The role of 'micro-decisions' in involuntary admissions decision-making for inpatient psychiatric care in general hospitals in South Africa.

While the ethics of involuntary admission for psychiatric inpatient care is widely contested, the practice is legally permissible across most jurisdictions. In many countries, laws governing the use of involuntary admission set out core criteria under which involuntary admission is permitted; these parameters broadly related to either risk of harm to self or others, need for treatment, or both. In South Africa, the use of involuntary admission is governed by the Mental Health Care Act no. 17 of 2002 (MHCA 2002), which sets out clear criteria to direct mental healthcare practitioners' decision-making and delineates a process by which decision-making should occur. However, recent research suggests that, in practice, the process of decision-making differs from the procedure prescribed in the MHCA 2002. To further explore how decision-making for involuntary admission occurs in practice, we interviewed 20 mental healthcare practitioners, all with extensive experience of making involuntary admission decisions, working in district, regional, and tertiary hospitals across five provinces. We also interviewed four mental health advocates to explore patient-centered insights. Our analysis suggests that the final decision to involuntarily admit individuals for a 72-h assessment period under the MHCA 2002 was preceded by a series of 'micro-decisions' made by a range of stakeholders: 1) the family's or police's decision to bring the individual into hospital, 2) a triage nurse's decision to prioritise the individual along a mental healthcare pathway in the emergency centre, and 3) a medical officer's decision to sedate the individual. Practitioners reported that the outcomes of each of these 'micro-decisions' informed aspects of their final decision to admit an individual involuntarily. Our analysis therefore suggests that the final decision to admit involuntarily cannot be understood in isolation because practitioners draw on a range of additional information, gleaned from these prior 'micro-decisions', to inform the final decision to admit.

Ending the evidence gap for pregnancy, HIV and co-infections: ethics guidance from the PHASES project.

INTRODUCTION: While pregnant people have been an important focus for HIV research, critical evidence gaps remain regarding prevention, co-infection, and safety and efficacy of new antiretroviral therapies in pregnancy. Such gaps can result in harm: without safety data, drugs used may carry unacceptable risks to the foetus or pregnant person; without pregnancy-specific dosing data, pregnant people face risks of both toxicity and undertreatment; and delays in gathering evidence can limit access to beneficial next-generation drugs. Despite recognition of the need, numerous barriers and ethical complexities have limited progress. We describe the process, ethical foundations, recommendations and applications of guidance for advancing responsible inclusion of pregnant people in HIV/co-infections research. DISCUSSION: The 26-member international and interdisciplinary Pregnancy and HIV/AIDS: Seeking Equitable Study (PHASES) Working Group was convened to develop ethics-centred guidance for advancing timely, responsible HIV/co-infections research with pregnant people. Deliberations over 3 years drew on extensive qualitative research, stakeholder engagement, expert consultation and a series of workshops. The guidance, initially issued in July 2020, highlights conceptual shifts needed in framing research with pregnant people, and articulates three ethical foundations to ground recommendations: equitable protection from drug-related risks, timely access to biomedical advances and equitable respect for pregnant people's health interests. The guidance advances 12 specific recommendations, actionable within the current regulatory environment, addressing multiple stakeholders across drug development and post-approval research, and organized around four themes: building capacity, supporting inclusion, achieving priority research and ensuring respect. The recommendations describe strategies towards ethically redressing the evidence gap for pregnant people around HIV and co-infections. The guidance has informed key efforts of leading organizations working to advance needed research, and identifies further opportunities for impact by a range of stakeholder groups. CONCLUSIONS: There are clear pathways towards ethical inclusion of pregnant people in the biomedical research agenda, and strong agreement across the HIV research community about the need for - and the promise of - advancing them. Those who fund, conduct, oversee and advocate for research can use the PHASES guidance to facilitate more, better and earlier evidence to optimize the health and wellbeing of pregnant people and their children.

An analysis of funding patterns in development assistance for mental health: who, when, what, and where.

BACKGROUND: Mental health has recently gained increasing attention on global health and development agendas, including calls for an increase in international funding. Few studies have previously characterized official development assistance for mental health (DAMH) in a nuanced and differentiated manner in order to support future funding efforts. METHODS: Data from the Organisation for Economic Cooperation and Development Creditor Reporting System were obtained through keyword searches. Projects were manually reviewed and categorized into projects dedicated entirely to mental health and projects that mention mental health (as one of many aims). Analysis of donor, recipient, and sector characteristics within and between categories was undertaken cumulatively and yearly. FINDINGS: Between the two categories of official DAMH defined, characteristics differed in terms of largest donors, largest recipient countries and territories, and sector classification. However, across both categories there were clear and consistent findings: the top donors accounted for over 80% of all funding identified; the top recipients were predominantly conflict-affected countries and territories, or were receiving nations for conflict-affect refugees; and sector classification demonstrated shifting international development priorities and political drivers. CONCLUSION: Across DAMH, significant amounts of funding are directed toward conflict settings and relevant emergency response by a small majority of donors. Our analysis demonstrated that, within minimal international assistance for mental health overall, patterns of donor, recipient, and sector characteristics favor emergency conflict-affected settings. Calls for increased funding should be grounded in understanding of funding drivers and directed toward both emergency and general health settings.

Global mental health should engage with the ethics of involuntary admission.

Global mental health, as a field, has focused on both increasing access to mental health services and promoting human rights. Amidst many successes in engaging with and addressing various human rights violations affecting individuals living with psychosocial disabilities, one human rights challenge remains under-discussed: involuntary inpatient admission for psychiatric care. Global mental health ought to engage proactively with the debate on the ethics of involuntary admission and work to develop a clear position, for three reasons. Firstly, the field promotes models of mental healthcare that are likely to include involuntary admission. Secondly, the field aligns much of its human rights framework with the UN Convention on the Rights of Persons with Disabilities, which opposes the discriminatory use of involuntary admission on the basis of psychosocial disability or impairment. Finally, global mental health, as a field, is uniquely positioned to offer novel contributions to this long-standing debate in clinical ethics by collecting data and conducting analyses across settings. Global mental health should take up involuntary admission as a priority area of engagement, applying its own orientation toward research and advocacy in order to explore the dimensions of when, if ever, involuntary admission may be permissible. Such work stands to offer meaningful contributions to the challenge of involuntary admission.

International funding for mental health: a review of the last decade.

Mental health represents one of the most significant and increasing burdens to global public health. Over the past decade, the once invisible field has gained recognition on the global health agenda and this increased recognition is expected to increase international funding for mental health. Our review found that few studies have been conducted as to the level of international funding for mental health and there is a need for a differentiated assessment. We conducted such an assessment of global development-related assistance for mental health between 2006 and 2016 and established categories to serve as a baseline for future measurement. We found that development assistance specifically dedicated to mental health accounted for just 0.3% of all development assistance for health. Given the limited public expenditure on mental health by national governments in low- and middle-income countries, renewed efforts by the international community and development partners to substantially increase funding for mental health are critical.

Beyond "Vessels and Vectors": A Global Review of Registered HIV-Related Clinical Trials with Pregnant Women.

BACKGROUND: Since the early 1990s, the HIV research agenda has prioritized to some degree the inclusion of pregnant women. However, concerns remain regarding the extent to which pregnant women's own health needs are addressed, representation in trials of HIV preventives or treatments for comorbidities, and equitable study of newer medications during pregnancy. METHODS: We employed a keyword search of the International Clinical Trials Registry Platform to identify interventional HIV-related trials conducted with pregnant women between January 2001 and December 2015. Retained trials were coded according to several key variables (e.g., study endpoints, trial phase, study compound) and analyzed using information provided in the database. RESULTS: In total, 63 trials studying use of a pharmacological compound during pregnancy were conducted across 35 countries and sponsored by 74 unique organizations, including pharmaceutical companies. Of trials analyzed, 86% (n = 54) listed maternal outcomes as a primary endpoint. More than 35% (n = 23) of trials assessed pharmacokinetic parameters of a study compound during pregnancy. Of 45 trials specifically studying HIV-related medication(s), just 4% (n = 2) focused on HIV preventives. One trial studied tuberculosis in HIV-infected pregnant women; 11 studied malaria. On average, medications were studied during pregnancy 4.4 years after licensure. CONCLUSIONS: Our findings demonstrate that trials with pregnant women are conducted across a range of countries and sponsors, and much progress has been made to better address pregnant women's own health needs in HIV research. However, our findings confirm other concerns, for example, lack of HIV preventives studied and the lag between medication licensure and study during pregnancy.

Research with pregnant women: a call to action.

Despite a global need for the use of medication during pregnancy, the medical research community lacks robust evidence for safety and efficacy of treatments and preventives often taken by pregnant women. Given the biological differences between pregnant women and the rest of the population, the need to gather data on the ways in which medications behave in the pregnant body is critical to the health of pregnant women and their offspring. Three ethical reasons are central to this need: 1. Pregnant women deserve access to effective treatment, 2. Pregnant women deserve access to safe treatment, and 3. Pregnant women deserve equitable access to trials carrying the prospect of direct benefit. In this paper, we introduce and frame this Supplement Issue, which presents important conference proceedings of the 2016 Global Forum on Bioethics in Research meeting held in Buenos Aires, Argentina, on the 3rd and 4th of November.