Rebekah McWhirter

Public trust in research depends in part on the capacity of the system to detect and correct errors in the research record. In Australia, this task is largely entrusted to research institutions through a self-regulatory framework. The present article seeks to contribute to ongoing conversations about whether the Australian framework is fit for purpose. Here, we assemble and analyze two sources of information that have been previously analyzed: research misconduct investigation policies at Australian Group of Eight universities (a group of Australian universities that purport to be its leading research-intensive universities) and published decisions and appeals arising from workplace disputes involving allegations of research misconduct. Together, these materials support existing concerns that universities are not adopting robust policies regarding reporting findings of misconduct and correcting the record, and that they sometimes fail to follow their own policies. Claims that the current self-regulatory approach is sufficient are not supported by our evidence. These findings provide a foundation for reform, including revisions to the existing guidelines and the creation of an independent oversight body with adequate enforcement powers.

A central challenge in vaccination policy, and public health generally, is the tension that arises between the interests of the community and the interests of individuals. Over the previous two centuries, a range of legislative interventions have been used in efforts to improve vaccination rates, with varying degrees of success in navigating that central challenge. Here, we use a historical and sociolegal approach to characterise and evaluate vaccination laws in Australia from 1853 to the present. In doing so, we provide both a descriptive account of how vaccination laws have operated in Australia and a normative argument for what the role of law should be in relation to vaccination. This study highlights that the role of law in creating accessible, trustworthy, and equitable systems for vaccination is more influential in achieving public health goals than coercive approaches.

The importance of generating and sharing human genomic data for human health is widely recognised. Whilst several international high-level frameworks provide guidance, local governance challenges and concerns of previously under-represented populations mean that the full potential of genomic data sharing remains unrealised. This commentary introduces the LINEAGE study, an Australian research project that is building an empirically-informed and normatively robust governance framework for the generation and sharing of genomic data.

Medical law is a maturing discipline. Although a relative newcomer to law school curricula, medical law is now widely offered, belying the efforts early adopters had to go to in order to defend its legitimacy as a field of serious legal scholarship. ¹ With a tendency to focus on the challenges of emerging technologies, it has been easy to categorise medical law as a new area of academic inquiry, and for research to concentrate on the present and future rather than looking to the lessons of history. This narrow focus, however, misses the potential insights that come from a longer-term view. As Margaret Brazier persuasively argues in this engaging new addition to Manchester University Press’s Contemporary Issues in Bioethics, Law and Medical Humanities series, ‘“Medical law” is not new: it just looked different’. ² Tracing the interactions and evolving relationship between law and healing from the 13th to the 19th century, she identifies numerous issues that resonate with present-day medical law concerns. This book builds upon, and more fully articulates, Brazier’s previously expressed ideas in relation to the value of studying the history of medical law, ³ which she argues is valuable both for its own sake and to inform the present. Her view is not uncritical, however: as she notes in the postscript, history can easily be distorted to fit the desired ends. She refers to Dobbs v Jackson Women’s Health Organization as an example of such practice, in which the Supreme Court drew upon the (questionable) views of a 13th-century monk and a 17th-century jurist, among others, to provide authority for the view that abortion was a common law crime. ⁴ Brazier’s unease with the misuse of medico-legal history doesn’t temper her enthusiasm for the subject. Rather, she agrees with Wofford that ‘History does not provide answers to the problems today: it merely helps to frame the question.’ ⁵

Hawe et al. raise concerns about Human Research Ethics Committees (HRECs) taking a risk-averse and litigation-sensitive approach to ethical review of research proposals. HRECs are tasked with reviewing proposals for compliance with the National Statement on Ethical Conduct in Human Research for the purpose of promoting the welfare of participants. While these guidelines intentionally include a significant degree of discretion in HREC decision making, there is also evidence that HRECs sometimes request changes that go beyond the guidance provided by the National Statement. When HRECs request changes outside their remit, inconsistencies between individual HRECs become more common, contributing to delays in ethical review and reducing the quality of HREC decision making. Improvements to the HREC regulatory system are needed to promote transparency and accountability.

Background: Absolute cardiovascular disease (aCVD) risk assessment is recommended in CVD prevention guidelines. Yet, General Practitioners (GPs) often focus on single risk factors, including blood pressure (BP). Pathology services may be suitable to undertake high‐quality automated unobserved BP (AOBP) measurement and aCVD risk assessment. This study explored GP attitudes towards AOBP measurement via pathology services and the role of BP in aCVD risk management.Methods: A brief survey was completed, after which a focus group (n = 8 GPs) and interviews (n = 10 GPs) explored attitudes to AOBP and aCVD risk via pathology services with an example pathology report discussed. Verbatim transcripts were thematically coded.Results: GPs predominantly used doctor‐measured BP despite low levels of confidence. High BP measured by AOBP reported with aCVD risk via pathology services, would prompt a follow‐up response. However, GPs focused on BP management. GPs were concerned about AOBP equivalency to routine BP measurements. After protocol explanation, GPs reported AOBP could value‐add to care delivery.Conclusion: GPs lacked familiarity of AOBP and maintained a focus on BP management in the context of absolute CVD risk. Targeted education on AOBP and BP management as part of absolute CVD risk is needed to support guideline‐directed care in practice.

White matter hyperintensities (WMH) are the most common brain-imaging feature of cerebral small vessel disease (SVD), hypertension being the main known risk factor. Here, we identify 27 genome-wide loci for WMH-volume in a cohort of 50,970 older individuals, accounting for modification/confounding by hypertension. Aggregated WMH risk variants were associated with altered white matter integrity (p = 2.5×10-7) in brain images from 1,738 young healthy adults, providing insight into the lifetime impact of SVD genetic risk. Mendelian randomization suggested causal association of increasing WMH-volume with stroke, Alzheimer-type dementia, and of increasing blood pressure (BP) with larger WMH-volume, notably also in persons without clinical hypertension. Transcriptome-wide colocalization analyses showed association of WMH-volume with expression of 39 genes, of which four encode known drug targets. Finally, we provide insight into BP-independent biological pathways underlying SVD and suggest potential for genetic stratification of high-risk individuals and for genetically-informed prioritization of drug targets for prevention trials.

Sharing of genomic and associated data is essential to clinical practice and biomedical research, and is increasingly encouraged by journals and funding bodies. Grappling with the range of legal and ethical issues raised by genomic data sharing presents a significant challenge, given the diversity of practices: from defined sharing of individual patient data, to broad-scale public sharing of research data, to uploading of direct-to-consumer test data by community members. Most commentary to date has discussed these issues in broad terms, but the debate can only progress if we engage with more granularity, grounded in jurisdictional and contextual specifics. We developed an empirical approach, creating a set of prototypical scenarios that capture the diversity of current genomic data sharing practices, which allows legal and ethical analysis of key issues at a granular level. The specificity of this approach provides a strong foundation for developing useful and relevant regulatory recommendations.