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)

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)

Human Infection Studies have emerged as an important research approach with the potential to fast track the global development of vaccines and treatments for infectious diseases, including in low resource settings. Given the high level of burdens involved in many HIS, particularly prolonged residency and biological sampling requirements, it can be challenging to identify levels of study payments that provide adequate compensation but avoid ‘undue’ levels of inducement to participate. Through this embedded ethics study, involving 97 healthy volunteers and other (...) research stakeholders in a malaria HIS programme in Kenya, and using in-depth interviews, focus group discussions and observations during and after a malaria HIS, we give a grounded account of ethical issues emerging in relation to study payments in this setting. While careful community, national, international scientific and ethics review processes meant that risks of serious harm were highly unlikely, the levels of motivation to join HIS seen could raise concerns about study payments being too high. Particular value was placed on the reliability, rather than level, of study payment in this setting, where subsistence livelihoods are common. Study volunteers were generally clear about the study aims at the point of recruitment, and this knowledge was retained over a year later, although most reported experiencing more burdens than anticipated at enrolment. Strict study screening procedures, regular clinical and laboratory monitoring of volunteers, with prompt treatment with antimalarial at predetermined endpoints suggested that the risks of serious harm were highly unlikely. Ethical concerns emerged in relation to volunteers’ attempts to conceal symptoms, hoping to prolong residency periods and increase study payments; and volunteers making decisions that compromised important family relationships and personal values. Our findings support an interpretation that, although study volunteers were keen to join the study to access cash payments, they also paid attention to other features of the study and the general clinical research landscape, including levels of risk associated with study participation. Overall, our analysis shows that the ethical concerns emerging from the study payments can be addressed through practical measures, hinged on reducing burdens and strengthening communication, raising important issues for research policy and planning. (shrink)

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

BackgroundDespite the rapid global growth of biobanking over the last few decades, and their potential for the advancement of health research, considerations specific to the sharing of benefits that accrue from biobanks have received little attention. Questions such as the types and range of benefits that can arise in biobanking, who should be entitled to those benefits, when they should be provided, by whom and in what form remain mostly unanswered. We conducted a scoping review to describe benefit sharing considerations (...) and practices in biobanking in order to inform current and future policy and practice. MethodsDrawing on the Arksey and O’Malley framework, we conducted a scoping review of the literature in three online databases (PubMed, Cochrane library, and Google Scholar). We extracted and charted data to capture general characteristics, definitions and examples of benefits and benefit sharing, justification for benefit sharing, challenges in benefit sharing, governance mechanisms as well as proposed benefit sharing mechanisms.Results29 articles published between 1999 and 2020 met the inclusion criteria for the study. The articles included 5 empirical and 24 non-empirical studies. Only 12 articles discussed benefit sharing as a stand-alone subject, while the remaining 17 integrated a discussion of benefits as one issue amongst others. Major benefit sharing challenges in biobanking were found to be those associated with uncertainties around the future use of samples and in resultant benefits.ConclusionMost of the benefit sharing definitions and approaches currently in use for biobanking are similar to those used in health research. These approaches may not recognise the distinct features of biobanking, specifically relating to uncertainties associated with the sharing and re-use of samples. We therefore support approaches that allow decisions about benefit sharing to be made progressively once it is apparent who samples are to be shared with, the intended purpose and expected benefits. We also highlight gaps in key areas informing benefit sharing in biobanking and draw attention to the need for further empirical research. (shrink)

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)

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)

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)

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)

The proposed framework by Lynch et al. (2021) for promoting ethical forms of payment in Human Infection Controlled Studies (HICS) in general and SARS-Cov-2 HICS in particular is an important contri...

BackgroundThe 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.MethodsThe 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.ResultsField 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.ConclusionsCommunity 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. (shrink)

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. (shrink)

A close relationship between masculinity, alcoholism, widowhood and gendered poverty is evident in contemporary African society. Alcohol consumption among young men begins at an increasingly early age due to availability of low-priced alcohol presented in different varieties. Young, beautiful and sexy girls are used to advertise alcohol. Many young men are addicted to alcohol and totally unable to be free from alcohol addiction. This sad state coupled with the impact of globalisation on the economies of many African countries has left (...) many men jobless. Consequently, many households are headed by women in a patriarchal context where men are supposed to be the heads of the family. Through an Afro-feminisation of Mother Earth lens, this article re-read Proverbs 31 in dialogue with Acts 9:36–43, to show the role of women in the socio-economic sustainability of the family, society and in enhancing gender equity.Contribution: This article re-read Proverbs 31 in dialogue with Acts 9:36–41 as resources for enhancing gender equity. An Afro-feminisation of Mother Earth for sustainable development was presented in ways that open up possibilities for the life of the Garden of Eden in Genesis 1:28 to flourish. (shrink)

The rate at which women and girls have been ‘butchered’ in Africa before and during the COVID-19 pandemic suggests that violence against women in patriarchal settings is more tolerable. According to Exodus 21:12, Leviticus 24:17, Deuteronomy 12:312, 2 Kings 17:31 and Isaiah 66:3, murder and human sacrifice are an abomination and defile the land. Unfortunately, it is heartbreaking to note how the murder of women finds justification, as shown in Judges 11:31–40. Ironically, in Genesis 22:13, the sacrifice of Isaac is (...) prevented through the provision of a sacrificial lamb. In this conversational platform, an African women’s hermeneutical lens to Judges 11:31–40 enables one to reimagine female bodies and motherhood as a theological phenomenon. It is proposed that ‘Sharon’s blood’ presents murdered women as Mother Earth’s sacrificial lambs of Africa, whose lives do not go unnoticed by God. Reimagining female bodies and motherhood as a theological phenomenon arguably enables the voices of murdered women to cry for justice from beyond the grave. If ‘the Sharons’ and their unborn babies do not receive justice, the ground continues to be defiled by human blood and remains ‘cursed’ (Mi 6:15). We will plant but not harvest; hence, there is a direct relationship between female bodies, motherhood and Mother Earth. One therefore asks: can scholarly conversational platforms enable murdered women of African descent to cry for justice from beyond the grave, allowing for life to flourish ‘again’? Contribution: This article contributed new knowledge to feminist studies by presenting murdered female victims of gender-based violence (GBV) as the sacrificial lambs of Mother Africa, whose innocent blood continues to cry for justice from beyond the grave. From an African hermeneutical lens, this research article reimagined female bodies and motherhood as a theological phenomenon in order to arguably enable the voices of murdered women to cry for justice from beyond the grave. (shrink)

This paper examines the effect of corporate governance mechanisms on earnings management within the Nigerian context. The study adopted the panel generalised least square regression to analyse the data. A sample size of 49 companies was selected from the non-financial companies listed on the Nigerian Stock Exchange for six years (2012-2017). Overall, corporate governance mechanisms jointly have not restrained the possibility of earnings management in Nigeria, but the degree of impact by individual corporate mechanisms showed mixed results. From the analysis, (...) five corporate governance variables (ownership concentration, managerial ownership, board size, gender diversity, and audit committee independence) have positive relationship with earnings management. This indicates that an increase in any of these variables increases managers' latitude for using earnings management to manage the firms' earnings. This confirms ineffectiveness of all these variables in restraining earnings management. In contrast, two variables (CEO duality and board independence) contribute to the reduction of earnings management of the selected firms in Nigeria. However, CEO duality is not statistically significant. Given the findings, the study recommends stricter compliance and enforcement to the corporate governance codes and appropriate legislation. Besides, more independent directors' representation on the board should be encouraged. (shrink)

This article uses the voices of women to investigate the horror of the cultural practice of female genital mutilation. Case studies graphically illustrate the way in which the bodies of young girls are literally moulded for male satisfaction, physical, religious and cultural. Female genital mutilation is a socio-cultural offensive against women and young girls which we would join with female theologians in condemning.

Öz: Bu çalışmama İslam’da bireyin kamuya karşı sorumluluk alanı ile bağlantılı bir ilkesini; “Emr-i bi’l- Ma’ruf ve Nehyi Ani’l-Münker”i İslam İnanç Ekolleri içerisinde nasıl algılandığını ve nasıl uygulandığını ele alacaktır. Bundaki amacım birey- kamu ilişkisinde, bireyin özgürlük alanlarının ihmal edildiği yönündeki varsayımımdır. Bu girişten sonra, çalışmada İslam inanç ekollerinin konuya ilişkin yaklaşımları ve bu yaklaşımlarına kaynak teşkil eden metinlere yer verilecektir. Çalışmamızda ekollerin kronolojik tarihlerini göz önünde bulunduran bir sıralama takip edeceğiz. Bundaki amacımız özellikle “Emr-i bi’l- Ma’ruf ve Nehyi (...) Ani’l- Münker” ilkesinin ekollerde ele alınışının erken dönem İslam Siyasal Tarihi ile önemli oranda bir ilişkisi olduğu anlayışımız sebebiyledir. İslam siyaset kuramının birlikte yaşam, özgürlük ve adalet iddia ve idealleri çerçevesinde konuya İslam teolojik mezhepleri yakın ilgi göstermişlerdir. Ekollerin “Emr-i bi’l-Ma’ruf ve Nehyi Ani’l-Münker” ilkesine yoğun ilgilerine karşın, farklı yaklaşımlar gösterdikleri de söylenebilir. İslam geleneği içerisinde bu kurucu ilke birey özgürlüğü ve kamu düzeni arasındaki gerilimler nedeniyle politik yorumları da beraberinde getirmiştir. “Haricî” ekoller her bir Müslüman için gereken bir sorumluluk olarak yorumlamış ve “ayn-i vacib” olduğunu dile getirmişlerdir. Diğer ekoller ise bu ilkeyi ” kifa-i bir vucûb” olarak kabul etmişlerdir. Diğer yandan Mu’tezile ekolü bu ilkeyi usulu’l-hamse’ den biri olarak kabul etmiştir. İslam siyaset geleneğinin önemli bileşenlerinden olan ilke mezhepler arasında farklı uygulamalara konu olmuştur. (shrink)