By: Graeme Laurie

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.