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View article: Author Correction: Returning raw genomic data to research participants in a pediatric cancer precision medicine trial
Author Correction: Returning raw genomic data to research participants in a pediatric cancer precision medicine trial Open
View article: Returning raw genomic data to research participants in a pediatric cancer precision medicine trial
Returning raw genomic data to research participants in a pediatric cancer precision medicine trial Open
In pediatric cancer precision medicine clinical trials settings, parents proactively seeking treatment and answers to causation may request return of their child's raw data and/or biospecimen. To satisfy such requests, the ZERO Childhood C…
View article: Data access arrangements in genomic research consortia
Data access arrangements in genomic research consortia Open
View article: Data ownership in genomic research consortia
Data ownership in genomic research consortia Open
Discourse around ownership of genomic sequence data has proliferated over recent years. There are likely to be few people who don’t feel a degree of connectedness to their genomic data. The inclusion of individuals’ genomic data in genomic…
View article: Policy and process for returning raw genomic data to parents and young adult participants in a pediatric cancer precision medicine trial.
Policy and process for returning raw genomic data to parents and young adult participants in a pediatric cancer precision medicine trial. Open
Sharing raw genomic data with research participants is not universally mandated. Yet, in padiatric cancer precision medicine clinical trials settings, parents proactively seeking treatment and answers to causation may request return of the…
View article: Mapping the intersection of intellectual property and competition law : misusing market power when refusing to license biomedical patents
Mapping the intersection of intellectual property and competition law : misusing market power when refusing to license biomedical patents Open
This thesis considers the conflict between intellectual property and competition law. There have been many attempts by noted scholars, regulatory authorities and courts to resolve this conflict, and determine how competition laws should be…
View article: Mapping the Intersection of Intellectual Property and Competition Law
Mapping the Intersection of Intellectual Property and Competition Law Open
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View article: An ethico-legal assessment of intellectual property rights and their effect on COVID-19 vaccine distribution: an Australian case study
An ethico-legal assessment of intellectual property rights and their effect on COVID-19 vaccine distribution: an Australian case study Open
This article posits that Australia, as an affluent country with increasing capacity to manufacture vaccines, has an obligation to assist its regional (and global) counterparts in implementing vaccination programs that protect their populat…
View article: Robot-Assisted Reconstruction of Ureteroileal Anastomotic Stricture with Y-V Plasty
Robot-Assisted Reconstruction of Ureteroileal Anastomotic Stricture with Y-V Plasty Open
View article: Returning raw genomic data: rights of research participants and obligations of health care professionals
Returning raw genomic data: rights of research participants and obligations of health care professionals Open
As the number of requests for raw genomic data increases, policies and protocols reflecting the perspectives of clinicians, patients, researchers and research participants are required Next generation sequencing technologies generate vast …
View article: Integrating Public Participation, Transparency and Accountability Into Governance of Marketing Authorisation for Genome Editing Products
Integrating Public Participation, Transparency and Accountability Into Governance of Marketing Authorisation for Genome Editing Products Open
Public participation, transparency and accountability are three of the pillars of good governance. These pillars become particularly important for innovative, personalised health technologies, because of the tendency of these technologies …
View article: Bespoke Regulation for Bespoke Medicine? A Comparative Analysis of Bioprinting Regulation in Europe, the USA and Australia
Bespoke Regulation for Bespoke Medicine? A Comparative Analysis of Bioprinting Regulation in Europe, the USA and Australia Open
Like most health-technology innovators, bioprinters are required to traverse a complex landscape featuring varied forms of regulation. This article focuses on one of the most complex aspects: the requirement imposed by regulatory authoriti…
View article: Induced Pluripotent Stem Cell-Based Systems for Personalising Epilepsy Treatment: Research Ethics Challenges and New Insights for the Ethics of Personalised Medicine
Induced Pluripotent Stem Cell-Based Systems for Personalising Epilepsy Treatment: Research Ethics Challenges and New Insights for the Ethics of Personalised Medicine Open
This is an Accepted Manuscript of an article published by Taylor & Francis in AJOB Neuroscience on 29 July 2021, available online: https://www.tandfonline.com/doi/full/10.1080/21507740.2021.1949404This paper examines potential ethical and …
View article: The Regulatory Role of Patents in Innovative Health Research and Its Translation from the Laboratory to the Clinic
The Regulatory Role of Patents in Innovative Health Research and Its Translation from the Laboratory to the Clinic Open
Regulators must ensure that innovative health research is safe and undertaken in accordance with laws, ethical norms and social values, and that it is translated into clinical outcomes that are safe, effective and ethically appropriate. Bu…
View article: Must ‘MTA’ equate with ‘delay’? Material Transfer Agreements and institutional processes in Australian biomedical research
Must ‘MTA’ equate with ‘delay’? Material Transfer Agreements and institutional processes in Australian biomedical research Open
The exchange of tangible materials remains essential to biomedical research, and has become increasingly formalised, including through use of Material Transfer Agreements (‘MTAs’). While MTAs provide comfort in clarifying legal relationshi…
View article: A Scenario-Based Methodology for Analyzing the Ethical, Legal, and Social Issues in Genomic Data Sharing
A Scenario-Based Methodology for Analyzing the Ethical, Legal, and Social Issues in Genomic Data Sharing Open
Sharing of genomic and associated data is essential to clinical practice and biomedical research, and is increasingly encouraged by journals and funding bodies. Grappling with the range of legal and ethical issues raised by genomic data sh…
View article: The myriad litigation and genetic diagnostic testing in Australia
The myriad litigation and genetic diagnostic testing in Australia Open
This article details a study conducted to ascertain whether the Myriad litigation has had a discernible effect on the availability and pricing of genetic diagnostic testing in Australia. It concludes that the impacts of the litigation have…
View article: Allocating Risk and Liability for Defective 3D Printed Products: Product Safety, Negligence or Something New?
Allocating Risk and Liability for Defective 3D Printed Products: Product Safety, Negligence or Something New? Open
The traditional relationships and roles of the manufacturer, wholesaler, retailer, and consumer are being challenged. The rise of the sharing economy, demonstrated through applications such as Uber, online auctions sites such as eBay, and …
View article: Patenting Nature — A Comparative Perspective
Patenting Nature — A Comparative Perspective Open
The landscape for patenting products and processes tied to the natural world has changed dramatically in recent times as a result of a series of decisions of the US Supreme Court, particularly Mayo Collaborative Services v Prometheus Labor…
View article: The Legal Vacuum Surrounding Access to Gene-based Research Materials and Data.
The Legal Vacuum Surrounding Access to Gene-based Research Materials and Data. Open
Tangible research materials and data sets are integral to biomedical research and diagnostic genetic testing. Patents over genes and other research tools have been blamed for restricting access to these tools, potentially slowing the pace …
View article: Patenting nature—a comparative perspective
Patenting nature—a comparative perspective Open
The landscape for patenting products and processes tied to the natural world has changed dramatically in recent times as a result of a series of decisions of the US Supreme Court, particularly Mayo Collaborative Services v Prometheus La…
View article: Provenance and risk in transfer of biological materials
Provenance and risk in transfer of biological materials Open
Whereas biological materials were once transferred freely, there has been a marked shift in the formalisation of exchanges involving these materials, primarily through the use of Material Transfer Agreements (MTAs). This paper considers ho…
View article: Correction to: Australia: regulating genomic data sharing to promote public trust
Correction to: Australia: regulating genomic data sharing to promote public trust Open
View article: Australia: regulating genomic data sharing to promote public trust
Australia: regulating genomic data sharing to promote public trust Open
View article: Provenance and Risk in Transfer of Biological Materials
Provenance and Risk in Transfer of Biological Materials Open
View article: My Way or the MTA: The Use of Material Transfer Agreements in Publicly Funded Research in Australia
My Way or the MTA: The Use of Material Transfer Agreements in Publicly Funded Research in Australia Open
This Occasional Paper is the product of a four-year study investigating theuse of material transfer agreements (MTAs) in Australian publiclyfunded, biological research. The study commenced in 2014, and wasinspired by similar studies, prima…
View article: Creating and governing new monsters: Why we need engagements across art, science and law
Creating and governing new monsters: Why we need engagements across art, science and law Open
View article: Key challenges in bringing CRISPR-mediated somatic cell therapy into the clinic.
Key challenges in bringing CRISPR-mediated somatic cell therapy into the clinic. Open
View article: Key challenges in bringing CRISPR-mediated somatic cell therapy into the clinic
Key challenges in bringing CRISPR-mediated somatic cell therapy into the clinic Open
View article: The Multiple Dimensions of Intellectual Property Infringement in the 3D Printing Era
The Multiple Dimensions of Intellectual Property Infringement in the 3D Printing Era Open
3D printing is contributing to a global trend toward customization, user innovation and democratisation of design and manufacture. A key element of 3D printing is that computer aided design (‘CAD’) files are used to instruct printers to cr…