register interest

Professor Catherine (Sassy) Molyneux

Research Area: Global Health
Scientific Themes: Tropical Medicine & Global Health
Keywords: Research ethics, Health systems research, Qualitative methods, Community accountability and Sub-Saharan Africa
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Sassy's research work focuses on two main themes: the interface between health systems and households (including exploring household treatment seeking behaviour, gender relations and affordability of health care); and the interface between health researchers and communities (including consent, community engagement, payments and benefits for research communities, and social science ethics). She also supports strategic planning around ethical issues that emerge during research across the KEMRI-Wellcome Trust programme in Kenya, and contributes to social science and research ethics training at the centre.

Current research projects:

  • Principal applicant on a Career Development Fellowship exploring community accountability in health delivery and research.
  • Co-applicant and theme lead on a DFID funded consortium: Resilient and Responsive Health Systems (RESYST).
  • Co-applicant and country manager on a programme to build capacity in global health research ethics and community engagement across the Wellcome Programmes. See Global Health Bioethics
  • Co-applicant and consortium representative on a Partnership to foster gender and ethics analysis in health systems research and practice across the three Department for International Development (DFID) funded Research Programme Consortia (RPC) on health systems (FHS, REBUILD, RESYST). See Research in Gender and Ethics
  • Co-applicant on a funding initiative to strengthen global Health Systems Research Capacity across relevant departments in Oxford and Kenya (OHSCAR). See Crossing Boundaries in Kenya and NDM in Kenya
  • Co-investigator on a study: Learning from community and research stakeholder views on how research data should be shared between health researchers.

There are no collaborations listed for this principal investigator.

Barasa EW, Molyneux S, English M, Cleary S. 2017. Hospitals as complex adaptive systems: A case study of factors influencing priority setting practices at the hospital level in Kenya. Soc Sci Med, 174 pp. 104-112. | Show Abstract | Read more

There is a dearth of literature on priority setting and resource allocation (PSRA) practices in hospitals, particularly in low and middle income countries (LMICs). Using a case study approach, we examined PSRA practices in 2 public hospitals in coastal Kenya. We collected data through a combination of in-depth interviews of national level policy makers, hospital managers, and frontline practitioners in the case study hospitals (n = 72), review of documents such as hospital plans and budgets, minutes of meetings and accounting records, and non-participant observations of PSRA practices in case study hospitals over a period of 7 months. In this paper, we apply complex adaptive system (CAS) theory to examine the factors that influence PSRA practices. We found that PSRA practices in the case hospitals were influenced by, 1) inadequate financing level and poorly designed financing arrangements, 2) limited hospital autonomy and decision space, and 3) inadequate management and leadership capacity in the hospital. The case study hospitals exhibited properties of complex adaptive systems (CASs) that exist in a dynamic state with multiple interacting agents. Weaknesses in system 'hardware' (resource scarcity) and 'software' (including PSRA guidelines that reduced hospitals decision space, and poor leadership skills) led to the emergence of undesired properties. The capacity of hospitals to set priorities should be improved across these interacting aspects of the hospital organizational system. Interventions should however recognize that hospitals are CAS. Rather than rectifying isolated aspects of the system, they should endeavor to create conditions for productive emergence.

Molyneux S, Tsofa B, Barasa E, Nyikuri MM, Waweru EW, Goodman C, Gilson L. 2016. Research Involving Health Providers and Managers: Ethical Issues Faced by Researchers Conducting Diverse Health Policy and Systems Research in Kenya. Dev World Bioeth, 16 (3), pp. 168-177. | Show Abstract | Read more

There is a growing interest in the ethics of Health Policy and Systems Research (HPSR), and especially in areas that have particular ethical salience across HPSR. Hyder et al (2014) provide an initial framework to consider this, and call for more conceptual and empirical work. In this paper, we respond by examining the ethical issues that arose for researchers over the course of conducting three HPSR studies in Kenya in which health managers and providers were key participants. All three studies involved qualitative work including observations and individual and group interviews. Many of the ethical dilemmas researchers faced only emerged over the course of the fieldwork, or on completion, and were related to interactions and relationships between individuals operating at different levels or positions in health/research systems. The dilemmas reveal significant ethical challenges for these forms of HPSR, and show that potential 'solutions' to dilemmas often lead to new issues and complications. Our experiences support the value of research ethics frameworks, and suggest that these can be enriched by incorporating careful consideration of context embedded social relations into research planning and conduct. Many of these essential relational elements of ethical practice, and of producing quality data, are given stronger emphasis in social science research ethics than in epidemiological, clinical or biomedical research ethics, and are particularly relevant where health systems are understood as social and political constructs. We conclude with practical and research implications.

Barasa EW, Cleary S, English M, Molyneux S. 2016. The influence of power and actor relations on priority setting and resource allocation practices at the hospital level in Kenya: a case study. BMC Health Serv Res, 16 (1), pp. 536. | Show Abstract | Read more

BACKGROUND: Priority setting and resource allocation in healthcare organizations often involves the balancing of competing interests and values in the context of hierarchical and politically complex settings with multiple interacting actor relationships. Despite this, few studies have examined the influence of actor and power dynamics on priority setting practices in healthcare organizations. This paper examines the influence of power relations among different actors on the implementation of priority setting and resource allocation processes in public hospitals in Kenya. METHODS: We used a qualitative case study approach to examine priority setting and resource allocation practices in two public hospitals in coastal Kenya. We collected data by a combination of in-depth interviews of national level policy makers, hospital managers, and frontline practitioners in the case study hospitals (n = 72), review of documents such as hospital plans and budgets, minutes of meetings and accounting records, and non-participant observations in case study hospitals over a period of 7 months. We applied a combination of two frameworks, Norman Long's actor interface analysis and VeneKlasen and Miller's expressions of power framework to examine and interpret our findings RESULTS: The interactions of actors in the case study hospitals resulted in socially constructed interfaces between: 1) senior managers and middle level managers 2) non-clinical managers and clinicians, and 3) hospital managers and the community. Power imbalances resulted in the exclusion of middle level managers (in one of the hospitals) and clinicians and the community (in both hospitals) from decision making processes. This resulted in, amongst others, perceptions of unfairness, and reduced motivation in hospital staff. It also puts to question the legitimacy of priority setting processes in these hospitals. CONCLUSIONS: Designing hospital decision making structures to strengthen participation and inclusion of relevant stakeholders could improve priority setting practices. This should however, be accompanied by measures to empower stakeholders to contribute to decision making. Strengthening soft leadership skills of hospital managers could also contribute to managing the power dynamics among actors in hospital priority setting processes.

Barasa EW, Cleary S, Molyneux S, English M. 2017. Setting healthcare priorities: a description and evaluation of the budgeting and planning process in county hospitals in Kenya. Health Policy Plan, 32 (3), pp. 329-337. | Show Abstract | Read more

This paper describes and evaluates the budgeting and planning processes in public hospitals in Kenya. We used a qualitative case study approach to examine these processes in two hospitals in Kenya. We collected data by in-depth interviews of national level policy makers, hospital managers, and frontline practitioners in the case study hospitals (n = 72), a review of documents, and non-participant observations within the hospitals over a 7 month period. We applied an evaluative framework that considers both consequentialist and proceduralist conditions as important to the quality of priority-setting processes. The budgeting and planning process in the case study hospitals was characterized by lack of alignment, inadequate role clarity and the use of informal priority-setting criteria. With regard to consequentialist conditions, the hospitals incorporated economic criteria by considering the affordability of alternatives, but rarely considered the equity of allocative decisions. In the first hospital, stakeholders were aware of - and somewhat satisfied with - the budgeting and planning process, while in the second hospital they were not. Decision making in both hospitals did not result in reallocation of resources. With regard to proceduralist conditions, the budgeting and planning process in the first hospital was more inclusive and transparent, with the stakeholders more empowered compared to the second hospital. In both hospitals, decisions were not based on evidence, implementation of decisions was poor and the community was not included. There were no mechanisms for appeals or to ensure that the proceduralist conditions were met in both hospitals. Public hospitals in Kenya could improve their budgeting and planning processes by harmonizing these processes, improving role clarity, using explicit priority-setting criteria, and by incorporating both consequentialist (efficiency, equity, stakeholder satisfaction and understanding, shifted priorities, implementation of decisions), and proceduralist (stakeholder engagement and empowerment, transparency, use of evidence, revisions, enforcement, and incorporating community values) conditions.

Muraya KW, Jones C, Berkley JA, Molyneux S. 2016. Perceptions of childhood undernutrition among rural households on the Kenyan coast - a qualitative study. BMC Public Health, 16 (1), pp. 693. | Show Abstract | Read more

BACKGROUND: Nutrition plays an important role in child survival and development. Treatment action in the management of child health and nutrition is influenced by perceptions of illness, and gender plays an important role. However, little is known about if and how moderate undernutrition is recognised among lay populations, or how local social norms and intra-household dynamics affect decisions to seek biomedical assistance for nutritional concerns. In this paper we describe how childhood nutritional problems are recognised and understood within rural households. We demonstrate how context influences local constructs of 'normal', and suggest the centrality of gender in the management of child health and nutrition in our research context. METHODS: This qualitative study was undertaken in Kilifi County on the Kenyan Coast. A set of 15 households whose children were engaged in a community-based nutrition intervention were followed up over a period of twelve months. Over a total of 54 household visits, group and individual in-depth interviews were conducted with a range of respondents, supplemented by non-participant observations. Eight in-depth interviews with community representatives were also conducted. RESULTS: Local taxonomies of childhood undernutrition were found to overlap with, but differ from, biomedical categories. In particular, moderate undernutrition was generally not recognised as a health problem requiring treatment action, but rather as routine and manageable, typically seasonal, weight-loss. Where symptoms were considered more serious and requiring remedial action, household management strategies were typically based on perceived aetiology of the illness. Additionally, gender emerged as a potentially central theme in childhood nutrition problems and related management. Women reported that they have primary responsibility for ensuring children's good health and nutritional status, and that they are often held accountable when their children are of sub-optimal health. CONCLUSION: Perceptions of child nutrition and illness and gendered roles within households influence treatment action, and engagement with nutrition interventions. Community-based nutrition interventions must recognise these complex realities.

Asante KP, Jones C, Sirima SB, Molyneux S. 2016. Clinical Trials Cannot Substitute for Health System Strengthening Initiatives or Specifically Designed Health Policy and Systems Research. Am J Bioeth, 16 (6), pp. 24-26. | Read more

Molyneux S, Sariola S, Allman D, Dijkstra M, Gichuru E, Graham S, Kamuya D, Gakii G, Kayemba B, Kombo B et al. 2016. Public/community engagement in health research with men who have sex with men in sub-Saharan Africa: challenges and opportunities. Health Res Policy Syst, 14 (1), pp. 40. | Show Abstract | Read more

BACKGROUND: Community engagement, incorporating elements of the broader concepts of public and stakeholder engagement, is increasingly promoted globally, including for health research conducted in developing countries. In sub-Saharan Africa, community engagement needs and challenges are arguably intensified for studies involving gay, bisexual and other men who have sex with men, where male same-sex sexual interactions are often highly stigmatised and even illegal. This paper contextualises, describes and interprets the discussions and outcomes of an international meeting held at the Kenya Medical Research Institute-Wellcome Trust in Kilifi, Kenya, in November 2013, to critically examine the experiences with community engagement for studies involving men who have sex with men. DISCUSSION: We discuss the ethically charged nature of the language used for men who have sex with men, and of working with 'representatives' of these communities, as well as the complementarity and tensions between a broadly public health approach to community engagement, and a more rights based approach. We highlight the importance of researchers carefully considering which communities to engage with, and the goals, activities, and indicators of success and potential challenges for each. We suggest that, given the unintended harms that can emerge from community engagement (including through labelling, breaches in confidentiality, increased visibility and stigma, and threats to safety), representatives of same-sex populations should be consulted from the earliest possible stage, and that engagement activities should be continuously revised in response to unfolding realities. Engagement should also include less vocal and visible men who have sex with men, and members of other communities with influence on the research, and on research participants and their families and friends. Broader ethics support, advice and research into studies involving men who have sex with men is needed to ensure that ethical challenges - including but not limited to those related to community engagement - are identified and addressed. Underlying challenges and dilemmas linked to stigma and discrimination of men who have sex with men in Africa raise special responsibilities for researchers. Community engagement is an important way of identifying responses to these challenges and responsibilities but itself presents important ethical challenges.

Morgan R, George A, Ssali S, Hawkins K, Molyneux S, Theobald S. 2016. How to do (or not to do)… gender analysis in health systems research. Health Policy Plan, 31 (8), pp. 1069-1078. | Show Abstract | Read more

Gender-the socially constructed roles, behaviours, activities and attributes that a given society considers appropriate for males, females and other genders-affects how people live, work and relate to each other at all levels, including in relation to the health system. Health systems research (HSR) aims to inform more strategic, effective and equitable health systems interventions, programs and policies; and the inclusion of gender analysis into HSR is a core part of that endeavour. We outline what gender analysis is and how gender analysis can be incorporated into HSR content, process and outcomes Starting with HSR content, i.e. the substantive focus of HSR, we recommend exploring whether and how gender power relations affect females and males in health systems through the use of sex disaggregated data, gender frameworks and questions. Sex disaggregation flags female-male differences or similarities that warrant further analysis; and further analysis is guided by gender frameworks and questions to understand how gender power relations are constituted and negotiated in health systems. Critical aspects of understanding gender power relations include examining who has what (access to resources); who does what (the division of labour and everyday practices); how values are defined (social norms) and who decides (rules and decision-making). Secondly, we examine gender in HSR process by reflecting on how the research process itself is imbued with power relations. We focus on data collection and analysis by reviewing who participates as respondents; when data is collected and where; who is present; who collects data and who analyses data. Thirdly, we consider gender and HSR outcomes by considering who is empowered and disempowered as a result of HSR, including the extent to which HSR outcomes progressively transform gender power relations in health systems, or at least do not further exacerbate them.

Kombe F. 2015. Enhancing quality and integrity in biomedical research in Africa: an international call for greater focus, investment and standardisation in capacity strengthening for frontline staff BMC Medical Ethics, 16 (1), | Read more

Jao I, Kombe F, Mwalukore S, Bull S, Parker M, Kamuya D, Molyneux S, Marsh V. 2015. Involving Research Stakeholders in Developing Policy on Sharing Public Health Research Data in Kenya: Views on Fair Process for Informed Consent, Access Oversight, and Community Engagement. J Empir Res Hum Res Ethics, 10 (3), pp. 264-277. | Show Abstract | Read more

Increased global sharing of public health research data has potential to advance scientific progress but may present challenges to the interests of research stakeholders, particularly in low-to-middle income countries. Policies for data sharing should be responsive to public views, but there is little evidence of the systematic study of these from low-income countries. This qualitative study explored views on fair data-sharing processes among 60 stakeholders in Kenya with varying research experience, using a deliberative approach. Stakeholders' attitudes were informed by perceptions of benefit and concerns for research data sharing, including risks of stigmatization, loss of privacy, and undermining scientific careers and validity, reported in detail elsewhere. In this article, we discuss institutional trust-building processes seen as central to perceptions of fairness in sharing research data in this setting, including forms of community involvement, individual prior awareness and agreement to data sharing, independence and accountability of governance mechanisms, and operating under a national framework.

Hodgson SH, Juma E, Salim A, Magiri C, Njenga D, Molyneux S, Njuguna P, Awuondo K, Lowe B, Billingsley PF et al. 2015. Lessons learnt from the first controlled human malaria infection study conducted in Nairobi, Kenya. Malar J, 14 (1), pp. 182. | Show Abstract | Read more

BACKGROUND: Controlled human malaria infection (CHMI) studies, in which healthy volunteers are infected with Plasmodium falciparum to assess the efficacy of novel malaria vaccines and drugs, have become a vital tool to accelerate vaccine and drug development. CHMI studies provide a cost-effective and expeditious way to circumvent the use of large-scale field efficacy studies to deselect intervention candidates. However, to date few modern CHMI studies have been performed in malaria-endemic countries. METHODS: An open-label, randomized pilot CHMI study was conducted using aseptic, purified, cryopreserved, infectious P. falciparum sporozoites (SPZ) (Sanaria® PfSPZ Challenge) administered intramuscularly (IM) to healthy Kenyan adults (n = 28) with varying degrees of prior exposure to P. falciparum. The purpose of the study was to establish the PfSPZ Challenge CHMI model in a Kenyan setting with the aim of increasing the international capacity for efficacy testing of malaria vaccines and drugs, and allowing earlier assessment of efficacy in a population for which interventions are being developed. This was part of the EDCTP-funded capacity development of the CHMI platform in Africa. DISCUSSION: This paper discusses in detail lessons learnt from conducting the first CHMI study in Kenya. Issues pertinent to the African setting, including community sensitization, consent and recruitment are considered. Detailed reasoning regarding the study design (for example, dose and route of administration of PfSPZ Challenge, criteria for grouping volunteers according to prior exposure to malaria and duration of follow-up post CHMI) are given and changes other centres may want to consider for future studies are suggested. CONCLUSIONS: Performing CHMI studies in an African setting presents unique but surmountable challenges and offers great opportunity for acceleration of malaria vaccine and drug development. The reflections in this paper aim to aid other centres and partners intending to use the CHMI model in Africa.

Waweru E, Goodman C, Kedenge S, Tsofa B, Molyneux S. 2016. Tracking implementation and (un)intended consequences: a process evaluation of an innovative peripheral health facility financing mechanism in Kenya. Health Policy Plan, 31 (2), pp. 137-147. | Show Abstract | Read more

In many African countries, user fees have failed to achieve intended access and quality of care improvements. Subsequent user fee reduction or elimination policies have often been poorly planned, without alternative sources of income for facilities. We describe early implementation of an innovative national health financing intervention in Kenya; the health sector services fund (HSSF). In HSSF, central funds are credited directly into a facility's bank account quarterly, and facility funds are managed by health facility management committees (HFMCs) including community representatives. HSSF is therefore a finance mechanism with potential to increase access to funds for peripheral facilities, support user fee reduction and improve equity in access. We conducted a process evaluation of HSSF implementation based on a theory of change underpinning the intervention. Methods included interviews at national, district and facility levels, facility record reviews, a structured exit survey and a document review. We found impressive achievements: HSSF funds were reaching facilities; funds were being overseen and used in a way that strengthened transparency and community involvement; and health workers' motivation and patient satisfaction improved. Challenges or unintended outcomes included: complex and centralized accounting requirements undermining efficiency; interactions between HSSF and user fees leading to difficulties in accessing crucial user fee funds; and some relationship problems between key players. Although user fees charged had not increased, national reduction policies were still not being adhered to. Finance mechanisms can have a strong positive impact on peripheral facilities, and HFMCs can play a valuable role in managing facilities. Although fiduciary oversight is essential, mechanisms should allow for local decision-making and ensure that unmanageable paperwork is avoided. There are also limits to what can be achieved with relatively small funds in contexts of enormous need. Process evaluations tracking (un)intended consequences of interventions can contribute to regional financing and decentralization debates.

Tsofa B, Molyneux S, Goodman C. 2016. Health sector operational planning and budgeting processes in Kenya-"never the twain shall meet". Int J Health Plann Manage, 31 (3), pp. 260-276. | Show Abstract | Read more

Operational planning is considered an important tool for translating government policies and strategic objectives into day-to-day management activities. However, developing countries suffer from persistent misalignment between policy, planning and budgeting. The Medium Term Expenditure Framework (MTEF) was introduced to address this misalignment. Kenya adopted the MTEF in the early 2000s, and in 2005, the Ministry of Health adopted the Annual Operational Plan process to adapt the MTEF to the health sector. This study assessed the degree to which the health sector Annual Operational Plan process in Kenya has achieved alignment between planning and budgeting at the national level, using document reviews, participant observation and key informant interviews. We found that the Kenyan health sector was far from achieving planning and budgeting alignment. Several factors contributed to this problem including weak Ministry of Health stewardship and institutionalized separation between planning and budgeting processes; a rapidly changing planning and budgeting environment; lack of reliable data to inform target setting and poor participation by key stakeholders in the process including a top-down approach to target setting. We conclude that alignment is unlikely to be achieved without consideration of the specific institutional contexts and the power relationships between stakeholders. In particular, there is a need for institutional integration of the planning and budgeting processes into a common cycle and framework with common reporting lines and for improved data and local-level input to inform appropriate and realistic target setting. © 2015 The Authors. International Journal of Health Planning and Management published by John Wiley & Sons, Ltd.

Nyikuri M, Tsofa B, Barasa E, Okoth P, Molyneux S. 2015. Crises and Resilience at the Frontline-Public Health Facility Managers under Devolution in a Sub-County on the Kenyan Coast. PLoS One, 10 (12), pp. e0144768. | Show Abstract | Read more

BACKGROUND: Public primary health care (PHC) facilities are for many individuals the first point of contact with the formal health care system. These facilities are managed by professional nurses or clinical officers who are recognised to play a key role in implementing health sector reforms and facilitating initiatives aimed at strengthening community involvement. Little in-depth research exists about the dimensions and challenges of these managers' jobs, or on the impact of decentralisation on their roles and responsibilities. In this paper, we describe the roles and responsibilities of PHC managers-or 'in-charges' in Kenya, and their challenges and coping strategies, under accelerated devolution. METHODS: The data presented in this paper is part of a wider set of activities aimed at understanding governance changes under devolution in Kenya, under the umbrella of a 'learning site'. A learning site is a long term process of collaboration between health managers and researchers deciding together on key health system questions and interventions. Data were collected through seven formal in depth interviews and observations at four PHC facilities as well as eight in depth interviews and informal interactions with sub-county managers from June 2013 to July 2014. Drawing on the Aragon framework of organisation capacity we discuss the multiple accountabilities, daily routines, challenges and coping strategies among PHC facility managers. RESULTS: PHC in-charges perform complex and diverse roles in a difficult environment with relatively little formal preparation. Their key concerns are lack of job clarity and preparedness, the difficulty of balancing multidirectional accountability responsibilities amidst significant resource shortages, and remuneration anxieties. We show that day-to-day management in an environment of resource constraints and uncertainty requires PHC in-charges who are resilient, reflective, and continuously able to learn and adapt. We highlight the importance of leadership development including the building of critical soft skills such as relationship building.

Barasa EW, Molyneux S, English M, Cleary S. 2015. Setting Healthcare Priorities at the Macro and Meso Levels: A Framework for Evaluation. Int J Health Policy Manag, 4 (11), pp. 719-732. | Show Abstract | Read more

BACKGROUND: Priority setting in healthcare is a key determinant of health system performance. However, there is no widely accepted priority setting evaluation framework. We reviewed literature with the aim of developing and proposing a framework for the evaluation of macro and meso level healthcare priority setting practices. METHODS: We systematically searched Econlit, PubMed, CINAHL, and EBSCOhost databases and supplemented this with searches in Google Scholar, relevant websites and reference lists of relevant papers. A total of 31 papers on evaluation of priority setting were identified. These were supplemented by broader theoretical literature related to evaluation of priority setting. A conceptual review of selected papers was undertaken. RESULTS: Based on a synthesis of the selected literature, we propose an evaluative framework that requires that priority setting practices at the macro and meso levels of the health system meet the following conditions: (1) Priority setting decisions should incorporate both efficiency and equity considerations as well as the following outcomes; (a) Stakeholder satisfaction, (b) Stakeholder understanding, (c) Shifted priorities (reallocation of resources), and (d) Implementation of decisions. (2) Priority setting processes should also meet the procedural conditions of (a) Stakeholder engagement, (b) Stakeholder empowerment, (c) Transparency, (d) Use of evidence, (e) Revisions, (f) Enforcement, and (g) Being grounded on community values. CONCLUSION: Available frameworks for the evaluation of priority setting are mostly grounded on procedural requirements, while few have included outcome requirements. There is, however, increasing recognition of the need to incorporate both consequential and procedural considerations in priority setting practices. In this review, we adapt an integrative approach to develop and propose a framework for the evaluation of priority setting practices at the macro and meso levels that draws from these complementary schools of thought.

Kamuya DM, Theobald SJ, Marsh V, Parker M, Geissler WP, Molyneux SC. 2015. "The one who chases you away does not tell you go": silent refusals and complex power relations in research consent processes in Coastal Kenya. PLoS One, 10 (5), pp. e0126671. | Show Abstract | Read more

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.

George A, Theobald S, Morgan R, Hawkins K, Molyneux S. 2015. Snap shots from a photo competition: what does it reveal about close-to-community providers, gender and power in health systems? Hum Resour Health, 13 (1), pp. 57. | Show Abstract | Read more

In this commentary, we discuss a photography competition, launched during the summer of 2014, to explore the everyday stories of how gender plays out within health systems around the world. While no submission fees were charged nor financial awards involved, the winning entries were exhibited at the Global Symposium on Health Systems Research in Cape Town, South Africa, in October 2014, with credits to the photographers involved. Anyone who had an experience of, or interest in, gender and health systems was invited to participate. Underlying the aims of the photo competition was a recognition of the importance of participation of community members, health workers and other non-academics in our research engagement and in venues where their perspectives are often missing. The competition elicited participation from a range of stakeholders engaged in health systems: professional photographers, project managers, donors, researchers, activists and community members. In total, 54 photos were submitted by 29 participants from 15 different nationalities and country locations. We unpack what the photos suggest about gender and health systems and the pivotal role of community-level systems that support health, including that of close-to-community health providers. Three themes emerged: women active on the frontlines of service delivery and as primary unpaid carers, the visibility of men in gender and health systems and the inter-sectoral nature and intra-household dynamics of community health that embed close-to-community health providers. The question of who has the right to take and display images, under what contexts and for what purpose also permeated the photo competition. We reflect on how photos can be valuable representations of the worlds that we, health workers and health systems are embedded in. Photographs broaden our horizons by capturing and connecting us to subjects from afar in seemingly unmediated ways but also reflect the politics, values and subjectivities of the photographer. They represent stereotypes, but also showcase alternate realities of people and health systems, and thereby can engender further reflection and change. We conclude with thoughts about the place of photography in health systems research and practice in highlighting and potentially transforming how we look at and address close-to-community providers.

Jao I, Kombe F, Mwalukore S, Bull S, Parker M, Kamuya D, Molyneux S, Marsh V. 2015. Research Stakeholders' Views on Benefits and Challenges for Public Health Research Data Sharing in Kenya: The Importance of Trust and Social Relations. PLoS One, 10 (9), pp. e0135545. | Show Abstract | Read more

BACKGROUND: There is increasing recognition of the importance of sharing research data within the international scientific community, but also of the ethical and social challenges this presents, particularly in the context of structural inequities and varied capacity in international research. Public involvement is essential to building locally responsive research policies, including on data sharing, but little research has involved stakeholders from low-to-middle income countries. METHODS: Between January and June 2014, a qualitative study was conducted in Kenya involving sixty stakeholders with varying experiences of research in a deliberative process to explore views on benefits and challenges in research data sharing. In-depth interviews and extended small group discussions based on information sharing and facilitated debate were used to collect data. Data were analysed using Framework Analysis, and charting flow and dynamics in debates. FINDINGS: The findings highlight both the opportunities and challenges of communicating about this complex and relatively novel topic for many stakeholders. For more and less research-experienced stakeholders, ethical research data sharing is likely to rest on the development and implementation of appropriate trust-building processes, linked to local perceptions of benefits and challenges. The central nature of trust is underpinned by uncertainties around who might request what data, for what purpose and when. Key benefits perceived in this consultation were concerned with the promotion of public health through science, with legitimate beneficiaries defined differently by different groups. Important challenges were risks to the interests of study participants, communities and originating researchers through stigmatisation, loss of privacy, impacting autonomy and unfair competition, including through forms of intentional and unintentional 'misuse' of data. Risks were also seen for science. DISCUSSION: Given background structural inequities in much international research, building trust in this low-to-middle income setting includes ensuring that the interests of study participants, primary communities and originating researchers will be promoted as far as possible, as well as protected. Important ways of building trust in data sharing include involving the public in policy development and implementation, promoting scientific collaborations around data sharing and building close partnerships between researchers and government health authorities to provide checks and balances on data sharing, and promote near and long-term translational benefits.

Njue M, Molyneux S, Kombe F, Mwalukore S, Kamuya D, Marsh V. 2015. Benefits in cash or in kind? A community consultation on types of benefits in health research on the Kenyan Coast. PLoS One, 10 (5), pp. e0127842. | Show Abstract | Read more

BACKGROUND: Providing benefits and payments to participants in health research, either in cash or in kind, is a common but ethically controversial practice. While much literature has concentrated on appropriate levels of benefits or payments, this paper focuses on less well explored ethical issues around the nature of study benefits, drawing on views of community members living close to an international health research centre in Kenya. METHODS: The consultation, including 90 residents purposively chosen to reflect diversity, used a two-stage deliberative process. Five half-day workshops were each followed by between two and four small group discussions, within a two week period (total 16 groups). During workshops and small groups, facilitators used participatory methods to share information, and promote reflection and debate on ethical issues around types of benefits, including cash, goods, medical and community benefits. Data from workshop and field notes, and voice recordings of small group discussions, were managed using Nvivo 10 and analysed using a Framework Analysis approach. FINDINGS AND CONCLUSIONS: The methods generated in-depth discussion with high levels of engagement. Particularly for the most-poor, under-compensation of time in research carries risks of serious harm. Cash payments may best support compensation of costs experienced; while highly valued, goods and medical benefits may be more appropriate as an 'appreciation' or incentive for participation. Community benefits were seen as important in supporting but not replacing individual-level benefits, and in building trust in researcher-community relations. Cash payments were seen to have higher risks of undue inducement, commercialising relationships and generating family conflicts than other benefits, particularly where payments are high. Researchers should consider and account for burdens families may experience when children are involved in research. Careful context-specific research planning and skilled and consistent communication about study benefits and payments are important, including in mitigating potential negative effects.

Angwenyi V, Asante K-P, Traoré A, Febir LG, Tawiah C, Kwarteng A, Ouédraogo A, Sirima SB, Owusu-Agyei S, Imoukhuede EB et al. 2015. Health providers' perceptions of clinical trials: lessons from Ghana, Kenya and Burkina Faso. PLoS One, 10 (5), pp. e0124554. | Show Abstract | Read more

BACKGROUND: Clinical trials conducted in Africa often require substantial investments to support trial centres and public health facilities. Trial resources could potentially generate benefits for routine health service delivery but may have unintended consequences. Strengthening ethical practice requires understanding the potential effects of trial inputs on the perceptions and practices of routine health care providers. This study explores the influence of malaria vaccine trials on health service delivery in Ghana, Kenya and Burkina Faso. METHODS: We conducted: audits of trial inputs in 10 trial facilities and among 144 health workers; individual interviews with frontline providers (n=99) and health managers (n=14); and group discussions with fieldworkers (n=9 discussions). Descriptive summaries were generated from audit data. Qualitative data were analysed using a framework approach. RESULTS: Facilities involved in trials benefited from infrastructure and equipment upgrades, support with essential drugs, access to trial vehicles, and placement of additional qualified trial staff. Qualified trial staff in facilities were often seen as role models by their colleagues; assisting with supportive supervision and reducing facility workload. Some facility staff in place before the trial also received formal training and salary top-ups from the trials. However, differential access to support caused dissatisfaction, and some interviewees expressed concerns about what would happen at the end of the trial once financial and supervisory support was removed. CONCLUSION: Clinical trials function as short-term complex health service delivery interventions in the facilities in which they are based. They have the potential to both benefit facilities, staff and communities through providing the supportive environment required for improvements in routine care, but they can also generate dissatisfaction, relationship challenges and demoralisation among staff. Minimising trial related harm and maximising benefits requires careful planning and engagement of key actors at the outset of trials, throughout the trial and on its' completion.

Kamuya DM, Marsh V, Njuguna P, Munywoki P, Parker M, Molyneux S. 2014. "When they see us, it's like they have seen the benefits!": experiences of study benefits negotiations in community-based studies on the Kenyan Coast. BMC Med Ethics, 15 (1), pp. 90. | Show Abstract | Read more

BACKGROUND: Benefit sharing in health research has been the focus of international debates for many years, particularly in developing countries. Whilst increasing attention is being given to frameworks that can guide researchers to determine levels of benefits to participants, there is little empirical research from developing countries on the practical application of these frameworks, including in situations of extreme poverty and vulnerability. In addition, the voices of those who often negotiate and face issues related to benefits in practice - frontline researchers and fieldworkers (FWs) - are rarely included in these debates. Against this background, this paper reports on experiences of negotiating research participation and benefits as described by fieldworkers, research participants and researchers in two community based studies. METHODS: The findings reported here are from a broader social science study that explored the nature of interactions between fieldworkers and participants in two community based studies on the Kenyan Coast. Between January and July 2010, data were collected using participant observation, and through group discussions and in-depth interviews with 42 fieldworkers, 4 researchers, and 40 study participants. RESULTS: Participants highly appreciated the benefits provided by studies, particularly health care benefits. Fieldworkers were seen by participants and other community members as the gatekeepers and conduits of benefits, even though those were not their formal roles. Fieldworkers found it challenging to ignore participant and community requests for more benefits, especially in situations of extreme poverty. However, responding to requests by providing different sorts and levels of benefits over time, as inadvertently happened in one study, raised expectations of further benefits and led to continuous negotiations between fieldworkers and participants. CONCLUSIONS: Fieldworkers play an important intermediary role in research; a role imbued with multiple challenges and ethical dilemmas for which they require appropriate support. Further more specific empirical research is needed to inform the development of guidance for researchers on benefit sharing, and on responding to emergency humanitarian needs for this and other similar settings.

Tindana P, Molyneux CS, Bull S, Parker M. 2014. Ethical issues in the export, storage and reuse of human biological samples in biomedical research: perspectives of key stakeholders in Ghana and Kenya. BMC Med Ethics, 15 (1), pp. 76. | Show Abstract | Read more

BACKGROUND: For many decades, access to human biological samples, such as cells, tissues, organs, blood, and sub-cellular materials such as DNA, for use in biomedical research, has been central in understanding the nature and transmission of diseases across the globe. However, the limitations of current ethical and regulatory frameworks in sub-Saharan Africa to govern the collection, export, storage and reuse of these samples have resulted in inconsistencies in practice and a number of ethical concerns for sample donors, researchers and research ethics committees. This paper examines stakeholders' perspectives of and responses to the ethical issues arising from these research practices. METHODS: We employed a qualitative strategy of inquiry for this research including in-depth interviews and focus group discussions with key research stakeholders in Kenya (Nairobi and Kilifi), and Ghana (Accra and Navrongo). RESULTS: The stakeholders interviewed emphasised the compelling scientific importance of sample export, storage and reuse, and acknowledged the existence of some structures governing these research practices, but they also highlighted the pressing need for a number of practical ethical concerns to be addressed in order to ensure high standards of practice and to maintain public confidence in international research collaborations. These concerns relate to obtaining culturally appropriate consent for sample export and reuse, understanding cultural sensitivities around the use of blood samples, facilitating a degree of local control of samples and sustainable scientific capacity building. CONCLUSION: Drawing on these findings and existing literature, we argue that the ethical issues arising in practice need to be understood in the context of the interactions between host research institutions and local communities and between collaborating institutions. We propose a set of 'key points-to-consider' for research institutions, ethics committees and funding agencies to address these issues.

Opwora A, Waweru E, Toda M, Noor A, Edwards T, Fegan G, Molyneux S, Goodman C. 2015. Implementation of patient charges at primary care facilities in Kenya: implications of low adherence to user fee policy for users and facility revenue. Health Policy Plan, 30 (4), pp. 508-517. | Show Abstract | Read more

With user fees now seen as a major hindrance to universal health coverage, many countries have introduced fee reduction or elimination policies, but there is growing evidence that adherence to reduced fees is often highly imperfect. In 2004, Kenya adopted a reduced and uniform user fee policy providing fee exemptions to many groups. We present data on user fee implementation, revenue and expenditure from a nationally representative survey of Kenyan primary health facilities. Data were collected from 248 randomly selected public health centres and dispensaries in 2010, comprising an interview with the health worker in charge, exit interviews with curative outpatients, and a financial record review. Adherence to user fee policy was assessed for eight tracer conditions based on health worker reports, and patients were asked about actual amounts paid. No facilities adhered fully to the user fee policy across all eight tracers, with adherence ranging from 62.2% for an adult with tuberculosis to 4.2% for an adult with malaria. Three quarters of exit interviewees had paid some fees, with a median payment of US dollars (USD) 0.39, and a quarter of interviewees were required to purchase additional medical supplies at a later stage from a private drug retailer. No consistent pattern of association was identified between facility characteristics and policy adherence. User fee revenues accounted for almost all facility cash income, with average revenue of USD 683 per facility per year. Fee revenue was mainly used to cover support staff, non-drug supplies and travel allowances. Adherence to user fee policy was very low, leading to concerns about the impact on access and the financial burden on households. However, the potential to ensure adherence was constrained by the facilities' need for revenue to cover basic operating costs, highlighting the need for alternative funding strategies for peripheral health facilities.

Barasa EW, Molyneux S, English M, Cleary S. 2015. Setting healthcare priorities in hospitals: a review of empirical studies. Health Policy Plan, 30 (3), pp. 386-396. | Show Abstract | Read more

Priority setting research has focused on the macro (national) and micro (bedside) level, leaving the meso (institutional, hospital) level relatively neglected. This is surprising given the key role that hospitals play in the delivery of healthcare services and the large proportion of health systems resources that they absorb. To explore the factors that impact upon priority setting at the hospital level, we conducted a thematic review of empirical studies. A systematic search of PubMed, EBSCOHOST, Econlit databases and Google scholar was supplemented by a search of key websites and a manual search of relevant papers' reference lists. A total of 24 papers were identified from developed and developing countries. We applied a policy analysis framework to examine and synthesize the findings of the selected papers. Findings suggest that priority setting practice in hospitals was influenced by (1) contextual factors such as decision space, resource availability, financing arrangements, availability and use of information, organizational culture and leadership, (2) priority setting processes that depend on the type of priority setting activity, (3) content factors such as priority setting criteria and (4) actors, their interests and power relations. We observe that there is need for studies to examine these issues and the interplay between them in greater depth and propose a conceptual framework that might be useful in examining priority setting practices in hospitals.

Angwenyi V, Kamuya D, Mwachiro D, Kalama B, Marsh V, Njuguna P, Molyneux S. 2014. Complex realities: community engagement for a paediatric randomized controlled malaria vaccine trial in Kilifi, Kenya. Trials, 15 (1), pp. 65. | Show Abstract | Read more

BACKGROUND: Community engagement (CE) is increasingly promoted for biomedical research conducted in resource poor settings for both intrinsic and instrumental purposes. Given the potential importance of CE, but also complexities and possibility of unexpected negative outcomes, there is need for more documentation of CE processes in practice. We share experiences of formal CE for a paediatric randomized controlled malaria vaccine trial conducted in three sites within Kilifi County, Kenya. METHODS: Social scientists independent of the trial held in-depth individual interviews with trial researchers (n=5), community leaders (n=8) and parents (15 with enrolled children and 4 without); and group discussions with fieldworkers (n=6) and facility staff (n=2). We conducted a survey of participating households (n=200) and observed over 150 CE activities. RESULTS: The overall CE plan was similar across the three study sites, although less community-based information in site C. Majority perceived CE activities to clear pre-existing concerns and misconceptions; increase visibility, awareness of and trust in trial staff. Challenges included: some community leaders attempting to exert pressure on people to enrol; local wording in information sheets and consent forms feeding into serious anxieties about the trial; and concerns about reduced CE over time. Negative effects of these challenges were mitigated through changes to on-going CE activities, and final information sharing and consent being conducted individually by trained clinical staff. One year after enrolment, 31% (n = 62) of participants' parents reported malaria prevention as the main aim of the activities their children were involved in, and 93% wanted their children to remain involved. CONCLUSION: The trial teams' goals for CE were relatively clear from the outset. Other actors' hopes and expectations (like higher allowances and future employment) were not openly discussed, but emerged over the course of engagements. Encouraging open discussion of all actors' intentions and goals from the outset takes time, risks raising expectations that cannot be met, and is complex. However, doing so in future similar trials may allow successes here to be built upon, and some challenges minimized or avoided. TRIAL REGISTRATION: ClinicalTrials.gov NCT00866619 (registration 19-Mar-2009).

Hodgson SH, Juma E, Salim A, Magiri C, Kimani D, Njenga D, Muia A, Cole AO, Ogwang C, Awuondo K et al. 2014. Evaluating controlled human malaria infection in Kenyan adults with varying degrees of prior exposure to Plasmodium falciparum using sporozoites administered by intramuscular injection. Front Microbiol, 5 (DEC), pp. 686. | Show Abstract | Read more

BACKGROUND: Controlled human malaria infection (CHMI) studies are a vital tool to accelerate vaccine and drug development. As CHMI trials are performed in a controlled environment, they allow unprecedented, detailed evaluation of parasite growth dynamics (PGD) and immunological responses. However, CHMI studies have not been routinely performed in malaria-endemic countries or used to investigate mechanisms of naturally-acquired immunity (NAI) to Plasmodium falciparum. METHODS: We conducted an open-label, randomized CHMI pilot-study using aseptic, cryopreserved P. falciparum sporozoites (PfSPZ Challenge) to evaluate safety, infectivity and PGD in Kenyan adults with low to moderate prior exposure to P. falciparum (Pan African Clinical Trial Registry: PACTR20121100033272). RESULTS: All participants developed blood-stage infection confirmed by quantitative polymerase chain reaction (qPCR). However one volunteer (110) remained asymptomatic and blood-film negative until day 21 post-injection of PfSPZ Challenge. This volunteer had a reduced parasite multiplication rate (PMR) (1.3) in comparison to the other 27 volunteers (median 11.1). A significant correlation was seen between PMR and screening anti-schizont Enzyme Linked Immunosorbent Assays (ELISA) OD (p = 0.044, R = -0.384) but not when volunteer 110 was excluded from the analysis (p = 0.112, R = -0.313). CONCLUSIONS: PfSPZ Challenge is safe and infectious in malaria-endemic populations and could be used to assess the efficacy of malaria vaccines and drugs in African populations. Whilst our findings are limited by sample size, our pilot study has demonstrated for the first time that NAI may impact on PMR post-CHMI in a detectable fashion, an important finding that should be evaluated in further CHMI studies.

Njue M, Kombe F, Mwalukore S, Molyneux S, Marsh V. 2014. What are fair study benefits in international health research? Consulting community members in Kenya. PLoS One, 9 (12), pp. e113112. | Show Abstract | Read more

BACKGROUND: Planning study benefits and payments for participants in international health research in low- income settings can be a difficult and controversial process, with particular challenges in balancing risks of undue inducement and exploitation and understanding how researchers should take account of background inequities. At an international health research programme in Kenya, this study aimed to map local residents' informed and reasoned views on the effects of different levels of study benefits and payments to inform local policy and wider debates in international research. METHODS AND FINDINGS: Using a relatively novel two-stage process community consultation approach, five participatory workshops involving 90 local residents from diverse constituencies were followed by 15 small group discussions, with components of information-sharing, deliberation and reflection to situate normative reasoning within debates. Framework Analysis drew inductively and deductively on voice-recorded discussions and field notes supported by Nvivo 10 software, and the international research ethics literature. Community members' views on study benefits and payments were diverse, with complex contextual influences and interplay between risks of giving 'too many' and 'too few' benefits, including the role of cash. While recognising important risks for free choice, research relationships and community values in giving 'too many', the greatest concerns were risks of unfairness in giving 'too few' benefits, given difficulties in assessing indirect costs of participation and the serious consequences for families of underestimation, related to perceptions of researchers' responsibilities. CONCLUSIONS: Providing benefits and payments to participants in international research in low-income settings is an essential means by which researchers meet individual-level and structural forms of ethical responsibilities, but understanding how this can be achieved requires a careful account of social realities and local judgment. Concerns about undue inducement in low-income communities may often be misplaced; we argue that greater attention should be placed on avoiding unfairness, particularly for the most-poor.

Marsh V, Kombe F, Fitzpatrick R, Molyneux S, Parker M. 2013. Managing misaligned paternity findings in research including sickle cell disease screening in Kenya: 'consulting communities' to inform policy. Soc Sci Med, 96 pp. 192-199. | Show Abstract | Read more

The management of misaligned paternity findings raises important controversy worldwide. It has mainly, however, been discussed in the context of high-income countries. Genetic and genomics research, with the potential to show misaligned paternity, are becoming increasingly common in Africa. During a genomics study in Kenya, a dilemma arose over testing and sharing information on paternal sickle cell disease status. This dilemma may be paradigmatic of challenges in sharing misaligned paternity findings in many research and health care settings. Using a deliberative approach to community consultation to inform research practice, we explored residents' views on paternal testing and sharing misaligned paternity information. Between December 2009 and November 2010, 63 residents in Kilifi County were engaged in informed deliberative small group discussions, structured to support normative reflection within the groups, with purposive selection to explore diversity. Analysis was based on a modified framework analysis approach, drawing on relevant social science and bioethics literature. The methods generated in-depth individual and group reflection on morally important issues and uncovered wide diversity in views and values. Fundamental and conflicting values emerged around the importance of family interests and openness, underpinned by disagreement on the moral implications of marital infidelity and withholding truth. Wider consideration of ethical issues emerging in these debates supports locally-held reasoning that paternal sickle cell testing should not be undertaken in this context, in contrast to views that testing should be done with or without the disclosure of misaligned paternity information. The findings highlight the importance of facilitating wider testing of family members of affected children, contingent on the development and implementation of national policies for the management of this inherited disorder. Their richness also illustrates the potential for the approach adopted in this study to strengthen community consultation.

Marsh V, Kombe F, Fitzpatrick R, Williams TN, Parker M, Molyneux S. 2013. Consulting communities on feedback of genetic findings in international health research: sharing sickle cell disease and carrier information in coastal Kenya. BMC Med Ethics, 14 (1), pp. 41. | Show Abstract | Read more

BACKGROUND: International health research in malaria-endemic settings may include screening for sickle cell disease, given the relationship between this important genetic condition and resistance to malaria, generating questions about whether and how findings should be disclosed. The literature on disclosing genetic findings in the context of research highlights the role of community consultation in understanding and balancing ethically important issues from participants' perspectives, including social forms of benefit and harm, and the influence of access to care. To inform research practice locally, and contribute to policy more widely, this study aimed to explore the views of local residents in Kilifi County in coastal Kenya on how researchers should manage study-generated information on sickle cell disease and carrier status. METHODS: Between June 2010 and July 2011, we consulted 62 purposively selected Kilifi residents on how researchers should manage study-generated sickle cell disease findings. Methods drew on a series of deliberative informed small group discussions. Data were analysed thematically, using charts, to describe participants' perceptions of the importance of disclosing findings, including reasoning, difference and underlying values. Themes were derived from the underlying research questions and from issues emerging from discussions. Data interpretation drew on relevant areas of social science and bioethics literature. RESULTS: Perceived health and social benefits generated strong support for disclosing findings on sickle cell disease, but the balance of social benefits and harms was less clear for sickle cell trait. Many forms of health and social benefits and harms of information-sharing were identified, with important underlying values related to family interests and the importance of openness. The influence of micro and macro level contextual features and prioritization of values led to marked diversity of opinion. CONCLUSIONS: The approach demonstrates a high ethical importance in many malaria endemic low-to-middle income country settings of disclosing sickle cell disease findings generated during research, alongside provision of effective care and locally-informed counselling. Since these services are central to the benefits of disclosure, health researchers whose studies include screening for sickle cell disease should actively promote the development of health policy and services for this condition in situations of unmet need, including through the prior development of collaborative partnerships with government health managers and providers. Community consultation can importantly enrich ethical debate on research practice where in-depth exploration of informed views and the potential for difference are taken into account.

Waweru E, Opwora A, Toda M, Fegan G, Edwards T, Goodman C, Molyneux S. 2013. Are Health Facility Management Committees in Kenya ready to implement financial management tasks: findings from a nationally representative survey. BMC Health Serv Res, 13 (1), pp. 404. | Show Abstract | Read more

BACKGROUND: Community participation in peripheral public health facilities has in many countries focused on including community representatives in Health Facility Management Committees (HFMCs). In Kenya, HFMC roles are being expanded with the phased implementation of the Health Sector Services Fund (HSSF). Under HSSF, HFMCs manage facility funds which are dispersed directly from central level into facility bank accounts. We assessed how prepared HFMCs were to undertake this new role in advance of HSSF roll out, and considered the implications for Kenya and other similar settings. METHODS: Data were collected through a nationally representative sample of 248 public health centres and dispensaries in 24 districts in 2010. Data collection included surveys with in-charges (n = 248), HFMC members (n = 464) and facility users (n = 698), and record reviews. These data were supplemented by semi-structured interviews with district health managers in each district. RESULTS: Some findings supported preparedness of HFMCs to take on their new roles. Most facilities had bank accounts and HFMCs which met regularly. HFMC members and in-charges generally reported positive relationships, and HFMC members expressed high levels of motivation and job satisfaction. Challenges included users' low awareness of HFMCs, lack of training and clarity in roles among HFMCs, and some indications of strained relations with in-charges. Such challenges are likely to be common to many similar settings, and are therefore important considerations for any health facility based initiatives involving HFMCs. CONCLUSION: Most HFMCs have the basic requirements to operate. However to manage their own budgets effectively and meet their allocated roles in HSSF implementation, greater emphasis is needed on financial management training, targeted supportive supervision, and greater community awareness and participation. Once new budget management roles are fully established, qualitative and quantitative research on how HFMCs are adapting to their expanded roles, especially in financial management, would be valuable in informing similar financing mechanisms in Kenya and beyond.

Participants in the Community Engagement and Consent Workshop , Kilifi, Kenya , March 2011. 2013. Consent and community engagement in diverse research contexts. J Empir Res Hum Res Ethics, 8 (4), pp. 1-18. | Show Abstract | Read more

Consent and community engagement (CE) in health research are two aspects of a single concern-that research is carried out in a respectful manner where social value is maximized. There are important overlaps and interdependencies between consent and CE; for example, CE can provide insights into how best to tailor consent to context and can be an important component of consent processes. Engaging communities can also have intrinsic and instrumental value beyond consent; for example, as a means of showing respect and identifying appropriate ways of working respectfully. In this paper we critically examine how CE and consent processes are characterized, conducted, and evaluated in diverse health research contexts, and propose a preliminary research agenda to support future learning in these critical areas.

Cleary SM, Molyneux S, Gilson L. 2013. Resources, attitudes and culture: an understanding of the factors that influence the functioning of accountability mechanisms in primary health care settings. BMC Health Serv Res, 13 (1), pp. 320. | Show Abstract | Read more

BACKGROUND: District level health system governance is recognised as an important but challenging element of health system development in low and middle-income countries. Accountability is a more recent focus in health system debates. Accountability mechanisms are governance tools that seek to regulate answerability between the health system and the community (external accountability) and/or between different levels of the health system (bureaucratic accountability). External accountability has attracted significant attention in recent years, but bureaucratic accountability mechanisms, and the interactions between the two forms of accountability, have been relatively neglected. This is an important gap given that webs of accountability relationships exist within every health system. There is a need to strike a balance between achieving accountability upwards within the health system (for example through information reporting arrangements) while at the same time allowing for the local level innovation that could improve quality of care and patient responsiveness. METHODS: Using a descriptive literature review, this paper examines the factors that influence the functioning of accountability mechanisms and relationships within the district health system, and draws out the implications for responsiveness to patients and communities. We also seek to understand the practices that might strengthen accountability in ways that improve responsiveness--of the health system to citizens' needs and rights, and of providers to patients. RESULTS: The review highlights the ways in which bureaucratic accountability mechanisms often constrain the functioning of external accountability mechanisms. For example, meeting the expectations of relatively powerful managers further up the system may crowd out efforts to respond to citizens and patients. Organisational cultures characterized by supervision and management systems focused on compliance to centrally defined outputs and targets can constrain front line managers and providers from responding to patient and population priorities. CONCLUSION: Findings suggest that it is important to limit the potential negative impacts on responsiveness of new bureaucratic accountability mechanisms, and identify how these or other interventions might leverage the shifts in organizational culture necessary to encourage innovation and patient-centered care.

Angwenyi V, Kamuya D, Mwachiro D, Marsh V, Njuguna P, Molyneux S. 2013. Working with Community Health Workers as 'volunteers' in a vaccine trial: practical and ethical experiences and implications. Dev World Bioeth, 13 (1), pp. 38-47. | Show Abstract | Read more

Community engagement is increasingly emphasized in biomedical research, as a right in itself, and to strengthen ethical practice. We draw on interviews and observations to consider the practical and ethical implications of involving Community Health Workers (CHWs) as part of a community engagement strategy for a vaccine trial on the Kenyan Coast. CHWs were initially engaged as an important network to be informed about the trial. However over time, and in response to community advice, they became involved in trial information sharing and identifying potential participants; thereby taking on roles that overlapped with those of employed fieldworkers (FWs). While CHWs involvement was generally perceived as positive and appreciated, there were challenges in their relations with FWs and other community members, partly related to levels and forms of remuneration. Specifically, payment of CHWs was not as high as for FWs and was based on 'performance'. This extrinsic motivation had the potential to crowd out CHWs intrinsic motivation to perform their pre-existing community roles. CHWs remuneration potentially also contributed to CHWs distorting trial information to encourage community members to participate; and to researchers encouraging CHWs to utilize their social connections and status to increase the numbers of people who attended information giving sessions. Individual consent processes were protected in this trial through final information sharing and consent being conducted by trained clinical staff who were not embedded in study communities. However, our experiences suggest that roles and remuneration of all front line staff and volunteers involved in trials need careful consideration from the outset, and monitoring and discussion over time.

Molyneux S, Kamuya D, Madiega PA, Chantler T, Angwenyi V, Geissler PW. 2013. Field workers at the interface. Dev World Bioeth, 13 (1), pp. ii-iv. | Read more

Gikonyo C, Kamuya D, Mbete B, Njuguna P, Olotu A, Bejon P, Marsh V, Molyneux S. 2013. Feedback of research findings for vaccine trials: experiences from two malaria vaccine trials involving healthy children on the Kenyan Coast. Dev World Bioeth, 13 (1), pp. 48-56. | Show Abstract | Read more

Internationally, calls for feedback of findings to be made an 'ethical imperative' or mandatory have been met with both strong support and opposition. Challenges include differences in issues by type of study and context, disentangling between aggregate and individual study results, and inadequate empirical evidence on which to draw. In this paper we present data from observations and interviews with key stakeholders involved in feeding back aggregate study findings for two Phase II malaria vaccine trials among children under the age of 5 years old on the Kenyan Coast. In our setting, feeding back of aggregate findings was an appreciated set of activities. The inclusion of individual results was important from the point of view of both participants and researchers, to reassure participants of trial safety, and to ensure that positive results were not over-interpreted and that individual level issues around blinding and control were clarified. Feedback sessions also offered an opportunity to re-evaluate and re-negotiate trial relationships and benefits, with potentially important implications for perceptions of and involvement in follow-up work for the trials and in future research. We found that feedback of findings is a complex but key step in a continuing set of social interactions between community members and research staff (particularly field staff who work at the interface with communities), and among community members themselves; a step which needs careful planning from the outset. We agree with others that individual and aggregate results need to be considered separately, and that for individual results, both the nature and value of the information, and the context, including social relationships, need to be taken into account.

Gikonyo C, Kamuya D, Mbete B, Njuguna P, Olotu A, Bejon P, Marsh V, Molyneux S. 2013. Feedback of Research Findings for Vaccine Trials: Experiences from Two Malaria Vaccine Trials Involving Healthy Children on the Kenyan Coast Developing World Bioethics, 13 (1), pp. 48-56. | Show Abstract | Read more

Internationally, calls for feedback of findings to be made an 'ethical imperative' or mandatory have been met with both strong support and opposition. Challenges include differences in issues by type of study and context, disentangling between aggregate and individual study results, and inadequate empirical evidence on which to draw. In this paper we present data from observations and interviews with key stakeholders involved in feeding back aggregate study findings for two Phase II malaria vaccine trials among children under the age of 5 years old on the Kenyan Coast. In our setting, feeding back of aggregate findings was an appreciated set of activities. The inclusion of individual results was important from the point of view of both participants and researchers, to reassure participants of trial safety, and to ensure that positive results were not over-interpreted and that individual level issues around blinding and control were clarified. Feedback sessions also offered an opportunity to re-evaluate and re-negotiate trial relationships and benefits, with potentially important implications for perceptions of and involvement in follow-up work for the trials and in future research. We found that feedback of findings is a complex but key step in a continuing set of social interactions between community members and research staff (particularly field staff who work at the interface with communities), and among community members themselves; a step which needs careful planning from the outset. We agree with others that individual and aggregate results need to be considered separately, and that for individual results, both the nature and value of the information, and the context, including social relationships, need to be taken into account. Copyright © 2013 Blackwell Publishing Ltd.

Kamuya DM, Theobald SJ, Munywoki PK, Koech D, Geissler WP, Molyneux SC. 2013. Evolving Friendships and Shifting Ethical Dilemmas: Fieldworkers' Experiences in a Short Term Community Based Study in Kenya Developing World Bioethics,

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Kamuya DM, Marsh V, Kombe FK, Geissler PW, Molyneux SC. 2013. Engaging Communities to Strengthen Research Ethics in Low-Income Settings: Selection and Perceptions of Members of a Network of Representatives in Coastal Kenya Developing World Bioethics, 13 (1), pp. 10-20. | Show Abstract | Read more

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. © 2013 Blackwell Publishing Ltd.

Okello G, Jones C, Bonareri M, Ndegwa SN, McHaro C, Kengo J, Kinyua K, Dubeck MM, Halliday KE, Jukes MCH et al. 2013. Challenges for consent and community engagement in the conduct of cluster randomized trial among school children in low income settings: experiences from Kenya. Trials, 14 (1), pp. 142. | Show Abstract | Read more

BACKGROUND: There are a number of practical and ethical issues raised in school-based health research, particularly those related to obtaining consent from parents and assent from children. One approach to developing, strengthening, and supporting appropriate consent and assent processes is through community engagement. To date, much of the literature on community engagement in biomedical research has concentrated on community- or hospital-based research, with little documentation, if any, of community engagement in school-based health research. In this paper we discuss our experiences of consent, assent and community engagement in implementing a large school-based cluster randomized trial in rural Kenya. METHODS: Data collected as part of a qualitative study investigating the acceptability of the main trial, focus group discussions with field staff, observations of practice and authors' experiences are used to: 1) highlight the challenges faced in obtaining assent/consent; and 2) strategies taken to try to both protect participant rights (including to refuse and to withdraw) and ensure the success of the trial. RESULTS: Early meetings with national, district and local level stakeholders were important in establishing their co-operation and support for the project. Despite this support, both practical and ethical challenges were encountered during consenting and assenting procedures. Our strategy for addressing these challenges focused on improving communication and understanding of the trial, and maintaining dialogue with all the relevant stakeholders throughout the study period. CONCLUSIONS: A range of stakeholders within and beyond schools play a key role in school based health trials. Community entry and information dissemination strategies need careful planning from the outset, and with on-going consultation and feedback mechanisms established in order to identify and address concerns as they arise. We believe our experiences, and the ethical and practical issues and dilemmas encountered, will be of interest for others planning to conduct school-based research in Africa. TRIAL REGISTRATION: National Institute of Health NCT00878007.

Molyneux S, Njue M, Boga M, Akello L, Olupot-Olupot P, Engoru C, Kiguli S, Maitland K. 2013. 'The words will pass with the blowing wind': staff and parent views of the deferred consent process, with prior assent, used in an emergency fluids trial in two African hospitals. PLoS One, 8 (2), pp. e54894. | Show Abstract | Read more

OBJECTIVE: To document and explore the views and experiences of key stakeholders regarding the consent procedures of an emergency research clinical trial examining immediate fluid resuscitation strategies, and to discuss the implications for similar trials in future. METHODS: A social science sub-study of the FEAST (Fluid Expansion As Supportive Therapy) trial. Interviews were held with trial team members (n = 30), health workers (n = 15) and parents (n = 51) from two purposively selected hospitals in Soroti, Uganda, and Kilifi, Kenya. FINDINGS: Overall, deferred consent with prior assent was seen by staff and parents as having the potential to protect the interests of both patients and researchers, and to avoid delays in starting treatment. An important challenge is that the validity of verbal assent is undermined when inadequate initial information is poorly understood. This concern needs to be balanced against the possibility that full prior consent on admission potentially causes harm through introducing delays. Full prior consent also potentially imposes worries on parents that clinicians are uncertain about how to proceed and that clinicians want to absolve themselves of any responsibility for the child's outcome (some parents' interpretation of the need for signed consent). Voluntariness is clearly compromised for both verbal assent and full prior consent in a context of such vulnerability and stress. Further challenges in obtaining verbal assent were: what to do in the absence of the household decision-maker (often the father); and how medical staff handle parents not giving a clear agreement or refusal. CONCLUSION: While the challenges identified are faced in all research in low-income settings, they are magnified for emergency trials by the urgency of decision making and treatment needs. Consent options will need to be tailored to particular studies and settings, and might best be informed by consultation with staff members and community representatives using a deliberative approach.

Carter JA, Molyneux CS, Mbuba CK, Jenkins J, Newton CRJC, Hartley SD. 2012. The reasons for the epilepsy treatment gap in Kilifi, Kenya: using formative research to identify interventions to improve adherence to antiepileptic drugs. Epilepsy Behav, 25 (4), pp. 614-621. | Show Abstract | Read more

Many people with epilepsy (PWE) in resource-poor countries do not receive appropriate treatment, a phenomenon referred to as the epilepsy treatment gap (ETG). We conducted a qualitative study to explore the reasons for this gap and to identify possible interventions in Kilifi, Kenya. Focus group discussions (FGDs) were carried out of PWE and their caregivers. Individual interviews were conducted of PWE, their caregivers, traditional healers, community health workers and leaders, nurses and doctors. In addition, a series of workshops was conducted, and four factors contributing to the ETG were identified: 1) lack of knowledge about the causes, treatment and prognosis of epilepsy; 2) inaccessibility to antiepileptic drugs; 3) misconceptions about epilepsy derived from superstitions about its origin; 4) and dissatisfaction with the communication skills of health providers. These data indicated possible interventions: 1) education and support for PWE and their caregivers; 2) communication skills training for health providers; 3) and improved drug provision.

Molyneux S, Mulupi S, Mbaabu L, Marsh V. 2012. Benefits and payments for research participants: experiences and views from a research centre on the Kenyan coast. BMC Med Ethics, 13 (1), pp. 13. | Show Abstract | Read more

BACKGROUND: There is general consensus internationally that unfair distribution of the benefits of research is exploitative and should be avoided or reduced. However, what constitutes fair benefits, and the exact nature of the benefits and their mode of provision can be strongly contested. Empirical studies have the potential to contribute viewpoints and experiences to debates and guidelines, but few have been conducted. We conducted a study to support the development of guidelines on benefits and payments for studies conducted by the KEMRI-Wellcome Trust programme in Kilifi, Kenya. METHODS: Following an initial broad based survey of cash, health services and other items being offered during research by all programme studies (n = 38 studies), interviews were held with research managers (n = 9), and with research staff involved in 8 purposively selected case studies (n = 30 interviewees). Interviews explored how these 'benefits' were selected and communicated, experiences with their administration, and recommendations for future guidelines. Data fed into a consultative workshop attended by 48 research staff and health managers, which was facilitated by an external ethicist. FINDINGS: The most commonly provided benefits were medical care (for example free care, and strengthened quality of care), and lunch or snacks. Most cash given to participants was reimbursement of transport costs (for example to meet appointments or facilitate use of services when unexpectedly sick), but these payments were often described by research participants as benefits. Challenges included: tensions within households and communities resulting from lack of clarity and agreement on who is eligible for benefits; suspicion regarding motivation for their provision; and confusion caused by differences between studies in types and levels of benefits. CONCLUSIONS: Research staff differed in their views on how benefits should be approached. Echoing elements of international benefit sharing and ancillary care debates, some research staff saw research as based on goodwill and partnership, and aimed to avoid costs to participants and a commercial relationship; while others sought to maximise participant benefits given the relative wealth of the institution and the multiple community needs. An emerging middle position was to strengthen collateral or indirect medical benefits to communities through collaborations with the Ministry of Health to support sustainability.

Scott JAG, Bauni E, Moisi JC, Ojal J, Gatakaa H, Nyundo C, Molyneux CS, Kombe F, Tsofa B, Marsh K et al. 2012. Profile: The Kilifi Health and Demographic Surveillance System (KHDSS). Int J Epidemiol, 41 (3), pp. 650-657. | Show Abstract | Read more

The Kilifi Health and Demographic Surveillance System (KHDSS), located on the Indian Ocean coast of Kenya, was established in 2000 as a record of births, pregnancies, migration events and deaths and is maintained by 4-monthly household visits. The study area was selected to capture the majority of patients admitted to Kilifi District Hospital. The KHDSS has 260 000 residents and the hospital admits 4400 paediatric patients and 3400 adult patients per year. At the hospital, morbidity events are linked in real time by a computer search of the population register. Linked surveillance was extended to KHDSS vaccine clinics in 2008. KHDSS data have been used to define the incidence of hospital presentation with childhood infectious diseases (e.g. rotavirus diarrhoea, pneumococcal disease), to test the association between genetic risk factors (e.g. thalassaemia and sickle cell disease) and infectious diseases, to define the community prevalence of chronic diseases (e.g. epilepsy), to evaluate access to health care and to calculate the operational effectiveness of major public health interventions (e.g. conjugate Haemophilus influenzae type b vaccine). Rapport with residents is maintained through an active programme of community engagement. A system of collaborative engagement exists for sharing data on survival, morbidity, socio-economic status and vaccine coverage.

Turner GDH, Bunthi C, Wonodi CB, Morpeth SC, Molyneux CS, Zaki SR, Levine OS, Murdoch DR, Scott JAG. 2012. The role of postmortem studies in pneumonia etiology research. Clin Infect Dis, 54 Suppl 2 (suppl_2), pp. S165-S171. | Show Abstract | Read more

The diagnosis of etiology in severe pneumonia remains a challenging area. Postmortem lung tissue potentially increases the sensitivity of investigations for identification of causative pathogens in fatal cases of pneumonia and can confirm antemortem microbiological diagnoses. Tissue sampling allows assessment of histological patterns of disease and ancillary immunohistochemical or molecular diagnostic techniques. It may also enhance the recognition of noninfectious conditions that clinically simulate acute pneumonia. Biobanking of lung tissue or postmortem culture isolates offers opportunities for new pathogen discovery and research into host-pathogen interactions. The Pneumonia Etiology Research for Child Health study proposes a percutaneous needle biopsy approach to obtain postmortem samples, rather than a full open autopsy. This has the advantage of greater acceptability to relatives, but risks greater sampling error. Both approaches may be susceptible to microbiological contamination or pathogen degradation. However, previous autopsy studies have confirmed the value of histological examination in revealing unsuspected pathogens and influencing clinical guidelines for the diagnosis and treatment of future pneumonia cases.

Molyneux S, Atela M, Angwenyi V, Goodman C. 2012. Community accountability at peripheral health facilities: a review of the empirical literature and development of a conceptual framework. Health Policy Plan, 27 (7), pp. 541-554. | Show Abstract | Read more

Public accountability has re-emerged as a top priority for health systems all over the world, and particularly in developing countries where governments have often failed to provide adequate public sector services for their citizens. One approach to strengthening public accountability is through direct involvement of clients, users or the general public in health delivery, here termed 'community accountability'. The potential benefits of community accountability, both as an end in itself and as a means of improving health services, have led to significant resources being invested by governments and non-governmental organizations. Data are now needed on the implementation and impact of these initiatives on the ground. A search of PubMed using a systematic approach, supplemented by a hand search of key websites, identified 21 papers from low- or middle-income countries describing at least one measure to enhance community accountability that was linked with peripheral facilities. Mechanisms covered included committees and groups (n = 19), public report cards (n = 1) and patients' rights charters (n = 1). In this paper we summarize the data presented in these papers, including impact, and factors influencing impact, and conclude by commenting on the methods used, and the issues they raise. We highlight that the international interest in community accountability mechanisms linked to peripheral facilities has not been matched by empirical data, and present a conceptual framework and a set of ideas that might contribute to future studies.

Davies A, Mbete B, Fegan G, Molyneux S, Kinyanjui S. 2012. Seeing ‘With my Own Eyes’: Strengthening Interactions between Researchers and Schools* IDS Bulletin, 43 (5), pp. 61-67. | Show Abstract | Read more

We describe a participatory action research (PAR) project aimed at initiating a schools project as a component of the wider Kenya Medical Research Institute (KEMRI)-Wellcome Trust Research Programme's (KWTRP) community engagement strategy in Kilifi. Students and teachers from three nearby secondary schools, and scientists from KWTRP, were involved in designing and implementing a set of interventions aimed at promoting school awareness of locally conducted research, and positive attitudes towards school science and health research. The project was evaluated using a mixture of pre- and post-intervention surveys and discussions with teachers, students, researchers and other stakeholders throughout the duration of the project. The project did appear to fill some knowledge gaps about research and contribute to enhancing students' educational experiences, as intended. However, the project also provided a forum where teachers and students could express their concerns and question research practices, and unexpectedly promoted learning among researchers themselves. Further work is needed to learn more about the potential of school engagement to provide benefits for research institutes, individual researchers and local schools. © 2012 Institute of Development Studies.

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Hassan AS, Sakwa EM, Nabwera HM, Taegtmeyer MM, Kimutai RM, Sanders EJ, Awuondo KK, Mutinda MN, Molyneux CS, Berkley JA. 2012. Dynamics and constraints of early infant diagnosis of HIV infection in rural Kenya AIDS and Behavior, 16 (1), pp. 5-12. | Show Abstract | Read more

A cohort design was used to determine uptake and drop out of 213 HIV-exposed infants eligible for Early Infant Diagnosis (EID) of HIV. To explore service providers and care givers knowledge, attitudes and perceptions of the EID process, observations and in-depth interviews were conducted. 145 (68%) infants enrolled after 2 months of age. 139 (65%) dropped out before follow up to 18 months old. 60 (43%) drop outs occurred within 2 months of enrolment. Maternal factors associated with infant drop out were maternal loss to follow up (48 [68%] vs. 8 [20%] , P\0.001) and younger maternal age (27.2 vs. 30.1 years, P = 0.033). Service providers and caregivers had inadequate training, knowledge and understanding of EID. Poverty and lack of social support were challenges in accessing EID services. EID should be more closely aligned within PMTCT services, integrated with routine mother and child health (MCH) activities and its implementation more closely monitored. © 2011. The Author (s).

Goodman C, Opwora A, Kabare M, Molyneux S. 2011. Health facility committees and facility management - exploring the nature and depth of their roles in Coast Province, Kenya. BMC Health Serv Res, 11 (1), pp. 229. | Show Abstract | Read more

BACKGROUND: Community participation has been emphasized internationally as a way of enhancing accountability, as well as a means to enhance health goals in terms of coverage, access and effective utilization. In rural health facilities in Kenya, initiatives to increase community accountability have focused on Health Facility Committees (HFCs). In Coast Province the role of HFCs has been expanded with the introduction of direct funding of rural facilities. We explored the nature and depth of managerial engagement of HFCs at the facility level in two rural districts in this Coastal setting, and how this has contributed to community accountability METHODS: We conducted structured interviews with the health worker in-charge and with patients in 30 health centres and dispensaries. These data were supplemented with in-depth interviews with district managers, and with health workers and HFC members in 12 health centres and dispensaries. In-depth interviews with health workers and HFC members included a participatory exercise to stimulate discussion of the nature and depth of their roles in facility management. RESULTS: HFCs were generally functioning well and played an important role in facility operations. The breadth and depth of engagement had reportedly increased after the introduction of direct funding of health facilities which allowed HFCs to manage their own budgets. Although relations with facility staff were generally good, some mistrust was expressed between HFC members and health workers, and between HFC members and the broader community, partially reflecting a lack of clarity in HFC roles. Moreover, over half of exit interviewees were not aware of the HFC's existence. Women and less well-educated respondents were particularly unlikely to know about the HFC. CONCLUSIONS: There is potential for HFCs to play an active and important role in health facility management, particularly where they have control over some facility level resources. However, to optimise their contribution, efforts are needed to improve their training, clarify their roles, and improve engagement with the wider community.

Boga M, Davies A, Kamuya D, Kinyanjui SM, Kivaya E, Kombe F, Lang T, Marsh V, Mbete B, Mlamba A et al. 2011. Strengthening the informed consent process in international health research through community engagement: The KEMRI-Wellcome Trust Research Programme Experience. PLoS Med, 8 (9), pp. e1001089. | Read more

Marsh VM, Kamuya DK, Parker MJ, Molyneux CS. 2011. Working with Concepts: The Role of Community in International Collaborative Biomedical Research. Public Health Ethics, 4 (1), pp. 26-39. | Show Abstract | Read more

The importance of communities in strengthening the ethics of international collaborative research is increasingly highlighted, but there has been much debate about the meaning of the term 'community' and its specific normative contribution. We argue that 'community' is a contingent concept that plays an important normative role in research through the existence of morally significant interplay between notions of community and individuality. We draw on experience of community engagement in rural Kenya to illustrate two aspects of this interplay: (i) that taking individual informed consent seriously involves understanding and addressing the influence of communities in which individuals' lives are embedded; (ii) that individual participation can generate risks and benefits for communities as part of the wider implications of research. We further argue that the contingent nature of a community means that defining boundaries is generally a normative process itself, with ethical implications. Community engagement supports the enactment of normative roles; building mutual understanding and trust between researchers and community members have been important goals in Kilifi, requiring a broad range of approaches. Ethical dilemmas are continuously generated as part of these engagement activities, including the risks of perverse outcomes related to existing social relations in communities and conditions of 'half knowing' intrinsic to processes of developing new understandings.

Maitland K, Molyneux S, Boga M, Kiguli S, Lang T. 2011. Use of deferred consent for severely ill children in a multi-centre phase III trial. Trials, 12 (1), pp. 90. | Show Abstract | Read more

BACKGROUND: Voluntary participation of a subject in research respects a subject's rights, strengthens its ethical conduct, and is formalized by the informed consent process. Clinical trials of life-saving interventions for medical emergencies often necessitate enrollment of patients where prior written individual informed consent is impossible. Although there are regulations and guidelines on protecting subjects in emergency research, these have been criticised for being limited and unnecessarily restrictive. Across Europe and the United States stringent regulations have resulted in a substantial decline of clinical trials involving emergency interventions. METHODS: We are conducting a trial of fluid resuscitation in children with hypovolaemic shock in six hospitals across three malaria-endemic African countries. The design is pragmatic as children are enrolled on clinical criteria alone and is being conducted in hospitals with facilities typical of many district hospitals across Africa. The trial aims to inform strategy for managing children with febrile illness and features of shock. In order to develop appropriate consent processes for the trial, we conducted a narrative review of current international recommendations for emergency consent. RESULTS: Practical or specific guidance was generally sparse or confusing with few examples in the literature to direct our informed consent process. For a sub-group of children who were critically sick or where parents themselves were otherwise too distressed to consider prior written consent, we opted for a modified form of deferred consent. This included verbal assent from guardians at the point of enrollment, with full written consent obtained after stabilising the child. For children who died prior to full written consent, ethical permission was received to waiver full consent. CONCLUSIONS: In light of the controversy around guidance and regulations in this area we report how and why we have used a modified system of deferred consent in an emergency intervention trial in children. Although approved by all relevant ethics committees and operational in 3 countries in Africa, formal research is now necessary to explore the perceptions and experiences of parents, health workers, researchers and ethics committees of the modified method of deferred consent.

O'Meara WP, Tsofa B, Molyneux S, Goodman C, McKenzie FE. 2011. Community and facility-level engagement in planning and budgeting for the government health sector - A district perspective from Kenya Health Policy, 99 (3), pp. 234-243. | Show Abstract | Read more

Health systems reform processes have increasingly recognized the essential contribution of communities to the success of health programs and development activities in general. Here we examine the experience from Kilifi district in Kenya of implementing annual health sector planning guidelines that included community participation in problem identification, priority setting, and planning. We describe challenges in the implementation of national planning guidelines, how these were met, and how they influenced final plans and budgets.The broad-based community engagement envisaged in the guidelines did not take place due to the delay in roll out of the Ministry of Health-trained community health workers. Instead, community engagement was conducted through facility management committees, though in a minority of facilities, even such committees were not involved. Some overlap was found in the priorities highlighted by facility staff, committee members and national indicators, but there were also many additional issues raised by committee members and not by other groups. The engagement of the community through committees influenced target and priority setting, but the emphasis on national health indicators left many local priorities unaddressed by the final work plans. Moreover, it appears that the final impact on budgets allocated at district and facility level was limited. The experience in Kilifi highlights the feasibility of engaging the community in the health planning process, and the challenges of ensuring that this engagement feeds into consolidated plans and future implementation. © 2010 Elsevier Ireland Ltd.

Kamuya D, Marsh V, Molyneux S. 2011. What we learned about voluntariness and consent: Incorporating "background situations" and understanding into analyses American Journal of Bioethics, 11 (8), pp. 31-33. | Read more

Marsh VM, Kamuya DM, Molyneux SS. 2011. 'All her children are born that way': gendered experiences of stigma in families affected by sickle cell disorder in rural Kenya. Ethn Health, 16 (4-5), pp. 343-359. | Show Abstract | Read more

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.

Kamuya D, Marsh V, Molyneux S. 2011. What we learned about voluntariness and consent: incorporating "background situations" and understanding into analyses. Am J Bioeth, 11 (8), pp. 31-33. | Read more

Hassan AS, Sakwa EM, Nabwera HM, Taegtmeyer MM, Kimutai RM, Sanders EJ, Awuondo KK, Mutinda MN, Molyneux CS, Berkley JA. 2012. Dynamics and constraints of early infant diagnosis of HIV infection in Rural Kenya. AIDS Behav, 16 (1), pp. 5-12. | Show Abstract | Read more

A cohort design was used to determine uptake and drop out of 213 HIV-exposed infants eligible for Early Infant Diagnosis (EID) of HIV. To explore service providers and care givers knowledge, attitudes and perceptions of the EID process, observations and in-depth interviews were conducted. 145 (68%) infants enrolled after 2 months of age. 139 (65%) dropped out before follow up to 18 months old. 60 (43%) drop outs occurred within 2 months of enrolment. Maternal factors associated with infant drop out were maternal loss to follow up (48 [68%] vs. 8 [20%], P < 0.001) and younger maternal age (27.2 vs. 30.1 years, P = 0.033). Service providers and caregivers had inadequate training, knowledge and understanding of EID. Poverty and lack of social support were challenges in accessing EID services. EID should be more closely aligned within PMTCT services, integrated with routine mother and child health (MCH) activities and its implementation more closely monitored.

O'Meara WP, Tsofa B, Molyneux S, Goodman C, McKenzie FE. 2011. Community and facility-level engagement in planning and budgeting for the government health sector--a district perspective from Kenya. Health Policy, 99 (3), pp. 234-243. | Show Abstract | Read more

Health systems reform processes have increasingly recognized the essential contribution of communities to the success of health programs and development activities in general. Here we examine the experience from Kilifi district in Kenya of implementing annual health sector planning guidelines that included community participation in problem identification, priority setting, and planning. We describe challenges in the implementation of national planning guidelines, how these were met, and how they influenced final plans and budgets. The broad-based community engagement envisaged in the guidelines did not take place due to the delay in roll out of the Ministry of Health-trained community health workers. Instead, community engagement was conducted through facility management committees, though in a minority of facilities, even such committees were not involved. Some overlap was found in the priorities highlighted by facility staff, committee members and national indicators, but there were also many additional issues raised by committee members and not by other groups. The engagement of the community through committees influenced target and priority setting, but the emphasis on national health indicators left many local priorities unaddressed by the final work plans. Moreover, it appears that the final impact on budgets allocated at district and facility level was limited. The experience in Kilifi highlights the feasibility of engaging the community in the health planning process, and the challenges of ensuring that this engagement feeds into consolidated plans and future implementation.

Marsh VM, Kamuya DM, Mlamba AM, Williams TN, Molyneux SS. 2010. Experiences with community engagement and informed consent in a genetic cohort study of severe childhood diseases in Kenya. BMC Med Ethics, 11 (1), pp. 13. | Show Abstract | Read more

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.

Opwora A, Kabare M, Molyneux S, Goodman C. 2010. Direct facility funding as a response to user fee reduction: implementation and perceived impact among Kenyan health centres and dispensaries. Health Policy Plan, 25 (5), pp. 406-418. | Show Abstract | Read more

There is increasing pressure for reduction of user fees, but this can have adverse effects by decreasing facility-level funds. To address this, direct facility funding (DFF) was piloted in Coast Province, Kenya, with health facility committees (HFCs) responsible for managing the funds. We evaluated the implementation and perceived impact 2.5 years after DFF introduction. Quantitative data collection at 30 public health centres and dispensaries included a structured interview with the in-charge, record reviews and exit interviews. In addition, in-depth interviews were conducted with the in-charge and HFC members at 12 facilities, and with district staff and other stakeholders. DFF procedures were well established: HFCs met regularly and accounting procedures were broadly followed. DFF made an important contribution to facility cash income, accounting for 47% in health centres and 62% in dispensaries. The main items of expenditure were wages for support staff (32%), travel (21%), and construction and maintenance (18%). DFF was perceived to have a highly positive impact through funding support staff such as cleaners and patient attendants, outreach activities, renovations, patient referrals and increasing HFC activity. This was perceived to have improved health worker motivation, utilization and quality of care. A number of problems were identified. HFC training was reportedly inadequate, and no DFF documentation was available at facility level, leading to confusion. Charging user fees above those specified in the national policy remained common, and understanding of DFF among the broader community was very limited. Finally, relationships between HFCs and health workers were sometimes characterized by mistrust and resentment. Relatively small increases in funding may significantly affect facility performance when the funds are managed at the periphery. Kenya plans to scale up DFF nationwide. Our findings indicate this is warranted, but should include improved training and documentation, greater emphasis on community engagement, and insistence on user fee adherence.

Molyneux S, Kamuya D, Marsh V. 2010. Community members employed on research projects face crucial, often under-recognized, ethical dilemmas. Am J Bioeth, 10 (3), pp. 24-26. | Read more

Molyneux S, Kamuya D, Marsh V. 2010. Community members employed on research projects face crucial, often under-recognized, ethical dilemmas American Journal of Bioethics, 10 (3), pp. 24-26. | Read more

Abuya T, Amin A, Molyneux S, Akhwale W, Marsh V, Gilson L. 2010. Importance of strategic management in the implementation of private medicine retailer programmes: case studies from three districts in Kenya. BMC Health Serv Res, 10 Suppl 1 (Suppl 1), pp. S7. | Show Abstract | Read more

BACKGROUND: The home-management of malaria strategy seeks to improve prompt and effective anti-malarial drug use through the informal sector, with a potential channel being the Private Medicine Retailers (PMRs). Previous evaluations of PMR programmes focused on their impact on retailer knowledge and practices, with limited evidence about the influence of implementation processes on the impacts at scale. This paper examines how the implementation processes of three PMR programmes in Kenya, each scaled up within a district, contributed to the outcomes observed. These were a Ministry of Health programme in Kwale district; and two programmes supported by non-governmental organizations in collaboration with government in Kisii Central and Bungoma districts. METHODS: The research methods included 24 focus group discussions with clients and PMRs, 19 in-depth interviews with implementing actors, document review and a diary of events. The data were analysed using the combination of a broad policy analysis framework and more specific scaling up/diffusion of innovations frameworks. RESULTS: The Kisii programme, a case study of successful implementation, was underpinned by good relationships between district health managers and a "resource team", supported by a memorandum of understanding which enabled successful implementation. It had flexible budgetary and decision making processes which were responsive to local contexts, and took account of local socio-economic activities. In contrast, the Kwale programme, which had implementation challenges, was characterised by a complex funding process, with lengthy timelines, that was tied to the government financial management system which constrained implementation Although there was a flexible funding system in Bungoma, a perceived lack of transparency in fund management, inadequate management of inter-organisational relationships, and inability to adapt and respond to changing circumstances led to implementation difficulties. CONCLUSIONS: For effective scaling up of PMR programmes, the provision of technical support and adequate resources are vital, but not sufficient on their own. An active strategy to manage relationships between implementing actors through effective communication mechanisms is essential. Successful outcomes may be realised if a strong and transparent management system, including management of financial resources, is put in place. This study provides evidence of the value of assessing implementation processes as part of impact evaluation for public health programmes.

Rowa Y, Abuya TO, Mutemi WK, Ochola S, Molyneux S, Marsh V. 2010. Factors influencing implementation of the Ministry of Health-led private medicine retailer programmes on malaria in Kenya. BMC Public Health, 10 (1), pp. 93. | Show Abstract | Read more

BACKGROUND: Kenya has experienced a number of retail sector initiatives aimed at improving access to antimalarial medicines. This study explored stakeholders' perceptions of the role of private medicine retailers (PMRs), the value and feasibility of programme goals, perceived programme impact, factors influencing implementation and recommendations in three districts of Kenya. METHODS: This study was part of a larger evaluation of PMR programmes, including quantitative and qualitative components. The qualitative research was conducted to assess implementation processes and actors' experiences in the programmes, through focus group discussions with trained PMRs and mothers of children under five years, and in-depth interviews with programme managers, trainers and co-trainers. RESULTS: PMRs were perceived to provide rapid cheap treatment for non-serious conditions and used as a deliberate and continuously evaluated choice between different treatment sources. All stakeholders supported programme goals and most PMRs described increased customer satisfaction, more rational purchasing of medicine stock and increased medicine sales after participation. Factors undermining programme implementation included a lack of MoH resources to train and monitor large numbers of PMRs, the relative instability of outlets, medicines stocked and retail personnel, the large number of proprietary brands and financial challenges to retailers in stocking antimalarial medicines, and their customers in buying them. Unambiguous national support and a broad range of strategies are important to strengthen the feasibility of change in OTC antimalarial use. CONCLUSIONS: Understanding the context and implementation processes of PMR programmes and the perspectives of key actors are critical to identifying measures to support their effective implementation. Financial barriers underlie many described challenges, with important implications for policies on subsidies in this sector. In spite of barriers to implementation, increased exposure to programme activities promoted trust and improved relationships between PMRs and their clients and trainers, strengthening feasibility of such interventions. Public information can strengthen PMR training programmes by engaging local communities and may facilitate performance monitoring of PMRs by their clients.

Lairumbi GM, Molyneux S, Snow RW, Marsh K, Peshu N, English M. 2008. Promoting the social value of research in Kenya: examining the practical aspects of collaborative partnerships using an ethical framework. Soc Sci Med, 67 (5), pp. 734-747. | Show Abstract | Read more

The ethics of research continue to attract considerable debate, particularly when that research is sponsored by partners from the North and carried out in the South. Ethical research should contribute to social value in the country where research is being carried out, but there is significant debate around how this might be achieved and who is responsible. The literature suggests that researchers might employ two inter-related strategies to maximise social value: collaborative partnerships with policy makers and communities from the outset of research, and dissemination of research results to participants, policy makers and implementers once the research is over. These areas have received relatively little empirical attention. In this study, we carried out 40 in-depth interviews to explore the role of collaborative partnerships in health research priority setting, and the way in which research findings are disseminated to aid policy making and implementation in Kenya. Interviewees included policy makers, researchers, policy implementers and representatives of organisations funding health reforms in Kenya. Two policy issues were drawn upon as tracers wherever possible: (1) the introduction of Artemesinin-based Combination Therapies (ACTs), an anti-malarial treatment policy; and (2) Haemophilus influenzae (Hib) vaccine for the prevention of pneumococcal diseases among children. The findings point to significant gaps in the 'research to policy to practice' pathway, particularly for national research institutions with a focus on clinical/biomedical research. These gaps reflect poorly effective partnerships among stakeholders and limit the potential social value of much research. While more investment is needed to establish strong structures for promoting and directing collaboration and partnership, how to target this investment is not entirely clear, especially in the context of the considerable power of the global health agenda and the research financing tied to it.

Molyneux S, Geissler PW. 2008. Ethics and the ethnography of medical research in Africa. Soc Sci Med, 67 (5), pp. 685-695. | Show Abstract | Read more

The ethics of medical research have grown as an area of expertise and debate in recent years, with two broad approaches emerging in relation to transnational research: (1) the refinement of guidelines and strengthening of review, processes primarily to protect the right of individual research participants and strengthen interpersonal relations at the micro-level; and (2) considering more centrally, as crucial ethical concerns, the wider interests of whole populations, the functioning of research institutions, the processes of collaboration, and the ethics of inequitable international relations. We see the two areas of debate and action as complementary, and believe that social science conducted in and around transnational medical research environments can bring these two perspectives together in a more 'situated ethics' of research. To explore this idea for medical research in Africa, we organized a conference in December 2005 in Kilifi, Kenya. In this introduction we outline the two emerging approaches to medical ethics, summarise each of seven papers selected from the conference for inclusion in this special issue on ethics and ethnography, and finally highlight two areas of lively debate at the conference itself: the appropriateness and value of ethics guidelines and review boards for medical research; and the ethical review of social science research. Together, the papers and debates point to the importance of focusing on the ethics of relationships and on justice in both biomedicine and social science research, and on giving greater voice and visibility to the field staff who often play a crucial and under-supported role in 'doing ethics' in the field. They also point to the potential value of social science research on the range of relationships operating at different levels and time scales in medical research, including those surrounding community engagement activities, and the role and functioning of ethics review boards. We conclude by highlighting the ethical priority of capacity strengthening in medical research, social science and research ethics in Africa to ensure that local and national priorities and concerns are considered at both the micro and macro levels.

Marsh V, Kamuya D, Rowa Y, Gikonyo C, Molyneux S. 2008. Beginning community engagement at a busy biomedical research programme: experiences from the KEMRI CGMRC-Wellcome Trust Research Programme, Kilifi, Kenya. Soc Sci Med, 67 (5), pp. 721-733. | Show Abstract | Read more

There is wide acknowledgement of the need for community engagement in biomedical research, particularly in international settings. Recent debates have described theoretical approaches to identifying situations where this is most critical and potential mechanisms to achieve it. However, there is relatively little published experience of community engagement in practice. A major component of the Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Programme is centred on Kilifi District General Hospital and surrounding community of 240,000 local residents. Documented community perceptions of the research centre are generally positive, but many indicate a low understanding of research and therapeutic misconceptions of its activities. As in other settings, these misunderstandings have contributed to concerns and rumours, and potentially undermine ethical aspects of research and local trust in the institution. Through a series of consultative activities, a community engagement strategy has been developed in Kilifi to strengthen mutual understanding between community members and the Centre. One important component is the establishment of a representative local resident network in different geographic locations commonly involved in research, to supplement existing communication channels. Early implementation of the strategy has provided new and diverse opportunities for dialogue, interaction and partnership building. Through the complex social interactions inherent in the community engagement strategy, the centre aims to build context specific ethical relations with local residents and to strengthen understanding of how ethical principles can be applied in practice. Evaluations over time will assess the effectiveness and sustainability of these strategies, provide generalisable information for similar research settings, and contribute to debates on the universality of ethical principles for research. This paper aims to summarise the rationale for community engagement in research, drawing on published literature and local findings, to outline the process of community engagement in Kilifi and to describe issues emerging from its development and early implementation.

Gikonyo C, Bejon P, Marsh V, Molyneux S. 2008. Taking social relationships seriously: lessons learned from the informed consent practices of a vaccine trial on the Kenyan Coast. Soc Sci Med, 67 (5), pp. 708-720. | Show Abstract | Read more

Individual informed consent is a key ethical obligation for clinical studies, but empirical studies show that key requirements are often not met. Common recommendations to strengthen consent in low income settings include seeking permission from community members through existing structures before approaching individuals, considering informed consent as a process rather than a single event, and assessing participant understanding using questionnaires. In this paper, we report on a qualitative study exploring community understanding and perceptions of a malaria vaccine trial (MVT) conducted in a rural setting on the Kenyan Coast. The MVT incorporated all of the above recommendations into its information-giving processes. The findings support the importance of community level information-giving and of giving information on several different occasions before seeking final individual consent. However, an emerging issue was that inter-personal interactions and relationships between researchers and community members, and within the community, play a critical role in participants' perceptions of a study, their decisions to consent or withdraw, and their advice to researchers on study practicalities and information to feedback at the end of the trial. These relationships are based on and continually tested by information-giving processes, and by context specific concerns and interests that can be difficult to predict and are well beyond the timescale and reach of single research activities. On the basis of these findings, we suggest that the current move towards increasingly ambitious and stringent formal standards for information-giving to individuals be counter-balanced with greater attention to the diverse social relationships that are essential to the successful application of these procedures. This may be assisted by emphasising respecting communities as well as persons, and by recognising that current guidelines and regulations may be an inadequate response to the complex, often unpredictable and ever shifting ethical dilemmas facing research teams working 'in the field'.

Mfutso-Bengo J, Ndebele P, Jumbe V, Mkunthi M, Masiye F, Molyneux S, Molyneux M. 2008. Why do individuals agree to enrol in clinical trials? A qualitative study of health research participation in Blantyre, Malawi MALAWI MEDICAL JOURNAL, 20 (2), pp. 37-41. | Show Abstract

Current literature suggests that therapeutic misconception - a belief by participants in a clinical trial that they are in fact simply being given clinical care - is common, especially among illiterate populations in developing countries. Therapeutic misconception reflects problems in informed consent, as people agree to participate in clinical trials without being aware that the trial procedures and test products may not in fact benefit them. In this study of Malawian adults who had participated in research projects of various kinds during the preceding years, we found that the majority participated in research for the sake of obtaining better quality treatment made available through the clinical trials as ancillary care. Their consent to participate was not due to a belief that the actual procedures of the trial would directly benefit their health. Respondents indicated that, government hospitals being crowded and commonly lacking drugs, they agreed to take part in research projects in the hope of obtaining access to ancillary care provided by clinical trials. We conclude that in this environment, possibly owing to inadequacy of routine health services, people make rational decisions to participate in research. We question whether the term 'therapeutic misconception' accurately describes participants' motivation under conditions of limited resources. We also discuss the relevance of these findings for understanding undue inducement in clinical trials.

Cited:

51

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Molyneux S, Geissler PW. 2008. Ethics and the ethnography of medical research in Africa Social Science and Medicine, 67 (5), pp. 685-695. | Show Abstract | Read more

The ethics of medical research have grown as an area of expertise and debate in recent years, with two broad approaches emerging in relation to transnational research: (1) the refinement of guidelines and strengthening of review, processes primarily to protect the right of individual research participants and strengthen interpersonal relations at the micro-level; and (2) considering more centrally, as crucial ethical concerns, the wider interests of whole populations, the functioning of research institutions, the processes of collaboration, and the ethics of inequitable international relations. We see the two areas of debate and action as complementary, and believe that social science conducted in and around transnational medical research environments can bring these two perspectives together in a more 'situated ethics' of research. To explore this idea for medical research in Africa, we organized a conference in December 2005 in Kilifi, Kenya. In this introduction we outline the two emerging approaches to medical ethics, summarise each of seven papers selected from the conference for inclusion in this special issue on ethics and ethnography, and finally highlight two areas of lively debate at the conference itself: the appropriateness and value of ethics guidelines and review boards for medical research; and the ethical review of social science research. Together, the papers and debates point to the importance of focusing on the ethics of relationships and on justice in both biomedicine and social science research, and on giving greater voice and visibility to the field staff who often play a crucial and under-supported role in 'doing ethics' in the field. They also point to the potential value of social science research on the range of relationships operating at different levels and time scales in medical research, including those surrounding community engagement activities, and the role and functioning of ethics review boards. We conclude by highlighting the ethical priority of capacity strengthening in medical research, social science and research ethics in Africa to ensure that local and national priorities and concerns are considered at both the micro and macro levels. © 2008 Elsevier Ltd. All rights reserved.

Cited:

67

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Marsh V, Kamuya D, Rowa Y, Gikonyo C, Molyneux S. 2008. Beginning community engagement at a busy biomedical research programme: Experiences from the KEMRI CGMRC-Wellcome Trust Research Programme, Kilifi, Kenya Social Science and Medicine, 67 (5), pp. 721-733. | Show Abstract | Read more

There is wide acknowledgement of the need for community engagement in biomedical research, particularly in international settings. Recent debates have described theoretical approaches to identifying situations where this is most critical and potential mechanisms to achieve it. However, there is relatively little published experience of community engagement in practice. A major component of the Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Programme is centred on Kilifi District General Hospital and surrounding community of 240,000 local residents. Documented community perceptions of the research centre are generally positive, but many indicate a low understanding of research and therapeutic misconceptions of its activities. As in other settings, these misunderstandings have contributed to concerns and rumours, and potentially undermine ethical aspects of research and local trust in the institution. Through a series of consultative activities, a community engagement strategy has been developed in Kilifi to strengthen mutual understanding between community members and the Centre. One important component is the establishment of a representative local resident network in different geographic locations commonly involved in research, to supplement existing communication channels. Early implementation of the strategy has provided new and diverse opportunities for dialogue, interaction and partnership building. Through the complex social interactions inherent in the community engagement strategy, the centre aims to build context specific ethical relations with local residents and to strengthen understanding of how ethical principles can be applied in practice. Evaluations over time will assess the effectiveness and sustainability of these strategies, provide generalisable information for similar research settings, and contribute to debates on the universality of ethical principles for research. This paper aims to summarise the rationale for community engagement in research, drawing on published literature and local findings, to outline the process of community engagement in Kilifi and to describe issues emerging from its development and early implementation. © 2008 Elsevier Ltd. All rights reserved.

Molyneux S, Gikonyo C, Marsh V, Bejon P. 2007. Incorporating a quiz into informed consent processes: qualitative study of participants' reactions. Malar J, 6 (1), pp. 145. | Show Abstract | Read more

BACKGROUND: Formal checks of participant understanding are now widely recommended to improve informed consent processes. However, the views of the participants these assessments are designed to protect are rarely considered. In this paper the findings of a qualitative study aimed at documenting community reactions to a semi-structured questionnaire ('quiz') are reported. The quiz was administered to 189 mothers after consenting for their children to participate in a malaria vaccine trial on the Kenyan Coast. METHODS: Once the malaria vaccine trial was underway, focus group discussions were held with some of these mothers (nine groups; 103 mothers), and with community-based field staff attached to the malaria vaccine trial (two groups of five workers). Individual interviews with other trial staff were also held. RESULTS: The quiz prompted community members to voice concerns about blood sampling and vaccine side-effects, thereby encouraging additional discussions and interactions between the research team and potential study participants. However, it also caused significant upset and concern. Some of the quiz questions, or the way in which they were asked, appeared to fuel misconceptions and fears, with potentially negative consequences for both the study and community members. CONCLUSION: Formal approaches to checking study understanding should be employed with sensitivity and caution. They are influenced by and impact upon complex social relationships between and among researchers and community members. Adequate consideration of these contexts in assessments of understanding, and in responding to the issues raised, requires strong social science capacity.

Kibe LW, Mbogo CM, Keating J, Molyneux S, Githure JI, Beier JC. 2006. Community based vector control in Malindi, Kenya. Afr Health Sci, 6 (4), pp. 240-246. | Show Abstract | Read more

BACKGROUND: Community involvement has become an important component of the National Malaria Control Strategy in Kenya, resulting in the organization of groups charged with addressing mosquito and malaria-related concerns within the community. OBJECTIVES: The purpose of this study was to identify community groups involved with intended malaria vector control activity in Malindi, Kenya. METHODS: Information was obtained from key informant interviews, focus group discussions, and a stakeholder meeting. The objectives were to determine the roles of community groups, identify examples of past successes and obstacles to successful implementation of vector control, and assess the level of knowledge about malaria and mosquitoes among the groups. RESULTS: Nineteen of 34 community groups (56%) registered at social services reported intended malaria vector control activities such as treating ditches, making and selling insecticide-treated mosquito nets, draining stagnant water, organizing clean-ups, making and selling neem soap, and the organization of campaigns such as the "Malaria Mosquito Day". Major challenges facing these groups include volunteerism, lack of technical expertise, supervision, and maintaining control activities in the absence of funds. Most groups reported limited knowledge about malaria vectors, and thus targeted all water bodies for control activities. CONCLUSIONS: We found that community groups are willing to participate in control operations, but lack government and technical support. We highlight the importance of strengthening organizational efforts and capacity building, as well as the need to clarify government policy on malaria vector control responsibilities within the communities.

Bejon P, Peshu N, Gilbert SC, Lowe BS, Molyneux CS, Forsdyke J, Lang T, Hill AVS, Marsh K. 2006. Safety profile of the viral vectors of attenuated fowlpox strain FP9 and modified vaccinia virus Ankara recombinant for either of 2 preerythrocytic malaria antigens, ME-TRAP or the circumsporozoite protein, in children and adults in Kenya. Clin Infect Dis, 42 (8), pp. 1102-1110. | Show Abstract | Read more

BACKGROUND: We are developing a heterologous prime-boost vaccine strategy against malaria. This approach uses sequential immunization with different vectors to deliver a common preerythrocytic malaria antigen. Preliminary evidence of efficacy and safety has been previously documented in studies from an area where malaria is nonendemic. Additional safety data from an area where malaria is endemic are now required before larger-scale studies are undertaken to determine the efficacy of this vaccine strategy in the field. Other modified vaccinia virus Ankara (MVA) recombinants and prime-boost immunizations are being developed as vaccines against human immunodeficiency virus (HIV) infection, tuberculosis, and cancer, and MVA is a candidate attenuated smallpox vaccine. METHODS: Candidate vaccines against malaria were intradermally administered to 73 adults (7 of whom were HIV positive) and 22 children in Kenya. These vaccines used the attenuated fowlpox strain FP9 and the MVA recombinant for either of 2 preerythrocytic malaria antigens, multiple preerythrocytic-stage epitopes joined with the preerythrocytic-stage antigen TRAP (ME-TRAP) and the circumsporozoite protein (CS). Adverse events were recorded. RESULTS: Reactogenicity was mild. MVA caused less frequent and less severe cutaneous reaction if given after FP9 priming. Half doses reduced the frequency and the severity of systemic reactogenicity, and particular vaccine lots were associated with different reactogenicities. Unexpectedly, prior immunity to the ME-TRAP antigen appeared to be protective against local reactions after immunization. CONCLUSIONS: Where the final intention is to use MVA after FP9 priming, previous testing of MVA alone overestimates reactogenicity. These recombinant vectors appear to be safe and suitable for use in larger-scale studies of children in Africa and of HIV-positive individuals.

Chuma JM, Thiede M, Molyneux CS. 2006. Rethinking the economic costs of malaria at the household level: evidence from applying a new analytical framework in rural Kenya. Malar J, 5 pp. 76. | Show Abstract | Read more

BACKGROUND: Malaria imposes significant costs on households and the poor are disproportionately affected. However, cost data are often from quantitative surveys with a fixed recall period. They do not capture costs that unfold slowly over time, or seasonal variations. Few studies investigate the different pathways through which malaria contributes towards poverty. In this paper, a framework indicating the complex links between malaria, poverty and vulnerability at the household level is developed and applied using data from rural Kenya. METHODS: Cross-sectional surveys in a wet and dry season provide data on treatment-seeking, cost-burdens and coping strategies (n = 294 and n = 285 households respectively). 15 case study households purposively selected from the survey and followed for one year provide in-depth qualitative information on the links between malaria, vulnerability and poverty. RESULTS: Mean direct cost burdens were 7.1% and 5.9% of total household expenditure in the wet and dry seasons respectively. Case study data revealed no clear relationship between cost burdens and vulnerability status at the end of the year. Most important was household vulnerability status at the outset. Households reporting major malaria episodes and other shocks prior to the study descended further into poverty over the year. Wealthier households were better able to cope. CONCLUSION: The impacts of malaria on household economic status unfold slowly over time. Coping strategies adopted can have negative implications, influencing household ability to withstand malaria and other contingencies in future. To protect the poor and vulnerable, malaria control policies need to be integrated into development and poverty reduction programmes.

Molyneux CS, Peshu N, Marsh K. 2005. Trust and informed consent: insights from community members on the Kenyan coast. Soc Sci Med, 61 (7), pp. 1463-1473. | Show Abstract | Read more

Trust is an important theme running through the literature on the ethics of biomedical research, but it is rarely given centre stage. In this paper, we present data gathered from a study aimed at exploring community views regarding the informed consent processes carried out by a large research centre on the Kenyan Coast. The findings point to the centrality of trust and elements of mistrust in general community views, in parents' (mis)understanding of studies they consent their children to be involved in, in refusals and concerns, and in community members' views about whether informed consent is a relevant and practical model to follow. Tentative ideas on how trust and a healthy mistrust might be balanced highlight the importance of strengthening communication surrounding basic health care as well as research, and of fostering 'an inner generated ethic of service'. The latter is particularly fundamental, but cannot be built and regulated through the laws, policies and guidelines that currently govern biomedical research practice.

Molyneux CS, Wassenaar DR, Peshu N, Marsh K. 2005. 'Even if they ask you to stand by a tree all day, you will have to do it (laughter)...!': community voices on the notion and practice of informed consent for biomedical research in developing countries. Soc Sci Med, 61 (2), pp. 443-454. | Show Abstract | Read more

Ethical dilemmas in biomedical research, especially in vulnerable populations, often spark heated debate. Despite recommendations and guidelines, many issues remain controversial, including the relevance, prioritisation and application of individual voluntary informed consent in non-Western settings. The voices of the people likely to be the subjects of research have been notably absent from the debate. We held discussions with groups of community members living in the rural study area of a large research unit in Kenya. Discussions were facilitated by three research study vignettes outlining one field-based and two hospital-based studies being planned or taking place at the time. In addition to gathering general views about the aims and activities of the research unit, questions focused on whether consent should be sought for studies, and if so from whom (chiefs, elders, men/women, children), and on ascertaining whether there are any special concerns about the physical act of signing consent forms. The findings revealed the community's difficulty in distinguishing research from clinical investigations conducted in clinical settings. There was a spectrum of views regarding perceived appropriateness of consent procedures, in part because of difficulty in disentangling clinical from research aims, and because of other challenges to applying consent in practice. Debates between community members highlight the inadequacy of simplistic assumptions about community members' views on informed consent, and the complexity of incorporating lay opinions into biomedical research. Failure to appreciate these issues risks exaggerating differences between settings, and underestimating the time and resources required to ensure meaningful community involvement in research processes. Ultimately, it risks inadequately responding to the needs and values of those on whom the success of most biomedical research depends. Although compliance with community views does not necessarily make the research more ethical, it is argued that community opinions on local issues and practices should inform ethical decision-making in health research.

Kombe F, Abuya T, Mutemi W, Molyneux S, Marsh V. 2005. Does injection use influence choice of and satisfaction with private health clinics? A user perspective [MIM-FK-216766] ACTA TROPICA, 95 pp. S246-S247.

Kai O, Mwacharo J, Bejon P, Lowe B, Molyneux S, Peshu N, Marsh K, Hill A. 2005. Safety and immunogenicity of the candidate malaria vaccines FP9 ME-TRAP and MVA METRAP in semi-immune adult males [MIM-OK-87312] ACTA TROPICA, 95 pp. S421-S421.

Molyneux CS, Peshu N, Marsh K. 2004. Understanding of informed consent in a low-income setting: three case studies from the Kenyan Coast. Soc Sci Med, 59 (12), pp. 2547-2559. | Show Abstract | Read more

In our research unit on the Kenyan Coast, parents sign consent for over 4000 children to be involved in research activities every year. Children are recruited into studies ranging from purely observational research to the testing of new procedures and drugs. Thousands more community members consent verbally or in writing to the interviews and sometimes invasive procedures required in community-based research. Although every study and consent form is reviewed in advance by independent national and international committees, the views and understanding of the 'subjects' of these activities had not been documented before this study. In this paper, we focus on participant understanding of one field-based and two hospital-based studies, all of which involve blood sampling. The findings highlight a range of inter-related issues for consideration in the study setting and beyond, including conceptual and linguistic barriers to communicating effectively about research, the critical and complex role of communicators (fieldworkers and nurses) in consent procedures, features of research unit-community relations which impact on these processes, and the special sensitivity of certain issues such as blood sampling. These themes and emerging recommendations are expected to be relevant to, and would benefit from, experiences and insights of researchers working elsewhere.

Molyneux CS, Mung'ala-Odera V, Harpham T, Snow RW. 2002. Maternal mobility across the rural-urban divide: empirical data from coastal Kenya. Environ Urban, 14 (1), pp. 203-217. | Show Abstract | Read more

This paper describes the mobility patterns, rural-urban linkages and household structures for a low-income neighbourhood on the outskirts of Mombasa, Kenya's main port, and a rural settlement 60 kilometres away. Drawing on interviews with a sample of mothers resident in each location, it documents their perceptions of the advantages and disadvantages of rural and urban life, and shows the continuous interchange between the two areas. It also highlights how most rural to urban migrants are familiar with urban environments before moving and how, having moved, many maintain strong rural ties. The ways in which households are split across rural and urban areas is influenced by intra-household relations and by household efforts to balance the income-earning opportunities in town, the relatively low cost of living in rural areas and future family security. This produces dramatic differences between and among rural and urban mothers and suggests a need for policy makers and planners to recognize diversity and to build upon complex livelihood strategies that span the rural-urban divide.

Molyneux CS, Murira G, Masha J, Snow RW. 2002. Intra-household relations and treatment decision-making for childhood illness: a Kenyan case study. J Biosoc Sci, 34 (1), pp. 109-131. | Show Abstract

This study, conducted on the Kenyan coast, assesses the effect of intra-household relations on maternal treatment-seeking. Rural and urban Mijikenda mothers' responses to childhood fevers in the last 2 weeks (n=317), and to childhood convulsions in the previous year (n=43), were documented through survey work. The intra-household relations and decision-making dynamics surrounding maternal responses were explored through in-depth individual and group interviews, primarily with women (n=223). Responses to convulsions were more likely than responses to fevers to include a healer consultation (p<0.0001), and less likely to include the purchase of over-the-counter medications (p<0.0001). Mothers received financial or advisory assistance from others in 71% (n=236) of actions taken outside the household in response to fevers. In-depth interviews suggested that general agreement on appropriate therapy results in relatively few intra-household conflicts over the treatment of fevers. Disputes over perceived cause and appropriate therapy of convulsions, however, highlighted the importance of age, gender and relationship to household head in intra-household relations and treatment decision-making. Although mothers' treatment-seeking preferences are often circumscribed by these relations, a number of strategies can be drawn upon to circumvent 'inappropriate' decisions, sometimes with implications for future household responses to similar syndromes. The findings highlight the complexity of intra-household relations and treatment decision-making dynamics. Tentative implications for interventions aimed at improving the home management of malaria, and for further research, are presented.

Snow RW, Howard SC, Mung'Ala-Odera V, English M, Molyneux CS, Waruiru C, Mwangi I, Roberts DJ, Donnelly CA, Marsh K. 2000. Paediatric survival and re-admission risks following hospitalization on the Kenyan coast. Trop Med Int Health, 5 (5), pp. 377-383. | Show Abstract | Read more

The district general hospital (DGH) is a common feature of health service provision in many developing countries. We have used linked demographic and clinical surveillance in a rural community located close to a DGH on the Kenyan coast to define the use and public health significance of essential clinical services provided by it. Of a birth cohort of over 4000 children followed for approximately 6 years, about a third were admitted to hospital at least once. Significantly more children admitted with major infectious diseases such as malaria and acute respiratory tract infections were readmitted with the same condition during the surveillance period than would have been expected by chance. Among surviving admissions, mortality post-discharge was significantly higher than in the cohort which had not been admitted within 3, 6 and 12 months. Most of the patients who died after discharge had been admitted with a diagnosis of gastroenteritis. Most children admitted to the DGH survive hospitalization and the remaining period of childhood. Despite no clinical trial evidence to support the claim, it seems reasonable to assume that in the absence of intensive clinical management provided by a DGH, a significant proportion of these children would not have survived. However, the DGH is able to define a group of at-risk children who re-present with severe complications of infectious disease, and of these several may have underlying conditions not amenable to DGH intervention and continue to have a poor prognosis. Both groups of children represent statistically significant subsets of a rural paediatric community and the future organization and co-ordination of DGH and primary care services need to work in unison to strengthen the service needs of children at risk.

Cited:

25

Scopus

Molyneux SJ, Hutton DHW. 2000. Evidence for significant granite creation by the ballooning mechanism: The example of the Ardara pluton, Ireland Bulletin of the Geological Society of America, 112 (10), pp. 1543-1558. | Show Abstract | Read more

The emplacement mechanism of the Ardara granite (a Caledonian pluton located on the northwestern seaboard of Ireland) has been a widely cited and a key point of reference in the debate about the granite space problem for nearly half a century. Early models related its subcircular tailed shape, concentric foliation pattern, and concentrically deformed envelope to diapirism. It was subsequently reinterpreted, using strain data, as a ballooning pluton that was created by ∼70% in situ expansion at the emplacement site and was later cut by a regional shear zone. Recently it was the leading example in a wide-ranging review of forcefully emplaced plutons of this type and was reinterpreted as a series of nested diapirs associated with only modest amounts (30%) of forceful space creation, but a large component of inferred early block stoping. We report the results of the complete remapping and extensive collection of new structural data from this 8-km-diameter, normally zoned, three-phase, calc-alkaline pluton. We confirm the existence of the steeply inclined internal foliation pattern and that it was formed in the magmatic state, although this and the outline of the pluton are modified by late-stage (high temperature solid state) regional transcurrent shear zones along two of the pluton contacts. Structural mapping has failed to identify a macroscopic lineation in the magmatic foliation planes, and this is confirmed by strain determinations (using mafic enclave populations and magmatic crystal separations) for the magmatic state deformation that show nearly pure flattening type strains (K = 0). Strains measured by these techniques show an apparently smooth gradient increasing outward toward the pluton contacts from an inner low-strain zone. We argue that these features, together with the simple normal petrographic zonation, a lack of small-scale structures that would indicate the pluton had moved up relative to the wall rocks, and an exposure level that is not in the roof zone, are inconsistent with diapirism (either singly, or multiply) but are most easily explained by a ballooning emplacement mechanism. Synmagmatic shear-sense data from both the pluton and the adjacent country rocks indicate, however, that within the overall context of radial ballooning there was a limited amount of late-stage nonradial (northward) injection of magma. An inversion of the deformed enclave and crystal spacing strain determinations and strain determinations within the country rocks suggest that more than 80% of the volume of the pluton was accommodated by the ballooning mechanism.

Molyneux CS, Mung'Ala-Odera V, Harpham T, Snow RW. 1999. Maternal responses to childhood fevers: a comparison of rural and urban residents in coastal Kenya. Trop Med Int Health, 4 (12), pp. 836-845. | Show Abstract | Read more

Urbanization is an important demographic phenomenon in sub-Saharan Africa, and rural-urban migration remains a major contributor to urban growth. In a context of sustained economic recession, these demographic processes have been associated with a rise in urban poverty and ill health. Developments in health service provision need to reflect new needs arising from demographic and disease ecology change. In malaria-endemic coastal Kenya, we compared lifelong rural (n = 248) and urban resident (n = 284) Mijikenda mothers' responses to childhood fevers. Despite marked differences between the rural and urban study areas in demographic structure and physical access to biomedical services, rural and urban mothers' treatment-seeking patterns were similar: most mothers sought only biomedical treatment (88%). Shop-bought medicines were used first or only in 69% of the rural and urban fevers that were treated, and government or private clinics were contacted in 49%. A higher proportion of urban informal vendors stocked prescription-only drugs, and urban mothers more likely to contact a private than a government facility. We conclude that improving self-treatment has enormous potential to reduce morbidity and mortality in low-income urban areas, as has frequently been argued for rural areas. However, because of the underlying socio-economic, cultural and structural differences between rural and urban areas, rural approaches to tackle this may have to be modified in urban environments.

Snow RW, McCabe E, Mbogo CN, Molyneux CS, Some ES, Mung'ala VO, Nevill CG. 1999. The effect of delivery mechanisms on the uptake of bed net re-impregnation in Kilifi District, Kenya. Health Policy Plan, 14 (1), pp. 18-25. | Show Abstract | Read more

The results of recently completed trials in Africa of insecticide-treated bed nets (ITBN) offer new possibilities for malaria control. These experimental trials aimed for high ITBN coverage combined with high re-treatment rates. Whilst necessary to understand protective efficacy, the approaches used to deliver the intervention provide few indications of what coverage of net re-treatment would be under operational conditions. Varied delivery and financing strategies have been proposed for the sustainable delivery of ITBNs and re-treatment programmes. Following the completion of a randomized, controlled trial on the Kenyan coast, a series of suitable delivery strategies were used to continue net re-treatment in the area. The trial adopted a bi-annual, house-to-house re-treatment schedule free of charge using research project staff and resulted in over 95% coverage of nets issued to children. During the year following the trial, sentinel dipping stations were situated throughout the community and household members informed of their position and opening times. This free re-treatment service achieved between 61-67% coverage of nets used by children for three years. In 1997 a social marketing approach, that introduced cost-retrieval, was used to deliver the net re-treatment services. The immediate result of this transition was that significantly fewer of the mothers who had used the previous re-treatment services adopted this revised approach and coverage declined to 7%. The future of new delivery services and their financing are discussed in the context of their likely impact upon previously defined protective efficacy and cost-effectiveness estimates.

Bull PC, Lowe BS, Kortok M, Molyneux CS, Newbold CI, Marsh K. 1998. Parasite antigens on the infected red cell surface are targets for naturally acquired immunity to malaria. Nat Med, 4 (3), pp. 358-360. | Show Abstract | Read more

The feasibility of a malaria vaccine is supported by the fact that children in endemic areas develop naturally acquired immunity to disease. Development of disease immunity is characterized by a decrease in the frequency and severity of disease episodes over several years despite almost continuous infection, suggesting that immunity may develop through the acquisition of a repertoire of specific, protective antibodies directed against polymorphic target antigens. Plasmodium falciparum erythrocyte membrane protein 1 (PfEMP1) is a potentially important family of target antigens, because these proteins are inserted into the red cell surface and are prominently exposed and because they are highly polymorphic and undergo clonal antigenic variation, a mechanism of immune evasion maintained by a large family of var genes. In a large prospective study of Kenyan children, we have used the fact that anti-PfEMP1 antibodies agglutinate infected erythrocytes in a variant-specific manner, to show that the PfEMP1 variants expressed during episodes of clinical malaria were less likely to be recognized by the corresponding child's own preexisting antibody response than by that of children of the same age from the same community. In contrast, a heterologous parasite isolate was just as likely to be recognized. The apparent selective pressure exerted by established anti-PfEMP1 antibodies on infecting parasites supports the idea that such responses provide variant-specific protection against disease.

Snow RW, Omumbo JA, Lowe B, Molyneux CS, Obiero JO, Palmer A, Weber MW, Pinder M, Nahlen B, Obonyo C et al. 1997. Relation between severe malaria morbidity in children and level of Plasmodium falciparum transmission in Africa. Lancet, 349 (9066), pp. 1650-1654. | Show Abstract | Read more

BACKGROUND: Malaria remains a major cause of mortality and morbidity in Africa. Many approaches to malaria control involve reducing the chances of infection but little is known of the relations between parasite exposure and the development of effective clinical immunity so the long-term effect of such approaches to control on the pattern and frequency of malaria cannot be predicted. METHODS: We have prospectively recorded paediatric admissions with severe malaria over three to five years from five discrete communities in The Gambia and Kenya. Demographic analysis of the communities exposed to disease risk allowed the estimation of age-specific rates for severe malaria. Within each community the exposure to Plasmodium falciparum infection was determined through repeated parasitological and serological surveys among children and infants. We used acute respiratory-tract infections (ARI) as a comparison. FINDINGS: 3556 malaria admissions were recorded for the five sites. Marked differences were observed in age, clinical spectrum and rates of severe malaria between the five sites. Paradoxically, the risks of severe disease in childhood were lowest among populations with the highest transmission intensities, and the highest disease risks were observed among populations exposed to low-to-moderate intensities of transmission. For severe malaria, for example, admission rates (per 1000 per year) for children up to their 10th birthday were estimated as 3.9, 25.8, 25.9, 16.7, and 18.0 in the five communities; the forces of infection estimated for those communities (new infections per infant per month) were 0.001, 0.034, 0.050, 0.093, and 0.176, respectively. Similar trends were noted for cerebral malaria and for severe malaria anaemia but not for ARI. Mean age of disease decreased with increasing transmission intensity. INTERPRETATION: We propose that a critical determinant of life-time disease risk is the ability to develop clinical immunity early in life during a period when other protective mechanisms may operate. In highly endemic areas measures which reduce parasite transmission, and thus immunity, may lead to a change in both the clinical spectrum of severe disease and the overall burden of severe malaria morbidity.

Snow RW, Molyneux CS, Njeru EK, Omumbo J, Nevill CG, Muniu E, Marsh K. 1997. The effects of malaria control on nutritional status in infancy. Acta Trop, 65 (1), pp. 1-10. | Show Abstract | Read more

Both malaria and undernutrition are major causes of paediatric mortality and morbidity in sub-Saharan Africa. The introduction of insecticide-treated bed nets (ITBN) during a randomized controlled trial on the Kenyan coast significantly reduced severe, life-threatening malaria and all-cause childhood mortality. This paper describes the effects of the intervention upon the nutritional status of infants aged between 1 and 11 months of age. Seven hundred and eighty seven infants who slept under ITBN and 692 contemporaneous control infants, were seen during one of three cross-sectional surveys conducted during a one year period. Standardized weight-for-age and mid-upper arm circumference measures were significantly higher among infants who used ITBN compared with control infants. Whether these improvements in markers of nutritional status were a direct result of concomitant reductions in clinical malaria episodes remains uncertain. Never-the-less evidence suggests that even moderate increases in weight-for-age scores can significantly reduce the probability of mortality in childhood and ITBN may provide additional gains to child survival beyond their impressive effects upon malaria-specific events.

Snow RW, Molyneux CS, Warn PA, Omumbo J, Nevill CG, Gupta S, Marsh K. 1996. Infant parasite rates and immunoglobulin M seroprevalence as a measure of exposure to Plasmodium falciparum during a randomized controlled trial of insecticide-treated bed nets on the Kenyan coast. Am J Trop Med Hyg, 55 (2), pp. 144-149. | Show Abstract

Repeated cross-sectional surveys among infants sleeping under insecticide-treated bed nets (ITBN) and contemporary control infants were used to estimate changes in Plasmodium falciparum exposure due to ITBN use on the Kenyan coast. Presence of P. falciparum parasites or total P. falciparum Immunoglobulin M (IgM) seropositivity were used independently and in combination in a constant risk catalytic conversion model to estimate the force of infection in ITBN and control communities. Such studies during infancy avoid problems of early saturation of prevalence due to high forces of infection and persistence of infection, minimize problems of self-treatment, and can be conducted among large populations covering a wide geographic area. These contrast previous parasitologic studies of ITBN among older children and the traditional entomologic studies of transmission that are logistically demanding. Our investigations demonstrated that parasite prevalence, IgM seropositivity, and the force of transmission were all significantly reduced by 50%. In addition, more infants under ITBN entered their second year of life without previous exposure to P. falciparum than control infants. These effects upon delayed acquisition of effective immunity require careful monitoring during future vector control programs using ITBN.

Molyneux S, Mulupi S, Mbaabu L, Marsh V. 2012. Benefits and payments for research participants: experiences and views from a research centre on the Kenyan coast. BMC Med Ethics, 13 (1), pp. 13. | Show Abstract | Read more

BACKGROUND: There is general consensus internationally that unfair distribution of the benefits of research is exploitative and should be avoided or reduced. However, what constitutes fair benefits, and the exact nature of the benefits and their mode of provision can be strongly contested. Empirical studies have the potential to contribute viewpoints and experiences to debates and guidelines, but few have been conducted. We conducted a study to support the development of guidelines on benefits and payments for studies conducted by the KEMRI-Wellcome Trust programme in Kilifi, Kenya. METHODS: Following an initial broad based survey of cash, health services and other items being offered during research by all programme studies (n = 38 studies), interviews were held with research managers (n = 9), and with research staff involved in 8 purposively selected case studies (n = 30 interviewees). Interviews explored how these 'benefits' were selected and communicated, experiences with their administration, and recommendations for future guidelines. Data fed into a consultative workshop attended by 48 research staff and health managers, which was facilitated by an external ethicist. FINDINGS: The most commonly provided benefits were medical care (for example free care, and strengthened quality of care), and lunch or snacks. Most cash given to participants was reimbursement of transport costs (for example to meet appointments or facilitate use of services when unexpectedly sick), but these payments were often described by research participants as benefits. Challenges included: tensions within households and communities resulting from lack of clarity and agreement on who is eligible for benefits; suspicion regarding motivation for their provision; and confusion caused by differences between studies in types and levels of benefits. CONCLUSIONS: Research staff differed in their views on how benefits should be approached. Echoing elements of international benefit sharing and ancillary care debates, some research staff saw research as based on goodwill and partnership, and aimed to avoid costs to participants and a commercial relationship; while others sought to maximise participant benefits given the relative wealth of the institution and the multiple community needs. An emerging middle position was to strengthen collateral or indirect medical benefits to communities through collaborations with the Ministry of Health to support sustainability.

Maitland K, Molyneux S, Boga M, Kiguli S, Lang T. 2011. Use of deferred consent for severely ill children in a multi-centre phase III trial. Trials, 12 (1), pp. 90. | Show Abstract | Read more

BACKGROUND: Voluntary participation of a subject in research respects a subject's rights, strengthens its ethical conduct, and is formalized by the informed consent process. Clinical trials of life-saving interventions for medical emergencies often necessitate enrollment of patients where prior written individual informed consent is impossible. Although there are regulations and guidelines on protecting subjects in emergency research, these have been criticised for being limited and unnecessarily restrictive. Across Europe and the United States stringent regulations have resulted in a substantial decline of clinical trials involving emergency interventions. METHODS: We are conducting a trial of fluid resuscitation in children with hypovolaemic shock in six hospitals across three malaria-endemic African countries. The design is pragmatic as children are enrolled on clinical criteria alone and is being conducted in hospitals with facilities typical of many district hospitals across Africa. The trial aims to inform strategy for managing children with febrile illness and features of shock. In order to develop appropriate consent processes for the trial, we conducted a narrative review of current international recommendations for emergency consent. RESULTS: Practical or specific guidance was generally sparse or confusing with few examples in the literature to direct our informed consent process. For a sub-group of children who were critically sick or where parents themselves were otherwise too distressed to consider prior written consent, we opted for a modified form of deferred consent. This included verbal assent from guardians at the point of enrollment, with full written consent obtained after stabilising the child. For children who died prior to full written consent, ethical permission was received to waiver full consent. CONCLUSIONS: In light of the controversy around guidance and regulations in this area we report how and why we have used a modified system of deferred consent in an emergency intervention trial in children. Although approved by all relevant ethics committees and operational in 3 countries in Africa, formal research is now necessary to explore the perceptions and experiences of parents, health workers, researchers and ethics committees of the modified method of deferred consent.

Marsh VM, Kamuya DM, Mlamba AM, Williams TN, Molyneux SS. 2010. Experiences with community engagement and informed consent in a genetic cohort study of severe childhood diseases in Kenya. BMC Med Ethics, 11 (1), pp. 13. | Show Abstract | Read more

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.

Opwora A, Kabare M, Molyneux S, Goodman C. 2010. Direct facility funding as a response to user fee reduction: implementation and perceived impact among Kenyan health centres and dispensaries. Health Policy Plan, 25 (5), pp. 406-418. | Show Abstract | Read more

There is increasing pressure for reduction of user fees, but this can have adverse effects by decreasing facility-level funds. To address this, direct facility funding (DFF) was piloted in Coast Province, Kenya, with health facility committees (HFCs) responsible for managing the funds. We evaluated the implementation and perceived impact 2.5 years after DFF introduction. Quantitative data collection at 30 public health centres and dispensaries included a structured interview with the in-charge, record reviews and exit interviews. In addition, in-depth interviews were conducted with the in-charge and HFC members at 12 facilities, and with district staff and other stakeholders. DFF procedures were well established: HFCs met regularly and accounting procedures were broadly followed. DFF made an important contribution to facility cash income, accounting for 47% in health centres and 62% in dispensaries. The main items of expenditure were wages for support staff (32%), travel (21%), and construction and maintenance (18%). DFF was perceived to have a highly positive impact through funding support staff such as cleaners and patient attendants, outreach activities, renovations, patient referrals and increasing HFC activity. This was perceived to have improved health worker motivation, utilization and quality of care. A number of problems were identified. HFC training was reportedly inadequate, and no DFF documentation was available at facility level, leading to confusion. Charging user fees above those specified in the national policy remained common, and understanding of DFF among the broader community was very limited. Finally, relationships between HFCs and health workers were sometimes characterized by mistrust and resentment. Relatively small increases in funding may significantly affect facility performance when the funds are managed at the periphery. Kenya plans to scale up DFF nationwide. Our findings indicate this is warranted, but should include improved training and documentation, greater emphasis on community engagement, and insistence on user fee adherence.

Lairumbi GM, Molyneux S, Snow RW, Marsh K, Peshu N, English M. 2008. Promoting the social value of research in Kenya: examining the practical aspects of collaborative partnerships using an ethical framework. Soc Sci Med, 67 (5), pp. 734-747. | Show Abstract | Read more

The ethics of research continue to attract considerable debate, particularly when that research is sponsored by partners from the North and carried out in the South. Ethical research should contribute to social value in the country where research is being carried out, but there is significant debate around how this might be achieved and who is responsible. The literature suggests that researchers might employ two inter-related strategies to maximise social value: collaborative partnerships with policy makers and communities from the outset of research, and dissemination of research results to participants, policy makers and implementers once the research is over. These areas have received relatively little empirical attention. In this study, we carried out 40 in-depth interviews to explore the role of collaborative partnerships in health research priority setting, and the way in which research findings are disseminated to aid policy making and implementation in Kenya. Interviewees included policy makers, researchers, policy implementers and representatives of organisations funding health reforms in Kenya. Two policy issues were drawn upon as tracers wherever possible: (1) the introduction of Artemesinin-based Combination Therapies (ACTs), an anti-malarial treatment policy; and (2) Haemophilus influenzae (Hib) vaccine for the prevention of pneumococcal diseases among children. The findings point to significant gaps in the 'research to policy to practice' pathway, particularly for national research institutions with a focus on clinical/biomedical research. These gaps reflect poorly effective partnerships among stakeholders and limit the potential social value of much research. While more investment is needed to establish strong structures for promoting and directing collaboration and partnership, how to target this investment is not entirely clear, especially in the context of the considerable power of the global health agenda and the research financing tied to it.

Molyneux S, Geissler PW. 2008. Ethics and the ethnography of medical research in Africa. Soc Sci Med, 67 (5), pp. 685-695. | Show Abstract | Read more

The ethics of medical research have grown as an area of expertise and debate in recent years, with two broad approaches emerging in relation to transnational research: (1) the refinement of guidelines and strengthening of review, processes primarily to protect the right of individual research participants and strengthen interpersonal relations at the micro-level; and (2) considering more centrally, as crucial ethical concerns, the wider interests of whole populations, the functioning of research institutions, the processes of collaboration, and the ethics of inequitable international relations. We see the two areas of debate and action as complementary, and believe that social science conducted in and around transnational medical research environments can bring these two perspectives together in a more 'situated ethics' of research. To explore this idea for medical research in Africa, we organized a conference in December 2005 in Kilifi, Kenya. In this introduction we outline the two emerging approaches to medical ethics, summarise each of seven papers selected from the conference for inclusion in this special issue on ethics and ethnography, and finally highlight two areas of lively debate at the conference itself: the appropriateness and value of ethics guidelines and review boards for medical research; and the ethical review of social science research. Together, the papers and debates point to the importance of focusing on the ethics of relationships and on justice in both biomedicine and social science research, and on giving greater voice and visibility to the field staff who often play a crucial and under-supported role in 'doing ethics' in the field. They also point to the potential value of social science research on the range of relationships operating at different levels and time scales in medical research, including those surrounding community engagement activities, and the role and functioning of ethics review boards. We conclude by highlighting the ethical priority of capacity strengthening in medical research, social science and research ethics in Africa to ensure that local and national priorities and concerns are considered at both the micro and macro levels.

Marsh V, Kamuya D, Rowa Y, Gikonyo C, Molyneux S. 2008. Beginning community engagement at a busy biomedical research programme: experiences from the KEMRI CGMRC-Wellcome Trust Research Programme, Kilifi, Kenya. Soc Sci Med, 67 (5), pp. 721-733. | Show Abstract | Read more

There is wide acknowledgement of the need for community engagement in biomedical research, particularly in international settings. Recent debates have described theoretical approaches to identifying situations where this is most critical and potential mechanisms to achieve it. However, there is relatively little published experience of community engagement in practice. A major component of the Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Programme is centred on Kilifi District General Hospital and surrounding community of 240,000 local residents. Documented community perceptions of the research centre are generally positive, but many indicate a low understanding of research and therapeutic misconceptions of its activities. As in other settings, these misunderstandings have contributed to concerns and rumours, and potentially undermine ethical aspects of research and local trust in the institution. Through a series of consultative activities, a community engagement strategy has been developed in Kilifi to strengthen mutual understanding between community members and the Centre. One important component is the establishment of a representative local resident network in different geographic locations commonly involved in research, to supplement existing communication channels. Early implementation of the strategy has provided new and diverse opportunities for dialogue, interaction and partnership building. Through the complex social interactions inherent in the community engagement strategy, the centre aims to build context specific ethical relations with local residents and to strengthen understanding of how ethical principles can be applied in practice. Evaluations over time will assess the effectiveness and sustainability of these strategies, provide generalisable information for similar research settings, and contribute to debates on the universality of ethical principles for research. This paper aims to summarise the rationale for community engagement in research, drawing on published literature and local findings, to outline the process of community engagement in Kilifi and to describe issues emerging from its development and early implementation.

Gikonyo C, Bejon P, Marsh V, Molyneux S. 2008. Taking social relationships seriously: lessons learned from the informed consent practices of a vaccine trial on the Kenyan Coast. Soc Sci Med, 67 (5), pp. 708-720. | Show Abstract | Read more

Individual informed consent is a key ethical obligation for clinical studies, but empirical studies show that key requirements are often not met. Common recommendations to strengthen consent in low income settings include seeking permission from community members through existing structures before approaching individuals, considering informed consent as a process rather than a single event, and assessing participant understanding using questionnaires. In this paper, we report on a qualitative study exploring community understanding and perceptions of a malaria vaccine trial (MVT) conducted in a rural setting on the Kenyan Coast. The MVT incorporated all of the above recommendations into its information-giving processes. The findings support the importance of community level information-giving and of giving information on several different occasions before seeking final individual consent. However, an emerging issue was that inter-personal interactions and relationships between researchers and community members, and within the community, play a critical role in participants' perceptions of a study, their decisions to consent or withdraw, and their advice to researchers on study practicalities and information to feedback at the end of the trial. These relationships are based on and continually tested by information-giving processes, and by context specific concerns and interests that can be difficult to predict and are well beyond the timescale and reach of single research activities. On the basis of these findings, we suggest that the current move towards increasingly ambitious and stringent formal standards for information-giving to individuals be counter-balanced with greater attention to the diverse social relationships that are essential to the successful application of these procedures. This may be assisted by emphasising respecting communities as well as persons, and by recognising that current guidelines and regulations may be an inadequate response to the complex, often unpredictable and ever shifting ethical dilemmas facing research teams working 'in the field'.

Cited:

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Scopus

Molyneux S, Geissler PW. 2008. Ethics and the ethnography of medical research in Africa Social Science and Medicine, 67 (5), pp. 685-695. | Show Abstract | Read more

The ethics of medical research have grown as an area of expertise and debate in recent years, with two broad approaches emerging in relation to transnational research: (1) the refinement of guidelines and strengthening of review, processes primarily to protect the right of individual research participants and strengthen interpersonal relations at the micro-level; and (2) considering more centrally, as crucial ethical concerns, the wider interests of whole populations, the functioning of research institutions, the processes of collaboration, and the ethics of inequitable international relations. We see the two areas of debate and action as complementary, and believe that social science conducted in and around transnational medical research environments can bring these two perspectives together in a more 'situated ethics' of research. To explore this idea for medical research in Africa, we organized a conference in December 2005 in Kilifi, Kenya. In this introduction we outline the two emerging approaches to medical ethics, summarise each of seven papers selected from the conference for inclusion in this special issue on ethics and ethnography, and finally highlight two areas of lively debate at the conference itself: the appropriateness and value of ethics guidelines and review boards for medical research; and the ethical review of social science research. Together, the papers and debates point to the importance of focusing on the ethics of relationships and on justice in both biomedicine and social science research, and on giving greater voice and visibility to the field staff who often play a crucial and under-supported role in 'doing ethics' in the field. They also point to the potential value of social science research on the range of relationships operating at different levels and time scales in medical research, including those surrounding community engagement activities, and the role and functioning of ethics review boards. We conclude by highlighting the ethical priority of capacity strengthening in medical research, social science and research ethics in Africa to ensure that local and national priorities and concerns are considered at both the micro and macro levels. © 2008 Elsevier Ltd. All rights reserved.

Cited:

67

Scopus

Marsh V, Kamuya D, Rowa Y, Gikonyo C, Molyneux S. 2008. Beginning community engagement at a busy biomedical research programme: Experiences from the KEMRI CGMRC-Wellcome Trust Research Programme, Kilifi, Kenya Social Science and Medicine, 67 (5), pp. 721-733. | Show Abstract | Read more

There is wide acknowledgement of the need for community engagement in biomedical research, particularly in international settings. Recent debates have described theoretical approaches to identifying situations where this is most critical and potential mechanisms to achieve it. However, there is relatively little published experience of community engagement in practice. A major component of the Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Programme is centred on Kilifi District General Hospital and surrounding community of 240,000 local residents. Documented community perceptions of the research centre are generally positive, but many indicate a low understanding of research and therapeutic misconceptions of its activities. As in other settings, these misunderstandings have contributed to concerns and rumours, and potentially undermine ethical aspects of research and local trust in the institution. Through a series of consultative activities, a community engagement strategy has been developed in Kilifi to strengthen mutual understanding between community members and the Centre. One important component is the establishment of a representative local resident network in different geographic locations commonly involved in research, to supplement existing communication channels. Early implementation of the strategy has provided new and diverse opportunities for dialogue, interaction and partnership building. Through the complex social interactions inherent in the community engagement strategy, the centre aims to build context specific ethical relations with local residents and to strengthen understanding of how ethical principles can be applied in practice. Evaluations over time will assess the effectiveness and sustainability of these strategies, provide generalisable information for similar research settings, and contribute to debates on the universality of ethical principles for research. This paper aims to summarise the rationale for community engagement in research, drawing on published literature and local findings, to outline the process of community engagement in Kilifi and to describe issues emerging from its development and early implementation. © 2008 Elsevier Ltd. All rights reserved.

Molyneux CS, Wassenaar DR, Peshu N, Marsh K. 2005. 'Even if they ask you to stand by a tree all day, you will have to do it (laughter)...!': community voices on the notion and practice of informed consent for biomedical research in developing countries. Soc Sci Med, 61 (2), pp. 443-454. | Show Abstract | Read more

Ethical dilemmas in biomedical research, especially in vulnerable populations, often spark heated debate. Despite recommendations and guidelines, many issues remain controversial, including the relevance, prioritisation and application of individual voluntary informed consent in non-Western settings. The voices of the people likely to be the subjects of research have been notably absent from the debate. We held discussions with groups of community members living in the rural study area of a large research unit in Kenya. Discussions were facilitated by three research study vignettes outlining one field-based and two hospital-based studies being planned or taking place at the time. In addition to gathering general views about the aims and activities of the research unit, questions focused on whether consent should be sought for studies, and if so from whom (chiefs, elders, men/women, children), and on ascertaining whether there are any special concerns about the physical act of signing consent forms. The findings revealed the community's difficulty in distinguishing research from clinical investigations conducted in clinical settings. There was a spectrum of views regarding perceived appropriateness of consent procedures, in part because of difficulty in disentangling clinical from research aims, and because of other challenges to applying consent in practice. Debates between community members highlight the inadequacy of simplistic assumptions about community members' views on informed consent, and the complexity of incorporating lay opinions into biomedical research. Failure to appreciate these issues risks exaggerating differences between settings, and underestimating the time and resources required to ensure meaningful community involvement in research processes. Ultimately, it risks inadequately responding to the needs and values of those on whom the success of most biomedical research depends. Although compliance with community views does not necessarily make the research more ethical, it is argued that community opinions on local issues and practices should inform ethical decision-making in health research.

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