Jane Nielsen

Defining Landscape Resistance Values in Least-Cost Connectivity Models for the Invasive Grey Squirrel: A Comparison of Approaches Using Expert-Opinion and Habitat Suitability Modelling

Publisher: Public Library of Science (PLoS)

Date: 07-11-2014

DOI: 10.1371/JOURNAL.PONE.0112119

Assessing Grey Squirrel Dispersal Patterns within the Landscape Using Sequence Variation

Publisher: Informa UK Limited

Date: 08-2013

DOI: 10.1080/01426397.2012.668179

Australia: regulating genomic data sharing to promote public trust

Publisher: Springer Science and Business Media LLC

Date: 08-2018

DOI: 10.1007/S00439-018-1914-Z

Key challenges in bringing CRISPR-mediated somatic cell therapy into the clinic

Publisher: Springer Science and Business Media LLC

Date: 25-09-2017

DOI: 10.1186/S13073-017-0475-4

Returning raw genomic data: rights of research participants and obligations of health care professionals

Publisher: Wiley

Date: 29-05-2022

DOI: 10.5694/MJA2.51546

Provenance and risk in transfer of biological materials

Publisher: Public Library of Science (PLoS)

Date: 13-08-2018

DOI: 10.1371/JOURNAL.PBIO.2006031

Patenting nature—a comparative perspective

Publisher: Oxford University Press (OUP)

Date: 10-2018

DOI: 10.1093/JLB/LSY021

Using GPS telemetry to validate least‐cost modeling of gray squirrel (Sciurus carolinensis) movement within a fragmented landscape

Publisher: Wiley

Date: 12-06-2013

DOI: 10.1002/ECE3.638

An ethico-legal assessment of intellectual property rights and their effect on COVID-19 vaccine distribution: an Australian case study

Publisher: Oxford University Press (OUP)

Date: 07-2022

DOI: 10.1093/JLB/LSAC020

Abstract: 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 populations. First, the article explores the capacity of high-income nations to meet their obligations, assist their neighbours and refrain from vaccine nationalism. This inquiry involves an analysis of the optimal ethical strategy for distributing vaccines globally, and the role that Australia might play in this distribution strategy. Secondly, the article examines the intellectual property landscape for vaccines in Australia, focusing on the patents that cover vaccine compositions and manufacturing techniques (recognizing the potential for know-how and access to materials as well as patents to affect manufacturing capacity). This article then discusses the strategies the Australian Government has at its disposal to counter potential intellectual property impediments whilst complying with existing obligations under the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS), as an ethically appropriate response to the pandemic. This article also considers whether a so-called TRIPS waiver could provide better options and concludes that the challenge of compelling disclosure of know-how remains.

A Scenario-Based Methodology for Analyzing the Ethical, Legal, and Social Issues in Genomic Data Sharing

Publisher: SAGE Publications

Date: 19-05-2020

DOI: 10.1177/1556264620920460

Abstract: 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 sharing presents a significant challenge, given the ersity of practices: from defined sharing of in idual patient data, to broad-scale public sharing of research data, to uploading of direct-to-consumer test data by community members. Most commentary to date has discussed these issues in broad terms, but the debate can only progress if we engage with more granularity, grounded in jurisdictional and contextual specifics. We developed an empirical approach, creating a set of prototypical scenarios that capture the ersity of current genomic data sharing practices, which allows legal and ethical analysis of key issues at a granular level. The specificity of this approach provides a strong foundation for developing useful and relevant regulatory recommendations.

Integrating Public Participation, Transparency and Accountability Into Governance of Marketing Authorisation for Genome Editing Products

Publisher: Frontiers Media SA

Date: 15-10-2021

DOI: 10.3389/FPOS.2021.747838

Abstract: 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 to raise distinct scientific, ethical, legal and social issues. Genome editing is perhaps the most personal of all innovative health technologies, involving precise modifications to an in idual’s genome. This article focuses on the adequacy of current requirements for public participation, transparency and accountability in the governance of the market authorisation for genome edited products. Although clinical trials for genome edited products are only just underway, lessons can be drawn from the marketing approvals pathways for related gene therapy products. This article provides a broad overview of the regulatory pathways that have been adopted by the US Food and Drugs Administration, the European Medicines Authority, and the Australian Therapeutic Goods Administration for reviewing gene therapy products for marketing approval. This analysis focuses on the extent to which public participation processes and transparency and accountability of review pathways are incorporated into marketing approval policy and practice. Following this review, the article proposes the application of Sheila Jasanoff’s “technologies of humility” as a foundation for meaningfully incorporating these pillars of good governance into regulatory processes for the review of products of genome editing. We conclude by articulating clear mechanisms for operationalising technologies of humility in the context of public participation, transparency and accountability, providing a blueprint for future policy development.

A Hypothetico-Deductive Approach to Assessing the Social Function of Chemical Signalling in a Non-Territorial Solitary Carnivore

Publisher: Public Library of Science (PLoS)

Date: 18-04-2012

DOI: 10.1371/JOURNAL.PONE.0035404

Induced Pluripotent Stem Cell-Based Systems for Personalising Epilepsy Treatment: Research Ethics Challenges and New Insights for the Ethics of Personalised Medicine

Publisher: Informa UK Limited

Date: 29-07-2021

DOI: 10.1080/21507740.2021.1949404

Abstract: ABSTRACTThis paper examines potential ethical and legal issues arising during the research, development and clinical use of a proposed strategy in personalized medicine (PM): using human induced pluripotent stem cell (iPSC)-derived tissue cultures as predictive models of in idual patients to inform treatment decisions. We focus on epilepsy treatment as a likely early application of this strategy, for which early-stage stage research is underway. In relation to the research process, we examine issues associated with biological s les data health vulnerable populations neural organoids and what level of accuracy justifies using the iPSC-derived neural tissue system. In relation to clinical use, we examine potential uses in pre-natal screening, and effects on clinical decision-making. Although our focus is providing recommendations for researchers developing work in this area, we identify the novel issue of deciding on an acceptable accuracy level for the system. We also emphasize an issue thus far neglected in the ethics of PM: PM tends to represent treatment decisions as though they should be directed solely by biomedical information, but this in itself could be detrimental to best personalizing treatment decisions in the clinic.

The Australian 'Valley of Death'? Australian research and patenting practices in bioprinting and genome editing

Publisher: Edward Elgar Publishing

Date: 14-07-2023

DOI: 10.4337/9781802206210.00009

Opening the dam: patent pools, innovation and access to essential medicines

Publisher: Cambridge University Press

Date: 24-06-2010

DOI: 10.1017/CBO9780511750786.012

Scent-marking investment and motor patterns are affected by the age and sex of wild brown bears

Publisher: Elsevier BV

Date: 08-2014

DOI: 10.1016/J.ANBEHAV.2014.05.017

Bespoke regulation for bespoke medicine? A comparative analysis of bioprinting regulation in Europe, the USA and Australia

Publisher: Future Medicine Ltd

Date: 09-2021

DOI: 10.2217/3DP-2021-0011

Abstract: 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 authorities to satisfy them of the safety, efficacy and clinical utility of resultant healthcare products. Satisfaction of such requirements can result in a significant lag between ‘breakthrough’ and clinical delivery. This article examines this aspect of regulation in the USA, Europe and Australia, three leading bioprinting research jurisdictions. In particular, it examines medical devices and medicines categories of regulation, questioning whether a new approach to regulation is required or whether existing product-based regimes are sufficiently adaptive.

The function of strategic tree selectivity in the chemical signalling of brown bears

Publisher: Elsevier BV

Date: 06-2013

DOI: 10.1016/J.ANBEHAV.2013.03.026

Colorado State University

Location: United States of America

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University Of Derby

Location: United Kingdom of Great Britain and Northern Ireland

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University Of Manchester

Location: United Kingdom of Great Britain and Northern Ireland

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University Of Birmingham

Location: United Kingdom of Great Britain and Northern Ireland

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The Innovation Pool In Australian Biotechnology: Assessing Optimal Strategies For Fostering Innovation Through Patenting And Patent Pooling

Start Date: 2009

End Date: 2012

Funder: Australian Research Council

Reforming The Regulatory Environment For Innovative Health Technologies

Start Date: 2018

End Date: 2021

Funder: Australian Research Council

Genomic Data Sharing: Issues In Law, Research Ethics And Society

Start Date: 2018

End Date: 2021

Funder: Australian Research Council

Discovery Projects - Grant ID: DP180100269

Start Date: 2018

End Date: 12-2024

Amount: $614,454.00

Funder: Australian Research Council

Discovery Projects - Grant ID: DP180101262

Start Date: 06-2018

End Date: 12-2024

Amount: $628,576.00

Funder: Australian Research Council

Discovery Projects - Grant ID: DP0985077

Start Date: 2009

End Date: 12-2013

Amount: $412,000.00

Funder: Australian Research Council