Transitional Spaces

Transitional Spaces explore opportunities to accelerate medical advances by anticipating regulatory issues.

The law is notoriously slow to respond to new and emerging advances in medicine, science and technology. The challenges are manifold because different areas of biomedicine develop at different rates, and different countries are affected in their regulatory responses by varying economic, cultural and moral considerations.

This space will address the following research questions:

  • What does legal foresighting contribute to bringing about effective transitions in the biomedical sciences?
  • What conditions are required to ensure the interoperability of effective regulatory approaches between different sectors of scientific enquiry, improving regulatory efficiency for emerging biomedical research?

Empty Spaces

Empty Spaces explore the grey, unregulated area of experimental therapies.

Some areas of biomedical enquiry proceed in the spaces between existing areas of legal regulation. One example is experimental therapy, conducted in the grey area between well- established medical practice and the highly-regulated domain of clinical trials. This space exists for a number of reasons; for example, because patients run out of treatment options, and/or because there are insufficient numbers of patients or insufficient baseline evidence with which to begin a trial.

This space will address the following research questions:

  • What values, attitudes and behaviours inform research in spaces where law is silent and professional discretion is considerable?
  • How can empty regulatory spaces be populated in ways that strike an optimal balance between protection and promotion of interests, private and public?

Clogged Spaces

Clogged Spaces involves an exploration of areas of regulatory congestion.

Regulatory congestion has grown rapidly as a rule-based approach that is largely uninformed about the workings and trajectories of modern life sciences. It has tended to operate in a compartmentalised fashion focusing on particular objects of regulatory concern such as tissue or data leading to stand-alone frameworks around those objects, rather than a broader perspective that views biomedical research trajectories holistically

This space will address the following research questions:

  • What lessons can be learned about proportionality in health research regulation, drawing in particular on experiences in the data and tissue spheres, and on the ways in which law deploys this concept in legal disputes?
  • What are the tacit dimensions of HRR such as influences from professional behaviours, attitudes, relationships and environments that are missed by fixing the regulatory object?

Liminal Spaces

The key goal of this research is to provide the first-ever integrated, interdisciplinary and cross- cutting analysis of health research regulation (HRR). 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 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

Empty Spaces

Transitional Spaces

Dangerous Spaces