Background Hospital infection prevention and control (IPC) programs are designed to minimise rates of preventable healthcare-associated infection (HAI) and acquisition of multidrug resistant organisms, which are among the commonest adverse effects of hospitalisation. Failures of hospital IPC in recent years have led to nosocomial and community outbreaks of emerging infections, causing preventable deaths and social disruption. Therefore, effective IPC programs are essential, but can be difficult to sustain in busy clinical environments. Healthcare workers’ adherence to routine IPC practices is often suboptimal, but there is evidence that doctors, as a group, are consistently less compliant than nurses. This is significant because doctors’ behaviours disproportionately influence those of other staff and their peripatetic practice provides more opportunities for pathogen transmission. A better understanding of what drives doctors’ IPC practices will contribute to development of new strategies to improve IPC, overall. Methods This qualitative case study involved in-depth interviews with senior clinicians and clinician-managers/directors (16 doctors and 10 nurses) from a broad range of specialties, in a large Australian tertiary hospital, to explore their perceptions of professional and cultural factors that influence doctors’ IPC practices, using thematic analysis of data. Results Professional/clinical autonomy; leadership and role modelling; uncertainty about the importance of HAIs and doctors’ responsibilities for preventing them; and lack of clarity about senior consultants’ obligations emerged as major themes. Participants described marked variation in practices between individual doctors, influenced by, inter alia, doctors’ own assessment of patients’ infection risk and their beliefs about the efficacy of IPC policies. Participants believed that most doctors recognise the significance of HAIs and choose to [mostly] observe organisational IPC policies, but a minority show apparent contempt for accepted rules, disrespect for colleagues who adhere to, or are expected to enforce, them and indifference to patients whose care is compromised. Conclusions Failure of healthcare and professional organisations to address doctors’ poor IPC practices and unprofessional behaviour, more generally, threatens patient safety and staff morale and undermines efforts to minimise the risks of dangerous nosocomial infection.

On March, 24, 2020, 818 cases of COVID-19 had been reported in New South Wales, Australia, and new cases were increasing at an exponential rate. In anticipation of resource constraints arising in clinical settings as a result of the COVID-19 pandemic, a working party of ten ethicists (seven clinicians and three fulltime academics) was convened at the University of Sydney to draft an ethics framework to support resource allocation decisions. The framework guides decisionmakers using a question-and-answer format, in language that avoids philosophical and medical technicality. The working party met five times over the following week and then submitted a draft Framework for consideration by two groups of intensivists and one group of academic ethicists. It was also presented to a panel on a national current affairs programme. The Framework was then revised on the basis of feedback from these sources and made publicly available online on April 3, ten days after the initial meeting. The framework is published here in full to stimulate ongoing discussion about rapid development of user-friendly clinical ethics resources in ongoing and future pandemics.

In response to the COVID-19 pandemic, there has been a rapid growth in research focused on developing vaccines and therapies. In this context, the need for speed is taken for granted, and the scientific process has adapted to accommodate this. On the surface, attempts to speed up the research enterprise appear to be a good thing. It is, however, important to consider what, if anything, might be lost when biomedical innovation is sped up. In this article we use the case of a study recently retracted from the Lancet to illustrate the potential risks and harms associated with speeding up science. We then argue that, with appropriate governance mechanisms in place (and adequately resourced), it should be quite possible to both speed up science and remain attentive to scientific quality and integrity. Keywords COVID-19. Pandemic. Research quality. Research governance. Research integrity. Biomedical publication The COVID-19 pandemic has changed the world in profound ways and led to significant shifts in our social, political, economic, and scientific priorities. Among these has been a major shift in both public and private research funding towards COVID-19-related projects, with the aim of mapping the pandemic and its effects and developing vaccines and therapies (London and Kimmelman 2020). In this context, the need for speed is taken for granted, and the scientific process has adapted to accommodate this. Rather than going through the usual research-dissemination-translation pathway, existing drugs are being "repurposed," usual preclinical testing regimes are being bypassed or shortened, study sizes are being reduced, and timeconsuming randomized controlled trials are being replaced or supplemented with observational studies. The results of research are already being reported mere months after the epidemic's onset-often prior to formal peer review or after so-called "rapid" review. And regulators are "fast tracking" their review of potentially promising drugs and vaccines (

Although the concept of ‘conflict of interest’ (COI) arises in many contexts in healthcare, it is often poorly understood, and commonly accepted, definitions are often circular, self‐contradictory and unable to provide procedural guidance. To overcome such confusion and imprecision, we offer a reformulation of COI that carefully defines interests, clarifies their scope and articulates a simple, non‐punitive approach to managing them. We define an ‘interest’ as ‘a commitment, goal, obligation or duty related to a particular social role or practice’. We show how in a particular setting multiple interests can be at play, which can be either financial or non‐financial, with the latter often being the most potent drivers of behaviour. We define a ‘conflict of interest’ as the condition that arises when two coexisting interests directly conflict with each other: that is, when they are likely to compel contrary and incompatible outcomes. COI therefore reflect objective states of affairs rather than internal mental states; they do not imply moral error; and they are identified through public rather than private processes involving ethical dialogues among relevant stakeholders. Once a COI has been identified, responses must be determined based on the seriousness of the conflict and the conditions that generated it. Such responses may be minimal or they may require a formal disengagement from one of the conflicting interests. The framework described, reflects the rich diversity of interests in modern societies, is universally applicable and provides simple, readily applicable guidelines for the identification and management of conflicts arising between them.

Although randomized controlled trials remain the scientific ideal for determining the efficacy and safety of new treatments, they are sometimes insufficient to address the evidentiary requirements of regulators and payers. This is particularly the case when it comes to precision medicines because trials are often small, deliver incomplete insights into outcomes of most interest to policymakers (eg, overall survival), and may fail to address other complex diagnostic and treatment-related questions. Additional methods, both experimental and observational, are increasingly being used to fill critical evidentiary gaps. A number of modified early- and late-phase trial designs have been proposed to better support earlier biomarker validation, patient identification, and selection for regulatory studies, but there is still a need for confirmatory evidence from real-world data sources. These data are usually provided through observational, postapproval, phase IIIB and IV studies, which rely heavily on registries and other electronic data sets—most notably data from electronic health records. It is, therefore, crucial to understand what ethical, practical, and scientific challenges are raised by the use of electronic health records to generate evidence about precision medicines.

The prevalence of businesses selling autologous stem cell-based interventions to patients in Australia has raised serious concerns about how weaknesses in regulation have enabled the emergence of an industry that engages in aggressive marketing of unproven treatments to patients. Little is known about how patients experience this marketing and their subsequent interactions with practitioners. This paper reports results from 15 semistructured interviews with patients and carers, and also draws upon discussion conducted with patients, carers and family members (22 participants) in a workshop setting. We explore how Australian patients and carers understand and experience these interventions, and how their presumptions about the ethics of medical practice, and the regulatory environment in Australia have conditioned their preparedness to undergo unproven treatments.

This chapter discusses clinical ethics support services (CES Services), the development of which has arisen to help respond to ethical issues arising in health care settings. CES services are comprised of an individual or group, usually in an organization, who can provide a suite of services to support all stakeholders in identifying and managing ethical issues they face. While there is a degree of consensus about the potential value of such services, they are also the focus of ongoing theoretical, methodological and political debates. The aim of this chapter is to provide health care managers with an account of how and why CES services are becoming a part of the contemporary organizational landscape of health care, and describe the concerns that bioethicists and others have raised regarding their role, function and dissemination.

Health care‐associated infections (HAIs) are a major clinical and economic problem in Australian hospitals, and a significant proportion are preventable. HAIs are the result of complex environmental, microbiological, pathological, behavioural and organisational factors, and prevention requires a multifaceted (“bundled”) approach, including appropriate policies, educational programs for health care workers, and adequate resources to implement them effectively. Failure to protect patients from avoidable harm, including HAIs, has significant ethical implications; it often reflects both organisational systems failure and non‐compliance of health care workers with evidence‐based policies, including hand hygiene. If implemented with appropriate safeguards, infection control “bundles” that include sanctions for poor compliance with hand hygiene and other infection control policies, will achieve sustained improvements where previous approaches have failed.