Melbourne Law School - Research Publications

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    Preferences of the Public for Sharing Health Data: Discrete Choice Experiment
    Johansson, JV ; Bentzen, HB ; Shah, N ; Haraldsdottir, E ; Jonsdottir, GA ; Kaye, J ; Mascalzoni, D ; Veldwijk, J (JMIR PUBLICATIONS, INC, 2021-07-01)
    BACKGROUND: Digital technological development in the last 20 years has led to significant growth in digital collection, use, and sharing of health data. To maintain public trust in the digital society and to enable acceptable policy-making in the future, it is important to investigate people's preferences for sharing digital health data. OBJECTIVE: The aim of this study is to elicit the preferences of the public in different Northern European countries (the United Kingdom, Norway, Iceland, and Sweden) for sharing health information in different contexts. METHODS: Respondents in this discrete choice experiment completed several choice tasks, in which they were asked if data sharing in the described hypothetical situation was acceptable to them. Latent class logistic regression models were used to determine attribute-level estimates and heterogeneity in preferences. We calculated the relative importance of the attributes and the predicted acceptability for different contexts in which the data were shared from the estimates. RESULTS: In the final analysis, we used 37.83% (1967/5199) questionnaires. All attributes influenced the respondents' willingness to share health information (P<.001). The most important attribute was whether the respondents were informed about their data being shared. The possibility of opting out from sharing data was preferred over the opportunity to consent (opt-in). Four classes were identified in the latent class model, and the average probabilities of belonging were 27% for class 1, 32% for class 2, 23% for class 3, and 18% for class 4. The uptake probability varied between 14% and 85%, depending on the least to most preferred combination of levels. CONCLUSIONS: Respondents from different countries have different preferences for sharing their health data regarding the value of a review process and the reason for their new use. Offering respondents information about the use of their data and the possibility to opt out is the most preferred governance mechanism.
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    Governance mechanisms for sharing of health data: An approach towards selecting attributes for complex discrete choice experiment studies
    Johansson, JV ; Shah, N ; Haraldsdottir, E ; Bentzen, HB ; Coy, S ; Kaye, J ; Mascalzoni, D ; Veldwijk, J (ELSEVIER SCI LTD, 2021-06-16)
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    Toward better governance of human genomic data
    O'Doherty, KC ; Shabani, M ; Dove, ES ; Bentzen, HB ; Borry, P ; Burgess, MM ; Chalmers, D ; De Vries, J ; Eckstein, L ; Fullerton, SM ; Juengst, E ; Kato, K ; Kaye, J ; Knoppers, BM ; Koenig, BA ; Manson, SM ; McGrail, KM ; McGuire, AL ; Meslin, EM ; Nicol, D ; Prainsack, B ; Terry, SF ; Thorogood, A ; Burke, W (NATURE PORTFOLIO, 2021-01-01)
    In this Commentary, we argue that in line with the dramatic increase in the collection, storage, and curation of human genomic data for biomedical research, genomic data repositories and consortia have adopted governance frameworks to address the dual objectives of enabling wide access while protecting against possible harms. However, there are ongoing debates in the scientific community about the merits and limitations of different governance frameworks in achieving these twin aims; and indeed, best practices and points for consideration are notably absent when it comes to devising a governance framework for genomic databases. Based on our collective experience of devising and assessing governance frameworks, our Commentary identifies five key functions of “good governance” (or what makes “better governance”) and three areas where trade-offs should be considered when specifying policies within those functions. We apply these functions as a benchmark to describe, as an example, the governance frameworks of six large-scale international genomic projects.
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    Landscape of Participant-Centric Initiatives for Medical Research in the United States, the United Kingdom, and Japan: Scoping Review
    Hamakawa, N ; Nakano, R ; Kogetsu, A ; Coathup, V ; Kaye, J ; Yamamoto, BA ; Kato, K (JMIR PUBLICATIONS, INC, 2020-08-04)
    BACKGROUND: Information and communication technology (ICT) has made remarkable progress in recent years and is being increasingly applied to medical research. This technology has the potential to facilitate the active involvement of research participants. Digital platforms that enable participants to be involved in the research process are called participant-centric initiatives (PCIs). Several PCIs have been reported in the literature, but no scoping reviews have been carried out. Moreover, detailed methods and features to aid in developing a clear definition of PCIs have not been sufficiently elucidated to date. OBJECTIVE: The objective of this scoping review is to describe the recent trends in, and features of, PCIs across the United States, the United Kingdom, and Japan. METHODS: We applied a methodology suggested by Levac et al to conduct this scoping review. We searched electronic databases-MEDLINE (Medical Literature Analysis and Retrieval System Online), Embase (Excerpta Medica Database), CINAHL (Cumulative Index of Nursing and Allied Health Literature), PsycINFO, and Ichushi-Web-and sources of grey literature, as well as internet search engines-Google and Bing. We hand-searched through key journals and reference lists of the relevant articles. Medical research using ICT was eligible for inclusion if there was a description of the active involvement of the participants. RESULTS: Ultimately, 21 PCIs were identified that have implemented practical methods and modes of various communication activities, such as patient forums and use of social media, in the field of medical research. Various methods of decision making that enable participants to become involved in setting the agenda were also evident. CONCLUSIONS: This scoping review is the first study to analyze the detailed features of PCIs and how they are being implemented. By clarifying the modes and methods of various forms of communication and decision making with patients, this review contributes to a better understanding of patient-centric involvement, which can be facilitated by PCIs. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/resprot.7407.
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    The practice of active patient involvement in rare disease research using ICT: experiences and lessons from the RUDY JAPAN project.
    Hamakawa, N ; Kogetsu, A ; Isono, M ; Yamasaki, C ; Manabe, S ; Takeda, T ; Iwamoto, K ; Kubota, T ; Barrett, J ; Gray, N ; Turner, A ; Teare, H ; Imamura, Y ; Yamamoto, BA ; Kaye, J ; Hide, M ; Takahashi, MP ; Matsumura, Y ; Javaid, MK ; Kato, K (Springer Science and Business Media LLC, 2021-02-01)
    BACKGROUND: The role of patients in medical research is changing, as more emphasis is being placed on patient involvement, and patient reported outcomes are increasingly contributing to clinical decision-making. Information and communication technology provides new opportunities for patients to actively become involved in research. These trends are particularly noticeable in Europe and the US, but less obvious in Japan. The aim of this study was to investigate the practice of active involvement of patients in medical research in Japan by utilizing a digital platform, and to analyze the outcomes to clarify what specific approaches could be put into practice. METHODS: We developed the RUDY JAPAN system, an ongoing rare disease medical research platform, in collaboration with the Rare and Undiagnosed Diseases Study (RUDY) project in the UK. After 2 years of preparation, RUDY JAPAN was launched in December 2017. Skeletal muscle channelopathies were initially selected as target diseases, and hereditary angioedema was subsequently added. Several approaches for active patient involvement were designed through patient-researcher collaboration, namely the Steering Committee, questionnaire development, dynamic consent, and other communication strategies. We analyzed our practices and experiences focusing on how each approach affected and contributed to the research project. RESULTS: RUDY JAPAN has successfully involved patients in this research project in various ways. While not a part of the initial decision-making phase to launch the project, patients have increasingly been involved since then. A high level of patient involvement was achieved through the Steering Committee, a governance body that has made a major contribution to RUDY JAPAN, and the process of the questionnaire development. The creation of the Patient Network Forum, website and newsletter cultivated dialogue between patients and researchers. The registry itself allowed patient participation through data input and control of data usage through dynamic consent. CONCLUSIONS: We believe the initial outcomes demonstrate the feasibility and utility of active patient involvement in Japan. The collaboration realized through RUDY JAPAN was enabled by digital technologies. It allowed busy patients and researchers to find the space to meet and work together for the Steering Committee, questionnaire development and various communication activities. While the practice of active patient involvement in Japan is still in its early stages, this research confirms its viability if the right conditions are in place. (331 words).
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    Governance of research consortia: challenges of implementing Responsible Research and Innovation within Europe
    Morrison, M ; Mourby, M ; Gowans, H ; Coy, S ; Kaye, J (BMC, 2020-11-16)
    Responsible Research and Innovation ('RRI') is a cross-cutting priority for scientific research in the European Union and beyond. This paper considers whether the way such research is organised and delivered lends itself to the aims of RRI. We focus particularly on international consortia, which have emerged as a common model to organise large-scale, multi-disciplinary research in contemporary biomedical science. Typically, these consortia operate through fixed-term contracts, and employ governance frameworks consisting of reasonably standard, modular components such as management committees, advisory boards, and data access committees, to co-ordinate the activities of partner institutions and align them with funding agency priorities. These have advantages for organisation and management of the research, but can actively inhibit researchers seeking to implement RRI activities. Conventional consortia governance structures pose specific problems for meaningful public and participant involvement, data sharing, transparency, and 'legacy' planning to deal with societal commitments that persist beyond the duration of the original project. In particular, the 'upstream' negotiation of contractual terms between funders and the institutions employing researchers can undermine the ability for those researchers to subsequently make decisions about data, or participant remuneration, or indeed what happens to consortia outputs after the project is finished, and can inhibit attempts to make project activities and goals responsive to input from ongoing dialogue with various stakeholders. Having explored these challenges, we make some recommendations for alternative consortia governance structures to better support RRI in future.
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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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    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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    A Factorial Survey Investigating the Effect of Disclosing Parental Intellectual Disability on Risk Assessments by Children's Social Workers in Child Safeguarding Scenarios
    Retzer, A ; Kaye, J ; Gray, R (Oxford University Press (OUP), 2020)
    Literature suggests that, as parents, people with intellectual disabilities experience disproportionately high rates of child removal compared to other groups. A factorial survey of 191 children's social workers investigated the effect of disclosing parental intellectual disability (ID) upon risk assessments in a range of hypothetical child safeguarding scenarios. The case scenarios depicted a range of child safeguarding situations and parents' ID status was randomly included as an additional item of information. The data were fitted into a generalised ordinal logistic regression model. Findings indicate that when presented with scenarios considered to be less risky, the parental ID disclosure contributed significantly to a higher risk assessment score. However, when presented with scenarios that were considered more risky, the additional parental ID disclosure did not significantly contribute to a higher score. These findings indicate that the risk associated with parental ID is not fixed but relative to the situation in which it is encountered. The research concludes that in cases of low risk, the effect of parental ID is identified as a support need, whereas the lesser contribution of the disclosure to assessments of higher risk cases may indicate that parental ID is overlooked.