentinian Stem Cell Commission. As examples, she was supported to attend the 13th World Congress of the International Association of Bioethics, hosted by the Liminal Spaces team in 2016. In the same year, Graeme Laurie travelled to Argentina to take part in events on the regulation of advanced therapies, and Arzuaga also participated in events in Scotland and Latin America on the regulation of reproductive rights.
Elected member of the Royal Society of Edinburgh Young Academy of Scotland
Agomoni Ganguli-Mitra was elected to the RSE Young Academy of Scotland, which is a highly prestigious institution designed to identify and nurture rising stars in academia. Her role is to provide robust bioethical input to the work of the Academy.
More about the RSE Young Academy of Scotland
Convenor of the Law Society of Scotland's Health and Medical Law Sub-Committee
While working as a Senior Research Fellow on the Liminal Spaces project, Catriona McMillan was appointed Convenor of the Law Society of Scotland's Health and Medical Law Sub-Committee.
Miscellaneous
Other policy-relevant activities included:
- Submission of various consultation responses on matters pertaining to health research regulation, including input to the Health Research Authority (HRA) review of its Framework.
- Advice to NHS Scotland Central Legal Office on its exceptional cases policy.
- Appointments on advisory panels such as Graeme Laurie’s membership of The HRA National Research & Ethics Advisors’ Panel (NREAP) and International Council of Reference for Health Data Research UK, and and Annie Sorbie’s appointment as lay advisor to the Royal College of Surgeons of Edinburgh and its Patient Safety Committee.
13th World Congress of Bioethics
The 13th World Congress of Bioethics (IAB 2016) was held on 14-17 June 2016 in Edinburgh. IAB 2016 was organised by staff from Edinburgh Law School's Mason Institute and the Liminal Spaces Project and brought together global thought-leaders in the field. It explored ‘Individuals, Public Interests, and Public Goods: What Is the Contribution of Bioethics?’, and welcomed over 700 delegates from 44 countries and offered a leading edge academic programme, development for early career researchers, and an Arts + Ethics strand.
Geographical reach
Although the principal geographic focus of the Liminal Spaces project was the UK and Europe, multiple opportunities for wider contribution across the globe arose during the programme of work. Three notable examples are:
Human Cell Atlas Consortium
Edward Dove was consultant on data protection law for the Human Cell Atlas Project consortium. This international research consortia sought to understanding the impact of European data protection law on their research activities. Along with colleagues, Dove led a research project that looked at the public interest as a legal basis for processing genetic data under the GDPR.
View more about the Human Cell Atlas Project
Developing a Big Data Ethics Framework
Graeme Laurie was Co-Chair of an international Working Group charged with developing a decision-making tool in the form of a Big Data Ethics Framework. This was delivered in 2019. This programme of work was led out of the National University of Singapore and involved an iterative process of contributions from diverse disciplines, and multiple engagement opportunities with stakeholders in practice to refine the Framework.
Regulation of Reproductive Rights in Latin America
Graeme Laurie was supported by funds from the Global Innovation Fund in the University of Edinburgh to pursue collaborations with colleagues in Latin America, looking at improving the regulation of reproductive rights in the region. Professor Laurie's contribution was a comparative perspective on diverse abortion laws around the globe. In particular, colleagues in Chile were facing law reform in their country where access to abortion would be completely outlawed. The collaboration led to a Spanish language publication of an edited collection involving contributions from law, bioethics, medicine, public policy, and political theory.
Liminal Spaces Podcast
A podcast series based on conversations with members of the Liminal Spaces project, each talking about their own research and how it contributed to the overarching objectives of the project.
Listen to the full series on Mediahopper
Episode 1: Public Interest in Human Health Research
Episode 2: Research Ethics Committees as Regulators
Episode 3: Best Practice in Health Research Regulation
Episode 4: Trustworthiness
Episode 5: Identity and Bioinformation
Episode 6: Regulating the Embryo
Episode 7: Regulation as Play
Just Emergencies: A Global Health Justice Podcast
Global Health Emergencies (GHEs) are crises that affect health, and that are, or should be, of international concern. These might include infectious outbreaks, humanitarian crises and disasters, conflicts, and forced displacements. GHEs are characterised by various forms of urgency and uncertainty, and are known to exacerbate existing inequalities, injustices and vulnerabilities in individuals and communities. This podcast delves into what we mean by ‘Global Health Emergencies’, why they matter, and why we care about justice in global health emergencies.
Visit the Just Emergencies Podcast channel on the project website
Our vision of the future of health research regulation: a whole system approach
Our work has led us to conclude that regulatory systems are best described as a trajectory that ranges from an initial research idea about improving human health and wellbeing, right through to delivery of that idea to patients. However, there is a failure to consider this trajectory as a whole system in terms of how regulation currently functions. Instead, health research regulatory systems operate in fragmented siloes, which can hold them hostage to unnecessary duplication of regulatory requirements and to challenges in navigating the gaps between different and complex regulatory areas.
To better represent the realities of health research and to further build on incremental improvements that have been ongoing for decades, there must be a shift away from this fragmented approach to more joined-up, reflective, and responsive systems of health research regulation.
We are not suggesting that the current regulatory systems have not made advances over the years. They have. But, equally, there are good reasons to believe that more work can be done to support the systems to operate optimally, both to protect research participants and to promote health research and the considerable social value it can deliver.
Our vision of the future of health research is informed by our own research but also our work with others. This includes a policy study we carried out with stakeholders – including regulators and researchers – working in the UK health research system. This study supports our vision that the system should continue to move away from strict, rules-based approaches, towards flexible regimes that promote the social value of research and which embody more examples of co-produced regulatory approaches and best practices.
A key part of realising a more flexible regime is to break out of the siloes that can operate in health research systems. Instead, for regulatory systems to support health research endeavours optimally in the future, they need to take a whole system approach. By ‘whole system approach’, we mean a regulatory system that captures the breadth and complexity of health research and the human values at stake across its lifespan. Indeed, a failure to address underlying public values and concerns in health research can result in research stalling because a social licence has not been attained or public trust is undermined. In short, it stalls, or even fails, because the system does not place people at the centre of its endeavours.
Read our full End of Project Vision Statement
Policy futures for the health research system
To bring together the significant academic outputs that we have developed over the last six years, we have published a series of policy documents. We also recognised that some of the concepts that we use frequently could benefit from some simple explanations. These explanations take the form of concept notes. These notes capture the concepts that we feel will be important for future debates on how health research systems should work.
How should the proposed Advanced Research and Invention Agency (ARIA) be regulated?
We recommend:
- ARIA and its stakeholders should collaborate to set guiding principles for its programmes of research.
- ARIA and its stakeholders shold consider what social value comes from their research at the initial proposal stage and throughout the lifecycle of the research.
- ARIA should meaningfully engage with the public by openly, accessibly and meaningfully interacting on all key aspects of the work that ARIA will undertake.
How can health research regulation better support access to experimental or innovative medical treatment?
We recommend:
- The establishment of a database for innovative treatments requires clear lawful authority and social licence for its operation.
- A model of regulatory stewardship under the auspices of a relevant regulatory agency could form the basis of guiding action for healthcare professionals and patients to navigate the complexities of providing experimental treatments safely and in a timely fashion.
- Policymakers and regulatory agencies should adopt a whole systems approach to experimental treatment.
- Those involved in research and the provision of experimental treatment should identify, publish and share all lessons learned, both positive and negative.
View Experimental Treatment policy brief
How the system can improve its responsiveness in times of crisis and change
We recommend:
- That research regulatory systems should aspire to learn lessons from uncertainties that occur throughout research. In the brief, we propose several action points for how this could be achieved.
- Health research regulators should work together, and with researchers, to explore how more flexible research governance systems can be developed.
- Regulators, researchers, and other stakeholders should be given opportunities to regularly review guiding principles of health research.
- Further support should be offered to researchers who face uncertainties in navigating regulatory requirements through the role of regulatory stewards.
- Regulators and funders should take the lead in promoting active collaboration between researchers and practitioners working across innovation, treatment, and research.
How the health research environment can better demonstrate how it is trustworthy across the whole system
We recommend:
- Researchers working across health research systems must constantly ask themselves if they are operating in a trustworthy way. Our brief suggests a range of mechanisms for how this might be achieved.
- When researchers reflect on their trustworthiness, their observations should be shared openly so that health research systems can learn about, and better understand, what trustworthy research scenarios ‘look like’.
- Regulators and funders should work together to establish how researchers can be supported to demonstrate their trustworthiness throughout their research, but particularly when trust is found to be in jeopardy.
- Regulators should consider how they could create ‘safe spaces’ for researchers to report errors and mistakes that undermine trust.
How social value can be better monitored and delivered across the whole system
We recommend:
- At each stage of the research trajectory, researchers, regulators, and others involved in carrying out research should ask, ‘is this research study on course to contribute social value?’
- The assessments of social value that arise out of answering this question should be routinely published, shared, and offered as learning experiences for others.
- If these assessments suggest social value is not, or unlikely to be, realised, regulators should step in to guide researchers through how they can re-establish the project’s social value.
- Noting that social value is not only generated by ‘positive’ research, researchers should therefore consider supporting research that aims to prove negatives.
View Social Value policy brief
How the system can take a fresh approach to proportionality in health research
We recommend:
- Researchers should be encouraged to consider using proportionality to navigate ethical issues throughout the course of their research as part of a whole system approach.
- Support should be available to researchers on how proportionality can be used to navigate such issues. There are several possible sources of such support, which we highlight in the brief.
View Proportionality policy brief
How we can better understand appeals to data ownership in biomedicine
We recommend:
- Funders should put in place appropriate resources in recognition of the fact that the creation of metadata and management of shared data costs time and effort.
- Funders can take the lead in generating the infrastructures needed for data sharing.
- The effort of data creation and analysis merits recognition for those expend the effort.
- Researchers should be given an appropriate time to generate original dissemination of their work.
- The ‘open access’ agenda requires careful rethinking to accommodate a range of stakeholder expectations and attitudes.
- Funders can play a greater role in ensuring fuller accountability in data sharing agreements.
Publications
The Liminal Spaces project produced over 90 publications, all of which appear in open access format and can be found below. As well as addressing and answering the top-level research questions that drove the project (see 'History of the project' above), the project stayed at the forefront of developments in biomedicine and research as these happened throughout the programme of work.
Thus, readers will find publications on public health emergencies (see 'Research and Global Health Emergencies: On the Essential Role of Best Practice' and 'Conducting research in the context of global health emergencies: identifying key ethical and governance issues'), COVID-19 (see 'Fail to Prepare and you Prepare to Fail: the Human Rights Consequences of the UK Government’s Inaction during the COVID-19 Pandemic'), the advent of Big Data (see 'What Role for Law, Human Rights, and Bioethics in an Age of Big Data, Consortia Science, and Consortia Ethics? The Importance of Trustworthiness' and 'An Ethics Framework for Big Data in Health and Research'), the implications of neurotechnologies for persons' identities (see 'Narrative Devices: Neurotechnologies, Information, and Self-Constitution'), and Brexit and its implications for health research regulation (see 'How do we make sense of chaos? Navigating health research regulation through the liminality of the Brexit process').
The project resulted in three monographs, two of which were published by colleagues who undertook and completed their doctoral work as part of the project:
A major output of the project is the Cambridge Handbook on Health Research Regulation (2021), now available as Open Access on Cambridge Core. This volume brings together contributions from experts across the globe to provide the first ever interdisciplinary handbook in the field. This resource offers wide-ranging analysis of health research regulation.
The chapters confront gaps between documented law and research in practice, and draw on legal, ethical and social theories about what counts as robust research regulation to make recommendations for future directions.
The Handbook provides an account and analysis of current regulatory tools - such as consent to participation in research and the anonymization of data to protection participants' privacy - as well as commentary on the roles of the actors and stakeholders who are involved in human health research and its regulation.
Drawing on a range of international examples of research using patient data, tissue and other human materials, the collective contribution of the volume is to explore current challenges in delivering good medical research for the public good and to provide insights on how to design better regulatory approaches.
A vaccine is here! How can the law promote the effective deployment and use of a COVID-19 vaccine to alleviate the current public health crisis? (Rhiannon Frowde, 8 December 2020)
The COVID-19 pandemic: are law and human rights also prey to the virus? (Graeme Laurie, 17 March 2020)
Social Norms and Health: is a cross-disciplinary vision possible? (Isabel Fletcher and Agomoni Ganguli Mitra, 1 February 2019)
Protecting and promoting: Can regulatory stewardship lead the way in health research? A roundtable discussion (Edward Dove, 10 May 2019)
Mason Institute advises Scottish government on organ donation policy (Emily Postan and Annie Sorbie, 28 November 2018)
Regulation as Play: Sandboxes as the new regulatory space in health research? (Graeme Laurie, 12 October 2018)
Ethics and liminality in humanitarian innovation (Matthew Hunt, 4 June 2018)
Should We All Give Up Meat to Save the Planet? (Isabel Fletcher, 27 April 2018)
Fractionis Panis (Emma Barnard, 6 February 2018)
The UK Policy Framework for Health and Social Care Research: politics, principles and proportionality (Edward Dove, 9 November 2017)
Revisiting Robust Regulation (Annie Sorbie, 20 June 2017)
Scotland’s Turn Towards ‘Realistic Medicine’: What’s in a Name? (Edward Dove, 30 March 2017)
Research in the context of global health emergencies: writing a background paper for the Nuffield Council on Bioethics (Agomoni Ganguli Mitra and Nayha Sethi, 2 March 2017)
Why a Sugar Tax? What Can the UK Learn From Mexico? (Isabel Fletcher, 14 February 2017)
Recent Reports Highlight Key Issues in Regulating Elderly Care (Catriona McMillan and Nayha Sethi, 1 December 2016)
Trust, Consent and Opt-outs in the Re-use of Health Data: Where Next? (Graeme Laurie, 16 August 2016)
The Embryo-shaped Elephant in the Room (Catriona McMillan, 13 May 2016)
Zika, Gandhi and the CDC (Agomoni Ganguli Mitra, 15 February 2016)
Debating the Nation: Biomedical Nationalism and Pharmaceutical Citizenship at Westminster Hall (Samuel Taylor-Alexander, 12 August 2015)
Consent to medical treatment: Scotland hammers home the final nail in the coffin of Bolam (Graeme Laurie, 2 June 2015)
The bioethics of transnational commercial pregnancy: reflections on the J Kenyon Mason Annual Lecture with Prof Francoise Baylis (Agomoni Ganguli Mitra, 20 March 2015)
Elberte v. Latvia: a curious case of tissue, relatives and the ‘right to private life’ (Edward Dove, 4 February 2015)
Revisiting Reciprocity in Health Research (Agomoni Ganguli Mitra, 12 December 2014
Confronting the Liminal Spaces of Human Health Research (Graeme Laurie, 15 October 2014)
‘Protecting and promoting: Can regulatory stewardship lead the way in health research?’ (March 2019)
This symposium was used to test research findings from the project, notably about the normative value of a role for regulatory stewardship (as conceived by the project team). A range of stakeholders were brought together from the health research regulatory environment to explore the concept and share experience of whether this function already happened and/or would be welcome. The consensus was that there is a degree of support for this being made more formally a part of regulation.
Regulating for Uncertainty (February 2018)
This symposium is a good example of engagement towards co-production of a refined research agenda. The overarching theme was how to regulate (better) for uncertainty, and through engagement with regulators and regulatees the research focus of the project was refined while the audience was supported to re-orient its own understandings of the precise nature of the 'research problem' in health research regulation.
Governing Health Research from Within: Empowering the Actors Who Occupy Regulatory Spaces (January 2017)
This event was a part of a series of workshops aimed at engaging with diverse issues and audiences within the health research regulation content. This particular workshop was aimed at regulators and those being regulated, to test research findings and deepen the research base.
What Does it Mean to Regulate in the Public Interest? (June 2016)
This was a Wellcome-sponsored symposium held at the 13th World Congress of the International Association of Bioethics (IAB2016), and curated by the Liminal Spaces Project.
Liminality, Biomedicine, and the Law (June 2015)
A symposium that explored how biomedicine and the life sciences continue to rearrange the relationship between culture and biology, problematising what it means to be a person, and introducing uncertainty and instability to individual and public life.
2022
Postan E. (2022). Embodied Narratives: Protecting Identity Interests through Ethical Governance of Bioinformation. United Kingdom: Cambridge University Press. View book
2021
Dove E. (2021). The EU General Data Protection Regulation: Implications for International Scientific Research in the Digital Era. Journal of Law, Medicine & Ethics, (4). View article
Dove E. (2021). Research Ethics Review. In Laurie G, Dove E, Ganguli Mitra A, McMillan C, Postan E, Sethi N, Sorbie A. (Ed.), The Cambridge Handbook of Health Research Regulation Cambridge: Cambridge University Press. View chapter
Ganguli Mitra A, Hunt M. (2021). Humanitarian Research. In Laurie G, Dove E, Ganguli Mitra A, McMillan C, Postan E, Sethi N, Sorbie A. (Ed.), The Cambridge Handbook of Health Research Regulation Cambridge: Cambridge University Press. View chapter
Harvey K, Laurie G. (2021). Concept Note: Public Interest. View note
Harvey K, Laurie G. (2021). Concept Note: Social Licence. View note
Harvey K, Laurie G. (2021). Concept Note: Processual Regulation. View note
Harvey K, Laurie G. (2021). Concept Note: Regulatory Stewardship. View note
Harvey K, Laurie G. (2021). How Can the Health Research Regulatory System Strengthen Its Trustworthiness? View brief
Harvey K, Laurie G. (2021). Proportionality in Health Research: Proposals for a Fresh Approach. View brief
Harvey K, Laurie G. (2021). End of Project Vision Statement: Driving a Whole System Approach to Health Research Regulation. View brief
Harvey K, Laurie G. (2021). The Challenge of Uncertainty in Health Research: How Can the Regulatory System Remain Fit for Purpose? View brief
Harvey K, Laurie G. (2021). Realising Social Value as an Objective for Health Research Regulation. View brief
Harvey K. (None/Unknown). Supporting the Trustworthiness of Health Research: A Novel Framework for Proxies of Trust.
Laurie G. (2021). What Could a Learning Health Research Regulation System Look Like?. In Laurie, G, Dove E, Ganguli Mitra A, McMillan C, Postan E, Sethi N, Sorbie A. (Ed.), The Cambridge Handbook of Health Research Regulation Cambridge: Cambridge University Press. View chapter
Laurie G. (2021). Towards a Learning Health Research Regulation System. In Laurie, G, Dove E, Ganguli Mitra A, McMillan C, Postan E, Sethi N, Sorbie A. (Ed.), The Cambridge Handbook of Health Research Regulation Cambridge: Cambridge University Press. View chapter
Laurie, G, Dove E, Ganguli Mitra A, McMillan C, Postan E, Sethi N, Sorbie A. (Ed.), (2021). The Cambridge Handbook of Health Research Regulation. (1st edition). Cambridge: Cambridge University Press. View book
McMillan C, Dove ES, Laurie G, Postan E, Sethi N, Sorbie A. (2021). Beyond Categorisation: Refining the Relationship Between Subjects and Objects in Health Research Regulation. Law, Innovation and Technology, 13. View article
McMillan C. (2021). When is Human? Rethinking the 14-day Rule. In Laurie, G, Dove E, Ganguli Mitra A, McMillan C, Postan E, Sethi N, Sorbie A. (Ed.), The Cambridge Handbook of Health Research Regulation Cambridge: Cambridge University Press. View chapter
McMillan. (2021). The Human Embryo In Vitro: Breaking the Legal Stalemate. United Kingdom: Cambridge University Press. View book
Milne R, Sorbie A, Dixon Woods M. (2021). What Can Data Trusts for Health Research Learn from Participatory Governance in Biobanks?. Journal of Medical Ethics. View article
Postan E. (2021). Changing Identities in Disclosure of Research. In Laurie, G, Dove E, Ganguli Mitra A, McMillan C, Postan E, Sethi N, Sorbie A. (Ed.), The Cambridge Handbook of Health Research Regulation Cambridge: Cambridge University Press. View chapter
Sethi N. (2021). Rules, Principles and Best Practice. In Laurie, G, Dove E, Ganguli Mitra A, McMillan C, Postan E, Sethi N, Sorbie A. (Ed.), The Cambridge Handbook of Health Research Regulation Cambridge: Cambridge University Press. View chapter
Sorbie A, Gueddana W, Laurie G, Townend D. (2021). Examining the power of the social imaginary through competing narratives of data ownership in health research. Journal of Law and the Biosciences. View article
Sorbie A. (2021). Concepts: The Public Interest. In Laurie, G, Dove E, Ganguli Mitra A, McMillan C, Postan E, Sethi N, Sorbie A. (Ed.), The Cambridge Handbook of Health Research Regulation Cambridge: Cambridge University Press. View chapter
2020
Dove, E., Chen J. (2020). Should consent for data processing be privileged in health research? A comparative legal analysis. International Data Privacy Law, (2). View article
Dove Edward S. (2020). Regulatory Stewardship of Health Research: Navigating Participant Protection and Research Promotion. United Kingdom: Edward Elgar Publishing Ltd. View book
Dove ES, Chen J. (2020). To What Extent Does the EU General Data Protection Regulation (GDPR) Apply to Citizen Scientist-led Health Research with Mobile Devices?. Journal of Law, Medicine and Ethics. View article
Fletcher I, Birko S, Dove ES, Laurie GT, McMillan C, Postan E, ... Sorbie A. (2020). Co-production and Managing Uncertainty in Health Research Regulation: A Delphi Study. Health care analysis : HCA : journal of health philosophy and policy, 28(2), pp. 99-120. View article
Frowde R, Dove ES, Laurie GT. (2020). Fail to Prepare and you Prepare to Fail: the Human Rights Consequences of the UK Government's Inaction during the COVID-19 Pandemic. Asian bioethics review, pp. 1-22. View article
Frowde R. (2020). A vaccine is here! How can the law promote the effective deployment and use of a COVID-19 vaccine to alleviate the current public health crisis?.
Laurie G, Coleman C. (2020). Biobanks. In Orentlicher D, Hervey T. (Ed.), The Oxford Handbook of Comparative Health Law Oxford University Press. View chapter
Laurie, G. (2020). COVID-19: UK Government inaction raises serious human rights concerns.
McMillan C, Dove ES, Laurie G, Postan E, Sethi N, Sorbie A. (2020). Beyond Categorisation: Refining the Relationship Between Subjects and Objects in Health Research Regulation. Edinburgh: School of Law, University of Edinburgh. View article
McMillan C, Sobolewska V. (2020). DNACPRs and advance care planning in the COVID19 pandemic: key lessons. Journal of Medical Ethics. View blog
McMillan C. (2020). ABC V. St George's Healthcare Trust And Ors: A New Duty Of Care?. Edinburgh Law Review, 24(3), pp. 394-399. View article
Postan E. (2020). Narrative Devices: Neurotechnologies, Information, and Self-Constitution. Neuroethics. View article
Postan E. (None/Unknown). Defining Ourselves: Narrative Identity and Access to Personal Biological Information. Cambridge: Cambridge University Press.
Sorbie A, Gueddana W, Laurie G, Townend D. (2020). Does data ownership hinder biomedical research?.
Sorbie A. (2020). Sharing confidential health data for research purposes in the UK: where are 'publics' in the public interest?. Evidence & Policy: A Journal of Research, Debate and Practice, (2). View chapter
2019
Dove ES, Chico V, Fay M, Laurie G, Lucassen AM, Postan E. (2019). Familial genetic risks: how can we better navigate patient confidentiality and appropriate risk disclosure to relatives?. Journal of medical ethics, 45(8), pp. 504-507. View article
Ganguli Mitra A, Postan E. (2019). Greater Glasgow Health Board v Doogan & Another [2014] UKSC 68. In Cowan S, Kennedy C, Munro VE. (Ed.), Scottish Feminist Judgments (Re)Creating Law from the Outside In Hart Publishing. View chapter
Laurie GT. (2019). Cross-Sectoral Big Data: The Application of an Ethics Framework for Big Data in Health and Research. Asian bioethics review, 11(3), pp. 327-339. View article
Laurie, G, Dove ES, Ganguli Mitra A, Fletcher I, McMillan C, Sethi N, ... Sorbie A. (2019). Charting Regulatory Stewardship in Health Research: Making the Invisible Visible. Cambridge Quarterly of Healthcare Ethics, 27(2), pp. 333-347. View article
Mascalzoni D, Bentzen HB, Budin-Ljøsne I, Bygrave LA, Bell J, Dove ES, ... Kaye J. (2019). Are Requirements to Deposit Data in Research Repositories Compatible With the European Union's General Data Protection Regulation?. Annals of internal medicine, 170(5), pp. 332-334. View article
Nicol D, Eckstein L, Bentzen HB, Borry P, Burgess M, Burke W, ... de Vries J. (2019). Consent insufficient for data release. Science (New York, N.Y.), 364(6439), pp. 445-446. View article
Sethi N. (2019). Regulating for uncertainty: bridging blurred boundaries in medical innovation, research and treatment. Law, innovation and technology, 11(1), pp. 112-133. View article
Sorbie A. (2019). Medical data donation, consent and the public interest after death: A gateway to posthumous data use. In Krutzinna J, Floridi L. (Ed.), The Ethics Of Medical Data Donation (pp. 115-130). Springer.
Staunton C, Adams R, Botes M, Dove ES, Horn L, Labuschaigne M, ... De Vries J. (2019). Safeguarding the future of genomic research in South Africa: Broad consent and the Protection of Personal Information Act No. 4 of 2013. South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde, 109(7), pp. 468-470. View article
Xafis V, Schaefer G, Labude M, Brassington I, Ballantyne A, Lim H, ... Tai E. (2019). An Ethics Framework for Big Data in Health and Research. Asian Bioethics Review, (3). View article
Dove E. (2019). The EU General Data Protection Regulation: Implications for International Scientific Research in the Digital Era. The Journal of Law, Medicine & Ethics, (4). View article
2018
Dove Edward Stellwagen. (2018). Liminality of NHS research ethics committees : navigating participant protection and research promotion across regulatory spaces. View thesis
Dove ES. (2018). Collection and protection of genomic data. In Gibbon S, Prainsack B, Hilgartner S, Lamoreaux J. (Ed.), Routledge Handbook of Genomics, Health and Society Routledge. View chapter
Kaye J, Terry SF, Juengst E, Coy S, Harris JR, Chalmers D, Dove E ... Cambon-Thomsen A. (2018). Including all voices in international data-sharing governance. Human genomics, 12(1), pp. 13. View article
Laurie G. (2018). How do we make sense of chaos? Navigating health research regulation through the liminality of the Brexit process. Medical law international, 18(2-3), pp. 110-134. View article
McMillan Catriona Alice Wilson. (2018). Human embryo in vitro : a processual entity in legal stasis. View thesis
Murtagh MJ, Blell MT, Butters OW, Cowley L, Dove ES, Goodman A, ... Burton PR. (2018). Better governance, better access: practising responsible data sharing in the METADAC governance infrastructure. Human genomics, 12(1), pp. 24. View article
Sethi N. (2018). Research and Global Health Emergencies: On the Essential Role of Best Practice. Public health ethics, 11(3), pp. 237-250. View article
2017
Dove E, Garattini C. (2017). Expert perspectives on ethics review of international data-intensive research: Working towards mutual recognition. Research Ethics, (1). View article
Dove ES, Townend D. (2017). Reimagining the ethics and governance of Biomedicine: Introduction to the special issue. Medicine and Law, 36. View article
Dove ES, Kelly SE, Lucivero F, Machirori M, Dheensa S, Prainsack B. (2017). Beyond individualism: Is there a place for relational autonomy in clinical practice and research?. Clinical ethics, 12(3), pp. 150-165. doi: 10.1177/1477750917704156
Ganguli Mitra A, Dove ES, Laurie G, Taylor-Alexander S. (2017). Reconfiguring Social Value in Health Research Through the Lens of Liminality. Bioethics, 31(2), pp. 87-96. View article
Ganguli Mitra A. (2017). Exploitation through the lens of structural injustice: re-visiting global commercial surrogacy. In Deveaux M, Panitch V. (Ed.), Exploitation: From Practice to Theory Rowman & Littlefield. View chapter
Jones KH, Laurie G, Stevens L, Dobbs C, Ford DV, Lea N. (2017). The other side of the coin: Harm due to the non-use of health-related data. International Journal of Medical Informatics, 97, pp. 43-51. View article
Phillips M, Dove ES, Knoppers BM. (2017). Criminal Prohibition of Wrongful Re‑identification: Legal Solution or Minefield for Big Data?. Journal of bioethical inquiry, 14(4), pp. 527-539. View article
Rahimzadeh V, Dove E, Knoppers B. (2017). The sIRB System: A Single Beacon of Progress in the Revised Common Rule?. The American Journal of Bioethics, (7). View article
Schaefer GO, Laurie G, Menon S, Campbell AV, Voo TC. (2020). Clarifying how to deploy the public interest criterion in consent waivers for health data and tissue research. BMC medical ethics, 21(1), pp. 23. View article
Shabani M, Dove ES, Murtagh M, Knoppers BM, Borry P. (2017). Oversight of Genomic Data Sharing: What Roles for Ethics and Data Access Committees?. Biopreservation and biobanking, 15(5), pp. 469-474. View article
Taylor MJ, Dove ES, Laurie G, Townend D. (2017). When can the Child Speak for Herself? The Limits of Parental Consent in Data Protection Law for Health Research. Medical Law Review, 26(3), pp. 369-391. View article
Townend DMR, Dove ES. (2017). "Approaching Ethics Review Equivalency Through Natural Justice and a 'Sounding Board' Model for Research Ethics Committees". Medicine and Law, 36(1), pp. 61-86. View article
2016
Dove E, Thompson B, Knoppers B. (2016). A step forward for data protection and biomedical research. The Lancet, (10026). View article
Dove ES, Townend D, Meslin EM, Bobrow M, Littler K, Nicol D, ... Knoppers BM. (2016). RESEARCH ETHICS. Ethics review for international data-intensive research. Science (New York, N.Y.), 351(6280), pp. 1399-400. View article
Dove ES. (2016). ABC v St George's healthcare NHS Trust and others: Should there be a right to be informed about a family member's genetic disorder?. law and the Human Genome Review, 44(1), pp. 91-112. View article
Dyke SO, Dove ES, Knoppers BM. (2016). Sharing health-related data: a privacy test?. NPJ genomic medicine, 1(1), pp. 160241-160246. View article
Ganguli Mitra A, Sethi N. (2016). Conducting research in the context of global health emergencies: Identifying key ethical and governance issues. View report
Laurie G. (2016). Liminality and the Limits of Law in Health Research Regulation: What are we Missing in the Spaces in-Between?. Medical Law Review, 25(1), pp. 47-72. View article
Laurie G. (2016). 'Ley, Practica y Procedimiento en el Aceso a Servicios de Aborto: Analisis Comparativo Critico'. In Salas S, Zegers F, Figueroa R. (Ed.), Aborto y Derechos Reproductivos: Implicancias dede la Etica, El Derecho y La Medicina (pp. 147-169). Santiago, Chile: Ediciones Universidad Diego Portales.
Lea NC, Nicholls J, Dobbs C, Sethi N, Cunningham J, Ainsworth J, ... Kalra D. (2016). Data Safe Havens and Trust: Toward a Common Understanding of Trusted Research Platforms for Governing Secure and Ethical Health Research. JMIR medical informatics, 4(2), pp. e22. View article
Postan E. (2016). Defining Ourselves: Personal Bioinformation as a Tool of Narrative Self-Conception. Journal of bioethical inquiry, 13(1), pp. 133-51. View article
Sethi N, Laurie G, Harmon S. (2016). International academic conferences Significance and legacy of the 13th World Congress of the International Association of Bioethics. Medical Law International, (3-4). View article
Sorbie A, Earle M. (2016). Legal report on the impact of Directive 2011/24/EU on patients' rights in cross-border healthcare in the UK. Law and the Human Genome Review, (44), pp. 249-272. View article
Sorbie A. (2016). Conference Report: Liminal Spaces Symposium at the International Association of Bioethics 2016. World Congress of the International Association of Bioethics. View article
Taylor-Alexander S, Dove ES, Fletcher I, Ganguli Mitra A, McMillan C, Laurie G. (2016). Beyond regulatory compression: confronting the liminal spaces of health research regulation. Law, Innovation and Technology, 8(2), pp. 149-176. View article
Townend D, Dove ES, Nicol D, Bovenberg J, Knoppers BM. (2016). Streamlining ethical review of data intensive research. BMJ (Clinical research ed.), 354, pp. i4181. View article
Wallace SE, Gourna EG, Laurie G, Shoush O, Wright J. (2016). Respecting Autonomy Over Time: Policy and Empirical Evidence on Re-Consent in Longitudinal Biomedical Research. Bioethics, 30(3), pp. 210-7. View article
2015
Burton PR, Murtagh MJ, Boyd A, Williams JB, Dove ES, Wallace SE, ... Knoppers BM. (2015). Data Safe Havens in health research and healthcare. Bioinformatics (Oxford, England), 31(20), pp. 3241-8. View article
Carter P, Laurie GT, Dixon-Woods M. (2015). The social licence for research: why care.data ran into trouble. Journal of medical ethics, 41(5), pp. 404-9. View article
Dove ES, Ganguli Mitra A, Laurie G, McMillan C, Taylor-Alexander S. (2015). Elberte v. Latvia: Whose tissue is it anyway - Relational autonomy or the autonomy of relations?. Medical law International, 15(2-3), pp. 77-96. View article
Dove ES, Özdemir V. (2015). What Role for Law, Human Rights, and Bioethics in an Age of Big Data, Consortia Science, and Consortia Ethics? The Importance of Trustworthiness. Laws, 4(3), pp. 515-540. View article
Dove ES. (2015). Biobanks, data sharing, and the drive for a global privacy governance framework. Journal of Law, Medicine and Ethics, 43(4), pp. 675-689. View article
Laurie, G, Ainsworth J, Cunningham J, Dobbs C, Jones KH, Kalra D, ... Sethi N. (2015). On moving targets and magic bullets: Can the UK lead the way with responsible data linkage for health research?. International Journal of Medical Informatics, 84(11), pp. 933-940. View article
Sethi N. (2015). Reimagining Regulatory Approaches: On the Essential Role of Principles in Health Research Regulation. SCRIPTed: A Journal of Law, Technology and Society, 12(2). View article
The Liminal Spaces Project was conducted under the auspices of the JK Mason Institute for Medicine, Life Sciences and the Law. For any queries about the Liminal Spaces project, please contact law.research@ed.ac.uk.
