Confronting the Liminal Spaces of Health Research Regulation. (360G-Wellcome-103360_Z_13_Z)

The key goal of this research is 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 mo ve 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: 1. Clogged spaces: this invo lves an exploration of areas of regulatory congestion. For example, it will deliver lessons from over-regulation in Genetics and Genomics that can be applied in other areas; 2. Empty spaces: this explores the grey, unregulated area of experimental therapies. This will promote Understanding the Brain. 3. Transitional spaces: this examines opportunities to accelerate medical advances by anticipating regulatory issues. This will drive Connecting Environment, Nutrition and Health. 4. Danger ous spaces: this engages regulatory hindrances that contribute to the notorious Valley of Death in commercial innovations.