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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Co-operative intellectual property management and technology transfer for the Australian biotechnology industry. The Australian biotechnology industry rests on a framework of internationally competitive research and should be well placed to capture a significant share of expanding global markets. However, existing intellectual property (IP) management strategies do not make the most of this potential because they raise barriers to much-needed co-operation among industry players. By developing an ....Co-operative intellectual property management and technology transfer for the Australian biotechnology industry. The Australian biotechnology industry rests on a framework of internationally competitive research and should be well placed to capture a significant share of expanding global markets. However, existing intellectual property (IP) management strategies do not make the most of this potential because they raise barriers to much-needed co-operation among industry players. By developing and refining new co-operative IP management models in an Australian context, this project offers direct economic benefits (more efficient industry structures), improved social and economic benefits (better and cheaper biotechnology products and services), and an opportunity for Australia to take the lead in developing innovative approaches to IP management.Read moreRead less
Using jurors to gauge informed public opinion on sentencing. Policy makers and judicial officers are under increasing pressure to respond to public opinion on sentencing issues and yet gauging public opinion on these issues is problematic. This project will use a new means of ascertaining informed public opinion on sentencing issues to better inform policy makers and judicial officers.
Geopolitical change and the Antarctic Treaty System. This project aims to analyse current and emerging geopolitical tensions within the Antarctic Treaty System. Geopolitical tension was a key factor in the formation of the 1959 Antarctic Treaty and continues to shape the evolution of the wider Antarctic Treaty System. This project will examine critical moments in the history of the Antarctic Treaty System, using a new database of diplomatic documents to identify key indicators of geopolitical te ....Geopolitical change and the Antarctic Treaty System. This project aims to analyse current and emerging geopolitical tensions within the Antarctic Treaty System. Geopolitical tension was a key factor in the formation of the 1959 Antarctic Treaty and continues to shape the evolution of the wider Antarctic Treaty System. This project will examine critical moments in the history of the Antarctic Treaty System, using a new database of diplomatic documents to identify key indicators of geopolitical tension. The project aims to draw lessons on successful management of these geopolitical tensions. In doing so, the project intends to address a key focus of the Australian Government's Antarctic 20 Year Strategy and Action Plan, maintaining Australia's influence in Antarctica.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