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.
17 May 2019
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
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
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
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.
Please, access the article by following:
LeungGKK. Criminalizing medical research fraud: Towards an appropriate legalframework and policy response. MedicalLaw International 2019 March14
View other publications by Gilberto on the Mason Institute website.
1 March 2019
1 February 2019
Shared ideas about how we should behave have an important influence on our health. How we maintain our appearance, what we eat, how we move around our neighbourhoods and what we do to look after ourselves when we are ill, are all affected by ideas about what is appropriate behaviour. This will vary considerably depending on, amongst other things, our age, ethnicity, gender, religion and social status. Such matters of individual preference are shaped by the ideas of those around us – by our parents, teachers, friends and neighbours. Such conventions are not formal rules, like laws or regulations, and so going against them may, at times, result in little more than social awkwardness, but they nevertheless, shape our behaviour. In other cases, social norms may be so strongly entrenched that flouting or ignoring them might come at great cost.
Sociologists and social psychologists often refer to such informal conventions as ‘social norms’. One sociologist defined a norm as: ‘a statement specifying how a person is, or persons of a particular sort are, expected to behave in given circumstances – expected, in the first instance, by the person that utters the norm. What I expect of you is what you ought to do.’ 
This definition raises questions about the dual aspects of norms. On the one hand a norm can describe what a particular kind of person might do, an average response to a specific situation. But norms also have a prescriptive aspect – a norm is not just an average response, but how a person is supposed to behave in given circumstances. To make this distinction clear, some authors reserve the term ‘social norm’ for these prescriptive (‘normative’) expectations, and use the term ‘descriptive norm’ for other less demanding requirements. However, whether individuals’ behaviour corresponds to any set of expectations is always an open question that needs empirical investigation.
As a bioethicist and a sociologist interested in the ethics of public health, we think that norms may provide additional description and explanation of people’s health-related behaviours to those used in current health policy. Neither approaches which explain everything in terms of individual choice (ignoring the contexts in which those choices are made), nor those that see individuals as blindly responding to their environments seem entirely satisfactory. Thinking about the operation of social norms in relation to health allows us to develop better understandings of people’s behaviour, and explain how certain behaviours are important to our identities.
In order to develop these ideas further we organised an interdisciplinary workshop in early September 2019. Our participants included ethicists, psychologists and social scientists. These researchers presented their work on topics such as the cost of beauty practices, healthy eating behaviour, public health campaigns on anti-microbial resistance, toilet use and vaccination refusal. Over two days we listened to this diverse and very rich range of collection of case studies and discussed our very different theoretical approaches to norms. As with many interdisciplinary conversations, one early challenge was to be clear about the terms we were using – including what we meant by the term ‘norm’. We also found that some disciplines allow researchers to develop strongly normative conclusions, whereas in other areas description is much more highly valued.
At the end of the event we felt like we had only just begun to address a complex topic and were left with a series of questions for further investigation. These include:
- Given that various disciplines define and approach social norms differently, how do we achieve cross-disciplinary dialogue?
- To what extent should we take a critical or normative approach to social norms?
- When and how do norms change, and can we direct these processes?
- Should we design public interventions that work with existing norms? Or, should we also aim at changing them?
- What happens when norms conflict?
28 November 2018
On Tuesday 27th November 2018 MI Deputy Directors and policy portfolio leads, Emily Postan and Annie Sorbie, attended the Health and Sport Committee to provide evidence on our MI consultation response to the Human Tissue (Authorisation) (Scotland) Bill. This Bill makes provision for the authorisation of the removal and use of parts of the body of a deceased person for transplantation and other purposes. Significantly, it proposes that Scotland move from the current ‘opt-in’ system, in which an individual’s organs may be used for transplantation only when they (or, after their death, a close relative) have explicitly authorised this, to one of ‘deemed authorisation’. Under the proposed law, adults who have not formally registered their wishes will be deemed to have authorised the use of their organs for transplant purposes, with some exceptions for particular groups of persons and types of body parts. Under the new law the option to ‘opt-out’ of donation will be placed on a statutory footing (as will a third option of explicitly ‘opting in’).
In our MI consultation response we had outlined our broad support for the policy objectives of the Bill, but emphasised that legislation is but one step towards improving donation and transplantation rates, and that a holistic package of regulatory, social and ethical measures are necessary to secure these objectives. These include the need for far-reaching public information programmes, training and resourcing of transplant coordination professionals, and comprehensive evidence-gathering about the impacts of the legislative changes.
Also giving evidence in this meeting of the Committee were Professor Alison Britton, Professor of Healthcare and Medical Law and Convenor of the Health and Medical Law Sub Committee for the Law Society of Scotland, and Dr Calum MacKellar, Director of Research at the Scottish Council on Human Bioethics.
In her oral evidence Dr Postan was able to answer the Committee’s questions on several issues.
The Committee was interested in the question of how the respective interests would be weighed and met under the new legislation, particularly whether relatives’ wishes might, in practice, often override those of deceased persons as they do under the current law. Under the proposed law, relatives will not have a legal entitlement to override the express or deemed wishes of the deceased, but if they present evidence that the most recent views of the deceased differ from those registered or deemed to hold, then this will be taken into account. Dr Postan suggested that providing guidance to transplant coordinators, to support them in judging what counts as reasonable evidence of changed wishes, could be of great value and noted the risks of sending mixed messages to family members about their degree of their involvement in decision-making when the deceased person’s wishes are not ambiguous. Along with the other witnesses she emphasised the need for a far-reaching communications and training strategy to support the changes in culture and expectations that will be needed if the new law is to function as intended.
Dr Postan responded to the Committee’s questions about the protection of adults lacking capacity under the proposed law by suggesting that as currently drafted the law perhaps reflects too binary a conception of capacity and that it ought to be interpreted in a way that is consistent with the recognition under the Adults with Incapacity (Scotland) Act 2000 that capacity can fluctuate and should be assessed in a context specific manner and that individuals should be supported to make decisions when they can.
The Committee reflected concerns of some consultees about the ethics and legality of also making pre-death procedures (preparatory to donation) subject to ‘deemed authorisation’. Dr Postan responded that even though these procedures might not be for the clinical benefit of the patient, as long as they are minimally invasive and do not cause discomfort or hasten death, they may be seen as being in the best interests of the patient (and therefore both lawful and ethical), insofar as they are a necessary and anticipated part of fulfilling their wishes to act as donors.
This work exemplifies the MI’s commitment to bringing our interdisciplinary approach and research to bear on practical questions. If you would like to bring a consultation to our attention or to discuss the possibility of working with us on a particular policy matter, please get in touch with us by emailing Emily Postan and Annie Sorbie.