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The Liminal Spaces Project is a five-year initiative that began in October 2014. This Wellcome Trust Senior Investigator Award in Medical Humanities led by Prof Graeme Laurie seeks to provide the first-ever integrated, interdisciplinary and cross- cutting analysis of health research regulation (HRR) as it impacts on, and often impedes, the Wellcome Trust vision of realising extraordinary improvements in human health. The research confronts the gaps between documented law and research practice – i.e., liminal regulatory spaces – and promotes an holistic approach thus far absent in HRR.

The liminal spaces framework suggests opportunity to move within and between spaces, but also exposes uncertainty and instability. When this occurs in regulation, law is often called upon. Crucially, this research challenges that response.

Four research strands will engage stakeholders across the Trust’s five challenges to ask: what is happening in the liminal spaces of HRR; what lessons can be learned across sectors and jurisdictions; and how can we better exploit liminal regulatory spaces?

The four strands are:

Clogged spaces: this involves an exploration of areas of regulatory congestion.

Empty spaces: this explores the grey, unregulated area of experimental therapies.

Transitional spaces: this examines opportunities to accelerate medical advances by anticipating regulatory issues.

Dangerous spaces: this engages regulatory hindrances that contribute to the notorious Valley of Death in commercial innovations.

The Liminal Spaces Project is being conducted under the auspices of the JK Mason Institute for Medicine, Life Sciences and the Law.