16 April 2020

DNACPRs and advance care planning in the COVID19 pandemic: key lessons

By Catriona McMillan and Victoria Sobolewska
Patient-doctor discussions surrounding do not attempt cardio-pulmonary resuscitation (DNACPR) orders amidst the COVID-19 pandemic have caused widespread, understandable panic in the UK, set against a backdrop of proportionately higher elderly deaths, discussions surrounding resource allocation (particularly with reference to ventilators), and emerging stories of rising care home deaths. Here, we highlight how current debates surrounding DNACPRs – and advanced care planning more generally – raise important lessons for the future surrounding how we might improve when clinicians and patients have these discussions in the process of care.
There is an understandable fear amidst the public at the moment that having a DNACPR order in place means that doctors will not try to save your life. This is not the case. The GMC guidance is clear that DNACPR orders do not imply that other treatments, for example oxygen, fluids, or antibiotics will be withheld or withdrawn. Moreover, DNACPR orders are not legally binding. Where DNACPR order has been made, CPR is still advised in certain situations, for example in cases of respiratory arrest from a reversible cause. However, it is important to be clear with patients that CPR is an undignified process, used to try to restart the heart. If successful, almost all patients require admission to ITU for ventilation, and this might not always be appropriate in patients with certain underlying co-morbidities, as full recovery would be very unlikely. The BMA ethical guidance on COVID-19 notes:
The pandemic, and the restricted availability of intensive care, will influence other clinical decision making within the hospital. For example, it will be important for clinicians to review and document the appropriateness of cardiopulmonary resuscitation for all inpatients (with or without COVID-19 associated illness) where there is a possibility of acute deterioration. If patients have sufficient background illness, co-morbidity and/or frailty that they would not be admitted to intensive care (because of the necessary restrictions on admissions), it is important that cardio-pulmonary resuscitation is not commenced in the event of a collapse. Performing advanced resuscitation for a patient for whom post-resuscitation intensive care cannot be provided would potentially cause harm to the patient, consume limited resources at a time of considerable strain, and potentially put the resuscitation team at unnecessary personal risk.
Ultimately the decision to put an order in place lies with the clinician, not the patient. However, clinicians considering making a recommendation for a DNACPR order, there is a legal requirement for them to discuss the matter with the patient (see Tracey v Cambridge University Hospital NHS Foundation). Exceptions to this are where a patient does not wish to discuss it, or if the clinician believes the discussion would cause the patient psychological harm (more than ‘distress’). Where patient lacks capacity to participate in discussion, clinicians must involve those appropriately interested in their welfare, for example a family member (see Winspear v City Hospitals Sundeerland NHS Foundation Trust).
We should carefully consider the ways in which we can learn from the understandable widespread concern surrounding DNACPRs in the context of COVID-19. As Ruth May (Chief Nursing Officer) and Stephen Powis (National Medical Director) have made clear, it is important that blanket polices with reference to age, disability, or medical condition should  not be adopted amidst this crisis. It is crucial that this continues to be the case. Reflection on the effects of the above concerns raised during this pandemic enables us to be more thorough with respect to when this decision process takes place between patient and clinician. Early discussions surrounding advance care decisions also enables patients to have more detailed, clear discussions surrounding why a DNACPR order has been suggested by their clinician. In urgent situations, for example at the time of an acute presentation to hospital, patients may be unable to communicate their wishes, or rationalise information about the likely effects of CPR (although this is certainly not always the case). Having these discussions while acutely unwell can cause distress, and have a detrimental effect to patient wellbeing. Facilitating advance care discussions when patients are well enables effective, sensitive communication, and avoids impersonal – and for some, alarming – methods such as letters. Making these decisions before triage thus enables clear doctor-patient communication as to a) why the patient may, or may not want a DNACPR order, and b) why the clinician does or does not believe a DNACPR order is appropriate. Dignity is a key factor in any discussion surrounding the end of life, and having these discussions earlier in the care process allows patients to consider what dying with dignity means for them, and while the decision ultimately lies with their clinician, it can also empower the patient to, for example, decide to stay at home for their last hours or days if they so wish.
Initiatives to reflect these suggestions are already underway. The ReSPECT form is a process to develop, and keep under review, choices about clinical care in emergency. Advance processes such as these enable patients to clearly distil and reflect their priorities in writing. However, this initiative is only being used in a few places at the moment. Public concerns raised about DNACPRs during the COVID-19 pandemic gives us opportunity to reflect on how we can improve normative clinical practice surrounding advance care planning in the long-term, for example by using ReSPECT forms, or advance statements. By improving the facilitation of patient-doctor and family discussions surrounding the end of life as common practice where appropriate, we can enable many more patients to record and update their wishes (in a legally valid manner), so that they are in place before any emergency care is required.
(Originally published on the Journal of Medical Ethics blog, here)
Authors and Affiliations:
Dr Catriona McMillan, Senior Research Fellow in Medical Law and Ethics, University of Edinburgh. Twitter: katy_mcmillan.
Dr Victoria Sobolewska, Internal Medicine Trainee, NHS Lothian.

Social justice should be key to pandemic planning and response

By Agomoni Ganguli Mitra
Covid-19 Supermarket
At the start of every public health ethics course I teach, I give my students a list of questions to explore, but leave the most important one until last: 'What kind of society do we want to be?'
I want them to circle back to this thought, no matter the topic, to instil in them the understanding that public health practice and policy are always based on value judgments. Our job, as ethicists, is not always to provide the right answer, but to clarify the values and interests embedded in our decision making.
The Covid-19 crisis illustrates why questions of social justice should be at the core of medical and public health responses. During a crisis, health care professionals are forced to make tragic choices. Should ventilators be prioritised for those with no underlying health conditions to help ensure better survival rates? Or should people in greatest need take precedence? The moral dilemmas facing health workers can be excruciating, but ethicists can help to illuminate the values that inform such decisions.
In our response to the current crisis, we can also provide direction on wider questions of social justice, which go far beyond how we determine medical priorities. Indeed, we face ethical dilemmas at a broader policy level. By adopting, for instance, a model that favours acquiring herd immunity – and opting to sacrifice some lives to save many more – we might fail to weigh up which lives, and vulnerable groups, we would be sacrificing.
Similarly, curbs on individual freedom – so highly prized in liberal societies – can become a focus of ethical tension. We might justify restrictive measures by invoking the collective good, or by showing that a relatively small burden on the general population will protect the most vulnerable. These varying approaches reflect different ethical values and attitudes towards justice, and the solutions are not straightforward.
Pandemics are as much about moral questions as medical ones. Issues of social justice, human vulnerabilityand structural inequality come into play at home and abroad. Pandemics, as we know, do not respect borders. Our global response should be one of partnership, rather than protectionism, and one based on solidarity and even a minimal sense of global justice.
A fresh approach is needed in our collective ethic. Reports of racism prompted by the pandemic are hugely concerning – a situation that is exacerbated by the protectionist political measures adopted by several countries, fuelling further nationalist sentiments. At an individual level, we see this ethos of looking after our own interests, at the expense of others, reflected in our empty supermarket shelves.
As politicians hasten to address economic concerns, we must stop to consider how our decisions are exacerbating inequalities associated with race, age, class, gender and disability. Are we only hearing the voices of the powerful, and silencing those of the most disadvantaged? It is a question we need to grapple with, individually and collectively.
There is growing evidence that the long-lasting effects of the pandemic will deepen structural and social inequalities. The imposition of strict social distancing will see many women and children forced to remain with their abusers while, in even the most privileged circumstances, women will bear the brunt of care work and provision of emotional support.
Similarly, people with disabilities not only face greater health risks, but will also suffer most from a lack of support services. In our rush to save lives, there is a growing risk that people with disabilities are seen as expendable. Among the worst affected will be those who have little or no claim on our governments; think of migrants stranded on the margins of society. There is no possibility of self-isolation in a refugee camp, or when you have a forced mass migration.
In the coming months, as our health systems focus on how to save lives – and, eventually, rebuild – an ethic based on social justice might prompt us to consider those socio-economically vulnerable members of society who have helped to prop up our economy and political structures during this crisis. Indeed, although we speak of a crisis, a pandemic of this nature has severe long-term repercussions. Will those of us who enjoy much privilege be willing to endure further sacrifice so that those who have lost the most in this pandemic are able to recuperate?
When I teach my class this autumn, the pandemic will loom large in my thinking. As I sit just now in my makeshift home-study and imagine training the next intake of doctors, lawyers and policy makers, I am increasingly convinced that ethics and justice should underpin all of public and global health. My key question to my new students will be: What kind of society do you want to build in the decades ahead? It may just make its way to the top of my list.
(Originally published on the Justice in Global Health Emergencies & Humanitarian Crises website, here)

17 March 2020

The COVID-19 pandemic: are law and human rights also prey to the virus?

By Graeme Laurie

COVID-19 was declared a global pandemic by the World Health Organization (WHO) on 11 March 2020. In the United Kingdom, after extensive criticism across different sectors of society regarding government inaction and ineffective policies  as well as piecemeal communication about possible measures relating to citizens over age 70 to maintain social distancing for a period of months   HM Government announced on 15 March that daily press conferences will be held “…to keep the public informed on how to protect themselves”. As for first responders and other professionals who find themselves at the front line of the battle to delay the spread of the virus, guidance is available, but its accessibility and absence of detail is worrying, as a cursory look at the official website will reveal. Importantly for this blog, the Department of Health and Social Care’s Coronavirus Action Plan makes no mention whatsoever of the legal position underpinning any of its initiatives. So, in this blog I ask:

Are law and human rights also prey to the impact of the COVID-19 virus?

In attempting to answer this question, I make the case for constant vigilance with respect to the role of the law and human rights in a public health emergency, as well as giving a brief account of the complex legal provisions that can be deployed as public health measures. I offer a checklist of considerations for delivering legal preparedness in emergency contexts, including the value of civil liberties impact assessments that can help to monitor compliance with law and human rights throughout these difficult times. 

On the importance of law in a public health emergency  

Law is a social tool of considerable importance. This is never truer than in the middle of a global health crisis when the situation changes rapidly and dramatically on an hourly basis. Law and legal institutions become crucial in maintaining the delicate balance between order and chaos, between public and private interests, and between promotion of the common good and protection of civil liberties. Global health emergencies require rapid, complex, multi-agency and multiple agent actions, as well as multi-layered-readiness at four stages, being: (1) preparation, (2) response (3) protection and (4) recovery. Lack of clarity about the role of law, or continued uncertainty about legal rights and responsibilities, can seriously hinder or impede effective responses. It is now clear that we are deep in the third phase (protection) of the COVID-19 pandemic, and any national and international governmental failures to prepare in advance for this latest pandemic will rapidly become apparent. This makes it all the more crucial that attention is paid to legal preparedness to respond responsibly to an rapidly-changing – and undoubtedly in the short-term  worsening situation, as plans and contingencies fail. 

At the time of the N1H1 flu pandemic, just over a decade ago, a speaker at a US summit on preparedness made the following astute comment:

 …when it comes to pandemics, any community that fails to prepare – expecting that federal government can or will offer a lifeline – will be tragically wrong. Leadership must come from governors, mayors, county commissioners, pastors, school principals, corporate planners, the entire medical community, individuals and families [1].

This suggests that there is a risk in over-centralisation of response mechanisms to global health emergencies. The threats are manifold, potentially affecting communication, coordination and contingency planning. From a legal perspective, it highlights that first responders and others, such as healthcare professionals, hospital and school administrators, and local officials must be properly supported and folded into rapid decision-making when responsibilities for hands-on management of the crisis falls to them. As a minimum, there must be clarity of legal responsibilities and obligations, including domestic laws and international human rights. 

What is the legal position on public health emergencies?

The legal position on responding to a public health emergency of international concern (PHEIC), as it is officially termed in legal parlance, begins with the International Health Regulations (IHRs, 2005). These establish ‘an agreed framework of commitments and responsibilities for States and for WHO to invest in limiting the international spread of epidemics and other public health emergencies while minimizing disruption to travel, trade and economies’. However, while acknowledging that the WHO and the IHRs may play an important role in surveillance and reporting of pandemics, and in providing a framework for tackling them, effective action must begin and end at the state level, as it remains the sole entity – in principle – with the sanctioned power to enact policies that can lawfully curtail civil liberties. This is also because of an obvious and serious limitation within the international regime: the absence of sanction mechanisms within the international framework to require compliance by countries. And, while WHO can assist a country in its surveillance and response if requested (Article 44), the real problem of dealing with an aberrant state remains.

Domestically in the UK, the legal position is piecemeal (to say the least). While the Coronavirus Action Plan acknowledges the importance of all four nations’ administrations to work together, the legal basis for this is fragmented. For example, in England and Wales, the bulk of legal authority is found in the Health and Social Care Act 2008, amending the Public Health (Control of Disease) Act 1984. The 2008 Act amendments are largely concerned with responses once a threat has already presented itself; it less concerned with contingency planning to coordinate responses prior to any such threat. While there are provisions for monitoring and notifying outbreaks, there is far less consideration for joined-up working beyond the very local response. Sections 45B and 45C of the 2008 Act confer powers on the Secretary of State to make provision by Regulations with respect to health protection measures for international travel and domestic affairs respectively. Provisions can be made both with respect to requiring action from professionals and authorities in the face of a public health threat and with respect to members of the public, their behaviour and their rights. As to the effect on members of the English and Welsh public, Regulations can impose restrictions or requirements in relation to persons, things or premises in the event of or in response to a threat to public health (s.45C(3)(c)). In particular, this can include a requirement that a child be kept away from school, and a prohibition or restriction on the holding of an event or gathering (s.45C(4)). Regulations can also include provision for imposing ‘a special restriction or requirement’ as set out in Sections 45G(2)(e)-(k), 45H(2), and 45I(2). These include, among other things, that a person be disinfected or decontaminated; that a person wear protective clothing; that a person’s health be monitored and the results reported; that a ‘thing’ be seized or retained, or be kept in isolation or quarantine; or that a premises be closed, decontaminated, or destroyed. Pursuant to section 45D(3), however, and unlike the powers in relation to international travel, domestic Regulations may not require that a person (i) submit to a medical examination; (ii) be removed to a hospital or other suitable establishment; (iii) be detained in a hospital or other suitable establishment, or (iv) be kept in isolation or quarantine. Such measures may be imposed only by an Order from a Justice of the Peace on application from a Local Authority. 

Similar provisions exist in Northern Ireland and Scotland, but underpinning all of this at the UK national level is the Civil Contingencies Act 2004.  The Civil Contingencies Act 2004 (CCA) is a measure of last resort when it comes to the creation of ‘emergency powers’, leaving existing legislation to govern responses across an incredibly wide range of areas and actors. The ability of this legislation to empower all relevant actors to respond adequately is questionable. The CCA itself lays down a broad framework for preparedness, but it is far from clear how, or indeed when, this would operate when we move from the stage of preparation to action, and whether the complex lines of communication and coordination that are essential to an effective response to a public health emergency are in place. Nor is it clear whether relevant actors are sufficiently apprised of the measures and the legal parameters within which they will be expected to act when an emergency such as COVID-19 is upon us. 

The legal position, albeit complex can be summed up as follows: legislation such as the 2008 Act (and equivalent measures in Scotland and Northern Ireland) should be used in the first instance, while escalation of a crisis to an ‘emergency’ – defined to include “(a) an event or situation which threatens serious damage to human welfare in a place in the United Kingdom”  triggers the centralised provisions of the CCA 2004. But how are officials, professionals and the public to navigate such complexities and to know what is being done legally or when the balance has been tipped too far away from the adequate protection of civil liberties in favour of a putative threat to public health?

Legal preparedness in the face of public health emergencies

In an attempt to begin to answer this question, I offer further core questions that should be at the heart of all plans and planning exercises for global or public health emergencies. These are:

i. Are all public health officials and other actors with responsibilities fully apprised of the relevant legal provisions, their duties and the limits of their roles?

ii. What is the level of informational joined-up-ness between sectors, jurisdictions, disciplines and professionals? That is, are lines of communication and balance of responsibilities clear within the complex web of potential actors? 

iii. Do existing laws impede preparedness, either through unnecessary provisions or lack of clarity or inflexibility?

iv. Are we aware of gaps in existing legal provision and are we clear on how these gaps will be filled (in particular how the CCA will be deployed)?

v. Are we naive in our premises, for example, that voluntary compliance with self-isolation or quarantine will prevail? If so, are we clear enough on what will happen next? 

vi. Do we have adequate mechanisms to test legal preparedness and to benchmark best practices? 

vii. Do we have adequate mechanisms to test the competencies of relevant actors with respect to legal preparedness?

viii. What are provisions for effective communication and coordination of legal materials and information about legal responsibilities?

ix. What provisions exist for decision-making when information is ‘less than complete’? 

x. What is the role of social distancing and who has authority to require or restrict it?

xi. What is the role, if any, of the military?

Wither human rights?

For so long as the UK remains a member of the Council of Europe and signatory to the European Convention on Human Rights, all legal preparedness must also be about ensuring that any measures taken that impact on civil liberties and human rights are necessary and proportionate to the social objective sought. The Civil Contingencies Act 2004 cannot amend the Human Rights Act 1998 (c.42), and any emergency regulations made under the Act are treated as subordinate legislation for the purposes of the 1998 Act. 

Pursuant to Section 22 of the 2004 Act (Part 2), emergency regulations may provide for: 

• The confiscation of property (with or without compensation); 
• The destruction of property, animal life or plant life (with or without compensation); 
• The prohibition or requirement of movement to or from a specific place; 
• The prohibition of assemblies (of specific kinds, at specific places or at specific times); 
• The prohibition of travel. 

Most obviously, these provisions could raise the following human rights/civil liberties issues:

• privacy; (Article 8 of the European Convention on Human Rights) 
• property; (First Protocol to the Convention); 
• mobility/liberty; (Article 5 of the Convention); and  
• freedom of association; (Article 11 of the Convention). 

There are a number of points to note about the nature and operation of human rights laws as they relate to global/public health emergencies. It is trite that while human rights are fundamental rights, in most instances they are not absolute. That is, while human rights instruments identify protections that are considered to be of core value to our society, these do not deserve protection at any cost. Exceptions are possible. The starting point is, however, that fundamental rights should be protected and the onus is on those who would interfere with such rights to justify any interference. Thus, Article 5 (protection of liberty) allows for detention of persons ‘for the prevention of the spreading of infectious diseases’, while Articles 8 and 11 (privacy and association respectively) permit interferences ‘…for the protection of health…or the rights and freedoms of others’. By the same token, interference with some rights is more readily justified than in other cases. For example, Article 5 only permits exceptions from a restricted and limited list, while Articles 8 and 11 permit a range of exceptions which are subject to the watchwords of necessity and proportionality. In such cases, interferences with human rights are only justifiable when they are in accordance with the law, necessary to address a pressing social need, and employ proportionate means towards specified ends. This can only be judged on a case-by-case basis, but permits a degree of latitude in determining what is necessary and proportionate, albeit with the proviso that interferences should be minimal to achieve the social objectives. The practical consequence of Article 5 is, however, that a potentially higher level of protection is accorded, in that it is more difficult to depart from its provisions. This gives effect to a form of hierarchy of rights, such that the ease with which interferences can be justified ranges from most difficult (Article 5) through moderate (Articles 8 and 11) to more easily justified (Article 1; Protocol 1 on property). 

Thus, central to the protection phase of legal preparedness is the need for the courts to be maintained, or at least for judicial oversight to be made possible at all times. There is a lack of clarity in the possible meanings of the threshold terms used in law, such as ‘necessary’, ‘proportionate’ and ‘public interest’. Notwithstanding, there is a wealth of case law and literature which has attempted to flesh-out meaning over time and on which to draw. 

Moreover, from the perspective of the ethical content of the value-based decisions, we can consider the intervention ladder developed by the Nuffield Council on Bioethics which offers a way of thinking about possible government action and appreciating the associated consequences for civil liberties. This ranges across options from ‘doing nothing’ and monitoring a situation, through measures oriented towards ‘enabling choice’, ‘guiding choice’, ‘restricting choice’ and, ultimately to ‘eliminating choice’. As the intervention becomes more intrusive, so the need for justification becomes more compelling. While acknowledging that there is an ethics element built into UK planning, governments and other responsible parties would do well to consider a Civil Liberties Impact Assessment to accompany all contingency plans with particularly close attention paid the points at which escalation of action will take place. Such an impact assessment might be modelled, for example, on existing privacy/data protection impact assessments which have operated in many countries world-wide for many years and that in some instances are now required under the EU’s General Data Protection Regulation (GDPR). A Civil Liberties Impact Assessment is also akin to human rights impact assessments, save that its scope will be wider than only looking at rights – our civil liberties encompass both rights and civic freedoms and protect us from state action even when any given human rights instrument might not apply. This is particularly important to bear in mind in the current UK post-Brexit era where there is open hostility in many quarters towards the European Convention on Human Rights. 

Legal Preparedness for Pandemic: a 10-point Plan

Drawing on all of the above, I suggest that there are 10 key areas where the UK could pay close attention to improving legal preparedness for dealing with the current COVID-19 pandemic (and all future global/public health emergencies). 

1. Assessing and meeting the (legal) training needs of all relevant actors, and not merely responders identified in legislation; 

2. Drafting legal instruments to govern practices in emergencies and testing legal validity beforehand; 

3. Establishing an open access central repository of legal instruments and measures; 

4. Identify more clearly tolerances for escalation of efforts and carrying out civil liberties impact assessments on all stages of contingency planning; 

5. Assessing and providing support for courts and associated personnel as crucial mechanism for dispute resolution and protection of civil liberties during outbreaks; 

6. Articulating and exploring the legal situation in the event of full escalation, and in particular, considering worst case scenario planning and the arrangements for policing such scenarios; 

7. Establishing and clarifying legal authority for deployment of military, limits and controls, if contemplated; 

8. Learning (legal) lessons from other public health emergencies, for example, SARS in Canada & Asia, Anthrax in Scotland, or even emergencies in other government departments such as the experiences of the Department for Environment, Food and Rural Affairs with foot-and-mouth disease.

9. Clarifying and assessing balance of powers and competencies across jurisdictions; 

10. Conducting further research on evaluating legal preparedness, for example, how best to protect civil liberties as threats increase and/or plans fail.

Acknowledgement

*This blog is based on research conducted to assessed legal preparedness in the wake of the H1N1 pandemic in 2008, and draws on the text published as Laurie, G & Hunter, KG (2009), 'Mapping, Assessing and Improving Legal Preparedness for Pandemic Flu in the United Kingdom', Medical Law International, vol. 10, no. 2, pp. 101-138. https://doi.org/10.1177/096853320901000202




[1] Special Supplement, The National Action Agenda for Public Health Legal Preparedness, (2008) 36:1 Journal of Law, Medicine and Ethics at 11.

17 May 2019

The professional duty of candour: widening the lens

A new, insightful blog post written by Annie Sorbie, Lecturer in Medical Law and Ethics and Zahra Jaffer, who is a PhD candidate at the Mason Institute. The article was published on the Professional Standards Authority blog, and can be accessed through the link.

10 May 2019

Protecting and promoting: Can regulatory stewardship lead the way in health research? A roundtable discussion at Edinburgh Law School – 29 March 2019


Edward Dove

On 29th March 2019, a roundtable of research ethics committee (REC) members, research managers, regulators, patient advocates, and scholars was convened at Edinburgh Law School to discuss “regulatory stewardship”, a potentially novel regulatory model of health research oversight that could improve regulatory interactions among different stakeholders.

The roundtable partially built on recent empirical research I conducted on the roles and practices of NHS RECs in light of recently implemented health research regulation that explicitly seeks to promote health research in the UK, in part by streamlining regulation itself. It was unclear to me how these recent regulatory changes, stressing efficiency and maximisation of UK competitiveness for health research and maximisation of return from investment in the UK, might affect the substantive and procedural workings of RECs. It was also unknown whether or how the modification of research regulation at the level of legal architecture to promote research—seen, for example, in the Care Act 2014 and in the mandate of the Health Research Authority (HRA)—might ‘trickle down’ to the day-to-day practices of RECs.

The research findings from that empirical investigation can serve as a basis for further assessments of the relationship between regulatory actors and health research, thereby opening the potential to inform policy decisions and policy reform. Indeed, a key aim of this roundtable was to consider a reimagining of ‘regulatory spaces’ in health research to optimise their effectiveness in delivering productive regulation. Core questions included:
  • How might participant protection and research promotion work together in a regulatory framework, if at all?
  • Is there a need for a deliberative space within which RECs can both negotiate the risks relevant to a research application and also work with researchers to get to a point where the application can be deemed ethically acceptable?
  • What range of actors needs to be involved, with which responsibilities, and towards which ends?
  • How might a regulatory deliberative space be protected to capture and promote the fluid, processual nature of REC deliberations and effective health research regulation? 
Research from the University of Edinburgh’s Liminal Spaces Project suggests that regulatory stewardship involves different actors—RECs and others involved in the regulation of health research—helping researchers and sponsors navigate complex regulatory pathways and work through the thresholds of regulatory approvals. Collective responsibility, as a component of regulatory stewardship, requires relevant actors to work together to design and conduct research that is ethical and socially and scientifically valuable and that ultimately aims to improve human health. This can only be accomplished if a framework delineates how and when regulators and regulatees should communicate with one another and makes clear who has what responsibility and role to be played (if any) at each stage in the research lifecycle.

To this end, in this roundtable we considered whether a regulatory framework for health research could identify different kinds of stewards with distinct roles, such as state stewards, institutional stewards, operational stewards and ethics stewards. If so, seen in this way, the example of the REC would serve as an illustration of a potentially much wider contribution to policy, regulation, law, and theory in the health research context. 

Using hexagon shapes to thematically group responses to several high-level questions posed to them (see the photo below), roundtable participants helped identify the key challenges and opportunities associated with regulatory stewardship. For example, several participants commented on the difficulty in teasing out the conceptual and practical difference between stewardship and gatekeeping, and considered whether there are aspects of health research regulation that can be researched more in-depth to see whether stewardship is observed or can be implemented as a pilot project. Participants also discussed the link between stewardship and proportionality: stewardship is partially about streamlining regulatory pathways, helping to avoid researchers and sponsors and getting bogged down in unnecessary paperwork or duplicative processes.
Overall, participants were enthused by the day-long discussion and the potentially beneficial impact of regulatory stewardship in health research. The immediate next step for our roundtable group is to construct a short policy brief that will chart the ways in which regulatory stewardship might be implemented in health research. Once finalised, as with the forthcoming roundtable report, it will be publicly disseminated on the Mason Institute website.

The roundtable participants acknowledge and thank Wellcome for funding the roundtable through a Senior Investigator Award entitled “Confronting the Liminal Spaces of Health Research Regulation” (Award No: WT103360MA), and the College of Arts, Humanities and Social Sciences at the University of Edinburgh for supporting the roundtable through funding from a Knowledge Exchange and Impact Grant.




26 April 2019

The Dissection of Medical Dramas: 19th February 2019


by Zahra Jaffer and Lynn Kennedy

As part of the Festival of Creative Learning (FCL), we hosted the event: The Dissection of Medical Dramas. This interactive workshop used popular television medical dramas and role-play to identify and discuss the relevant ethical issues that arise in the medical context. The workshop specifically focused on issues of consent and the provision of treatment.

Our aim in organising this event was to introduce participants to issues of medical law and ethics in an interactive and accessible manner. In the first segment of the event, we used clips from popular television series such as Grey's Anatomy, Chicago Med and Scrubs to identify and discuss a wide range of issues, such as, the refusal of treatment in late pregnancy, Do Not Attempt Cardiopulmonary Resuscitation (DNACPR) orders and treatment of patients with body dysmorphic disorder. The role-play segment was designed in a way that required participants to use the skills and information they learned from the first segment to identify and discuss issues in the role-play segment. We used television medical dramas and role-play because these mediums are easily accessible and engaging methods that would allow us to provide a fun and interactive workshop that would appeal to a wide audience. By using these mediums, we were celebrating creative learning methods, which was in line with the spirit of FCL.

There were three key points that we wanted participants to take away from our event:
1.     A competent adult’s right to refuse medical treatment and the evolving approach to a pregnant woman’s right to refuse treatment
2.     The differences in the approaches to consent and refusal of treatment in relation to children and mature minors
3.     Issues relating to when advance decisions are upheld

We raised these issues by showing participants relevant clips from the television series and then we asked their opinions regarding them. We developed the discussions further by using a number of methods, such as by positing ‘what if’ questions or by first discussing the legal position on the matter and then asking participants for their views on the position. The participants were very engaged and we had some illuminating discussions on the various issues raised, such as:

1.     Questions regarding the cessation of treatment versus actively bringing about the death of the patient in context of withdrawal of life support from a braindead patient. In turn, this raised questions concerning euthanasia and the distinction between acts and omissions.

2.     In relation to a pregnant woman’s right to refuse treatment, a participant observed that by not giving a pregnant woman the same rights as any other competent adult to refuse treatment, we would be limiting the woman’s autonomy and would be attempting to give legal rights to a foetus.

3.     In relation to the consent to treatment in the cases of children, participants raised the topical issue of vaccination. One of the participants pointed out that in Greece, parents have no legal authority to refuse to vaccinate their children. We were therefore able to learn about the approach of other jurisdictions on the matter.

We were very pleased to have such a good turnout and a highly engaged audience that raised thought-provoking discussions. The feedback from the event was positive, which suggests that the University of Edinburgh student community has interest in medical law and ethics issues and discussing this in an interactive, media-supported manner. Since this event was designed to aid learning in the area of medical law and ethics, we were delighted to see that all participants who provided feedback gave the event a high score on its usefulness, and that all stated that they learnt something new and that they would recommend the event to others. Overall, this has been a wonderful and a highly rewarding experience.

22 March 2019

Criminalizing medical research fraud: Towards an appropriate legal framework and policy response


Blog post by Gilberto Leung

When hunting for a topic for my Dissertation, I went from ‘research ethics’ to ‘research misconduct’ and eventually cases of medical research fraud that had been treated criminally in the US. Although there have also been calls for greater criminalization in the UK, little has been written about how the criminal law may actually be applied in this context. People were saying we should probably prosecute researchers such as Wakefield but no one seemed to know or wanted to know how to go about it. I thought I would examine the knowledge gap.

What I found was that the Fraud Act 2006 would work very well in dealing with MRF but it casts such a wide net that many ‘minor’ cases would also be caught. The main issue in front of me then was about determining the appropriate threshold for prosecution in something as complex as research fraud. I borrowed the concept of the CPS policy on assisted suicide and proposed a balance sheet approach. Together with some amateur work on actus reus and mens rea, I ended up with a (kind of) legal framework to complement the Fraud Act. In retrospect, it was a brave/mad move to dive into criminal law just like that but my supervisor (Professor Graeme Laurie) was extremely helpful and encouraging. Not sure if the government would listen to me but I am glad that the Dissertation got a prize and I shall always be grateful for the wonderful learning experience.

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View other publications by Gilberto on the Mason Institute website.