Evolving friendships and shifting ethical dilemmas: fieldworkers' experiences in a short term community based study in Kenya

Fieldworkers (FWs) are community members employed by research teams to support access to participants, address language barriers, and advise on culturally appropriate research conduct. The critical role that FWs play in studies, and the range of practical and ethical dilemmas associated with their involvement, is increasingly recognised. In this paper, we draw on qualitative observation and interview data collected alongside a six month basic science study which involved a team of FWs regularly visiting 47 participating households in their homes. The qualitative study documented how relationships between field workers and research participants were initiated, developed and evolved over the course of the study, the shifting dilemmas FWs faced and how they handled them. Even in this one case study, we see how the complex and evolving relationships between fieldworkers and study participants had important implications for consent processes, access to benefits and mutual understanding and trust. While the precise issues that FWs face are likely to depend on the type of research and the context in which that research is being conducted, we argue that appropriate support for field workers is a key requirement to strengthen ethical research practice and for the long term sustainability of research programmes

Establishing a single-sex controlled human Schistosoma mansoni infection model for Uganda: protocol for safety and dose-finding trial

Control of schistosomiasis depends on a single drug, praziquantel, with variable cure rates, high reinfection rates, and risk of drug resistance. A vaccine could transform schistosomiasis control. Preclinical data show that vaccine development is possible, but conventional vaccine efficacy trials require high incidence, long-term follow-up, and large sample size. Controlled human infection studies (CHI) can provide early efficacy data, allowing the selection of optimal candidates for further trials. A Schistosoma CHI has been established in the Netherlands but responses to infection and vaccines differ in target populations in endemic countries. We aim to develop a CHI for Schistosoma mansoni in Uganda to test candidate vaccines in an endemic setting. This is an open-label, dose-escalation trial in two populations: minimal, or intense, prior Schistosoma exposure. In each population, participants will be enrolled in sequential dose-escalating groups. Initially, three volunteers will be exposed to 10 cercariae. If all show infection, seven more will be exposed to the same dose. If not, three volunteers in subsequent groups will be exposed to higher doses (20 or 30 cercariae) following the same algorithm, until all 10 volunteers receiving a particular dose become infected, at which point the study will be stopped for that population. Volunteers will be followed weekly after infection until CAA positivity or to 12 weeks. Once positive, they will be treated with praziquantel and followed for one year. The trial registry number is ISRCTN14033813 and all approvals have been obtained. The trial will be subjected to monitoring, inspection, and/or audits

A Pragmatic Trial of Glucocorticoids for Community-Acquired Pneumonia

BACKGROUND: Adjunctive glucocorticoids may reduce mortality among patients with severe community-acquired pneumonia (CAP) in well-resourced settings. Whether these drugs are beneficial in low-resource settings with limited diagnostic and treatment facilities is unclear. METHODS: In this pragmatic, open-label, randomized, controlled trial conducted in 18 public hospitals in Kenya, we assigned adult patients who had received a diagnosis of CAP and who did not have a clear indication for glucocorticoids to receive either standard care for CAP or oral low-dose glucocorticoids for 10 days in addition to standard care. The primary outcome was death from any cause at 30 days after enrollment. RESULTS: A total of 2180 patients underwent randomization (1089 assigned to the glucocorticoid group and 1091 to the standard-care group). The median age of the patients was 53 years (interquartile range, 38 to 72); 46% were women. At day 30, deaths were reported in 530 patients (24.3%): 246 patients (22.6%) in the glucocorticoid group and 284 patients (26.0%) in the standard-care group (hazard ratio, 0.84; 95% confidence interval, 0.73 to 0.97; P = 0.02). The frequencies of adverse events and serious adverse events were similar in the two trial groups. Serious adverse events that were considered to be related to glucocorticoid administration occurred in 5 patients (0.5%). CONCLUSIONS: In patients with CAP in a low-resource setting, adjunctive glucocorticoid therapy was associated with a lower risk of death than standard care. (Funded by Wellcome Trust and others; SONIA PACTR number, PACTR202111481740832; ISRCTN number, ISRCTN36138594.)

“The One Who Chases You Away Does Not Tell You Go”: Silent Refusals and Complex Power Relations in Research Consent Processes in Coastal Kenya

Consent processes have attracted significant research attention over the last decade, including in the global south. Although relevant studies suggest consent is a complex negotiated process involving multiple actors, most guidelines assume consent is a one-off encounter with a clear ‘yes’ or ‘no’ decision. In this paper we explore the concept of ‘silent refusals’, a situation where it is not clear whether potential participants want to join studies or those in studies want to withdraw from research, as they were not actively saying no. We draw on participant observation, in-depth interviews and group discussions conducted with a range of stakeholders in two large community based studies conducted by the KEMRI Wellcome Trust programme in coastal Kenya. We identified three broad inter-related rationales for silent refusals: 1) a strategy to avoid conflicts and safeguard relations within households, - for young women in particular—to appear to conform to the wishes of elders; 2) an approach to maintain friendly, appreciative and reciprocal relationships with fieldworkers, and the broader research programme; and 3) an effort to retain study benefits, either for individuals, whole households or wider communities. That refusals and underlying rationales were silent posed multiple dilemmas for fieldworkers, who are increasingly recognised to play a key interface role between researchers and communities in many settings. Silent refusals reflect and reinforce complex power relations embedded in decisions about research participation, with important implications for consent processes and broader research ethics practice. Fieldworkers need support to reflect upon and respond to the ethically charged environment they work in

‘All her children are born that way’: gendered experiences of stigma in families affected by sickle cell disorder in rural Kenya

OBJECTIVES: To explore early experiences of sickle cell disorder (SCD) in families with a young affected child, and the way these experiences influence relations within families. To consider ways in which stigma could be counteracted in health and research programmes in sub Saharan Africa. DESIGN: A qualitative study was conducted in a rural area of coastal Kenya including in-depth interviews with 13 families affected by SCD and 12 staff of a local biomedical research progamme. Purposive selection aimed to maximize diversity in socioeconomic and educational status, religion, severity of illness burden and religion amongst families and draw on relevant experience for staffs. Interviews were recorded, transcribed and analysed using the constant comparative method for family interviews and a thematic framework approach for staff data. RESULTS: Low initial recognition of SCD and its cause were associated with lay practices of surveillance within affected families, contributing to stigmatisation that occurred independently of genetic knowledge. Blame was often placed on mothers, including a risk of blame for misaligned paternity. Mothers are often particularly affected by SCD through the loss of independent livelihoods and their limited options in coping with this chronic condition. CONCLUSIONS: Mothers of children with SCD were particularly vulnerable to stigmatisation within families, with underlying structural influences that suggest these findings may apply to other similar settings in Africa, and have relevance for other genetic conditions. The potential, nature and form of stigmatisation point to the role of effective communication and SCD management in addressing for blame and discriminative effects of having a child with SCD. The findings highlight the importance of broader social programmes targeting underlying gender and economic inequalities

Experiences with community engagement and informed consent in a genetic cohort study of severe childhood diseases in Kenya.

BACKGROUND: The potential contribution of community engagement to addressing ethical challenges for international biomedical research is well described, but there is relatively little documented experience of community engagement to inform its development in practice. This paper draws on experiences around community engagement and informed consent during a genetic cohort study in Kenya to contribute to understanding the strengths and challenges of community engagement in supporting ethical research practice, focusing on issues of communication, the role of field workers in 'doing ethics' on the ground and the challenges of community consultation. METHODS: The findings are based on action research methods, including analysis of community engagement documentation and the observations of the authors closely involved in their development and implementation. Qualitative and quantitative content analysis has been used for documentation of staff meetings and trainings, a meeting with 24 community leaders, and 40 large public and 70 small community group meetings. Meeting minutes from a purposive sample of six community representative groups have been analysed using a thematic framework approach. RESULTS: Field workers described challenges around misunderstandings about research, perceived pressure for recruitment and challenges in explaining the study. During consultation, leaders expressed support for the study and screening for sickle cell disease. In community meetings, there was a common interpretation of research as medical care. Concerns centred on unfamiliar procedures. After explanations of study procedures to leaders and community members, few questions were asked about export of samples or the archiving of samples for future research. CONCLUSIONS: Community engagement enabled researchers to take account of staff and community opinions and issues during the study and adapt messages and methods to address emerging ethical challenges. Field workers conducting informed consent faced complex issues and their understanding, attitudes and communication skills were key influences on ethical practice. Community consultation was a challenging concept to put into practice, illustrating the complexity of assessing information needs and levels of deliberation that are appropriate to a given study.http://dx.doi.org/10.1186/1472-6939-11-1

Chapter 23: Capacities to exercise strategic decision-making agency: exploring the gendered production of health within intimate partnerships and households

This chapter explores the conceptualization and empirical evidence for gendered social processes for the production of health and illness within intimate relationships and households, drawing on international literature, additional grey literature from the Global South and four case studies from the authors’ own research. In particular, the chapter considers the capacity (by both women and men in different contexts) to exercise strategic agency in making decisions with regard to health and well-being both in their own lives and in those of their children. The authors explore how these capacities are conceptualized in both the development and health literature and the findings of empirical research in this area, particularly in three areas that have received particular attention in health: maternal, sexual and reproductive and child health. They then present and discuss four case studies from their own research in sub-Saharan Africa which illustrate the dynamics of the gendered production of health in intimate partnerships and households at different stages of the life cycle, including gendered bargaining processes (and their material and ideological bases), in order to explore these complex processes and outcomes in more depth. The case studies also examine the ways in which gender interacts with other axes of inequality to shape health experiences and outcomes, including for example age, livelihood strategies, socio-economic status, geographical location (for example, urban or rural), marital status and household structure. Finally, the authors discuss whether and how capacities for exercising strategic agency have been considered in health policies, programming and interventions within different contexts, and identify key areas for action and further research

Engaging Communities to Strengthen Research Ethics in Low‐Income Settings: Selection and Perceptions of Members of a Network of Representatives in Coastal <scp>K</scp> enya

There is wide agreement that community engagement is important for many research types and settings, often including interaction with 'representatives' of communities. There is relatively little published experience of community engagement in international research settings, with available information focusing on Community Advisory Boards or Groups (CAB/CAGs), or variants of these, where CAB/G members often advise researchers on behalf of the communities they represent. In this paper we describe a network of community members ('KEMRI Community Representatives', or 'KCRs') linked to a large multi-disciplinary research programme on the Kenyan Coast. Unlike many CAB/Gs, the intention with the KCR network has evolved to be for members to represent the geographical areas in which a diverse range of health studies are conducted through being typical of those communities. We draw on routine reports, self-administered questionnaires and interviews to: 1) document how typical KCR members are of the local communities in terms of basic characteristics, and 2) explore KCR's perceptions of their roles, and of the benefits and challenges of undertaking these roles. We conclude that this evolving network is a potentially valuable way of strengthening interactions between a research institution and a local geographic community, through contributing to meeting intrinsic ethical values such as showing respect, and instrumental values such as improving consent processes. However, there are numerous challenges involved. Other ways of interacting with members of local communities, including community leaders, and the most vulnerable groups least likely to be vocal in representative groups, have always been, and remain, essential