Melbourne Law School - Research Publications

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    Clinical Decision Support Systems and Medico-Legal Liability in Recall and Treatment: A Fresh Examination
    Prictor, M ; Taylor, M ; Kaye, J ; Emery, J ; Nelson, C ; Manski-Nankervis, J (Thomson Reuters, 2020)
    Clinical decision support systems (CDSSs) provide a valuable tool for clinicians to aid in the care of patients with chronic disease. Various questions have emerged about their implications for the doctor’s legal duty of care to their patients, in terms of recognition of risk, recall, testing and treatment. In this article, through an analysis of Australian legislation and international case law, we address these questions, considering the potential impact of CDSSs on doctors’ liability in negligence. We conclude that the appropriate use of a well-designed CDSS should minimise, rather than heighten, doctor’s potential liability. It should support optimal patient care without diminishing the capacity of the doctor to make individualised decisions about recall, testing and treatment for each patient. We foreshadow that in the future doctors in Australia may have a duty to use available well-established software systems in patient care.
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    Consent
    Kaye, J ; Prictor, M ; Laurie, G ; Dove, E ; Ganguli-Mitra, A ; McMillan, C ; Postan, E ; Sethi, N ; Sorbie, A (Cambridge University Press, 2021-06-24)
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    Reflections on dynamic consent in biomedical research: the story so far
    Teare, HJA ; Prictor, M ; Kaye, J (SPRINGERNATURE, 2020-11-28)
    Dynamic consent (DC) was originally developed in response to challenges to the informed consent process presented by participants agreeing to 'future research' in biobanking. In the past 12 years, it has been trialled in a number of different projects, and examined as a new approach for consent and to support patient engagement over time. There have been significant societal shifts during this time, namely in our reliance on digital tools and the use of social media, as well as a greater appreciation of the integral role of patients in biomedical research. This paper reflects on the development of DC to understand its importance in an age where digital health is becoming the norm and patients require greater oversight and control of how their data may be used in a range of settings. As well as looking back, it looks forwards to consider how DC could be further utilised to enhance the patient experience and address some of the inequalities caused by the digital divide in society.
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    'CTRL': an online, Dynamic Consent and participant engagement platform working towards solving the complexities of consent in genomic research
    Haas, MA ; Teare, H ; Prictor, M ; Ceregra, G ; Vidgen, ME ; Bunker, D ; Kaye, J ; Boughtwood, T (SPRINGERNATURE, 2021-01-06)
    The complexities of the informed consent process for participating in research in genomic medicine are well-documented. Inspired by the potential for Dynamic Consent to increase participant choice and autonomy in decision-making, as well as the opportunities for ongoing participant engagement it affords, we wanted to trial Dynamic Consent and to do so developed our own web-based application (web app) called CTRL (control). This paper documents the design and development of CTRL, for use in the Australian Genomics study: a health services research project building evidence to inform the integration of genomic medicine into mainstream healthcare. Australian Genomics brought together a multi-disciplinary team to develop CTRL. The design and development process considered user experience; security and privacy; the application of international standards in data sharing; IT, operational and ethical issues. The CTRL tool is now being offered to participants in the study, who can use CTRL to keep personal and contact details up to date; make consent choices (including indicate preferences for return of results and future research use of biological samples, genomic and health data); follow their progress through the study; complete surveys, contact the researchers and access study news and information. While there are remaining challenges to implementing Dynamic Consent in genomic research, this study demonstrates the feasibility of building such a tool, and its ongoing use will provide evidence about the value of Dynamic Consent in large-scale genomic research programs.
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    Dynamic Consent: An Evaluation and Reporting Framework
    Prictor, M ; Lewis, M ; Newson, A ; Haas, M ; Baba, S ; Kim, H ; Kokado, M ; Minari, J ; Molnar-Gabor, F ; Yamamoto, B ; Kaye, J ; Teare, H (SAGE Publications (UK and US), 2020)
    Dynamic consent (DC) is an approach to consent that enables people, through an interactive digital interface, to make granular decisions about their ongoing participation. This approach has been explored within biomedical research, in fields such as biobanking and genomics, where ongoing contact is required with participants. It is posited that DC can enhance decisional autonomy and improve researcher–participant communication. Currently, there is a lack of evidence about the measurable effects of DC-based tools. This article outlines a framework for DC evaluation and reporting. The article draws upon the evidence for enhanced modes of informed consent for research as the basis for a logic model. It outlines how future evaluations of DC should be designed to maximize their quality, replicability, and relevance based on this framework. Finally, the article considers best-practice for reporting studies that assess DC, to enable future research and implementation to build upon the emerging evidence base.
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    Australian Aboriginal and Torres Strait Islander Collections of Genetic Heritage: The Legal, Ethical and Practical Considerations of a Dynamic Consent Approach to Decision Making.
    Prictor, M ; Huebner, S ; Teare, H ; Burchill, L ; Kaye, J (SAGE Publications, 2020)
    The article considers whether a Dynamic Consent (DC) approach might be adopted with cultural leadership to support communication, education, deliberation and flexible choices by First Peoples. It posits that the DC model can provide for autonomous and informed choice by donors and their descendants about the treatment of individual samples, cognizant of both the samples’ value for future research and their profound personal and cultural meaning.