Melbourne Law School - Research Publications

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    Ethics guidelines use and Indigenous governance and participation in Aboriginal and Torres Strait Islander health research: a national survey
    Burchill, LJ ; Kotevski, A ; Duke, D ; Ward, JE ; Prictor, M ; Lamb, KE ; Kennedy, M (WILEY, 2022-10-17)
    OBJECTIVES: To assess the use of NHMRC Indigenous research guidelines by Australian researchers and the degree of Aboriginal and Torres Strait Islander governance and participation in Indigenous health research. DESIGN, SETTING, PARTICIPANTS: Cross-sectional survey of people engaged in Indigenous health research in Australia, comprising respondents to an open invitation (social media posts in general and Indigenous health research networks) and authors of primary Indigenous health research publications (2015-2019) directly invited by email. MAIN OUTCOME MEASURES: Reported use of NHMRC guidelines for Indigenous research; reported Indigenous governance and participation in Indigenous health research. RESULTS: Of 329 people who commenced the survey, 247 people (75%) provided responses to all questions, including 61 Indigenous researchers (25%) and 195 women (79%). The NHMRC guidelines were used "all the time" by 206 respondents (83%). Most respondents (205 of 247, 83%) reported that their research teams included Indigenous people, 139 reported dedicated Indigenous advisory boards (56%), 91 reported designated seats for Indigenous representatives on ethics committees (37%), and 43 reported Indigenous health research ethics committees (17%); each proportion was larger for respondents working in Indigenous community-controlled organisations than for those working elsewhere. More than half the respondents reported meaningful Indigenous participation during five of six research phases; the exception was data analysis (reported as apparent "none" or "some of the time" by 143 participants, 58%). CONCLUSIONS: Indigenous health research in Australia is largely informed by non-Indigenous world views, led by non-Indigenous people, and undertaken in non-Indigenous organisations. Re-orientation and investment are needed to give control of the framing, design, and conduct of Indigenous health research to Indigenous people.
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    'As Long as It's Used for Beneficial Things': An Investigation of non-Maori, Maori and Young People's Perceptions Regarding the Research use of the Aotearoa New Zealand Integrated Data Infrastructure (IDI)
    Thabrew, H ; Aljawahiri, N ; Kumar, H ; Bowden, N ; Milne, B ; Prictor, M ; Jordan, V ; Breedvelt, J ; Shepherd, T ; Hetrick, S (SAGE PUBLICATIONS INC, 2022-07-18)
    The Aotearoa New Zealand Integrated Data Infrastructure (IDI) is a national database containing a wide range of data about people and households. There is limited information about public views regarding its use for research.A qualitative study was undertaken to examine the views of forty individuals attending a large hospital in Auckland, including those of Māori ethnicity and young people. Semi-structured interview data were analysed using Braun and Clarke's method of thematic analysis.Seven key themes emerged: 1) Limited knowledge about medical data held in national databases; 2) Conditional support for the use of the IDI, including for research; 3) Concerns regarding the misuse of IDI data; 4) The importance of privacy; 5) Different views regarding consent for use of data for research; 6) Desire for access to personal data and the results of research; and 7) Concerns regarding third party and commercial use. Young people and those of Māori ethnicity were more wary of data misuse than others.Although there is reasonable support for the secondary use of public administrative data in the IDI for research, there is more work to be done to ensure ethical and culturally appropriate use of this data via improved consent privacy management processes and researcher training.
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    Where does responsibility lie? Analysing legal and regulatory responses to flawed clinical decision support systems when patients suffer harm
    PRICTOR, MEGAN (OXFORD UNIV PRESS, 2022-07-15)
    Clinical decision support systems (CDSSs) are digital healthcare information systems that apply algorithms to patient data to generate tailored recommendations. They are designed to support, but neither dictate nor execute, clinical decisions. CDSSs can introduce new risks, both by design features that heighten clinician burden and by outright errors that generate faulty recommendations for care. In the latter instance, if such unintercepted recommendations were to result in harm to the patient, novel legal questions emerge. Does legal responsibility for this harm lie with the clinician, the software developer or both? What is the clearest path to a remedy? Further, how does the Australian regulatory framework provide for oversight and redress? This article analyses the potential forms of legal redress in negligence, contract and under statutory consumer law, for the patient and the clinician. It also examines the Australian regulatory framework, specifically in relation to the Australian Competition and Consumer Commission and the Therapeutic Goods Administration, and reflects on the framework's adequacy to protect patients and clinicians. It finds that the regulatory approach and the contour of legal risk still centre upon the clinician's duty to exercise decisional autonomy and to intercept flawed recommendations generated by algorithmic errors within CDSSs.
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    Impact of Electronic Health Records on Information Practices in Mental Health Contexts: Scoping Review
    Kariotis, TC ; Prictor, M ; Chang, S ; Gray, K (JMIR PUBLICATIONS, INC, 2022-05-04)
    BACKGROUND: The adoption of electronic health records (EHRs) and electronic medical records (EMRs) has been slow in the mental health context, partly because of concerns regarding the collection of sensitive information, the standardization of mental health data, and the risk of negatively affecting therapeutic relationships. However, EHRs and EMRs are increasingly viewed as critical to improving information practices such as the documentation, use, and sharing of information and, more broadly, the quality of care provided. OBJECTIVE: This paper aims to undertake a scoping review to explore the impact of EHRs on information practices in mental health contexts and also explore how sensitive information, data standardization, and therapeutic relationships are managed when using EHRs in mental health contexts. METHODS: We considered a scoping review to be the most appropriate method for this review because of the relatively recent uptake of EHRs in mental health contexts. A comprehensive search of electronic databases was conducted with no date restrictions for articles that described the use of EHRs, EMRs, or associated systems in the mental health context. One of the authors reviewed all full texts, with 2 other authors each screening half of the full-text articles. The fourth author mediated the disagreements. Data regarding study characteristics were charted. A narrative and thematic synthesis approach was taken to analyze the included studies' results and address the research questions. RESULTS: The final review included 40 articles. The included studies were highly heterogeneous with a variety of study designs, objectives, and settings. Several themes and subthemes were identified that explored the impact of EHRs on information practices in the mental health context. EHRs improved the amount of information documented compared with paper. However, mental health-related information was regularly missing from EHRs, especially sensitive information. EHRs introduced more standardized and formalized documentation practices that raised issues because of the focus on narrative information in the mental health context. EHRs were found to disrupt information workflows in the mental health context, especially when they did not include appropriate templates or care plans. Usability issues also contributed to workflow concerns. Managing the documentation of sensitive information in EHRs was problematic; clinicians sometimes watered down sensitive information or chose to keep it in separate records. Concerningly, the included studies rarely involved service user perspectives. Furthermore, many studies provided limited information on the functionality or technical specifications of the EHR being used. CONCLUSIONS: We identified several areas in which work is needed to ensure that EHRs benefit clinicians and service users in the mental health context. As EHRs are increasingly considered critical for modern health systems, health care decision-makers should consider how EHRs can better reflect the complexity and sensitivity of information practices and workflows in the mental health context.
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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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    Digital Mega-Studies as a New Research Paradigm: Governing the Health Research of the Future
    Bell, J ; Prictor, M ; Davenport, L ; O'Brien, L ; Wake, M (SAGE Publications, 2021-09-09)
    'Digital Mega-Studies' are entirely or extensively digitised, longitudinal, population-scale initiatives, collecting, storing, and making available individual-level research data of different types and from multiple sources, shaped by technological developments and unforeseeable risks over time. The Australian 'Gen V' project exemplifies this new research paradigm. In 2019, we undertook a multidisciplinary, multi-stakeholder process to map Digital Mega-Studies' key characteristics, legal and governance challenges and likely solutions. We conducted large and small group processes within a one-day symposium and directed online synthesis and group prioritisation over subsequent weeks. We present our methods (including elicitation, affinity mapping and prioritisation processes) and findings, proposing six priority governance principles across three areas-data, participation, trust-to support future high-quality, large-scale digital research in health.
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    Towards optimising chronic kidney disease detection and management in primary care: Underlying theory and protocol for technology development using an Integrated Knowledge Translation approach
    Manski-Nankervis, J-A ; Alexander, K ; Biezen, R ; Jones, J ; Hunter, B ; Emery, J ; Lumsden, N ; Boyle, D ; Gunn, J ; McMorrow, R ; Prictor, M ; Taylor, M ; Hallinan, C ; Chondros, P ; Janus, E ; McIntosh, J ; Nelson, C (SAGE PUBLICATIONS INC, 2021-04-01)
    Worldwide, Chronic Kidney Disease (CKD), directly or indirectly, causes more than 2.4 million deaths annually with symptoms generally presenting late in the disease course. Clinical guidelines support the early identification and treatment of CKD to delay progression and improve clinical outcomes. This paper reports the protocol for the codesign, implementation and evaluation of a technological platform called Future Health Today (FHT), a software program that aims to optimise early detection and management of CKD in general practice. FHT aims to optimise clinical decision making and reduce practice variation by translating evidence into practice in real time and as a part of quality improvement activities. This protocol describes the co-design and plans for implementation and evaluation of FHT in two general practices invited to test the prototype over 12 months. Service design thinking has informed the design phase and mixed methods will evaluate outcomes following implementation of FHT. Through systematic application of co-design with service users, clinicians and digital technologists, FHT attempts to avoid the pitfalls of past studies that have failed to accommodate the complex requirements and dynamics that can arise between researchers and service users and improve chronic disease management through use of health information technology.
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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.