New ESRC grant: Biomodifying technologies and experimental space: organisational and regulatory implications for the translation and valuation of health research.
Investigators: Prof. Alex Faulkner (Centre for Global Health Policy); Dr Phoebe Li (Law,University of Sussex); Dr Michael Morrison (Principal Investigator, HELEX, University of Oxford); Prof. Jane Kaye (HELEX, University of Oxford), Prof .Andrew Webster (SATSU, University of York)
ESRC £610, 773 (FEC £763. 466) April 2017 – March 2020.
The research investigates three key biomedical innovations: ‘gene-editing' aiming to understand and remove disease-related genetic mutations, induced pluripotent stem cells (iPSCs) for regenerative therapies, and the emergence of medical 3D bioprinting. These 'biomodifying technologies' all increase the level of ‘personalisation’ in advanced medicine. They challenge existing governance frameworks of safety, quality control, traceability of biological materials, and medical product regulation and liability, and raise new questions for health systems and social science as 'gateway' technologies with wide-ranging healthcare applications. The project will contribute towards STS theory through the development of a conceptual framework of 'experimental space', focusing on spatial aspects of the science, the processes of ‘valuation’, and the regulatory and governance landscape. The research develops understanding of the impact of these technologies in the hospital, the clinic, the firm and the wider implications they will have for the health system.
The research team combines Science & Technology Studies, political sociology, ethics and law scholarship. The project uses a mixed methods approach combining documentary analysis with qualitative semi-structured interviews with stakeholders, inculding scientists working in academic laboratories, representatives of SMEs, patient groups, research agencies, regulators, and senior staff in important service organisations (e.g. biobanks). Secondary data from other European, US and East Asian sources will set the UK analysis in context. The project will result in data, academic papers and policy reports and engagements providing the first comprehensive social science analysis of these major trends in biomedicine.