Negotiating Research Participation in Community-Based Studies on the Kenyan Coast: Fieldworkers' Roles, and Implications for Ethical Practice

In this thesis, I explore the nature of research interactions between fieldworkers (FWs) and research participants in a large, long-term international collaborative centre on the Kenyan Coast. Fieldworkers are members of local communities employed in research with the main responsibilities of communicating about studies, and carrying out biomedically simple, non-invasive procedures. Being socially embedded in the communities in which research is conducted, fieldworkers can potentially strengthen studies and research ethics through their insider knowledge of local norms, and of hard-to-reach populations. Being socially embedded can also present problems on how to respond to questions and demands in a context of wealth and health inequalities. I designed a mixed methodology study, primarily qualitative, to unpack the issues that fieldworkers at the frontline of research implementation face, how they resolve these, and the implications for policy and practice. I found that fieldworkers and other research staff working in communities face considerable dilemmas including those related to household decision-making dynamics for research; and those related to types, levels and scope of research benefits given to participants and communities. The nature of pre-existing relationships within households, and of relationships developed between FWs and household members, apparently strongly influenced discussions and research participation choices. Relationships were often built and nurtured by both fieldworkers and participants. ‘Silent refusals’- a situation of inconsistent participation and reluctance to openly refuse or withdraw from research - emerged as a key challenge for fieldworkers. Negotiations were often imbued with subtle power relations across different sets of interactions; within households, between FWs and participants, and between FWs and supervisors, with potential to shift and shape the research implementation processes. There were often no easy answers to these and other issues fieldworkers faced; they appeared to draw on study guidelines, formal and informal supervision, peers and their own judgements in making choices. Drawing on these findings, I suggest that understanding and responding to the issues that fieldworkers face throughout their fieldwork is important in supporting the practical application of ethics guidelines including those related to community engagement and consent; and in contributing to normative debates

Rethinking benefit sharing in collaborative human genetic research from an Afrocommunitarian perspective

This article draws on reflections about humanness, friendliness and partiality, in the writings of Afro-communitarians to develop principles for thinking critically about why benefit sharing, what may count as benefits within the context of human research in Africa and the limits of the obligation of benefit sharing. Suppose the thinking about humanness, friendliness, and partiality in Afro-communitarianism were the foundation of human genetic research in Africa, then, individuals who have contributed to research or borne its burden would benefit from its rewards. This is even more important if participants have pressing needs that researchers and/or research institutions can help ease. A failure to aid sample contributors and data providers in need when researchers and research institutions can—as well as an indifference to the serious needs of contributors—are failures to exhibit friendliness in the relevant ways. Finally, though providing benefits to contributors can be an important way of showing humanity to them, nonetheless, this obligation is not absolute and may be limited by the stronger obligation of shared experience—to advance science. Studies are still required to inquire how well these norms will work in practice and inform regulatory and legal frameworks

Ethical issues of involving people with intellectual disabilities in genomic research: a scoping review protocol

Background: Psychiatric genomic research is a growing field of research in Africa that is looking at epigenetics of psychiatric disorders; within which a specific focus is neurodevelopmental disorders including intellectual disability (ID). Conducting this type of research is important to identify etiologies and possible interventions or areas for further research. However, genomic research generally, and psychiatric genomic research, faces many social, ethical, cultural, and legal issues; research involving people with ID is particularly challenging. All research stakeholders - researchers, research review bodies, regulators, patient groups - generally agree that involving people with ID require several considerations, including extra protection. It is also recognized that not involving people with ID in research that is relevant to them means that opportunities to learn on specific issues including lived experiences are missed. In this scoping review, we aim to describe the range of ethical and social-cultural issues concerning involvement of people with intellectual disability in genomic research from existing literature. Methods: This scoping review will be conducted based on the Joanna Briggs Institute guidance for scoping review and reported using the PRISMA-ScR guidelines. Iterative review stages will include systematic search of six databases (Embase, Ovid Global Health, PubMed, Scopus, PsycInfo and Web of Science core collection), screening, charting and synthesis of the data. Forward and backward citation screening will also be done for the articles included in the final review. We will include peer reviewed journal articles, guidance documents and reports. Screening and selection of studies based on the eligibility criteria will be done independently by three reviewers; conflicts will be resolved through discussion with a third reviewer and other experts. Results: The results will be included in the scoping review publication. Conclusions: This scoping review will identify key areas of ethical tensions and possible solutions and inform opportunities for empirical ethics studies

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

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

A scoping review of ethics review processes during public health emergencies in Africa

Background: The COVID-19 pandemic forced governments, multilateral public health organisations and research institutions to undertake research quickly to inform their responses to the pandemic. Most COVID-19-related studies required swift approval, creating ethical and practical challenges for regulatory authorities and researchers. In this paper, we examine the landscape of ethics review processes in Africa during public health emergencies (PHEs). Methods: We searched four electronic databases (Web of Science, PUBMED, MEDLINE Complete, and CINAHL) to identify articles describing ethics review processes during public health emergencies and/or pandemics. We selected and reviewed those articles that were focused on Africa. We charted the data from the retrieved articles including the authors and year of publication, title, country and disease(s) reference, broad areas of (ethical) consideration, paper type, and approach. Results: Of an initial 4536 records retrieved, we screened the titles and abstracts of 1491 articles, and identified 72 articles for full review. Nine articles were selected for inclusion. Of these nine articles, five referenced West African countries including Liberia, Guinea and Sierra Leone, and experiences linked to the Ebola virus disease. Two articles focused on South Africa and Kenya, while the other two articles discussed more general experiences and pitfalls of ethics review during PHEs in Africa more broadly. We found no articles published on ethics review processes in Africa before the 2014 Ebola outbreak, and only a few before the COVID-19 outbreak. Although guidelines on protocol review and approval processes for PHEs were more frequently discussed after the 2014 Ebola outbreak, these did not focus on Africa specifically. Conclusions: There is a gap in the literature about ethics review processes and preparedness within Africa during PHEs. This paper underscores the importance of these processes to inform practices that facilitate timely, context-relevant research that adequately recognises and reinforces human dignity within the quest to advance scientific knowledge about diseases. This is important to improve fast responses to PHEs, reduce mortality and morbidity, and enhance the quality of care before, during, and after pandemics

Ethical considerations in Controlled Human Malaria Infection studies in low resource settings: Experiences and perceptions of study participants in a malaria Challenge study in Kenya [version 2; referees: 2 approved]

Background: The range and amount of volunteer infection studies, known as Controlled Human Infection Model (CHMI) studies, in Low-Middle Income Countries (LMICs) is increasing with rapid technological advancement, world-class laboratory facilities and increasing capacity development initiatives. However, the ethical issues these studies present in LMICs have not been empirically studied. We present findings of a descriptive social science study nested within a malaria volunteer infection study, on-going at the time of writing, at the KEMRI-Wellcome Trust Research Programme (KWTRP) on the Kenyan Coast. Methods: The study included non-participant observations, five group discussions with more than half of the CHMI study participants, two in-depth interviews with study team members, and an exit questionnaire administered to the participants. Results: Participants understood the key elements of the study, including that they would be deliberately infected with malaria parasites and may get malaria as a result, there would be regular blood draws, and they would spend up to 24 days in a residence facility away from their homes. The greatest motivation for participation was the monetary compensation of 20 USD per overnight stay given as a lump-sum at the end of their residency stay. Also appreciated were the health screening tests prior to enrolment and the positive relations with the study team. Concerns raised included the amount and regularity of blood draws experienced, and concerns that this type of research may feed into on-going rumours about research generally. Conclusion: With the increasing range and number of CHMI studies being conducted in LMICs, current ethical guidance are inadequate. This study highlights some of the ethical issues that could emerge in these settings, emphasizing the heavy responsibility placed on research review and regulatory systems, researchers and funders, as well as the importance of carefully tailored community engagement and consent processes

The hidden emotional labour behind ensuring the social value of research: Experiences of frontline health policy and systems researchers based in Kenya during COVID-19

Health policy and systems research (HPSR) is a multi-disciplinary, largely applied field of research aimed at understanding and strengthening the performance of health systems, often with an emphasis on power, policy and equity. The value of embedded and participatory HPSR specifically in facilitating the collection of rich data that is relevant to addressing real-world challenges is increasingly recognised. However, the potential contributions and challenges of HPSR in the context of shocks and crises are not well documented, with a particular gap in the literature being the experiences and coping strategies of the HPSR researchers who are embedded in health systems in resource constrained settings. In this paper, we draw on two sets of group discussions held among a group of approximately 15 HPSR researchers based in Nairobi, Kenya, who were conducting a range of embedded HPSR studies throughout the COVID-19 pandemic. The researchers, including many of the authors, were employed by the KEMRI-Wellcome Trust Research Programme (KWTRP), which is a long-standing multi-disciplinary partnership between the Kenya Medical Research Institute and the Wellcome Trust with a central goal of contributing to national and international health policy and practice. We share our findings in relation to three inter-related themes: 1) Ensuring the continued social value of our HPSR work in the face of changing priorities; 2) Responding to shifting ethical procedures and processes at institutional and national levels; and 3) Protecting our own and front-line colleagues' well-being, including clinical colleagues. Our experiences highlight that in navigating research work and responsibilities to colleagues, patients and participants through the pandemic, many embedded HPSR staff faced difficult emotional and ethical challenges, including heightened forms of moral distress, which may have been better prevented and supported. We draw on our findings and the wider literature to discuss considerations for funders and research leads with an eye to strengthening support for embedded HPSR staff, not only in crises such as the on-going COVID-19 pandemic, but also more generally