ORCID Profile
0000-0002-7161-7521
Current Organisation
University of Tasmania
Does something not look right? The information on this page has been harvested from data sources that may not be up to date. We continue to work with information providers to improve coverage and quality. To report an issue, use the Feedback Form.
In Research Link Australia (RLA), "Research Topics" refer to ANZSRC FOR and SEO codes. These topics are either sourced from ANZSRC FOR and SEO codes listed in researchers' related grants or generated by a large language model (LLM) based on their publications.
Law | Law not elsewhere classified | Ethical Use of New Technology (e.g. Nanotechnology, Biotechnology) | Intellectual Property Law | Social and Community Psychology
Law Reform | Technological Ethics | Expanding Knowledge in Psychology and Cognitive Sciences | Justice and the Law not elsewhere classified | Legislation, Civil and Criminal Codes |
Publisher: Springer International Publishing
Date: 2016
Publisher: Informa UK Limited
Date: 14-11-2015
DOI: 10.1080/08989621.2014.919230
Abstract: Data and Safety Monitoring Boards (DSMBs) have become an increasingly common feature of clinical trial oversight, yet a paucity of legal or ethical frameworks govern these Boards' composition or operation, or their relationship with other actors with monitoring responsibilities. This paper argues that prevailing structural gaps are impeding harmonized systems for monitoring the ongoing ethical acceptability of clinical trials. Particular tensions stem from DSMBs' sweeping discretion in deciding whether and when to recommend that a trial should be terminated or amended based on safety and efficacy information. This discretion becomes especially challenging in light of DSMBs' monopoly over emerging trial data, which prevents Institutional Review Boards, sponsors, and investigators from participating in certain pivotal and ethically charged decisions. To address these disconnects, I advocate for strengthened pre-trial and post-trial communication in addition to innovative strategies to support DSMB decision making through the life of a trial.
Publisher: Cambridge University Press (CUP)
Date: 2014
DOI: 10.1111/JLME.12135
Abstract: Over the past decade, there has been an extensive debate about whether researchers have an obligation to disclose genetic research findings, including primary and secondary findings. There appears to be an emerging (but disputed) view that researchers have some obligation to disclose some genetic findings to some research participants. The contours of this obligation, however, remain unclear. As this paper will explore, much of this confusion is definitional or conceptual in nature. The extent of a researcher's obligation to return secondary and other research findings is often limited by reference to terms and concepts like “incidental,” “analytic validity,” “clinical validity,” “clinical relevance,” “clinical utility,” “clinical significance,” “actionability,” and “desirability.” These terms are used in different ways by different writers to describe obligations in different sorts of cases.
Publisher: Springer Science and Business Media LLC
Date: 08-2018
Publisher: Future Medicine Ltd
Date: 05-2014
DOI: 10.2217/PME.14.3
Abstract: While the development of next-generation sequencing technology has had a paradigm-changing impact on biomedical research, there is likely to be a gap between discovery of therapeutic benefits in research and actual adoption of the new technology into clinical practice. This gap can create pressure on the research enterprise to provide in idualized care more typical of the clinic setting because it is uniquely accessible in research. This blurring of the line between research and clinical care is understandable, and perhaps even inevitable. But even if the gap is only transitory, such a blurring can have lasting implications, both by expanding obligations imposed on researchers, but also by challenging long-held ethical views. We explore this idea, focusing on how the dissolving distinction between research and clinical care has influenced the vigorous debate around how researchers should manage genetic findings (sometimes separated into primary and incidental or secondary findings) resulting from research.
Publisher: Springer Science and Business Media LLC
Date: 25-09-2017
Publisher: Oxford University Press (OUP)
Date: 24-03-2021
DOI: 10.1093/CID/CIAB239
Abstract: Coronavirus disease 2019 (COVID-19) vaccines are being developed and implemented with unprecedented speed. Accordingly, trials considered ethical at their inception may quickly become concerning. We provide recommendations for Data and Safety Monitoring Boards (DSMBs) on monitoring the ethical acceptability of COVID-19 vaccine trials, focusing on placebo-controlled trials in low- and middle-income countries.
Publisher: Oxford University Press
Date: 25-07-2013
Publisher: Informa UK Limited
Date: 25-08-2015
Publisher: Informa UK Limited
Date: 02-01-2019
Publisher: Springer Science and Business Media LLC
Date: 16-05-2018
DOI: 10.1007/S11673-018-9856-7
Abstract: In Australia, along with many other countries, limited guidance or other support strategies are currently available to researchers, institutional research ethics committees, and others responsible for making decisions about whether to return genomic findings with potential value to participants or their blood relatives. This lack of guidance results in onerous decision-making burdens-traversing technical, interpretative, and ethical dimensions-as well as uncertainty and inconsistencies for research participants. This article draws on a recent targeted consultation conducted by the Australian National Health and Medical Research Council to put forward strategies for supporting return of finding decision-making. In particular, we propose a pyramid of decision-making support: decision-making guidelines, technical and interpretative assistance, and ethical assistance for intractable "tough" cases. Each step of the pyramid involves an increasing level of regulatory involvement and applies to a smaller subsection of genomic research findings. Implementation of such strategies would facilitate a growing evidence base for return of finding decisions, thereby easing the financial, time, and moral burdens currently placed on researchers and other relevant decision-makers while also improving the quality of such decisions and, consequently, participant outcomes.
Publisher: Springer Science and Business Media LLC
Date: 12-03-2018
DOI: 10.1007/S11673-018-9843-Z
Abstract: Allowing persons to make an informed choice about their participation in research is a pre-eminent ethical and legal requirement. Almost universally, this requirement has been addressed through the provision of written patient information sheets and consent forms. Researchers and others have raised concerns about the extent to which such forms-particularly given their frequent lengthiness and complexity-provide participants with the tools and knowledge necessary for autonomous decision-making. Concerns are especially pronounced for certain participant groups, such as persons with low literacy and Indigenous persons. Multimedia strategies have the potential to usefully supplement current consent practices in Australia however, information is needed about the need for supplementary consent practices, along with drivers for and barriers against adoption. This study initiates the required evidence base through an audit of informed consent practices for medical research in the Australian state of Tasmania to assess the need for, and current uptake of, supplementary consent strategies. Drivers for and barriers against adoption of multimedia consent practices were explored in detail through interviews with key stakeholders, including researchers, HREC chairs and members, and research participants, including Indigenous participants.
Publisher: Oxford University Press (OUP)
Date: 13-08-2019
DOI: 10.1093/JLB/LSZ012
Abstract: Randomized controlled clinical trials, leading to large-scale meta-analyses, are considered the gold standard for research evaluating new drugs and other therapeutic interventions. To promote scientific integrity and prevent the adoption of potentially fallacious early trends, emerging information is commonly shielded from sponsors, investigators, and other clinical trial actors, including through the use of independent Data and Safety Monitoring Boards (DSMBs). Once established, a DSMB is usually the only body to have access to unblinded information until trial completion or the crossing of pre-specified, and often highly stringent, stopping boundaries. Yet, in certain circumstances, clinical trial actors have legal obligations to trial participants and others to use or disclose emerging information. This paper canvasses potential legal obligations to use or disclose emerging clinical trial data, including through tort law and securities laws. The analysis is supplemented by a comprehensive search of US cases in which courts have adjudicated upon such allegations. Notably, available cases demonstrate widespread judicial deference to clinical trial practices designed to shield clinical trial actors from emerging information. As a result, despite a theoretical possibility of legal obligations of use or disclosure, it appears that these will rarely be enforceable.
Publisher: American Association for the Advancement of Science (AAAS)
Date: 03-05-2019
Publisher: SAGE Publications
Date: 19-05-2020
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.
Publisher: Springer Science and Business Media LLC
Date: 26-08-2021
Publisher: Frontiers Media SA
Date: 15-10-2021
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.
Publisher: American Association for the Advancement of Science (AAAS)
Date: 03-05-2019
Publisher: Informa UK Limited
Date: 02-07-2020
Publisher: Oxford University Press (OUP)
Date: 07-2022
DOI: 10.1093/PHE/PHAC010
Abstract: Hawe et al. raise concerns about Human Research Ethics Committees (HRECs) taking a risk-averse and litigation-sensitive approach to ethical review of research proposals. HRECs are tasked with reviewing proposals for compliance with the National Statement on Ethical Conduct in Human Research for the purpose of promoting the welfare of participants. While these guidelines intentionally include a significant degree of discretion in HREC decision making, there is also evidence that HRECs sometimes request changes that go beyond the guidance provided by the National Statement. When HRECs request changes outside their remit, inconsistencies between in idual HRECs become more common, contributing to delays in ethical review and reducing the quality of HREC decision making. Improvements to the HREC regulatory system are needed to promote transparency and accountability.
Publisher: Springer Science and Business Media LLC
Date: 2017
Start Date: 2018
End Date: 12-2024
Amount: $614,454.00
Funder: Australian Research Council
View Funded ActivityStart Date: 06-2018
End Date: 12-2024
Amount: $628,576.00
Funder: Australian Research Council
View Funded Activity