1 May 2018

What can socio-legal studies contribute to medical law? Thoughts from a workshop in Paris

By Edward Dove

Socio-legal studies is a multi-, inter-, or trans-disciplinary academic field that investigates the nature, form, and function of law, legalities, and legal institutions through social science methods and methodologies. The approaches can be empirical, statistical, or conceptual (e.g. exploring law through the perspective of a conceptual approach such as feminism, actor network theory, or governmentality). While socio-legal studies has long been employed in diverse areas of law such as criminal law, refugee and asylum law, property law, and contract law, its operation in medical law seems to be more limited.[1] In part, this may be because medical law is still a nascent discipline, but it may also be that scholars have not thoroughly considered how socio-legal studies can enrich the study of the social and legal worlds of medical practice and health research.

I reflected on this overarching question while attending a day-long workshop in April 2018, co-organised by Professor Emilie Cloatre (Kent Law School) and Dr Olivier Leclerc (CNRS/Centre de Recherches Critiques sur le Droit). The workshop was organised with a view to:
a) exploring the methods, traditions, and theories of socio-legal studies in France and the UK, and
b) reflecting on what ‘socio-legal studies in context’ means for research traditions and forms of knowledge produced.

The nature and future of socio-legal studies

The workshop was divided into four sessions. In the first three, short papers were given by speakers, followed by discussions. In the final session, early career scholars (including doctoral candidates) offered short overviews of their research projects, with particular attention to the methodological and conceptual approaches adopted.

I particularly enjoyed the presentation in the first session from Professor Rosie Harding (University of Birmingham) on ‘The Presence and Futures of Socio-Legal Studies’. Speaking in her capacity as current Chair of the Socio-Legal Studies Association, Prof Harding observed that socio-legal studies has grown in the UK into a diverse, multi- and transdisciplinary strand of legal studies and social science. While there is much to laud regarding the growth of the field since the 1980s, the future is somewhat cloudy. ‘Brexit’ may move European research funding out of the UK’s reach and regulatory divergence may make cross EU collaborative work more difficult. Moreover, the UK research funding environment increasingly emphasises measurable impact; this might thwart contributions of social sciences and humanities research. Nonetheless, Prof Harding argued that socio-legal scholars are well placed to embrace the new difficulties and can work together to forge a brighter future than one might otherwise anticipate.

The take-home messages

In listening to the excellent presentations, three ideas came to mind regarding the ways in which socio-legal studies can contribute to medical law.

First, it offers opportunity to explore how medical law works at particular crossroads of human interactions in the so-called ‘real world’. Self-evidently, socio-legal studies is predicated on looking at law in context – moving beyond the written text and exegesis of code, judgment, and book and into the messy world of daily life. This phenomenological approach encourages the researcher to uncover how the law is shaped by everyday practices and to capture and understand subjective experience. Medical law is a prime site for empirical and conceptual investigation in human places and spaces where this messiness and complexity is particularly acute (and so law might be under most pressure). The wards, consulting rooms, operating theatre, and civil servant desk allow the intrepid researcher to consider the ways in which law structures – or does not structure – human action and interaction. Consider the recent cases of Charlie Gard and Alfie Evans. What, for example, do these cases imply for the long-standing reign of the best interests test? Socio-legal accounts of such difficult decisions and cases would reveal how law is structured by the actions that govern the individual and group undertaking medical (and research) duties.

Second, socio-legal studies can offer a richer theoretical understanding of law and how it is expressed and experienced in healthcare and health research contexts. That is, it can illuminate the nature of law through theoretical development (e.g. sociological studies of law, legal pluralism, legal consciousness) and through theorising from empirical findings (e.g. a grounded theory approach that builds theory through the data). For example, through empirical investigation of the practices of NHS research ethics committees (RECs), we come to better understand how law shapes and is shaped and experienced by those ‘on the ground’, be they regulators, REC members, researchers, or sponsors. In the same way, socio-legal studies help us to test theories that scholars propose as explanations for why certain laws have emerged and why they are structured in certain ways. For example, regulatory theory might suggest that the Medicines and Healthcare products Regulatory Agency (MHRA) is designed to operate in the public interest as a risk-based regulator. But is this really the case? Theory helps inform the inquiries that enable us to explore the ways in which law (and regulation) is shaped, works, and develops in specific contexts.

Lastly, socio-legal studies can enable scholars to provide empirical evidence to policymakers, regulators, legislators, the judiciary, academics, NGOs, and practitioners that can lead to reform. By investigating how law is applied, expressed, and experienced in the real world, be it through secondary data analysis, surveys, interviews, or observation, scholars are afforded opportunities to provide decision-makers with evidence that informs discussion of policy and evaluation of legislative and regulatory reform. In this way, the medical law scholar can demonstrate real-world impact and influence change in society. An example of this can be found in medical law’s sister discipline, public health law. Temple University’s Center for Public Health Law Research engages in public health law research and ‘legal epidemiology’ methods, which include legal mapping and policy surveillance. Through these socio-legal methods, the Center maps and evaluates the impact of law on health, identifying laws and policies that can improve health, increase access to care, and create or remove barriers to health.

Moving beyond the ‘what’

Medical law cannot sustain itself alone on inquiries into what the law is on a particular issue – doctrinal analysis driven by descriptive questions – what we might call a tyranny of the ‘what’. Scholars must also branch out to ask and answer evaluative questions, investigating whether the law is fit for purpose, whether it is as effective or just as it purports to be, and whether it adequately achieves its stated aims.

Medical law also requires explanatory questions to be asked, investigating the underlying causes behind, for example, why there is compliance (or not) with rules and regulations. In teasing out the ‘what’, ‘whether’, ‘how’, and ‘why’ questions, scholars of medical law not only will deepen their knowledge of the discipline and round it out, they will also contribute to a richer intellectual endeavour that can improve the regulation of medical practice, the quality of healthcare delivery, and the facilitation of ethical health research that benefits society.

Medical law is a multi-layered tapestry of rules, norms, principles, standards, and legal devices that a) governs the relationships among healthcare professionals, patients, participants, government, and society, and b) influences the functioning of healthcare and health research. As a nascent but established sub-discipline within law, it warrants well-rounded scholarship that investigates the what, how, and why – the doctrinal, the empirical, and the socio-legal. Socio-legal studies offers this. It reveals particular insights when we are at the crossroads of health and illness, and of professions and values, namely through charting the interconnecting roles of law, theory, and practice as experienced in real life, at both micro and macro levels. And, it illuminates particular challenges in medical law that we must understand better. Arguably, the Gard and Evans cases suggest that the authority and all-encompassing nature of the best interests test might still not be enough – in law and practice – to reflect a changing set of values, expectations, and needs. As lawyers, do we properly understand how best interests is actually working on the ground? Without question, socio-legal studies and medical law have much to contribute each other; in bringing them together, scholars can forge research excellence and real-world impact that improve our collective health and wellbeing.

[1] This is a relative, rather than absolute, claim of limited application. See e.g. Emilie Cloatre, Pills for the Poorest: An Exploration of TRIPS and Access to Medication in Sub-Saharan Africa (Palgrave McMillan, 2013), which uses ethnographic case studies in Djibouti and Ghana, and insights from actor-network theory, to explore the links between intellectual property and access to medication. Also, the Socio-Legal Studies Association, the UK organisation that promotes and supports the work of socio-legal academics, regularly features socio-legal research in medical law at its annual conferences.

27 April 2018

Should We All Give Up Eating Meat to Save the Planet?

'Should We All Give Up Eating Meat to Save the Planet?', was an event held recently in the Red Theatre at Summerhall as part of the Edinburgh International Science Festival (EISF) on the 6th April 2018.

I have recently been conducting interviews with researchers, policymakers and those working for NGOs asking them about sustainable diets, and how sustainability criteria might be incorporated into existing dietary advice. These interviews showed me how, even among those who work in this area, there is a lot of uncertainty about applying the concept of sustainability to the food system in general and individual diets in particular. Public interest in nutrition and environmental research public is high but sustainable diets are a new and relatively unfamiliar idea, so they seemed an ideal topic to discuss.

The event was structured around two short (15min) presentations based on current environmental and nutrition research, followed by a 30 minute question and answer session that allowed audience members to ask questions about, or comment further on, specific issues covered in the two talks. The overall aim of the event was introduce participants to research in these areas, and encourage them to think about the impacts their own diets might have on the environment. Between the talks and the discussion session, there was also a short break to serve a selection of sustainable snacks, provided by Edinburgh Larder.

I gave the first talk which outlined the environmental impacts of food production and consumption, focusing on the greenhouse gas emissions associated with the production and consumption of food. Such data shows very clearly that the foods with the greatest impact are red meat, particularly from sheep and cows. The second talk was given by Pamela Mason, a nutritionist who has recently co-authored a textbook on sustainable diets. She outlined the health impacts of the average British diet and outlined why we need to reduce our consumption of red and processed meat, eating less but better meat. One element of these changes, Pamela suggested, should be the development of sustainable dietary guidelines to advise both individuals and those in charge of public procurement, i.e. meals in schools, hospital and care homes.

The discussion session was lively and a range of divergent views were expressed, but the tone remained constructive throughout. Topics raised included: insects and in-vitro meat as alternative sources of protein; why are the GHG emissions for lamb are so high and whether changing the diet of sheep can mitigate this; is it possible to include fish in a sustainable diet; and the need for new regulation to drive reductions in food-related GHG emissions. Feedback on the event was largely favourable: ‘Very knowledgeable presenters. Really enjoyed the snack. Informative but not judgemental’. Many respondents seemed to have particularly appreciated the opportunity to ask questions and discuss these issues in more detail: ‘The long discussion was good and allowed a variety of points of view to be aired’.  

Funding for this event was provided by a University of Edinburgh CAHSS Knowledge Exchange and Impact grant, the Wellcome Trust Liminal Spaces project and Edinburgh School of Law Research Support grant.

Isabel Fletcher's slides from the event can be found here.
Pamela Mason's slides from the event can be found here.

6 February 2018

Fractionis Panis

Fractionis Panis 2015
Giclee print on Hahnemuhle Pearl 56 x 36cm
By Emma Barnard

The invitation came to become a member of the AERG through my involvement on the Arts and Ethics Subcommittee for the World Congress in Bioethics held in Edinburgh in 2016. My artwork fits within the CT1 group - Approaches to Understanding Patient Experiences and Medical Texts

‘Some doctors believe they have a duty to preserve life at all costs. There is no such duty’.
Doctors who play God
Dr Richard Nicholson
Guardian, 08/03/02

Collaborative work as an artist with surgeons and their patients over several years has produced much artwork and many questions. The issue that I wanted to focus upon for the work that I chose to exhibit at the world congress and also for the AERG ‘Fieldworks’ exhibition in Berlin is the notion that medicine is becoming the new religion and more significantly, how the patient views their surgeon as a miracle worker, a saviour figure. A large part of my work as an artist working within medicine has involved spending time with patients of Mr Mike Papesch FRACS and Mr Paul Stimpson FRCS ENT Consultant Surgeons who specialise in head and neck cancers.

After observation of the consultation I invite the patient into another consulting room where we discuss their experience as a patient. Here they are free to express their thoughts and feelings about being in the medical environment, a particularly vulnerable time for them. On their printed photographic portrait often they write just one word eg ‘surreal’, ‘routine’ or perhaps an illustration of how they feel eg a drawing of a boiling kettle, this work is dependant upon their individual experience. Repeatedly I have witnessed them discussing and illustrating on their portrait their thoughts of the surgeon as ‘a miracle worker, a saviour figure’. When facing a potential life limiting disease surgeons have been gifted the power to prolong life. This situation is exacerbated when a person has no faith and time on earth is all that they can hope for, naturally they desire to extend this time. In the main and due to many reasons, the patient has a passive part in the relationship dynamics and displays much reverence to the consultant who holds the power to heal.

When investigating how this relationship might be visualised I explored the Catholic faith for the similarities with the ritualistic nature of both. Very little appears to be written on this subject but here I reference journalist Oliver Clerc’s book ‘Modern Medicine: The New World Religion, in it he raises some really interesting points such as:
‘Medicine has become the religion of modern times. Since Louis Pasteur, the deep Christian founder of modern day medicine and father of vaccines, the beliefs and practices of traditional Christianity have been transferred into medicine: physicians have taken the place of priests; the search for health replaces the quest for salvation; the hope of physical immortality (through cryonnisation, cloning and genetic manipulation) will soon take over hope of eternal life; vaccination plays the same initiatory role as baptism; and a hypothetical universal vaccine shall save all mankind from illness, tomorrow, just as the Saviour atoned for the sins of the world’.

In the Middle Ages, doctors blamed amongst other things, sin for ill health and subsequent cures involved prayer.

The intention of my work for the AERG is to highlight this phenomenon of projection and transfer of religious content that takes place within medicine.

Dr Nicholson R. Doctors who play God
Clerc O. (2014), Modern Medicine; The New World Religion, America, Personhood Press (back cover)

Emma Barnard is a visual artist specialising in lens based media and inter-disciplinary practice and research within Fine Art and Medicine. Her work deals with social commentary, seeking to highlight contemporary issues and encourage debate surrounding them.

Her "Patient As Paper" (co-founded with Mr Mike Papesch FRACS, consultant ENT surgeon) artwork is currently being exhibited widely in galleries, universities and hospitals in England and internationally. It has been presented at several conferences within the medical and medical humanities fields, and most recently at University College London, Medical School and in a series of presentations at Surrey University for the Department of Health Sciences. The experience Emma has gained through several years of working with consultant surgeons and their patients from various disciplines, including ENT and Psychodermatology, is now influencing the field of medical education. At King's Medical School in London Emma has led a highly successful pilot project to introduce art into medical education, undertaken in conjunction with a critical care consultant and a 4th yr. medical student. Most recently she has taught on a pilot project within the Department of Medical and Health Sciences at Surrey University and has led on workshops for students on the MBBS Stage 2 GP Longitudinal Placement, GKT School of Medical Education.

25 January 2018

We began as part of the body, 3D prints, 2017

Photography by Erika Stevenson

From January – May 2017 I undertook a micro-artist-in-residency at the laboratory of Professor Sara Brown, an eczema genetic research facility, within the School of Medicine, University of Dundee, organised by ASCUS Art & Science, and funded by the Wellcome Trust, with additional support from the Arts & Ethics Research Group.

The work I created, evolved through a period spent observing the day to day activities of the lab, from carefully nurturing skin cultures, to the precise, complex and delicate processes use to analyse these samples. The resulting projects ‘We began as part of the body’ (a 6minute sound piece), ‘Exhume’ (a series of 3D printed skin cells) and the ‘Atopic’ images (360 degrees photography from the lab) were intended to be a series of experiential works, that immerse the viewer in the work of lab, but also embody the poetic, human and ethical issues that it’s work raises.

The script for the sound piece was written in response to a series of interviews with staff from the Brown Lab, and follows the cells journey from theatre to lab, to disposal, and is written from the point of view of the organotypic, artificial skin samples. What is so fascinating to me about these cells, is that they are real but synthetic, taken from an actual person, but then processed and maintained outside of the body. They are other. Almost indescribably similar and different from the cells that exist within our actual body. Are they better, worse or just different? And what does that difference mean? Does it affect how we understand our own bodies, not just in medical and scientific terms but in terms of what it means to be human?

My approach also involved experimenting with various imaging technologies that are used within and around the lab, in particular, microscopy. I was interested in how these methods of staining, capturing, slicing and processing, provide meaning about the cells, cultures and their behaviours. I used these methods to create the series of 3D prints of skin cells, to give what are otherwise somewhat abstract, image based representations, a tangible, physical manifestation, and explore their made-ness. These objects attempt to challenge our understanding of scale within the body and medical imaging software. The 3D prints I created are 2000 times bigger that the real-life cells, blown-up in size, into objects that fit in the hand. The objects were made by capturing a culture of skin cells, which are a group, but are also individual cells, each different to one another. They are also going through a process of differentiation, and are therefore in the process of changing, not in themselves fixed shapes or forms. They are active, responsive and precious in their short 3 weeks lifespan.

A series of three 360 photographic images accompanied the above works, which present the viewer with an immersive experience of the different environments of the lab; a VR window into a world not normally accessible to the public. Here we are presented with a somewhat ghostly version of the lab environment, without researchers or technicians, which now appears to only be inhabited by specimens; the organotypic, artificial skin.

The works were exhibited as part of the Beyond Skin exhibition at the LifeSpace: Science Art Research Gallery, University of Dundee from 27 June – 2 September 2017, at the Slessor Gardens, Dundee from Sept – Dec 2017, and as part of the AERG organised Fieldworks – Arts and Ethics Research Group, at the Berlin Blue Gallery, Berlin, Germany from 18 – 21 July 2017.

The work will feature in an upcoming lecture Positively Squishy – creative research in the lab, which I’m presenting as part of the Mason Institute Lunchtime Lecture series on 22 February 2018, and then as within the paper We began as part of the part of the body – a sound artwork as creative correspondence at the Design Anthropology panel at Art, Materiality & Representation conference at the British Museum, London, 1-3 June 2018.

14 November 2017

Foreword and Poem by Tanya Davis

By Tanya Davis

In 2016, I was Artist in Residence in Medical Humanities at Dalhousie University in Halifax, Nova Scotia. Upon completing my term, and after giving a short presentation (poem) on my observations thereof, I was approached by medical anthropologist Janice Graham to join a working group comprised of scholars and artists from various countries, disciplines, and backgrounds. The common link between their work, and mine, was a shared interest in the crossover of arts, humanities, social justice, and health. The Arts and Ethics Research Group (AERG) was formed to generate scholarly knowledge, artistic creations, and broader social debate around ethical, legal, and social aspects of the practice and governance of medical research and healthcare.

My interest piqued, I attended a local meeting in Halifax, Canada, eager to learn more about the people involved and in hopes to better understand the concept itself. Perhaps unsurprisingly, the concept itself was as vast as the ocean and therefore difficult, initially, to grasp. Regardless, or perhaps because of this, I was keen to join the working committee, one of 4 comprising the AERG (the focus of this one being on social justice and global health). I was curious how scholars and artists would collaborate, how we might use our respective skill sets to produce relevant and complementary work. Our Halifax-based component consisted of myself, Janice Graham (Professor of Pediatrics (Infectious Diseases) and Medical Anthropology), Shawn Harmon (Reader in Law at the University of Edinburgh), and Author/Artist Emma Fitzgerald.

Initially, we circled around the wider issues of health and justice, seeking a landing place in which to house our common ideas. I craved concrete objectives and deadlines. Word counts. Parameters. As a self-directed artist, unattached to institution or team, my work is often circuitous and fickle; I relish opportunities to be a part of something clearly defined, confined even. Contrary to stereotypes of creative workers, I love to be boxed in (once in awhile).

And so I was eager for our small group to identify a clear direction and point of focus under the larger mandate of the AERG. But medical ethics are not clear and concise, not neat and tidy. Neither are the humanities, nor the arts, nor the scope of social justice, science, or governance. It was fitting, then, that our discussions meandered like rivers, ebbed and flowed like ocean tides.

In any case, we soon began to notice a pattern in our conversations—no matter what disparate but complementary topic we touched upon, the notion of water weaved its way through our words. Whether global health or localized care, governmental shortfall, pharmaceutical windfall, or community resistance, access to safe and clean water stood firm as an indisputable need, a pillar of global health and justice, and a basic human right. Resoundingly, we agreed upon this tenet and thus placed it at the fore, thereafter guiding our discussions, our objectives, and our work.

In anticipation of an AERG meeting in Edinburgh this past spring, I summarized a fraction of our notes and thoughts in the poem that follows. It is an attempt to rouse further dialogue on the importance of water to global health, to the planet and all life upon it. This piece hopes to highlight not only the basic, physical need we have for water and safe access to it, but also the soulful and emotional ways in which we are connected. It seeks, as do we, a meeting place between arts and ethics.

For the Water
Tanya Davis, for AERG, 2017

In the beginning we are in it
from it
kept warm and comforted
we don't question it
we float and
we rest in it
connection is no effort
it just is

But fissures begin
they start little
we hardly feel them
but there are reasons we keep drifting
there are consequences, too

We saunter off
slowly, so we
hardly notice
we start to wander
we wonder less
or no longer
and with no awe for the water
we show it no honour
bonds break
divisions grow stronger

If we stayed there...
enthralled with it
in unison with all of it
would we still call it a product
and bottle it?

Would we see water as commodity
and make dollars off of it
molecules as tools to profit with
would we fence in fountains
and block access
drain rivers to fuel progress
would we inject noxious gases
into the ground that's always had us
leaving sources poisoned
one less well to which we shall return

Water is a nexus issue
connected to all we do
it is not the next big issue
in a long long of issues
awaiting patiently it's turn to concern us
—it is current
and alarming
like cures owned by big pharma
and guarded

Water under crisis
water bargained, siphoned
and all bought up
water under lock and key, hoarded
and bottled up
by corporations and leaders
exchanging land for litres
thirsty people
empty cups

Water treated, mistreated
saving us from / delivering diseases
dirty water in gorgeous places  
water unfit to drink on reserves, for first nations
water tainted or unavailable
in whole neighbourhoods
in hospitals
policy, bureaucracy as obstacles
or governments with pocketfuls of cash

Water as an access way
water as a right
water as a privilege for the rich and for the white

Wars waged over waterways
on the way to water people die
lacking water people cross vast waters and also die
people stay behind
fighting over wilting beds
and drying wells
in short supply

If you're watching certain news
in which water is clean and endless
in which there isn't yet a crisis
change the channel

It is better to know and tremble
than ignore and gamble             

Put your hand up
if ever you drank a glass of water
and acknowledged
how essential
it was to your survival

Put your head down
for all the times that all the people can't get it
for the sullied streams and crooked schemes that take it
take a minute to consider your place in it
it's place in us
the significance of water to the fate of us

Water is a basic human need
and a right
any debate of this is futile
in the chain of birth to death it connects us to the people
to the planet we inhabit
it is seamless
we are of it
there is never any gonna be healing without it

Every disease treated
every public policy stamped and applauded
all the dreams of justice never finished

If world-wide health is an objective
universal wellness a target
then water must be a freely-flowing part of it

In fact, it is
even if we hardly notice
even if we drift slowly from old knowledge                 
where water is power, real and symbolic
even if we don't talk about it                             
it is the current continuing through us
it is current news inherent to us
it needs our fervent care
a certain courage
of the innermost kind

In the beginning we are in, of it
and as any heart will tell us
and as we may notice:
water is life. 

Introducing the Arts and Ethics Research Group

By Shawn Harmon

In between confidence and doubt, fear and hope, knowing and uncertainty, fragility and resilience, aggregation and disaggregation. In between entitlements and responsibilities, law and morality. In between boundaries and disciplinary fields. In between the meaningful pauses from one note to the next, one word to the next. In the lab, the studio, the pub, the clinic, the classroom, the office, the market, and the imagination. That is where the Arts and Ethics Research Group (AERG) has been searching for insight and inspiration in relation to some of the most pressing issues that confront the patient, the physician, the researcher, and the artist working in the medical, innovation, and science communication settings.

The AERG, founded at the University of Edinburgh, seeks to encourage both new insights and public debate around ethical, legal, and social aspects of the practice and governance of medical research and healthcare. Comprised of academics from a range of fields (e.g., law, social science, medicine) and artists working in a range of media (e.g., visual arts, design, sound, film, poetry, etc.), it draws on diverse approaches and methodologies. Though the overarching question behind the work of the AERG has been about the transformative potential of the arts to ethics and medical practice, the AERG has been loosely organised around three themes: medical practice (i.e., the doctor-patient relationship and the patient experience); science/healthcare communication (i.e., how arts and the humanities can facilitate robust knowledge-exchange and dialogue); and innovation and global justice (i.e., values, interests, and power dynamics in designing and delivering global healthcare).

In June 2016, members of the AERG successfully exhibited work at the World Congress of the International Association of Bioethics in Edinburgh, and contributed to a lively Arts+Ethics theme of work at that Congress. More recently, the AERG exhibited at BerlinBlue Art, an independent gallery in Berlin, Germany. Presented from 28 July 2017 to 5 August 2017, ‘Field Works’ was curated by Renata Kudlacek and Emma Barnard, both AERG members, and consisted of visual, video, sonic, written, and interactive works meant to both challenge and inform, probe and provoke. Pieces included films about the experience of being a minority and having and being treated for cancer, images about the expectations imposed on physicians, images exploring death and the human devotion to longevity, a poem about our evolving relationship with water which is so essential to our wellbeing, a game to help young scientists and doctors develop the skills and confidence needed to engage with diverse publics, and much more.

One can surmise from this brief description that the pieces strongly engage with the themes which orient the work of the Mason Institute, particularly that of the Ethics, Art, Culture and Law theme, which is comprised of a range of projects examining the interactions between cultural practices and governance frameworks, including ethics and law, as well as the significance of the former to the latter. In the coming weeks and months, the Motley Coat will host a number of guest blogs from AERG members wherein they explain their working methods, the significance of ethical questions to their work, and the utility of their involvement with the AERG.

9 November 2017

The UK Policy Framework for Health and Social Care Research: politics, principles and proportionality

On 16 October 2017, the UK Health Research Authority (‘HRA’), a statutory Non Departmental Public Body established in 2011 to promote and protect the interests of patients, streamline regulation, and promote transparency in health and social care research, published a new UK Policy Framework for Health and Social Care Research (‘Policy Framework’). This Policy Framework was published in accordance with the Care Act 2014, which requires the HRA to ‘publish guidance’ on ‘principles of good practice in the management and conduct of health and social care research’.[1] Symbolising the efforts of the HRA to harmonise the health research regulatory environment across the UK, the Policy Framework replaces separate Research Governance Frameworks (‘RGFs’) that were previously published in each of the four nations. Indeed, as an exercise in joint policy-making and public engagement, the Policy Framework was developed by the HRA and the Health Departments in Northern Ireland, Scotland and Wales,[2] following public consultation.

The principles-based Policy Framework applies to health and social care research that is within the responsibility of the HRA or the Devolved Administration’s Health Departments, e.g. health and social care research involving NHS patients, service users or their relatives or carers. This includes research involving them indirectly, such as using information that the NHS or social care services have collected about them. The Policy Framework is targeted primarily to individuals and organisations with responsibilities for the management and conduct of health and social care research.
In this blog, I highlight the key aspects of the Policy Framework, as well as a couple areas that may raise questions about the effectiveness of governance of health and social care research.

Key aspects of the Policy Framework

The RGFs provided a framework for the governance of research in health and social care through principles, requirements, and standards of good practice. In large part, the second editions of the RGFs (published in 2005-6) were drafted in response to the Medicines for Human Use (Clinical Trials) Regulations 2004, and sought to clarify specific legal duties of sponsors, investigators and others in clinical trials. Unhelpfully, the RGFs did not tease out the distinction between principles, requirements, and standards; moreover, the RGFs were seen to suffer from ambiguity and to present more obstacles than solutions to conducting research (as indeed has been the criticism of the Clinical Trials Regulations 2004). The Policy Framework aims to overcome this by focussing on charting high-level ‘principles of good practice in the management and conduct of health and social care research’.

As the HRA itself notes, since the previous RGFs were issued over ten years ago, the environment for health and social care research has changed considerably. Both technological developments and shifts in societal attitudes signalled the need for a revised framework that would set out, at a high level, principles and responsibilities that took account of legal requirements and professional standards.
The Policy Framework does indeed reflect an appropriately updated, high-level governance document for the management and conduct of health and social care research. Key aspects of the Policy Framework include the following:

  • An important titular change from a ‘governance framework’ to a ‘policy framework’. Much more than a rudimentary semantic modification, ‘governance’ entails a complex (and full) array of principles, requirements and standards, not to mention mechanisms to deliver them, including monitoring and assessment arrangements. Unsurprisingly, such a governance framework can easily suffer from perplexity. ‘Policy’, on the other hand, tends to be a system of principles that is solution-orientated; generally, it avoids operational details. Consequently, the Policy Framework is more explicitly high level than the RGFs (though, it should be noted, no shorter in length). This is reflected in the document’s structure, which removes the headings ‘Standards’ and ‘Responsibilities and Accountability’ that was in the RGFs and replaces them with ‘Principles’ and ‘Responsibilities’. Helpfully, there is now an introductory ‘Context’ section (the equivalent of a preamble), which explains the environment that the HRA and the UK Health Departments are committed to achieving.
  • Unlike the RGFs, the Policy Framework is placed on firm legal footing, at least in England. The Policy Framework constitutes ‘statutory guidance’ to which local authorities, NHS trusts and NHS foundation trusts in England ‘must have regard’.[3] In contrast, while the Policy Framework has equal application in Northern Ireland, Scotland and Wales, there is no legal obligation per se for local authorities or health boards to have regard to it.
  • The Policy Framework lists 19 principles of good practice in research for those who manage and conduct health and social research in the UK, including Safety, Competence, Respect for Privacy, and Duty of Care. Arguably, this is too many principles for a high-level document.
  • There is an explicit focus on encouraging patients, service users, and the public to become more involved where appropriate in the design, management and conduct of research. For example, Principle 4 (‘Patient, Service User and Public Involvement’) actively encourages these actors in the ‘design, management, conduct, and dissemination of research, unless otherwise justified’.
  • As with the RGFs, the Policy Framework charts responsibilities for key actors in health and social care research, including chief investigators, research teams, funders, sponsors, regulators of professions, and employers.
  • All health and social care research, not just clinical trials, is encouraged to be registered, and research findings are encouraged to be published and summarised for those who took part in them and made publicly available.
  • The principle of proportionality colours the entire Policy Framework. In part, this is due to the HRA’s role, which is to ensure that ‘the regulation of health and social care research is proportionate, so that research that is clearly lower-risk gets processed accordingly’ (para 9.19 of the Policy Framework). The previous RGFs made only a passing reference to proportionality and its link to risk-based assessments (e.g. ‘If there are any risks to participants, the risks must be in proportion to the potential benefit’; independent expert review ‘must be proportionate to the scale and complexity of each research proposal’.) By contrast, the Policy Framework injects the principle of proportionality throughout the framework, emphasising that research regulation should be proportionate to the level of risk to which the participants are exposed. It also defines proportionality as ‘having an approach to mitigating risks that gives at least the same consideration to the risks that arise if the research does not take place as to those that arise if it does, and the same consideration to their likelihood as to their impact. The risk appetite should favour the research taking place. The prevailing focus should be on the risks to the potential participants and the target population, not on the reputational risks.’ Proportionality is seen, for example, in para 2.1 of the Policy Framework, which sets out the document’s purpose: ‘These principles protect and promote the interests of patients, service users and the public in health and social care research, by describing ethical conduct and proportionate, assurance-based management of health and social care research, so as to support and facilitate high-quality research in the UK that has the confidence of patients, service users and the public.’
  • Connected with the injection of proportionality, the Policy Framework seeks to create an environment that ‘remove[s] unnecessary bureaucracy for researchers, both in what the framework expects of them directly and what it expects of others that then affects them’. Thus, it does not intend to add another layer of work to researchers or others with responsibilities under the Policy Framework. Rather, it intends to set out high-level principles and  responsibilities, driven by aims of proportionality, efficiency, and straightforwardness that will be met through operational arrangements, supported by detailed operational guidance.

Critical questions

In reading through the 40-page Policy Framework, a few sections jump out to me in terms of interest and possible controversy. In the interest of space, I address two.
First, Principle 1 (Safety) offers a twist to a classic principle in research ethics. It reads: ‘The safety and well-being of the individual prevail over the interests of science and society.’ Compare this to the Declaration of Helsinki (2013), which reads at Paragraph 8: ‘While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects.’ Compare this also to the CIOMS Guidelines (2016) at Guideline 1: ‘All research with humans must be carried out in ways that show respect and concern for the rights and welfare of individual participants and the communities in which research is carried out.’ One wonders why the Policy Framework excludes explicit mention of rights and interests here. Is this a new twist to an old principle that heralds a turn away from rights-based discourse in research governance frameworks and towards a focus on participant safety and wellbeing only? Does it suggest that individual interests should not hold absolute sway over the interests of science and society? Or, might this new phrasing reflect a more pragmatic position that 1) tacitly recognises that collective interests may sometimes hold sway over individual interests, and 2) focuses on safety and well-being as particular manifestations of ‘rights’, rather than reiterating an amorphous obligation to respect rights which already exist and sit above the Policy Framework and are covered by ‘hard law’ in any event?

Second, the Policy Framework’s focus on proportionality and risk reflects a desire by the HRA (and other bodies, such as the Academy of Medical Sciences) to ensure that research that presents ‘lower risk’ is processed accordingly, i.e. faces less regulatory burden. Much of the HRA’s recent work has been on developing tools that lessen the workload for researchers, sponsors and others; see e.g. the proportionate consent guidance). While arguably laudable as a regulatory principle, the connection of proportionality to risk remains under-defined. The HRA, working alongside ground-level actors (researchers and sponsors in particular, but also participants), should craft careful and transparent operational guidance under the umbrella of this Policy Framework to help stakeholders undertake adequate risk assessment and management and achieve the aim of proportionate – and responsible – regulation. Key questions to consider should include: what risks will be evaluated (and conversely, which will be ignored) and what risks will be mitigated through regulatory means? Will the methods of risk assessment be open to periodic revision in light of changing circumstances (e.g. new risks and changes in risk profiles)?

Overall, the HRA should be commended for navigating what was undoubtedly a difficult political process of negotiation and compromise with the Devolved Administrations. The Policy Framework brings consistency across the UK regarding principles of good practice in health and social care research. It also puts the UK on solid footing for the governance of health and social care research in an era marked by internationally collaborative, data-driven research, and participant and patient engagement. This era, of course, is also marked by increasing uncertainty in light of Brexit and the putative decoupling of the UK from the EU’s regulatory reach. In time, we will learn whether the Policy Framework achieves its aim of helping to ‘make the UK an even better place to do research’ through its increasing emphasis on proportionate, risk-based regulation.[4] It may well drive regulatory harmonisation. However, due to the legal basis of the Policy Framework, where England is statutorily required to ‘have regard’ to it but the other countries are not, it may also drive (or create opportunity for) different attitudes and cultures towards interpretation and implementation.

[1] Care Act 2014, s 111(6).
[2] Department of Health (Northern Ireland), Scottish Governance Health and Social Care Directorates (Scotland), Department for Health and Social Services (Wales).
[3] Care Act 2014, s 111(7).
[4] HRA, ‘Draft UK policy framework for health and social care research: for comment: Summary of responses’ (2015), available at: http://www.hra.nhs.uk/documents/2015/11/draft-uk-policy-framework-health-social-care-research-summary-responses-v1-2.pdf