Reforming the regulatory environment for innovative health technologies. This project aims to comprehensively map the regulatory pathways that innovative health technologies must navigate from the laboratory to the clinic, and to identify areas of over and under regulation. Pathways for innovative procedures, medicines and devices will be analysed in three cutting edge case studies - genome editing, biologic medicines and bio-printing - with particular focus on therapeutic goods registration and ....Reforming the regulatory environment for innovative health technologies. This project aims to comprehensively map the regulatory pathways that innovative health technologies must navigate from the laboratory to the clinic, and to identify areas of over and under regulation. Pathways for innovative procedures, medicines and devices will be analysed in three cutting edge case studies - genome editing, biologic medicines and bio-printing - with particular focus on therapeutic goods registration and patents. Doctrinal, qualitative and iterative research methods will be used. The primary intended outcome is a set of recommendations to assist policy makers in ensuring consistency of regulatory policy and practice, thereby supporting innovation and safe clinical translation, for the benefit of all Australians.Read moreRead less
Genomic data sharing: issues in law, research ethics and society. This project aims to provide recommendations for best practice regulation and governance of genomic data sharing in Australia. Sharing of genomic data is essential to biomedical research and clinical practice. Scenarios will be used to map legal and quasi legal facilitators issues including barriers to sharing, and to assess their role in promoting public trust, using evidence-based processes and law reform methodology. Developin ....Genomic data sharing: issues in law, research ethics and society. This project aims to provide recommendations for best practice regulation and governance of genomic data sharing in Australia. Sharing of genomic data is essential to biomedical research and clinical practice. Scenarios will be used to map legal and quasi legal facilitators issues including barriers to sharing, and to assess their role in promoting public trust, using evidence-based processes and law reform methodology. Developing more effective and efficient regulation of genomic data sharing will promote public trust and encourage broader data sharing, facilitating scientific progress and delivery of precision medicine.Read moreRead less
Discovery Early Career Researcher Award - Grant ID: DE220100264
Funder
Australian Research Council
Funding Amount
$451,711.00
Summary
A Socio-Legal History of Australia's Environmental Lawyers. This historical study of 50 years of Australian environmental lawyering (1970-2020) aims to develop and preserve an unprecedented data set of environmental lawyers over multiple generations. It will create important new knowledge, challenging the common and limited treatment of lawyers as mere instruments of social causes and revealing a novel, and previously unexplored, layer of environmental governance. This new knowledge can be used ....A Socio-Legal History of Australia's Environmental Lawyers. This historical study of 50 years of Australian environmental lawyering (1970-2020) aims to develop and preserve an unprecedented data set of environmental lawyers over multiple generations. It will create important new knowledge, challenging the common and limited treatment of lawyers as mere instruments of social causes and revealing a novel, and previously unexplored, layer of environmental governance. This new knowledge can be used by environmentalists, researchers and policy makers to better understand and engage with this important class of social reformers. It can inform environmental advocacy, governance and environmental protection. Other benefits include building capacity in Australian socio-legal historical research. Read moreRead less