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

20 June 2017

Revisiting Robust Regulation

Few can have missed media reports of the actions of Ian Stuart Paterson, the former breast surgeon who faced criminal charges on the basis that he had carried out “extensive, life-changing operations for no medically justifiable reason”. On Friday 28 April 2017, at Nottingham Crown Court, he was convicted of 10 counts of wounding with intent between 1997 and 2011, relating to nine women and one man, and three further wounding charges.  During the period in question Paterson was employed by Heart of England NHS Trust (as it was then) and also practised privately at Spire Healthcare. This blog considers some of the specific regulatory challenges that arise in this case, but also reflects upon the more fundamental question as to what might constitute “robust regulation” in these circumstances. 

review concerning Paterson’s surgical practice had previously been conducted in 2013, by Sir Ian Kennedy, at the request of the board of Heart of England NHS Foundation Trust.   At the outset of his report, he summarised the tragic story thus:

It is a story of women faced with a life threatening disease who have been harmed. It is a story of clinicians at their wits’ ends trying for years to get the Trust to address what was going on. It is a story of clinicians going along with what they knew to be poor performance. It is a story of weak and indecisive leadership from senior managers. It is a story of secrecy and containment. It is a story of a Board which did not carry out its responsibilities. It is a story of a surgeon who chose on occasions to operate on women in a way unrecognised by his peers and thereby exposed them to harm.”[1]

This highlights just some of the complex issues raised by the Paterson case.  Here also there are echoes of the organisational, cultural and regulatory failings that were identified in the 2013 report of the public inquiry chaired by Robert Francis QC into failings at Mid Staffordshire Foundation Trust (“the Mid Staffordshire Inquiry).

The lengthy background to Paterson’s recent criminal conviction makes difficult reading, in circumstances where it is reported that concerns had been raised by his colleagues as early as 2003 concerns had been raised by his colleagues as early as 2003[2]. The criminal conviction followed numerous investigations, with Paterson’s registration finally being suspended by the GMC in October 2012.[3] This had the effect that he restricted from practising as a doctor, either within the NHS or privately, in the UK.  This background prompts the same question asked of the Mid Staffordshire Inquiry, namely “why problems … were not identified sooner,and appropriate action taken?”[4]

A few weeks after the end of the criminal trial (17 May 2017), the Royal College of Surgeons (RCS) issued an open letter in response to the Paterson case, calling for a review of private sector transparency and safety standards. This letter also welcomed the Secretary of State for Health’s suggestion that an inquiry be conducted by the next Government to understand how Paterson was able to practise for so long.  In her introduction the President of the RCS, Miss Clare Marx, recognised improvements – such as appraisals and revalidation of doctors – that make the detection of “rogue doctors” more likely.  However, she further noted that: “…there are still a number of areas which require urgent improvements to protect patients from harm. Robust regulation remains an important way of protecting the public”.

Some of the regulatory challenges highlighted by the RCS include:

  • improving safety standards and data transparency in the private sector, and not just in the NHS.
  • scrutinising the private sector’s participation in clinical audits, and how this is enforced and monitored (for example by the Care Quality Commission).
  • examining better regulation of cosmetic surgery, which the RCS note happens almost entirely in the private sector.  In particular, they call for legislation to enable the General Medical Council to annotate the medical register with details of which surgeons are qualified to undertake cosmetic surgery.
However, leaving to one side for a moment these specific regulatory issues, Miss Marx’s statement raises the more fundamental question of what might constitute “robust regulation” in these circumstances.  In particular, does it simply mean more regulation? 

The report of the Mid Staffordshire Inquiry suggests not.  At the outset of that report Robert Francis QC listed the healthcare systems regulators and performance managers that had scrutinised the failing Trust in the relevant period.  This list included the Board, the local Strategic Health Authority, the Department of Health, Monitor and the Healthcare Commission.[5] The report went on to make the observation that: “It does not need a public inquiry to recognise that this elaborate system failed dramatically in the case of Stafford.”[6]  That Report’s recommendations were wide ranging and have shone a spotlight on issues of patient safety, quality of care, leadership, and creating positive organisational cultures. Thus, while regulation can provide a framework within which the practice of medicine takes place, it cannot necessary dictate or direct the culture of human practices that prevail over time.

As the RCS have stated:

 “The actions of Ian Paterson are beyond comprehension. Throughout the private and public health service, we must now try and understand what more we can do to prevent this from happening again and to take action to improve patient safety more generally.” 

How this learning will be delivered is beyond the scope of this blog post – as flagged above, there may be a public inquiry in due course.  However, if we are to move beyond a call for more regulation, this will require deep scrutiny around the roles and limits of the law in regulating health related issues, and the relationship between robust regulation, professional practices and ethics, and public protection as a matter of the central mission of all public health institutions. 

9 May 2017

What is a festschrift?

By Graeme Laurie

Book Review: Law, Ethics, and Medicine: Essays in Honour of Peter Skegg, Mark Henaghan and Jesse Wall (eds), (Wellington; The Law Foundation/Thomson Reuters, New Zealand, 2016)

What is a festschrift? I do not ask this question for want of an Oxford English Dictionary (real or virtual), but rather out of genuine intellectual curiosity and professional commitment to ensuring that academic work continues to make distinctive and valuable contributions. As a minimum, a festschrift is a liber amicorum –a book of friends– as highlighted by Ron Paterson in the Foreword to this collection. It is undoubtedly an opportunity to demonstrate admiration for a colleague, and this is abundantly evident in this book. Having never met Peter Skegg, I am nonetheless struck by the warmth and affection in which he is held among contributors for his collegial commitment, kindness, wisdom, mentoring, intellectual leadership, unfailing drive towards quality, and pioneering contributions. The descriptions of Peter Skegg as humble and whimsical invoke a deep regret that our paths have never crossed. And this sentiment is a good thing because, at base, a festschrift must reflect a sense of the person not only as the academic, but also as an individual. In this respect, this volume succeeds admirably throughout.

But, what else is a festschrift? As I write, I realise that perhaps I am asking the wrong question. Let me rephrase: what has a festschrift, in law, become? It is timely to ask this question because the age of the first pioneers in medical law is coming to an end. The moment of the festschrift is upon us. It is noted in this book, for example, that Peter Skegg has enjoyed a 46-year academic career at the Universities of Auckland, Oxford, and Otago. There are multiple examples in the book of his works being truly seminal in exploring new territory in the nascent discipline. However much we might argue and angst about when medical law began, there can be no credible history of the field that does not include accounts of the works of Skegg. The period starts particularly in the 1970s, but also – we learn – with ‘Capacity of a Minor to Consent to Medical Treatment’ in 1969. This time frame saw other key figures emerge, particularly in the United Kingdom, and each now has a festschrift of their own. Beyond Ian Kennedy and Andrew Grubb (both of whom moved on to other endeavours), we have the publication of First Do No Harm in honour of J Kenyon Mason in 2006,[1]and other festschrifts for Sheila McLean in 2015,[2] and for Margaret Brazier in 2016.[3]  Moreover, just as Peter Skegg is lauded as ‘one of the two fathers of medical law’,[4] so too have Mason, Brazier and McLean been hailed as parentibus of the nascent discipline.[5] If ever there was a good reason to produce a festschrift, it is when there is a sound claim to have shaped an entire discipline in its own right. There is a wealth of evidence in this book of the robustness of any such claim for Peter Skegg. In terms of breadth, Skegg has written on a staggering array of topics that would overwhelm the contemporary medical lawyer. As highlighted in the Foreword, these include informed consent, termination of life support and the law of murder, the legal definition of death, body as property, HIV/AIDS, health research, experimentation on children, and patients’ rights. As to their significance, it is here that we get to the crux of the added value and importance of the festschrift. What has Skegg said (for whom we could replace Kennedy, Grubb, Mason, Brazier and McLean) that is, or has been, of any import? Why should we pay attention, and why should we continue to listen?

This returns me to my question: what has the festschrift, in law, become? If it is seemingly a random collection of contributions from academic friends, then this is the liber amicorum mentioned above, but it does not differentiate the intellectual contribution of the festschrift from the ubiquitous edited book. In the same way that the good edited collection must focus in and around a theme(s), so too the good festschrift must focus in and around the academic at its heart. Also, reflecting comment above, in medical law we are genuinely reaching an end of an era both in the development of the discipline and for the contributions of these pioneers. Kennedy and Grubb have already moved on, McLean is retired, Brazier serially succumbs to pressure to continue, and sadly Mason passed away in January 2017 after 22 years as Honorary Fellow in Edinburgh Law School.[6]

In the works honouring these colleagues, we should be able to discern a strong sense of their intellectual legacy. Can we do so with this collection honouring Peter Skegg?

One of the editors, Jesse Wall, provides a summary of each of the twelve contributions. This is helpful, and saves this writer the task of doing so in the style of the standard book review. But, this is also valuable for this review precisely because I am suggesting that we must move beyond what is standard when it comes to the festschrift. For Skegg’s book, I suggest that we can find examples of at least four dimensions of the contemporary (legal) festschrift in terms of how a colleague is being honoured: (i) honour through inclusion of work; (ii) honour through collegiality, (iii) honour through continuation of tradition, and (iv) honour through intellectual legacy. In what follows, I do not suggest that these categories are hard and fixed, nor that they are exhaustive, nor that any one contribution fits only into one category. Rather, I offer these insights for future contributions and editors alike to help us all to reflect collectively on the role and value of the festschrift.

Honour through inclusion

To have a festschrift prepared in one’s name is indeed an honour; but the converse is also true: it is an honour for certain colleagues to include their work in your festschrift. The quintessential example of this is John Keown’s contribution in Law, Ethics, and Medicine on ‘Debating Euthanasia: A Reply to Emily Jackson’. This is an unashamed continuation of the recent book, Debating Euthanasia,7 in which Keown and Emily Jackson wrote blind essays from diametrically different perspectives. This approach and the calibre of the contributions have already made that book a central element in medical law teaching. Keown had stated that he would write a reply after he read his opponent’s views. This chapter in Skegg’s festschrift is that reply, both to Jackson and also to reviewers of the original text. As a stand-alone contribution, its quality is unassailable. As a tribute to Peter Skegg, this is conveyed by its inclusion, but there is little evidence of engagement with Skegg’s multiple works on the topic. More evidence of direct engagement is found in the chapter by Lemmens and Kurz on ‘The Future of Medically-Hastened Death in Canada’. The authors use Skegg’s prediction in 1988 that the gradual lessening of influence of the concept of sanctity of life will impact greatly on legalisation of medically-hastened death: they suggest that this in part explains the current Canadian position, and they examine the consequences as a result. In yet another contribution by John Dawson on ‘The Powers Conferred By Community Treatment Orders’ we are offered a detailed account of powers under mental health law to supervise treatment of compulsory psychiatric patients, but again the voice of Skegg is absent.

Honour through collegiality

The range of antipodean contributors to this book is impressive and speaks volumes about the regard in which Peter Skegg is held. Colleagues who have themselves made long-standing contributions in the field continue to do so here. Thus, we have Loane Skene on ‘Proprietary Rights in Human Bodily Material: Recent Developments’, and Mark Henaghan with colleagues Ruth Ballantyne and Devon Helm on ‘Genes Versus Gestation” Protecting the Interests of Surrogate Mothers’. Skegg’s mentoring influence is very visible in Joanna Manning’s chapter on compensation for research-related injury in commercially-sponsored clinical trials in New Zealand.

Honour through tradition

In contrast, the chapter by Margaret Brazier on ‘The Criminal Process and Medical Practitioners: Shield or Sword’ is a tribute to the fact that much of Skegg’s work has been influenced and impacted by the criminal process. It is easy to forget today that medical law had to fight for its corner. Historically, it was dismissed, variously, as an aspect of tort and/or public law and/or criminal law. In adopting an historical account of the medical profession’s changing relationship with criminal law in its own attempt to regulate quackery, Brazier does justice to Skegg’s own interest in the persistent role of criminal law in the emergence of medical law and the modern medical profession. It is also important to remember that tradition starts with inspiration. Josephine Johnston’s piece entitled ‘If Thy Leg Offends Thee, Cut It Off: Surgery, Consent and the Criminal Law’ is testament to Peter Skegg as a mentor. The topic of body dysmorphia has emerged in recent years and Johnston’s proposed research topic clearly caught his intellectual attention. The chapter is the culmination of their academic relationship and will doubtless continue Skegg’s tradition of walking and exploring the medical/criminal divide. Tradition is also about enduring influence. In a gripping chapter by Nicola Peart on ‘Health and Disability Research Ethics Committees in New Zealand: Will the Current System Prevent Another “Unfortunate Experiment”?’, we are privy both to the NZ ethics review system and how it has changed over time, and also – most intriguingly – to a behind-the-scenes history of influences, particular from Peter Skegg. The enriching value of this chapter is considerable, seen most strongly in its Appendix that attempts to capture the experiential backdrop. Precisely this kind of added value can come from the festschrift format.

Honour through intellectual legacy

In this final section, I group three chapters that do the most work to engage with Peter Skegg’s intellectual contributions. They offer real insights into where and how these might endure. Jonathan Herring’s title speaks for itself: ‘Peter Skegg and the Question No-One Asks: Why Presume Capacity?’. Herein Herring revisits an early article by Skegg that adopts a paradigm-flipping stance and argues for its correctness, but he also shows why he – as a successor academic – would take this even further. In similar style, Marie Bismark’s insightful chapter on ‘Lifting Our Gaze: An Epidemiological Approach to Medical Regulation’ takes Skegg’s work to the next level, so to speak, by arguing for the benefits of having been taught by Skegg and his brother, David, an epidemiologist. This chapter is a wonderful example of next-generation socio-legal-scientific scholarship. Finally, the last word goes to one of the editors, Jesse Wall, who argues eloquently from Skegg’s own position on rights about principles of justice and the New Zealand Code of Patients’ Rights – leaving a disjunct between pragmatism and principle in future directions of protection.

In sum, each of these types of contribution will be found in other festschrifts. I offer this categorisation to alert all of us in academia to our public responsibility to ensure that we always strive to deliver added value through academia.

Notes and References

[1] Sheila A.M. McLean (ed), ‘First Do No Harm’ (Ashgate, Aldershot, 2006). 
[2] Catherine Stanton, Sarah Devaney, Anne-Maree Farrell and Alexandra Mullock (eds), ‘Pioneering Healthcare Law: Essays in Honour of Margaret Brazier’ (Routledge, Abingdon, 2016). 
[3] Pamela R. Ferguson and Graeme T. Laurie (eds) ‘Inspiring a Medico-legal Revolution: Essays in Honour of Sheila A.M. McLean’ (Ashgate, Aldershot, 2015).
[4] Attributed in the book to Andrew Grubb, ‘Glanville Williams: A Personal Appreciation’ (1998) 6 Med L Rev 133 at 136. 
[5] See Stephen Smith, ‘Catherine Stanton, Sarah Devaney, Anne-Maree Farrell and Alexandra Mullock (eds), Pioneering Healthcare Law: Essays in Honour of Margaret Brazier’; Pamela R Ferguson and Graeme T Laurie (eds), ‘Inspiring a Medico-Legal Revolution: Essays in Honour of Sheila McLean’ (2017) 25(1) Med Law Rev 165-175. 
[6] In honour of Ken Mason: http://masoninstitutekenmemories.blogspot.com.es/.
[7]Emily Jackson and John Keown, ‘Debating Euthanasia’ (Hart Publishing, Oxford, 2012).