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
Legal and Ethical Regulation of the Use and Commercialisation of Human Biological Material. The Australian government has a policy of promoting expertise in genomics. An essential ingredient of research and development of the genomics industry is access to human biological material. A clear regulatory framework is required, consistent with national ethical principles. There is lack of clarity, legally and ethically, in relation to ownership (including derivative claims), consented and un-consent ....Legal and Ethical Regulation of the Use and Commercialisation of Human Biological Material. The Australian government has a policy of promoting expertise in genomics. An essential ingredient of research and development of the genomics industry is access to human biological material. A clear regulatory framework is required, consistent with national ethical principles. There is lack of clarity, legally and ethically, in relation to ownership (including derivative claims), consented and un-consented use, contracts, conflict of interest and benefit sharing in human biological material, including regenerative tissue. Clarification will facilitate ethical research and commercialisation. These issues will be analysed systematically with recommendations for Australia consistent with international standards.Read moreRead less
Facilitation and Regulation of Research and Development Involving Human Genetic Databanks. Australia's medical biotechnology research feeds into our biotechnology industries, with flow-on benefits for national health and prosperity. Realisation of these benefits is contingent upon community protection and public trust. An effective and appropriate regulatory regime is a foundation requirement. This project aims to shape a national regulatory framework for human genetic databanks that both facili ....Facilitation and Regulation of Research and Development Involving Human Genetic Databanks. Australia's medical biotechnology research feeds into our biotechnology industries, with flow-on benefits for national health and prosperity. Realisation of these benefits is contingent upon community protection and public trust. An effective and appropriate regulatory regime is a foundation requirement. This project aims to shape a national regulatory framework for human genetic databanks that both facilitates research and maintains highest ethical standards. By examining the balance between facilitation and regulation, assessing existing law reform proposals, making recommendations for further reform, and placing this analysis in the international context, this project will significantly benefit the nation and the research community. Read moreRead less
Governing solar radiation management research, development and deployment. This project will expand Australia’s climate response options by developing a governance framework for research, development and deployment of solar radiation management. These emerging technologies seek to reflect part of the sun’s energy from the earth to reduce climate change impacts. Through case studies of key proposals, marine cloud brightening and stratospheric aerosol injection, the project aims to develop nationa ....Governing solar radiation management research, development and deployment. This project will expand Australia’s climate response options by developing a governance framework for research, development and deployment of solar radiation management. These emerging technologies seek to reflect part of the sun’s energy from the earth to reduce climate change impacts. Through case studies of key proposals, marine cloud brightening and stratospheric aerosol injection, the project aims to develop national laws and research policies to responsibly govern research, development and deployment in Australia. This will deliver benefits for Australian governments, civil society, communities and researchers by managing risks and building public confidence in these technologies and provide a best practice model for other countries.Read moreRead less
Material Transfer Agreements and Open Science in the Genome Era. Research paradigms are changing rapidly in the Genome Era. Open access databases are increasingly popular and are required by public funding agencies. The role of material transfer agreements (MTAs) in this open access era is not clear. This project aims to assess the extent to which MTAs facilitate exchanges of biological materials between organisation in Australia and internationally. The project will assess whether MTAs are refl ....Material Transfer Agreements and Open Science in the Genome Era. Research paradigms are changing rapidly in the Genome Era. Open access databases are increasingly popular and are required by public funding agencies. The role of material transfer agreements (MTAs) in this open access era is not clear. This project aims to assess the extent to which MTAs facilitate exchanges of biological materials between organisation in Australia and internationally. The project will assess whether MTAs are reflecting the open data access movement or maintaining traditional closed proprietary practices. The project will make policy, ethical and legal recommendations for the development of MTAs to promote exchange of materials nationally and internationally and to facilitate the developing collaborative research culture. Read moreRead less
Genetic discrimination in Australia: an exploration of the nature and extent of the phenomenon within the legal and social context. This project involves national, groundbreaking research into the newly-emerging phenomenon of genetic discrimination in Australia. Undertaken by a multi-disciplinary, cross-institutional team with a wide range of expertise, this innovative and topical research will investigate genetic discrimination across three key perspectives: consumers, third parties and the le ....Genetic discrimination in Australia: an exploration of the nature and extent of the phenomenon within the legal and social context. This project involves national, groundbreaking research into the newly-emerging phenomenon of genetic discrimination in Australia. Undertaken by a multi-disciplinary, cross-institutional team with a wide range of expertise, this innovative and topical research will investigate genetic discrimination across three key perspectives: consumers, third parties and the legal system. It will advance the existing knowledge base, both nationally and internationally, and establish comprehensive baseline data for further evaluative research. Important outcomes for each of the three sectors will be generated, as well as a comprehensive overview of this important new Australian social issue. Recommendations will inform the development of appropriate law and policy.
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Sustainable fiscal federalism and reform of the GST distribution system. The primary source of funds for Australian States and Territories is GST revenue distributed by the Commonwealth using an equalisation formula that has proved to be politically unsustainable and in recent times manifestly inadequate to provide the revenue needed in response to crises and natural disasters. A tipping point has been reached and reform is urgently needed. Drawing on international experience with GST distributi ....Sustainable fiscal federalism and reform of the GST distribution system. The primary source of funds for Australian States and Territories is GST revenue distributed by the Commonwealth using an equalisation formula that has proved to be politically unsustainable and in recent times manifestly inadequate to provide the revenue needed in response to crises and natural disasters. A tipping point has been reached and reform is urgently needed. Drawing on international experience with GST distributions specifically and fiscal federalism more generally, the project aims to develop a reform blueprint for a sustainable and equitable fiscal federalism regime in Australia that best aligns with Australia’s current and long-term fiscal needs.Read moreRead less
Policing Hazardous Waste Disposal. In a specific sense, the research will advance understanding of the nature of environmental law enforcement in the particular area of hazardous waste (that in itself has major implications for the health and wellbeing of humans, ecological systems and nonhuman animals within Australia). More generally, interrogating environmental law enforcement in this manner will provide insight into models of intervention applicable to the further development of climate chan ....Policing Hazardous Waste Disposal. In a specific sense, the research will advance understanding of the nature of environmental law enforcement in the particular area of hazardous waste (that in itself has major implications for the health and wellbeing of humans, ecological systems and nonhuman animals within Australia). More generally, interrogating environmental law enforcement in this manner will provide insight into models of intervention applicable to the further development of climate change strategies, as well as building enforcement capacity and collaborative work practices that are relevant to combating other types of criminal activity (e.g., terrorism, transnational organised crime). Read moreRead less
Using Conservation Covenants for Ecosystem Restoration & Climate Adaptation. This project aims to investigate the role of conservation covenants in facilitating ecological restoration and adaptation to climate change. In light of international experience, the project examines Australia's legal experience with conservation covenants, with case studies in NSW, Queensland, Tasmania and Victoria. The project expects to generate new theoretical insights and practical knowledge about the obstacles an ....Using Conservation Covenants for Ecosystem Restoration & Climate Adaptation. This project aims to investigate the role of conservation covenants in facilitating ecological restoration and adaptation to climate change. In light of international experience, the project examines Australia's legal experience with conservation covenants, with case studies in NSW, Queensland, Tasmania and Victoria. The project expects to generate new theoretical insights and practical knowledge about the obstacles and opportunities for enabling covenants to play a more ambitious role in meeting biodiversity conservation and recovery goals. This should generate significant benefits to Australia in meeting its international environmental obligations, and improving collaboration between governments and community and landholder stakeholders.Read moreRead less
The age of personalised medicine: regulatory challenges for Australia. Australia is entering an age of personalised medicine where therapies and tests will be based on individual genetic profiles. This project aims to ensure that there is a best practice regulatory and governance environment for facilitating responsible research and clinical service delivery through a process of evidence-based regulatory reform.