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. (shrink)

In recent years, there has been an increase in the establishment of biobanks for genetic and genomic studies around the globe. One example of this is the Human Heredity and Health in Africa Initiative (H3Africa), which has established biobanks in the sub‐region to facilitate future indigenous genomic studies. The concept of ‘broad consent’ has been proposed as a mechanism to enable potential research participants in biobanks to give permission for their samples to be used in future research studies. However, questions (...) remain about the acceptability of this model of consent. Drawing on findings from empirical research about the role of trust in decision‐making, we argue that an account of entrustment may be an appropriate way of addressing current challenges of seeking consent for biobank research in Africa. We propose a set of key points to consider that can support the proposed entrustment framework. (shrink)

Controlled human malaria infection (CHMI) studies involve the deliberate infection of healthy volunteers with malaria parasites under controlled conditions to study immune responses and/or test drug or vaccine efficacy. An empirical ethics study was embedded in a CHMI study at a Kenyan research programme to explore stakeholders’ perceptions and experiences of deliberate infection and moral implications of these. Data for this qualitative study were collected through focus group discussions, in‐depth interviews and non‐participant observation. Sixty‐nine participants were involved, including CHMI study (...) volunteers, community representatives and research staff. Data were managed using QSR Nvivo 10 and analysed using an inductive‐deductive approach, guided by ethics literature. CHMI volunteers had reasonable understanding of the study procedures. Decisions to join were influenced by study incentives, trust in the research institution, their assessment of associated burdens and motivation to support malaria vaccine development. However, deliberate malaria infection was a highly unusual research strategy for volunteers, community representatives and some study staff. Volunteers’ experiences of physical, emotional and social burdens or harms were often greater than anticipated initially, and fluctuated over time, related to specific procedures and events. Although unlikely to deter volunteers' participation in similar studies in furture, we argue that the dissonance between level of understanding of the burdens involved and actual experiences are morally relevant in relation to community engagement, informed consent processes, and ongoing support for volunteers and research staff. We further argue that ethics oversight of CHMI studies should take account of these issues in deciding whether consent, engagement and the balance of benefits and harms are reasonable in a given context. (shrink)

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 - 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. (shrink)

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

Despite advances in theory, often driven by feminist ethicists, research ethics struggles in practice to adequately account for and respond to the agency and autonomy of people considered vulnerable in the research context. We argue that shifts within feminist research ethics scholarship to better characterise and respond to autonomy and agency can be bolstered by further grounding in discourses from the social sciences, in work that confirms the complex nature of human agency in contexts of structural and other sources of (...) vulnerability. We discuss some of the core concepts and critiques emerging from the literature on women and children's agency in under‐resourced settings, highlighting calls to move from individualistic to relational models of agency, and to recognise the ambiguous, value‐laden, and heterogeneous nature of the concept. We then draw out what these conceptual shifts might mean for research ethics obligations and guidance, illustrating our analysis using a case vignette based on research ethics work conducted in South Africa. We conclude that if research practices are to be supportive of agency, it will be crucial to scrutinise the moral judgements which underpin accounts of agency, derive more situated definitions of and responses to agency, and enable people and participants to influence these based on their own experiences and self‐perceptions. (shrink)

BackgroundVerbal autopsy is a pragmatic approach for generating cause-of-death data in contexts without well-functioning civil registration and vital statistics systems. It has primarily been conducted in health and demographic surveillance systems (HDSS) in Africa and Asia. Although significant resources have been invested to develop the technical aspects of verbal autopsy, ethical issues have received little attention. We explored the benefits and burdens of verbal autopsy in HDSS settings and identified potential strategies to respond to the ethical issues identified.MethodsThis research was (...) based on a case study approach centred on two contrasting HDSS in Kenya and followed the Mapping-Framing-Shaping Framework for empirical bioethics research. Data were collected through individual interviews, focus group discussions, document reviews and non-participant observations. 115 participants were involved, including 86 community members (HDSS residents and community representatives), and 29 research staff (HDSS managers, researchers, census field workers and verbal autopsy interviewers).ResultsThe use of verbal autopsy data for research and public health was described as the most common potential benefit of verbal autopsy in HDSS. Community members mentioned the potential uses of verbal autopsy data in addressing immediate public health problems for the local population while research staff emphasized the benefits of verbal autopsy to research and the wider public. The most prominent burden associated with the verbal autopsy was emotional distress for verbal autopsy interviewers and respondents. Moral events linked to the interview, such as being unsure of the right thing to do (moral uncertainty) or knowing the right thing to do and being constrained from acting (moral constraint), emerged as key causes of emotional distress for verbal autopsy interviewers.ConclusionsThe collection of cause-of-death data through verbal autopsy in HDSS settings presents important ethical and emotional challenges for verbal autopsy interviewers and respondents. These challenges include emotional distress for respondents and moral distress for interviewers. This empirical ethics study provides detailed accounts of the distress caused by verbal autopsy and highlights ethical tensions between potential population benefits and risks to individuals. It includes recommendations for policy and practice to address emotional and moral distress in verbal autopsy. (shrink)

The American Journal of Bioethics, Volume 11, Issue 8, Page 31-33, August 2011.

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. (shrink)

International research guidance has shifted towards an increasingly proactive inclusion of children and adolescents in health research in recognition of the need for more evidence-based treatment. Strong calls have been made for the active involvement of children and adolescents in developing research proposals and policies, including in decision-making about research participation. Much evidence and debate on this topic has focused on high-income settings, while the greatest health burdens and research gaps occur in low-middle income countries, highlighting the need to take (...) account of voices from more diverse contexts. Between January and March 2014, 56 community representatives and secondary school students were involved in eight group discussions to explore views on the acceptability of involving children and adolescents in research, and how these groups should be involved in decision-making about their own participation. Discussions were voice-recorded and transcriptions analyzed using Framework Analysis, combining deductive and inductive approaches. Across these discussions, the idea of involving children and adolescents in decision-making about research participation was strongly supported given similar levels of responsibility carried in everyday life; existing capacity that should be recognized; the opportunity for learning involved; varying levels of parental control; and generational shifts towards greater understanding of science for adolescents than their parents. Joint decision-making processes were supported for older children and adolescents, with parental control influenced by perceptions of the risks involved in participation. Moves towards more active involvement of children and adolescents in planning studies and in making decisions about their participation are supported by these findings from Kenya. Important emerging considerations include the need to take account of the nature of proposed studies and prevailing attitudes and understanding of research in identifying children’s and adolescents’ roles. More research is needed to expand diversity and develop approaches to joint assent and consent processes that would fairly represent children’s and adolescents’ wishes and interests, towards their long term benefit. (shrink)

There is a growing interest in the ethics of Health Policy and Systems Research, and especially in areas that have particular ethical salience across HPSR. Hyder et al 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. (shrink)

BackgroundCarefully planned research is critical to developing policies and interventions that counter physical, psychological and social challenges faced by young people living with HIV/aids, without increasing burdens. Such studies, however, must navigate a ‘vulnerability paradox’, since including potentially vulnerable groups also risks unintentionally worsening their situation. Through embedded social science research, linked to a cohort study involving Adolescents Living with HIV/aids (ALH) in Kenya, we develop an account of researchers’ responsibilities towards young people, incorporating concepts of vulnerability, resilience, and agency (...) as ‘interacting layers’.MethodsUsing a qualitative, iterative approach across three linked data collection phases including interviews, group discussions, observations and a participatory workshop, we explored stakeholders’ perspectives on vulnerability and resilience of young people living with HIV/aids, in relation to home and community, school, health care and health research participation. A total of 62 policy, provider, research, and community-based stakeholders were involved, including 27 ALH participating in a longitudinal cohort study. Data analysis drew on a Framework Analysis approach; ethical analysis adapts Luna’s layered account of vulnerability.ResultsALH experienced forms of vulnerability and resilience in their daily lives in which socioeconomic context, institutional policies, organisational systems and interpersonal relations were key, interrelated influences. Anticipated and experienced forms of stigma and discrimination in schools, health clinics and communities were linked to actions undermining ART adherence, worsening physical and mental health, and poor educational outcomes, indicating cascading forms of vulnerability, resulting in worsened vulnerabilities. Positive inputs within and across sectors could build resilience, improve outcomes, and support positive research experiences.ConclusionsThe most serious forms of vulnerability faced by ALH in the cohort study were related to structural, inter-sectoral influences, unrelated to study participation and underscored by constraints to their agency. Vulnerabilities, including cascading forms, were potentially responsive to policy-based and interpersonal actions. Stakeholder engagement supported cohort design and implementation, building privacy, stakeholder understanding, interpersonal relations and ancillary care policies. Structural forms of vulnerability underscore researchers’ responsibilities to work within multi-sectoral partnerships to plan and implement studies involving ALH, share findings in a timely way and contribute to policies addressing known causes of vulnerabilities. (shrink)

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.FindingsThe 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. (shrink)

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. (shrink)

BackgroundHealth service delivery should ensure ethical principles are observed at all levels of healthcare. Working towards this goal requires understanding the ethics-related priorities and concerns in the day-to-day activities among different health practitioners. These practitioners include community health workers (CHWs) who are involved in healthcare delivery in communities in many low-and middle-income countries such as Uganda. In this study, we used photovoice, an innovative community based participatory research method that uses photography, to examine CHWs' perspectives on ethical concerns in their (...) work.MethodsWe explored perspectives of 10 CHWs (5 females and 5 males) on ethical dimensions of their work for 5 months using photovoice in a rural community in Wakiso district, Uganda. As part of the study, we: 1. Oriented CHWs on photovoice research and ethics; 2. Asked CHWs to take photographs of key ethical dimensions of their work; 3. Held monthly meetings to discuss and reflect on the photos; and 4. Disseminated the findings. The discussions from the monthly meetings were audio recorded, transcribed, and emerging data analysed using conventional content analysis with the help of Atlas ti version 6.0.15.ResultsCHWs were aware of and highly concerned about the need to observe ethical principles while carrying out their roles. The ethical principles CHWs were aware of and endeavoured to observe during their work were: maintaining professional integrity and abiding by ethical principles of practice; ethical responsibility in patient care; maintaining confidentiality while handling clients; respect for persons and communities; and enhancing their knowledge and skills for better practice. However, CHWs also identified challenges concerning their observance of ethical principles including: low commitment to their work due to other obligations; availability of some reference materials and guidelines in English yet majority could only read in the local language; and minimal avenues for knowledge enhancement such as trainings.ConclusionsCHWs were aware of and keen to discuss ethical issues in their work. However, there is need to address the challenges they face so as to facilitate observing ethical principles during the course of their work in communities. (shrink)

Increasing adoption of electronic health records in hospitals provides new opportunities for patient data to support public health advances. Such learning healthcare models have generated ethical debate in high-income countries, including on the role of patient and public consent and engagement. Increasing use of electronic health records in low-middle income countries offers important potential to fast-track healthcare improvements in these settings, where a disproportionate burden of global morbidity occurs. Core ethical issues have been raised around the role and form of (...) information sharing processes for learning healthcare systems, including individual consent and individual and public general notification processes, but little research has focused on this perspective in low-middle income countries. We conducted a qualitative study on the role of information sharing and governance processes for inpatient data re-use, using in-depth interviews with 34 health stakeholders at two public hospitals on the Kenyan coast, including health managers, providers and researchers. Data were collected between March and July 2016 and analysed using a framework approach, with Nvivo 10 software to support data management. Most forms of clinical data re-use were seen as an important public health good. Individual consent and general notification processes were often argued as important, but contingent on interrelated influences of the type of data, use and secondary user. Underlying concerns were linked to issues of patient privacy and autonomy; perceived risks to trust in health systems; and fairness in how data would be used, particularly for non-public sector re-users. Support for engagement often turned on the anticipated outcomes of information-sharing processes, as building or undermining trust in healthcare systems. As reported in high income countries, learning healthcare systems in low-middle counties may generate a core ethical tension between supporting a public good and respecting patient autonomy and privacy, with the maintenance of public trust acting as a core requirement. While more evidence is needed on patient and public perspectives on learning healthcare activities, greater collaboration between public health and research governance systems is likely to support the development of efficient and locally responsive learning healthcare activities in LMICs. (shrink)

BackgroundThere 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.MethodsFollowing 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.FindingsThe 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.ConclusionsResearch 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. (shrink)

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. (shrink)