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
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