The Global Forum for Bioethics in Research: Past present and future

The Global Forum on Bioethics in Research (GFBR) served as a global platform for debate on ethical issues in international health research between 1999 and 2008, bringing together research ethics experts, researchers, policy makers and community members from developing and developed countries. In total, nine GFBR meetings were held on six continents. Work is currently underway to revive the GFBR. This paper describes the purpose and history of the GFBR and presents key elements for its reinstatement, future functioning and sustainability. Potential participants and sponsors are encouraged to contribute actively to the future of this unique international research ethics event

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

Research ethics capacity building in Sub-Saharan Africa: a review of NIH Fogarty-funded programs 2000–2012

The last fifteen years have witnessed a significant increase in investment in research ethics capacity development throughout the world. We examine nine research ethics training programs that are focused on Sub-Saharan Africa and supported by the US National Institutes of Health. We collected data from grants awards' documents and annual reports supplemented by questionnaires completed by the training program directors. Together, these programs provided long-term training in research ethics to 275 African professionals, strengthened research ethics committees in 19 countries in Sub-Saharan Africa, and created research ethics curricula at many institutions and bioethics centers within Africa. Trainees' leadership resulted in new national systems and policies on research ethics, human tissue storage and export, and methods of monitoring compliance with research ethics guidelines. Training programs adapted to challenges that arose due to varied trainees' background knowledge in ethics, duration of time available for training, spoken and written English language skills, administrative obstacles, and the need to sustain post-training research ethics activities. Our report showcases the development of awareness of research ethics and building/strengthening of basic research ethics infrastructure in Sub-Saharan Africa. Nevertheless, the increasing amount and complexity of health research being conducted in Sub-Saharan Africa suggests the need for continued investment in research ethics capacity development in this region. This paper is part of a collection of papers analyzing the Fogarty International Center's International Research Ethics Education and Curriculum Development program

Undue inducement : a case study in CAPRISA 008.

CAPRISA, 2017.Abstract available in pdf

African AIDS Vaccine Programme for a Coordinated and Collaborative Vaccine Development Effort on the Continent

The African AIDS Vaccine Programme, formed in 2000, is a network of African HIV vaccine stakeholders, led by Africans across the continent, with a vision of an African continent without AIDS

Research ethics support during the COVID-19 epidemic : a collaborative effort by South African research ethics committees

The COVID-2019 pandemic caused disruption of health services globally due to increased need for critical care facilities and collateral damage to routine healthcare services. Global and local research into disease pathogenesis and management strategies is central to a public health emergency response. South African legislation mandates that no health research may be conducted without approval from a registered Research Ethics Committee. For results to have maximum impact and relevance in a pandemic situation, ethics review and approval must be rapid and timeous, without compromising rigour and quality of review. This chapter argues that South African Research Ethics Committees were under-prepared for this task, largely due to gaps in national ethics guidance and the critical absence of the National Health Research Ethics Council. Although ethics guidance documents contain enabling clauses, no specified procedures for rapid review in emergencies exist. Consequently, and in an unprecedented initiative, several Research Ethics Committee chairpersons and members formed a spontaneous informal, ad hoc group, ‘Research Ethics Support in COVID-19 Pandemic’ (RESCOP), to share resources and support for managing the review of research related to COVID-19. The chapter outlines the processes put in place and mechanisms introduced by RESCOP in the interest of responsible and accountable, but rapid, ethics review. We describe good practices for rapid full ethics review of COVID-19 health research, including clinical trials. RESCOP’s innovative collaboration enabled rapid but thorough ethics review of research protocols during the epidemic. The processes established can serve as a good-practice model that could be adopted and adapted by other committees and future versions of national research ethics guidelines.http://www.journals.co.za/content/journal/healthrImmunolog

Gendered endings: Narratives of male and female suicides in the South African Lowveld

This is the author's accepted manuscript. The final publication is available at Springer via http://dx.doi.org/10.1007/s11013-012-9258-y. Copyright @ Springer Science+Business Media, LLC 2012.Durkheim’s classical theory of suicide rates being a negative index of social solidarity downplays the salience of gendered concerns in suicide. But gendered inequalities have had a negative impact: worldwide significantly more men than women perpetrate fatal suicides. Drawing on narratives of 52 fatal suicides in Bushbuckridge, South Africa, this article suggests that Bourdieu’s concepts of ‘symbolic violence’ and ‘masculine domination’ provide a more appropriate framework for understanding this paradox. I show that the thwarting of investments in dominant masculine positions have been the major precursor to suicides by men. Men tended to take their own lives as a means of escape. By contrast, women perpetrated suicide to protest against the miserable consequences of being dominated by men. However, contra the assumption of Bourdieu’s concept of ‘habitus’, the narrators of suicide stories did reflect critically upon gender constructs

Promoting Research Integrity in Africa: An African Voice of Concern on Research Misconduct and the Way Forward: Promoting Research Integrity in Africa

African researchers and their collaborators have been making significant contributions to useful research findings and discoveries in Africa. Despite evidence of scientific misconduct even in heavily regulated research environments, there is little documented information that supports prevalence of research misconduct in Africa. Available literature on research misconduct has focused on the developed world, where credible research integrity systems are already in place

A developing country response to Lavery et al. "In global health research, is it legitimate to stop clinical trials early on account of their opportunity costs?"

<p>Abstract</p> <p>Background</p> <p>A recent paper presents an argument and mechanism for the possible stopping of clinical trials early based on opportunity costs.</p> <p>Discussion</p> <p>Although we agree that the costs and opportunity costs of clinical trials need to be reduced wherever possible, we raise concerns about the motivation and mechanism for stopping clinical trials early raised by Lavery <it>et al</it>.</p> <p>Summary</p> <p>We argue that there are already enough acceptable criteria and actors in the clinical trials arena to justify early stoppage of clinical trials, and argue that factors other than efficacy need to be carefully considered, especially in developing country contexts.</p