Can I record this? A scoping review of Australian hospital policies governing consultation recording.

ObjectiveRecording consultations can benefit patients and healthcare providers, but advantageous recording practices are dogged by legal concerns. In Australia, relevant laws are poorly understood. We postulate that local policies are more important than law in guiding consultation recording.

How often are patients recording their healthcare consultations in Australia and why? An online survey.

Purpose: Recording important healthcare consultations can benefit patients. Technological developments enable recordings by patients and health professionals, as well as real-time 'listening' by AI scribes. Not enough is known about whether and why patients record their consultations.

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.

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.

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.

'As Long as It's Used for Beneficial Things': An Investigation of non-Māori, Māori 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 Māori ethnicity and young people.

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.

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.

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.

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.

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.

'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.

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.

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.

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.

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.

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.

United Kingdom: transfers of genomic data to third countries.

In the United Kingdom (UK), transfer of genomic data to third countries is regulated by data protection legislation. This is a composite of domestic and European Union (EU) law, with EU law to be adopted as domestic law when Brexit takes place. In this paper we consider the content of data protection legislation and the likely impact of Brexit on transfers of genomic data from the UK to other countries.

Audio-visual presentation of information for informed consent for participation in clinical trials.

Background: Informed consent is a critical component of clinical research. Different methods of presenting information to potential participants of clinical trials may improve the informed consent process. Audio-visual interventions (presented, for example, on the Internet or on DVD) are one such method.

Interventions to improve safe and effective medicines use by consumers: an overview of systematic reviews.

Background: Many systematic reviews exist on interventions to improve safe and effective medicines use by consumers, but research is distributed across diseases, populations and settings. The scope and focus of such reviews also vary widely, creating challenges for decision-makers seeking to inform decisions by using the evidence on consumers' medicines use.This is an update of a 2011 overview of systematic reviews, which synthesises the evidence, irrespective of disease, medicine type, population or setting, on the effectiveness of interventions to improve consumers' medicines use.