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Revising public health policy based on new data does not happen automatically. This is acutely relevant to the now undeniable evidence that many diseases develop differently between the sexes and may also be affected by gender. Current health and medical practices across the globe generally fail to cater for sex and gender effects in common diseases. Inadequate policy frameworks to guide the comprehensive inclusion of sex and gender in research jeopardises scientific rigour and ultimately the practices they underpin. To ensure that Australian health and medical research is fit-for-purpose, we realised that potent initiatives would be necessary to expedite strategic reframing of thought and behaviour. Here we report on our innovative engagement of end-users for democratic self-determined policy reform to guide health and medical research, based on robust data. We draw upon our specific study to outline seven key steps that can be adopted to accelerate effective change, across a breadth of evidence-based initiatives to reform health policies.

AbstractAbortion is significantly restricted by law in most Pacific Island countries, and this has profound implications for the lives and health of women from this region. There are limited data on how abortion is framed in the Pacific Islands: that is, interpreted, discussed, and made meaningful as an issue in public forums. How abortion is framed can have implications for how it is treated in public and political debate and policy, abortion stigmatisation, and inform advocacy strategies. We undertook a thematic analysis of 246 articles, opinion pieces, and letters to the editor that covered the topic of abortion in mainstream print media. We found three dominant framings. Abortion was often positioned in opposition to gender ideology and national identity, with gender and national identity constructed by many commentators according to socially conservative, Christian doctrine. Abortion was also constructed as the killing of the “unborn,” with the fetus positioned as the key social subject. Alternatively, abortion was framed as often unsafe and a response to teenage pregnancy, with various solutions suggested in this context. Few commentators constructed women who experienced unwanted pregnancies and abortions as making decisions about their pregnancies in response to complex gendered and socio-economic conditions. Dominant framings of abortion as opposed to gender ideals, nationalism, and the killing of the “unborn” complicate simplified appeals to “choice” in advocacy efforts. Focusing on health and broader injustice experienced by women offer alternative framings.

This paper explores the intricate dynamics of trust, power, and vulnerability in the relationship between researchers and study participants/communities in the field of bioethics. The power and knowledge imbalances between researchers and participants create a structural vulnerability for the latter. While trust-building is important between researchers and study participants/communities, the consenting process can be challenging, often burdening participants with power abrogation. Trust can be breached. The paper highlights the contractual nature of the research relationship and argues that trust alone cannot prevent exploitation as power imbalances and vulnerabilities persist. To protect participants, bioethics guidance documents promote accountability and ethical compliance. These documents uphold fairness in the researcher-participant relationship and safeguard the interests of socially vulnerable participants. The paper also highlights the role of shared decision-making and inclusive deliberation with diverse stakeholders and recommends that efforts should be made by researchers to clarify roles and responsibilities, while research regulatory agents should transform the research-participant relationship into a legal-based contract governed by accountability principles. While trust remains important, alternative mechanisms may be needed to ensure ethical research practices and protect the interests of participants and communities. Striking a balance between trust and accountability is crucial in this regard.

In 2022, a global outbreak of mpox (formerly 'monkeypox') emerged in non-endemic countries, including Australia, predominantly affecting gay, bisexual and other men who have sex with men. Public health advice on transmission and isolation emerged rapidly from different sources, sometimes conflicting and producing uncertainty. Using the concept of 'counterpublic health', which acknowledges the incorporation of official science and experiences of affected communities into embodied practice, this paper investigates how people affected by mpox in Australia managed risk of transmission and navigated self-isolation. In-depth interviews were conducted with 16 people: 13 people diagnosed with mpox and three close contacts. All participants were cisgender gay and bisexual men living in Australia. Participants thought critically about public health advice, often finding it restrictive and unresponsive to the needs of people with mpox. Participants' decisions about reducing mpox risk and isolating often drew on experiences with other infections (i.e. HIV; COVID-19) and were made collaboratively with the people closest to them (e.g. partners, friends, family) to sustain relationships. Future public health responses to infectious disease outbreaks would benefit from identifying more opportunities to formalise and embed mechanisms to obtain feedback from affected communities so as to inform responses. [ABSTRACT FROM AUTHOR]

Abstract Background In response to the threat of COVID-19 infection, Australia mandated a 14 day quarantine period in a designated facility for all travellers returning from overseas from late March 2020. These facilities were usually hotels, or hotel-like serviced apartments, and also included a repurposed former mining village in the Northern Territory. This paper aimed to investigate the experiences of risk of people quarantined in designated supervised facilities in Australia, which has not been systematically explored before. Methods In this qualitative study semi-structured interviews were conducted with 58 participants quarantined between March 2020 and January 2021. Participants were returned Australian citizens and residents who were required to undergo mandatory supervised quarantine for COVID-19. Interviews were conducted using video teleconferencing (via Zoom), transcribed and coded, then analysed thematically. Results While participants generally supported the concept of quarantine to protect the Australian public, they were critical of elements of it where they felt exposed to risk (COVID-related or not). They also described instances where infection control within the system seemed inadequate. For some, particularly those quarantined with small children, they reported that the facilities were inadequate or inappropriate for health and wellbeing. Using thematic analysis, three major themes were identified that related to problems in the existing system: perception of being subjected to high risk through lax standards of COVID protection in the quarantine process; risks to the community identified in quarantine; and risk in non-hotel managed quarantine facilities. Conclusions There are systemic issues with infection control in hotel quarantine, which can be further undermined by individual non-compliance. Risks to safety for those in quarantine can be reduced, both in terms of infection control within hotel quarantine and, in the case of the Northern Territory facility, timely in-person medical care as needed for non-COVID conditions. Systems of infection control need ongoing review to ensure that people entering quarantine are protected from known risks of infection at every stage. Medical services in quarantine facilities should be examined to ensure timely and appropriate non-COVID medical services are available.

1 | INTRODUCTION In January 2020, a novel coronavirus, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), was identified as the causative agent of COVID-19 disease [1]. The World Health [...], Introduction: The InternationalAIDS Society convened a multidisciplinary committee of experts in December 2020 to provide guidance and key considerations for the safe and ethicalmanagement of clinicaltrials involving people living with HIV (PLWH) during the SARS-CoV-2 pandemic. This consultation did not discuss guidance for the design of prevention studies for people at risk of HIV acquisition, nor for the programmatic delivery of antiretroviral therapy (ART). Discussion: There is strong ambition to continue with HIV research from both PLWH and the research community despite the ongoing SARS-CoV-2 pandemic. How to do this safely and justly remains a criticaldebate. The SARS-CoV-2 pandemic continues to be highly dynamic. It is expected that with the emergence of effective SARS-CoV-2 prevention and treatment strategies, the risk to PLWH in clinicaltrials willdecline over time. However, with the emergence of more contagious and potentially pathogenic SARS-CoV-2 variants, the effectiveness of current prevention and treatment strategies may be compromised. Uncertainty exists about how equally SARS-CoV-2 prevention and treatment strategies willbe available globally, particularly for marginalized populations, many of whom are at high risk of reduced access to ART and/or HIV disease progression. All of these factors must be taken into account when deciding on the feasibility and safety of developing and implementing HIV research. Conclusions: It can be assumed for the foreseeable future that SARS-CoV-2 will persist and continue to pose challenges to conducting clinical research in PLWH. Guidelines regarding how best to implement HIV treatment studies will evolve accordingly. The risks and benefits of performing an HIV clinical trial must be carefully evaluated in the local context on an ongoing basis. With this document, we hope to provide a broad guidance that should remain viable and relevant even as the nature of the pandemic continues to develop. Keywords: HIV; clinicaltrial; analyticaltreatment interruption (ATI); COVID-19; SARS-CoV-2; risk mitigation

Culturally responsive evaluation contests that Western-derived evaluation methods represent a universal truth and promotes approaches that reflect the local context. Taking this approach, we examine how the method of contribution analysis may be modified to reflect a different worldview. We reframe contribution analysis using a Confucian lens as Confucianism represents a value system that is still integral to the way societies operate in several East and Southeast Asian countries today. First, we unpack the theory behind contribution analysis and how it is applied by Western evaluators then compare this with aspects of Confucianism. We then examine how the application of contribution analysis might be modified to take into account a Confucian worldview. Finally, we discuss how, in a world of globalized, complex societies, this approach could be used by evaluators to adapt evaluation methods to be congruent with the worldviews in the local context where an evaluation is occurring.

Owing to the historical and ongoing impacts of colonisation, there is a large health equity gap in sexual and reproductive health (SRH) outcomes between Aboriginal and Torres Strait Islander peoples and non‐Indigenous populations. Whilst qualitative research has identified the barriers and enablers to sexual healthcare engagement among young Aboriginal and Torres Strait Islander people in remote settings, little is known about the ways in which young people navigate sexual healthcare in a regional setting. This study aims to address this gap. Sixty‐five young (aged 15–29) Aboriginal and Torres Strait Islander people participated in semistructured interviews across three regional communities in New South Wales, Australia. The candidacy framework informed this analysis. A large proportion of participants expressed having agency and resources to attend health services for SRH needs (primarily STI testing and contraception). Women in particular described being supported by social networks to access SRH services. Male participants were less likely to identify their own candidacy for healthcare. Services that were culturally safe and had trustworthy, nonjudgemental staff and a feeling of community were easier to access (more permeable). Factors that decreased accessibility were confidentiality concerns, difficulty making appointments, and lack of visibility of services, or what they offer. Using the candidacy framework, this study identified the importance of culturally safe service provision, reducing barriers to accessing appointments and the provision of nonjudgemental care in engaging young Aboriginal and Torres Strait Islander people in SRH care. This study also highlighted the various strategies and actions that young Aboriginal and Torres Strait Islander people are already taking to protect their sexual health and that of their partners. [ABSTRACT FROM AUTHOR]

Background: Currently in Australia, men are deferred from donating blood if they have had sex with another man within the past 3 months. However, a proposed gender‐neutral assessment (GNA) process will ask all donors questions about sex with new or multiple recent partners, with deferral based on responses to a question about anal sex. Understanding the acceptability of such questions among existing and potential blood donors is paramount for successful implementation of GNA. Study Design and Methods: We used data from a nationally representative survey to estimate the levels of comfort with the proposed GNA questions among the Australian population and subgroups, defined by self‐reported ethnicity and religion. Respondents were aged over 18 and living in Australia. Results were weighted to represent the population. Results: Most of the 5178 respondents described themselves as comfortable with answering questions about new partners (73.1%) or anal sex (64.0%) to donate blood. However, 2.2% and 4.5% indicated that questions about new sex partners and anal sex, respectively, would stop them from donating, and 4.4% and 7.7% respectively, said they were "completely uncomfortable." By religion, the least comfortable were Muslim or Eastern Orthodox respondents, and by country of birth, the least comfortable were those born in the Middle East, followed by those born in Southern Europe and Asia. Discussion: GNA appears to be broadly acceptable in the Australian context, but our findings suggest that key GNA questions are less acceptable in some population subgroups, indicating a need for targeted campaigns that consider cultural sensitivities. [ABSTRACT FROM AUTHOR]

In May 2022, a global outbreak of mpox (formerly monkeypox virus) affected thousands of mainly gay and bisexual men. Mpox is usually a time-limited illness that can involve fever, pain, and skin lesions, but may require hospitalisation. There is scant research into the firsthand experiences of people affected by mpox, including experiences of symptoms, healthcare, and recovery. This study considers the different illness narratives of people who experienced mpox in Australia in 2022. In-depth interviews and 6-month follow-up interviews were conducted with 16 people, including 13 people diagnosed with mpox and three close contacts. All participants were cisgender gay or bisexual men living in Australia. Participants' accounts described minor to severe periods of sickness, negative and stigmatising experiences engaging with healthcare, and some participants experienced long-term effects on their sexual well-being and complications from mpox. The emergency outbreak context meant that mpox was highly distressing, making it difficult to manage and producing varying forms of disruption to everyday life. Mpox was narrated as disruptive in different ways: as a minor interruption to holiday plans, a prolonged period of poor health, or a biographically disruptive event prompting a re-evaluation of sexual values and health. This analysis demonstrates that an unfamiliar emergent disease outbreak related to sexual practices and sociality can reconfigure personal life and sexual well-being, suggesting a need to focus on providing quality patient care in outbreaks of mpox and other infectious diseases. [ABSTRACT FROM AUTHOR]

BACKGROUND: The global interest in developing therapies for Ebola infection management and its prevention is laudable. However the plan to conduct an emergency immunization program specifically for healthcare workers using experimental vaccines raises some ethical concerns. This paper shares perspectives on these concerns and suggests how some of them may best be addressed. DISCUSSION: The recruitment of healthcare workers for Ebola vaccine research has challenges. It could result in coercion of initially dissenting healthcare workers to assist in the management of EVD infected persons due to mistaken beliefs that the vaccine offers protection. It could also affect equity and justice. For example, where people who are not skilled health care professionals but who provide care to patients infected with Ebola (such as in home care settings) are not prioritized for vaccination. The possibility of study participants contracting Ebola infection despite the use of experimental vaccine, and the standard of care they would receive, needs to be addressed clearly, transparently and formalized as part of the ethics review process. Future access to study products in view of current status of the TRIPS agreement needs to be addressed. Finally, broad stakeholder engagement at local, regional and international levels needs to be promoted using available communication channels to engage local, regional and international support. These same concerns are applicable for current and future epidemics. Successful Ebola vaccine development research requires concerted efforts at public dialogue to address misconceptions, equity and justice in participant selection, and honest discussions about risks, benefits and future access. Public dialogue about Ebola vaccine research plans is crucial and should be conducted by trusted locals and negotiated between communities, researchers and ethics committees in research study sites.

HIV prevention is a critical health issue in Nigeria; a country that has one of the worst HIV epidemic profiles in the world. With 270,000 new infections in 2012, Nigeria is a prime site for HIV prevention research. One effect of the HIV epidemic has been to revolutionalise ethical norms for the conduct of research: it is now considered unethical to design and implement HIV related studies without community engagement. Unfortunately, there is very little commensurate effort in building the capacity of local persons to engage actively with researchers, and there is no existing platform to facilitate dialogue between researchers and communities engaged in research in Nigeria. In an effort to address this gap, we undertook a series of three community dialogues (Phase One) and two community-researcher interface meetings (Phase Two) in Nigeria. This paper aims to give an empirical account of the dialogue from these community engagement processes and provide a resulting critique of the implementation of research ethics practices in Nigeria. It is anticipated that the outputs will: (i) support researchers in designing community-based research protocols; (ii) inform ethics committees of key considerations during research protocol reviews from a community perspective; and (iii) inform policy makers and research sponsors about issues of primary concern to communities with respect to HIV research.

Abstract Background Media exposés and academic literature reveal high rates of bullying and harassment of medical students, most commonly by consultant physicians and/or surgeons. Recent reports reveal the medical profession to be characterised by hierarchy, with verbal abuse a ‘rite of passage’, as well as sexist and racist behaviours. Methods Semi-structured in-depth interviews were conducted with ten current or recently graduated medical students from Sydney-based medical schools. Interviews were audio-recorded, transcribed verbatim, and thematically analysed. Results Hierarchy, and a culture of self-sacrifice, resilience and deference, were identified as problematic elements of the medical profession. In the minds of participants, these factors created barriers to reporting mistreatment, as participants felt reporting led to being labelled a ‘troublemaker’, affecting career progression. Additionally, participants stated that avenues of recourse were unclear and did not guarantee confidentiality or desired outcomes. Conclusions Mistreatment is continuing in clinical teaching and has negative consequences on medical students’ mental health and learning. Structural change is needed to combat institutionalised mistreatment to ensure the wellbeing of future doctors and high quality patient care.

This special issue of Research Ethics focuses on research ethics and research integrity during global crises, particularly the challenges faced during the COVID-19 pandemic. The papers in this issue discuss the changing dynamics and pressures of conducting research during crisis situations, including the need for speed in developing vaccines and treatments. Some papers highlight the importance of adhering to ethical and methodological standards, while others reflect on new ethical considerations that emerged during the pandemic. The issue aims to contribute to ongoing reflection and improvement in research ethics practice, both during crises and in general. The editorial also introduces the new co-Editors-in-Chief of Research Ethics and welcomes new Associate Editors to the journal. [Extracted from the article]

IntroductionThis study aimed to explore the experiences of healthcare access in a diverse sample of trans and gender diverse individuals with complex needs using qualitative methods. We recruited 12 individuals using trans community-based networks facilitated by the Gender Centre. Each individual participated in an in-depth, semi structured interview conducted by a peer interviewer. Interviews were analysed thematically.FindingsParticipants had a range of complex health needs to manage, including ongoing access to gender-affirming hormones, mental health care and sexual health care. Some also had chronic diseases. Accordingly, scheduling appointments and affording the co-payments required were major preoccupations. Most participants were not in full time work, and economic hardship proved to be a major compounding factor in issues of healthcare access, impacting on the choice of clinician or practice. Other barriers to accessing health included issues within health services, such as disrespectful attitudes, misgendering, 'deadnaming' (calling the person by their previous name), displaying an excessive interest is aspects of the participants' life that were irrelevant to the consultation, and displaying ignorance of trans services such that the participants felt an obligation to educate them. In addition, participants noted how stereotyped ideas of trans people could result in inaccurate assumptions about their healthcare needs. Positive attributes of services were identified as respectful communication styles, clean, welcoming spaces, and signs that indicated professionalism, care and openness, such as relevant information pamphlets and visibility of LGBTIQ service orientation. Participants valued peer-based advice very highly, and some would act on and trust medical advice from peers above advice from medical professionals.ConclusionThese findings demonstrate a need for comprehensive wrap-around service provision for trans people with complex needs which includes a substantial peer-based component, and addresses physical and mental health and social services conveniently and affordably.