Evaluation of CTRL: a web application for dynamic consent and engagement with individuals involved in a cardiovascular genetic disorders cohort.

There has been keen interest in whether dynamic consent should be used in health research but few real-world studies have evaluated its use. Australian Genomics piloted and evaluated CTRL ('control'), a digital consent tool incorporating granular, dynamic decision-making and communication for genomic research. Individuals from a Cardiovascular Genetic Disorders Flagship were invited in person (prospective cohort) or by email (retrospective cohort) to register for CTRL after initial study recruitment. Demographics, consent choices, experience surveys and website analytics were analysed using descriptive statistics. Ninety-one individuals registered to CTRL (15.5% of the prospective cohort and 11.8% of the retrospective cohort). Significantly more males than females registered when invited retrospectively, but there was no difference in age, gender, or education level between those who did and did not use CTRL. Variation in individual consent choices about secondary data use and return of results supports the desirability of providing granular consent options. Robust conclusions were not drawn from satisfaction, trust, decision regret and knowledge outcome measures: differences between CTRL and non-CTRL cohorts did not emerge. Analytics indicate CTRL is acceptable, although underutilised. This is one of the first studies evaluating uptake and decision making using online consent tools and will inform refinement of future designs.

WHERE DOES RESPONSIBILITY LIE? ANALYSING LEGAL AND REGULATORY RESPONSES TO FLAWED CLINICAL DECISION SUPPORT SYSTEMS WHEN PATIENTS SUFFER HARM.

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.

Recording our genes: Stakeholder views on genetic test results in networked electronic medical records.

Background: In Australia, national policy prioritises the integration of clinical genetic data with networked electronic medical records (EMRs) for enhanced coordination of care and clinical decision-making. Objective: To examine the needs, privacy expectations and concerns of patients, family members, patient advocates and clinicians in relation to the use of networked EMRs for clinical genetic information. Method: Purposive sampling was used to recruit 27 participants for a semi-structured qualitative interview, primarily over Zoom. The interviews were audio and video-recorded and externally transcribed. Interview transcripts were then coded and analysed in NVivo, using an inductive thematic approach. Results: Thematic analysis revealed diverse preferences regarding genetic information access and handling across participants, with five core themes being identified: degree of access and control; central role of genetic professionals as information gatekeepers; complexities of familial implications; external risks; and law, governance and policy; all strong themes that emerged across numerous participants. Conclusion: This project yielded unprecedented and significant insights into the views, needs and concerns of key stakeholders in Australia regarding the inclusion of health-related genetic test results in networked EMRs. Implications: These findings provide a critical reference point for much-needed law reform and policy-making around genetic test results in Australia.

Ethics guidelines use and Indigenous governance and participation in Aboriginal and Torres Strait Islander health research: a national survey.

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.

'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).

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 Maori 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 Maori 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.

Impact of Electronic Health Records on Information Practices in Mental Health Contexts: Scoping Review.

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.

Digital Mega-Studies as a New Research Paradigm: Governing the Health Research of the Future.

'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.

Culturally Adaptive Governance-Building a New Framework for Equity in Aboriginal and Torres Strait Islander Health Research: Theoretical Basis, Ethics, Attributes and Evaluation.

Indigenous health inequities persist in Australia due to a system of privilege and racism that has political, economic and social determinants, rather than simply genetic or behavioural causes. Research involving Aboriginal and Torres Strait Islander ('Indigenous') communities is routinely funded to understand and address these health inequities, yet current ethical and institutional conventions for Indigenous health research often fall short of community expectations. Typically, mainstream research projects are undertaken using traditional "top-down" approaches to governance that hold inherent tensions with other dominant governance styles and forms. This approach perpetuates long-held power imbalances between those leading the research and those being researched. As an alternative, Indigenous governance focuses on the importance of place, people, relationships and process for addressing power imbalances and achieving equitable outcomes. However, empowering principles of Indigenous governance in mainstream environments is a major challenge for research projects and teams working within organisations that are regulated by Western standards and conventions. This paper outlines the theoretical basis for a new Culturally Adaptive Governance Framework (CAGF) for empowering principles of Indigenous governance as a prerequisite for ethical conduct and practice in Indigenous health research. We suggest new orientations for mainstream research project governance, predicated on translating theoretical and practical attributes of real-world ethics, adaptive governance and critical allyship frameworks to Indigenous health research. The CAGF is being implemented in a national Indigenous multicenter trial evaluating the use of continuous blood glucose monitors as a new technology with the potential to improve diabetes care and treatment for Indigenous Australians-the FlashGM Study. The CAGF is a governance framework that identifies the realities of power, acknowledges the complexities of culture and emerging health technologies, and foregrounds the principle of equity for mainstream Indigenous health research.

Towards optimising chronic kidney disease detection and management in primary care: Underlying theory and protocol for technology development using an Integrated Knowledge Translation approach.

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.

'CTRL': an online, Dynamic Consent and participant engagement platform working towards solving the complexities of consent in genomic research.

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.

Reflections on dynamic consent in biomedical research: the story so far.

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.

Australian Aboriginal and Torres Strait Islander Collections of Genetic Heritage: The Legal, Ethical and Practical Considerations of a Dynamic Consent Approach to Decision Making.

Dynamic Consent (DC) is both a model and a specific web-based tool that enables clear, granular communication and recording of participant consent choices over time. The DC model enables individuals to know and to decide how personal research information is being used and provides a way in which to exercise legal rights provided in privacy and data protection law. The DC tool is flexible and responsive, enabling legal and ethical requirements in research data sharing to be met and for online health information to be maintained. DC has been used in rare diseases and genomics, to enable people to control and express their preferences regarding their own data. However, DC has never been explored in relationship to historical collections of bioscientific and genetic heritage or to contexts involving Aboriginal and Torres Strait Islander people (First Peoples of Australia). In response to the growing interest by First Peoples throughout Australia in genetic and genomic research, and the increasing number of invitations from researchers to participate in community health and wellbeing projects, this article examines the legal and ethical attributes and challenges of DC in these contexts. It also explores opportunities for including First Peoples' cultural perspectives, governance, and leadership as a method for defining (or redefining) DC on cultural terms that engage best practice research and data analysis as well as respect for meaningful and longitudinal individual and family participation.

Dynamic Consent: An Evaluation and Reporting Framework.

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.

Clinical Decision Support Systems and Medico-Legal Liability in Recall and Treatment: A Fresh Examination.

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.

Mind the Gap: Information Sharing Between Health, Mental Health and Social Care Services.

Information sharing is key to integrated, collaborative, and continuous care. People with a lived experience of mental illness may access several services across the health, mental health and social care sectors, which creates challenges for information sharing. The health informatics community has traditionally not prioritised social care informatics. However, with the growing role of social care in the lives of people with complex health conditions, now is the time when we must consider the articulation between health informatics and social care informatics in Australia. This paper reports the results of a qualitative study to understand the current context of information sharing between health, mental health and social care services. Interviews and focus groups with nine clinicians, caseworkers and support workers were undertaken. Thematic analysis supported the development of several themes. These include the growing role of social care services, the importance of trust and the challenge created by the complexity of conditions people can present with when accessing social care services. To ensure the growing range of social care services do not get left behind with the increasing digitisation of the Australian health system, the health informatics community should prioritise the inclusion of social care informatics in its scope of practice.

Evaluating the Contextual Integrity of Australia's My Health Record.

My Health Record (MyHR) is Australia's national personally-controlled electronic health record. Initially established in 2012, it moved from an opt-in to an opt-out system in 2018. This paper considers the privacy aspects of MyHR shared health summary. Drawing on Nissenbaum's theory of privacy as contextual integrity, we argue that the shift in the event-specific nature of information sharing leads to MyHR breaching contextual integrity. As per Nissenbaum's decision heuristic for contextual integrity, we evaluate this breach through a reflection on the changing nature of health care, including patient empowerment, and the greater complexity of care. It is evident that more needs to be known about the benefits of shared health summaries, as well as the actual use of MyHR by clinicians and patients. Though we focus on MyHR, this evaluation has broader applicability to other national electronic health records and electronic shared health summaries.

Equitable Participation in Biobanks: The Risks and Benefits of a "Dynamic Consent" Approach.

Participation in biobanks tends to favor certain groups-white, middle-class, more highly-educated-often to the exclusion of others, such as indigenous people, the socially-disadvantaged and the culturally and linguistically diverse. Barriers to participation, which include age, location, cultural sensitivities around human tissue, and issues of literacy and language, can influence the diversity of samples found in biobanks. This has implications for the generalizability of research findings from biobanks being able to be translated into the clinic. Dynamic Consent, which is a digital decision-support tool, could improve participants' recruitment to, and engagement with, biobanks over time and help to overcome some of the barriers to participation. However, there are also risks that it may deepen the "digital divide" by favoring those with knowledge and access to digital technologies, with the potential to decrease participant engagement in research. When applying a Dynamic Consent approach in biobanking, researchers should give particular attention to adaptations that can improve participant inclusivity, and evaluate the tool empirically, with a focus on equity-relevant outcome measures. This may help biobanks to fulfill their promise of enabling translational research that is relevant to all.