Research Area:	Global Health
Scientific Themes:	Tropical Medicine & Global Health
Keywords:	Research ethics, Health systems research, Qualitative methods, Community accountability and Sub-Saharan Africa

Key current RESEARCH responsibilities

• A Wellcome Trust Career Development Fellow whose research is aimed at exploring community accountability in health delivery and health research.
• Co-PI on an action research study aimed at building a research agenda around the application of ethical principles in practice in low income settings.
• Co-PI on a mixed methodology study exploring equity in prevention and treatment of malaria in Districts of Kenya.
• Co- PI on a mixed methodology study exploring the impact of a new financing mechanism on dispensaries and health centers on the Kenyan Coast

Key COMMUNITY LIAISON and ethical practice support activities

• Senior social scientist supporting large and innovative operational and research activities for community engagement at the KEMRI-WT programme. Current special interest in community engagement, clinical trials, and paediatric research.
• Initiated and run an ethics review committee linked to the monthly scientific review committee for the research programme.

Key SOCIAL SCIENCE capacity building activities

• Initiated and running two groups (Social Science Perspectives and Social Sciences Group) for Kenyan social scientists, and co-organises a series of workshops taught in Kenya by external experts.
• PhD and masters level supervision
• Has also organised a series of international meetings around social science and ethics in Kilifi

There are no collaborations listed for this principal investigator.

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. Read abstract | Read more

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. Hide abstract

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 pp. 90. Read abstract | Read more

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. Hide abstract

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. Read abstract | Read more

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. Hide abstract

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. Read 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. Hide abstract

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. Read 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. Hide abstract

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

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. Read 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. Hide abstract

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. Read 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'. Hide abstract

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.

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

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. Read 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. Hide abstract