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.

Please, access the article by following:

1 March 2019

The sixth annual ‘Great Medico-Legal Debate’: 21 February 2019

After five successful previous installments, the sixth annual ‘Great Medico-Legal Debate’ was held on 21 February 2019 at the University of Strathclyde. This was the first time that Strathclyde hosted this annual event, which explores the arguments on both sides of a current and exciting medical law and ethics topic.

This year’s debate topic concerned whether the best interests test regarding care of children should be reformed. As demonstrated by the recent high-profile media cases of Charlie Gard and Alfie Evans, there have been ongoing questions around whether the best interests test is fit for purpose in an era of increasing importance of patient and parental autonomy. Teams were divided into ‘Team for reform’ and ‘Team against reform’ and a wide audience attended, both from within and beyond the academy.

In a lively debate, the two teams considered issues of issues of human rights, medical ethics, and public policy arising over changes to the judicial test. Audience members were asked to consider and vote on the issue, after a brief introduction to the topic by the co-Director of the Mason Institute, Dr Agomoni Ganguli-Mitra. After arguments took place, audience members were asked to consider their stance and vote once more on whether the best interests test should indeed be reformed, in light of the debate that took place. Ultimately, after a close competition, the invited expert judge, Professor Alison Britton of Glasgow Caledonian University, decided in favour of ‘Team again reform’. Audience members’ voting also reflected this view that, while the application of the best interests test remains vexed, it has the advantage of providing what Professor Britton described as an ‘end point’. She praised the proposals for reform that had been argued for including alternative methods for dispute resolution between doctors and parents and models based on consensus building rather than a ‘test’. However, as Professor Britton underlined, the need for decisions to be made promptly and for such decisions to be final is particularly pressing in the context of a gravely ill child. As such, it was this consideration that ultimately swayed her finely balanced decision.
After six events, the ‘Great Medico-Legal Debate’ continues to deliver thoughtful and in-depth coverage of pressing issues in law and medical ethics, in a creative and stimulating format. Indeed, Professor Britton remarked upon the exceptional skills of the debate teams, who not only explored the topic of medical futility and the best interests test in detail, but also showcased their skills in legal research and argumentation.

We would like to say a huge thank you to everyone who made this year’s debate such a success, including our expert Judge, Professor Britton; our host at Strathclyde, Dr Mary Neal; the audience members who attended and participated so enthusiastically; and, most of all, the members of the debate teams, who gave up their own time to prepare for the debate and delivered such an excellent performance on the day. We look forward to continuing the seventh installment of the debate in 2020, and further building our medical law and ethics collaboration with universities across Scotland.

1 February 2019

Social Norms and Health: is a cross-disciplinary vision possible?

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.’ [1]

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.[2] 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?

[1] George Homans (1974) Social Behavior: its elementary forms (2nd edition) (New York: Harcourt, Brace & World).
[2] Christina Bicchieri (2017) Norms in the Wild: How to Diagnose, Measure, and Change Social Norms (Oxford: Oxford University Press)

28 November 2018

Mason Institute advises Scottish government on organ donation policy

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.

26 November 2018

Claims over human genome editing: scientific irresponsibility at its worst

The announcement made today, that the world’s first genome-edited babies have been born in China, is of grave ethical concern. 

In evaluating this news, we should first remember that these claims have not yet been scientifically validated through peer reviewed publication and independent scientific review. Yet whether or not the veracity of these reports is eventually borne out, making such claims, in a way that seems deliberately designed to provoke maximum controversy and shock value, is irresponsible and unethical.

Human genome editing is a highly contested, still emerging technology. While it holds tremendous potential for benefit, its development must be carefully governed via a process of inclusive global discussion amongst all those concerned. Instead, the covert application of human genome editing followed by this cavalier announcement of the work as a fait accompli puts at risk the entire future of this crucial technology. It threatens to jeopardise the relationship between science and society as well as causing damage to China’s international scientific reputation, and might potentially set the global development of valuable therapies back by years. Good science is not just about generating knowledge in a vacuum; context and consequences are vitally important, and the consequences of this irresponsible action may be dire indeed.

Furthermore, leaving aside the wider scientific and social consequences, the research in itself is deeply ethically problematic. Every scientific and ethical statement issued to date (notable examples of which include those from the US National Academies of Science and the UK's Nuffield Council on Bioethics) has emphasized the need for further research before genome editing is ready for clinical application to human embryos. The premature application of this experimental procedure involved exposing the children to as-yet uncharacterised, poorly understood risks. This might be justifiable where there are huge benefits to be gained, as for example where children would otherwise suffer a life-threatening, otherwise incurable disease. The claim made by those responsible for the research, however, is that the babies have been genome-edited in an attempt to make them immune to HIV. The lifetime risk of contracting HIV is extremely low in the first place; there are other means of prevention; and it is no longer an incurable, inevitably terminal disease. Putting these children at such drastic risk for such a marginal gain is unjustifiable. And playing with children's health and families' hopes in order to use them as a means for a cheap publicity stunt is nothing short of disgraceful.

Sarah Chan is Director of the Mason Institute for Medicine, Life Sciences and the Law; Chancellor's Fellow in the Usher Institute for Population Health Sciences, University of Edinburgh; and Co-Principal Investigator on the Wellcome Trust-funded Centre for Biomedicine, Self and Society

Author's declaration: The views expressed in this statement are my own as an academic working on the ethics of human genome editing, and do not reflect any official position of the Mason Institute, my employer or any organisations with which I am associated.

12 October 2018

Alternatives to Physician Dismissal of Vaccine Refusers

Despite robust evidence that routine immunization is safe and effective in averting a range of vaccine-preventable diseases and related complications, some parents refuse some or all vaccines for their children. Indeed, vaccine refusals have increased in the last decade; short of refusals, parents are increasingly delaying vaccines for their children, or are seeking alternative immunization schedules.[1] Given the challenges that vaccine refusers may present for physicians, some clinicians simply dismiss refusers (and their families) from their practice.[2] While dismissal data is not readily available for most jurisdictions, dismissal of patients by physicians is a growing phenomenon which the American Academy of Pediatrics seems to have recently endorsed.[1] Kathryn Edwards, Director of the Vanderbilt Vaccine Research Program, has defended the move as follows:

A number of pediatricians feel so strongly that if they [patients and their physician] don’t agree on vaccines, which are so basic to the delivery of care and have made such a big difference in children’s lives, how will they agree on a number of other things they’ll need to discuss?”[4]

However, it is important to recall that both parents and physicians have legal responsibilities when it comes to treatment decisions respecting children.

The starting point, of course, is that patients can refuse medical treatment, regardless of the harm that might come to them.  Similarly, in the absence of conflict between them, parents can refuse vaccines for their children, and the state will not normally interfere.[5] The law generally assumes that parents making healthcare decisions for their children will act in the children’s best interests. If conflict arises, and court direction as to the lawfulness of the treatment is requested, then a best interests analysis will be undertaken by the court, and a decision imposed.[6] In the UK vaccination cases heard to date – which rely on expert evidence to variable degrees – courts have consistently permitted the vaccinations to be administered.[7] Given the proven track record of vaccination, and the many salutary public health outcomes of broad vaccination, a parent ought to have a very high threshold to meet in making a case that routine vaccination is not in the child’s best interests.

For their part, physicians owe duties to individual patients and to the broader public, and failures to properly meet those duties can lead to liability. Under tort law, physicians can be held liable for the provision of information, advice, or treatment that fails to meet the accepted standard, and that causes foreseeable harm to someone in close enough proximity. For a patient to make an informed choice about vaccination, good information must be provided in comprehensible formats; both content and presentation need to be tailored to fit the parent’s/patient’s needs and capabilities, and it should not be presented in an adversarial manner.[8]

Physicians also have responsibilities – and can face sanctions for their breach – under their professional regulations and codes of conduct.[9] Most pertinent for present purposes, the GMC’s Good Medical Practice (2013) states:

62.         You should end a professional relationship with a patient only when the breakdown of trust between you and the patient means you cannot provide good clinical care to the patient.[9]

While this instruction might seem rather vague, and opens the possibility of dismissal for a wide range of reasons, the GMC has expanded in its guidance, Ending your Professional Relationship with a Patient (2013), stating:

3.            In rare circumstances, the trust between you and a patient may break down, for example, if the patient has: been violent, threatening or abusive to you or a colleague; stolen from you or the premises; persistently acted inconsiderately or unreasonably; made a sexual advance to you.[10]

The guidance is clear that dismissal will be rare and should only be undertaken in the most extreme cases. Moreover, in adopting this ‘nuclear’ option, physicians must not discriminate against patients by allowing personal views to affect treatment decisions.[11] If physicians base their dismissal on a conscientious objection to treating those who refuse to follow advice or to sufficiently provide for the health of their children, then they must explain to patients their objection.[12] However, given the nature of Article 52, it is not clear that this ground for dismissal is open to the physician, and it is a ground that, in any event, ought to be clearly and strongly circumscribed in availability.[13]

Parenthetically, the Canadian Medical Protective Association (CMPA) has offered professional advice with respect to dismissal in the vaccine context; it summarizes the physician’s legal responsibilities as: (1) obtaining appropriate consent to vaccinate; (2) documenting any refusal; and (3) refraining from dismissing refusers.[14] It further emphasises that:

Physicians should make every effort to continue to care for patients in the existing doctor-patient relationship in accordance with current standards of care.[14]

Given this legal and regulatory landscape, there is significant uncertainty around the scope to justifiably dismiss vaccine refusers (and their family). An alternative to dismissal, and one that better meets the physician’s broader patient and public health responsibilities, is to contact child protection agencies, or make applications to the court for an order with respect to the lawfulness of the intervention. While this may effectively end the doctor-patient relationship, it has the benefit of ensuring that the child will at least (most likely) get vaccinated.

Ultimately, while vaccine refusers can be frustrating for physicians to counsel in the surgery, it is important to avoid overly strong or strident messaging, which is often perceived as attacks on beliefs, making it unlikely that the refuser will hear the message. Strategies for preserving the doctor-patient relationship – which at least offers the possibility that the parent might be led to a vaccine-accepting stance – include the following:

·        Accept: Accept and embrace the parent refuser, no matter their decision; make them know their opinions are valued and they are being heard; this builds trust.

·        Acknowledge: Acknowledge that the refuser has good intentions and affirming that both the parent and the physician want the child/patient to be safe, healthy, and happy can be very powerful.

·        Actively Listen: Never assume or guess why the parent is refusing vaccines. Instead, through dialogue, elicit underlying vaccine concerns. Listening to the parent’s/patient’s responses is key.

·        Avoid Confrontation: Minimize confrontational approaches, adversarial stances, and overtly pressurized tactics. Do not emphasize or repeat ‘myths’ as this may reinforce the myth in the refuser’s mind.

·        Advise: Remember that physicians are (trusted) advisors. Thus, patients should be advised not only of the personal benefits of vaccination, but also the public health issues implicated, including the full range of risks and responsibilities.

·        Annotate: Document in the chart the refusal (or reasons for hesitancy) and that the risks and responsibilities have been reviewed.

While theoretically possible, patient dismissal for vaccine refusal should not be adopted lightly. Dismissal (of a family) for vaccine refusal has a complex array of professional, ethical, legal, and public health considerations.[15] It is in neither the best interests of the child patient nor the community to dismiss vaccine refusers. The most powerful tool for combatting vaccine refusal is a good doctor-patient relationship, the maintenance of which is at the heart of the physician’s legal and ethical responsibilities.

[1] K Edwards, J Hackell, et al. ‘Countering Vaccine Hesitancy’ (2016) 138 Pediatrics e20162146.
[2] O Yaqub, S Castle-Clarke et al., ‘Attitudes to Vaccination: A Critical Review’ (2014) 112 Social Science & Medicine 1-11
[3] C Hough-Telford, D Kimberlin et al., ‘Vaccine Delays, Refusals, and Patient Dismissals: A Survey of Pediatricians’ (2016) 138 Pediatrics e20162127.
[4] T Haelle, ‘AAP speaks out on dismissal of vaccine-refusing patients, vaccine hesitancy’, Pediatric News, 30 August 2016, at https://www.mdedge.com/pediatricnews/article/112056/vaccines/aap-speaks-out-dismissal-vaccine-refusing-patients-vaccine.
[5] B (A Child: Immunisation) [2018] EWFC 56 (Fam). See also BMA, Parental Responsibility (2006); Medical protection Association, Parental Responsibility (2012).
[6] Re C and F (Children) [2003] EWHC 1376 (Fam).
[7] LCC v A, B, C & D (Minors by their Children’s Guardian) K,S [2011] EWHC 4033 (Fam); F v F [2013] EWHC 2683 (Fam); Re M and N (Parental Responsibility: Immunisations) [2016] EWFC 69 (Fam); London Borough of Barnet v SL [2017] EWHC 125(Fam); B (A Child: Immunisation) [2018] EWFC 56 (Fam).
[8] Montgomery v Lanarkshire Health Board [2015] UKSC 11.
[9] GMC, Good Medical Practice (2013).
[10] GMC, Ending your Professional Relationship with a Patient (2013).
[11] GMC, Good Medical Practice (2013), Article 59.
[12] GMC, Good Medical Practice (2013), Article 52.
[13] S Harmon, ‘Abortion and Conscientious Objection: Doogan–A Missed Opportunity for an Instructive Rights-Based Analysis’ (2016) 16 Medical Law International 143-173.
[14] CMPA, How to Address Vaccine Hesitancy and Refusal by Patients or their Legal Guardians (2017).

[15] For more, see N MacDonald, S Harmon, et al., ‘Is physician dismissal of vaccine refusers an acceptable practice in Canada? A 2018 overview’ (2018) Paediatrics & Child Health, at https://academic.oup.com/pch/advance-article/doi/10.1093/pch/pxy116/5112977.

Regulation as Play: Sandboxes as the new regulatory space in health research?

The metaphor of the ‘regulatory space’ is now in widespread use in many sectors of regulation, and its appeal is strong for the interpretative flexibility that it brings and the kinds of questions that it raises. For example, what kinds of spaces exist? Who occupies such spaces, and what happens within them? Are these fixed and unchanging with clear roles and responsibilities?, or can they be more open, flexible and permissive? Ultimately, what does regulation look like in these spaces, and what can it become?

These are the kinds of questions that have occupied us for the last few years as part of our Liminal Spaces project, funded by Wellcome. This project explores a range of regulatory spaces that exist in the health research context. Our overarching objective is to effect lasting change in health research regulation across all fields of biomedicine, by transformative reconceptualisation and reorientation of current approaches away from legalistic, cautious and risk-driven paradigms. In other words, while there are many examples in health research regulation of the so-called Command & Control model of regulation – imagine the caricature of the Regulator with the Big Stick, legal authority, an inspectorate function, and the threat of criminal sanction for non-compliance as typified by the embryo research framework or clinical trials regimes– we have been exploring richer ways to understand the regulatory spaces that are possible and desirable across the wide range of activities that make up human health research.  

We have argued elsewhere that because of the inherent complexities in health research, and the multiple regulatory spaces that must be navigated to realise the social value from research – such as tissue management, data protection and sharing, ethics review and regulatory compliance – there is an unmet need to recognised the role of regulatory stewardship  For us, regulatory stewardship involves ‘guiding others with prudence and care across one or more endeavours—without which there is risk of impairment or harm—and with a view to collective betterment’. This answers, in part, one of the questions above about who needs to occupy regulatory spaces to help other actors engage with the complexities and to deliver on the promises of robust ethical research. 

But we are also interested in the nature of these regulatory spaces themselves, in particular when, whether and how these spaces can promote more flexible and imaginative ways of delivering supportive regulation while not unduly hindering the exploration of novel pathways for innovation. An emerging idea that reflects this is the notion of the regulatory sandbox, initially developed in the field of financial services . Most recently, the UK’s Information Commissioner’s Office has launched a public consultation for such an approach for data protection (closing date 12 October 2018 

“The ICO sandbox will be a safe space where organisations are supported to develop innovative products and services using personal data in innovative ways. They won’t be exempt from complying with data protection law, but they will have the opportunity to engage with us; drawing upon our expertise and advice on mitigating risks and data protection by design, whilst ensuring that appropriate protections and safeguards are in place.”

This approach has resonance with many of the findings from our Liminal Spaces project. For example:

-        Our empirical engagement with stakeholders through a Delphi study shows strong support for co-production of regulatory paradigms, and a move away from a Them and Us approach (Delphi publication forthcoming);
-        Our use of the lens of liminality to understand regulation better has revealed the importance of paying more attention to the processual nature of regulation, that is, involving the dynamic processes of interaction of affected actors over time, and the purposive reimagining of regulation as a collective enterprise (Laurie, 2017) and Taylor-Alexander et al, 2016;
-        Our work points to the crucial importance of having a Representative of Order in liminal spaces – i.e. those typified by uncertainty and transition and change – to lead participants through such spaces towards a valuable end point, even when uncertainty might reign as to precisely what that destination might look like.

Taken together, I would cast these elements and the example of the regulatory sandbox as an instance of Regulation as Play. This deliberately counter-intuitive term might seems frivolous, but it reflects deep thinking in the literature about the importance of play for human beings at all stages of life, especially when play is seen as ‘a process, not a thing…. that it begins in anticipation and hopefully ends in poise…in between you find surprise, pleasure, understanding — as skill and empathy — and strength of mind, body, and spirit.” (Eberle, first issue editorial, American Journal of Play).

Moreover, there are links between play literature and some key ideas from the field of liminality. One such idea is that of anti-structure that happens in liminal moments. As the famous liminality scholar, Victor Turner wrote about the work of the play scholar Sutton-Smith:

“Brian Sutton-Smith borrowed a term which I had earlier applied to “liminality” (and other social phenomena and events), namely, “anti-structure” (meaning the dissolution of normative social structure, with its role sets, statuses, jural rights and duties, etc.) and related it to a series of experimental studies he has been making of children’s (and some adult) games both in tribal and industrial societies…He writes: ‘The normative structure represents the working equilibrium, the ‘antistructure’ represents the latent system of potential alternatives from which novelty will arise when contingencies in the normative system require it. We might more correctly call this second system the protostructural system [he says] because it is the precursor of innovative normative forms. It is the source of new culture.’” (See V Turner, From Ritual to Theatre, PAJ Books, 1982, pp.18-19)

Turner further posited that we might actively seek antistructure, either because:

1.         …we have an overdose of order, or
2.         …because we have something to learn through being disorderly (ibid, p.17).

It is in these senses that I suggest initiatives such as the regulatory sandbox ought to be cast as Regulation as Play. Indeed, some initial work has been done on the role of play in the realm of responsible research and innovation. Regulatory sandboxes provide safe spaces where the imagination can take a more prominent role as opposed to the more typical ‘safe’ regulatory spaces that are too often obsessed with risk management and minimisation. As such, these new regulatory spaces are to be welcomed and explored fully in the genuine spirit that is the very embodiment of play. Our work continues as to how such approaches might be translated into the health research sphere.