Collecting data

Several foundational documents of bioethics mention the special obligation researchers have to vulnerable research participants. However, the treatment of vulnerability offered by these documents often relies on enumeration of vulnerable groups rather than an analysis of the features that make such groups vulnerable. Recent attempts in the scholarly literature to lend philosophical weight to the concept of vulnerability are offered by Luna and Hurst. Luna suggests that vulnerability is irreducibly contextual and that Institutional Review Boards (Research Ethics Committees) can only identify vulnerable participants by carefully examining the details of the proposed research. Hurst, in contrast, defines the vulnerable as those especially at risk of incurring the wrongs to which all research ethics participants are exposed. We offer a more substantive conception of vulnerability than Luna but one that gives rise to a different rubric of responsibilities from Hurst’s. While we understand vulnerability to be an ontological condition of human existence, in the context of research ethics, we take the vulnerable to be research subjects who are especially prone to harm or exploitation. Our analysis rests on developing a typology of sources of vulnerability and showing how distinct sources generate distinct obligations on the part of the researcher. Our account emphasizes that the researcher’s first obligation is not to make the research participant even more vulnerable than they already are. To illustrate our framework, we consider two cases: that of a vulnerable population involved in international research and that of a domestic population of people with diminished capacity.

Lange M.M., Rogers W. and Dodds S. (2013) Vulnerability in research ethics: a way forward, Bioethics. 2013 Jul;27(6):333-40

Community engagement, incorporating elements of the broader concepts of public and stakeholder engagement, is increasingly promoted globally, including for health research conducted in developing countries. In sub-Saharan Africa, community engagement needs and challenges are arguably intensified for studies involving gay, bisexual and other men who have sex with men, where male same-sex sexual interactions are often highly stigmatised and even illegal. This paper contextualises, describes and interprets the discussions and outcomes of an international meeting held at the Kenya Medical Research Institute-Wellcome Trust in Kilifi, Kenya, in November 2013, to critically examine the experiences with community engagement for studies involving men who have sex with men.

We discuss the ethically charged nature of the language used for men who have sex with men, and of working with ‘representatives’ of these communities, as well as the complementarity and tensions between a broadly public health approach to community engagement, and a more rights based approach. We highlight the importance of researchers carefully considering which communities to engage with, and the goals, activities, and indicators of success and potential challenges for each. We suggest that, given the unintended harms that can emerge from community engagement (including through labelling, breaches in confidentiality, increased visibility and stigma, and threats to safety), representatives of same-sex populations should be consulted from the earliest possible stage, and that engagement activities should be continuously revised in response to unfolding realities. Engagement should also include less vocal and visible men who have sex with men, and members of other communities with influence on the research, and on research participants and their families and friends. Broader ethics support, advice and research into studies involving men who have sex with men is needed to ensure that ethical challenges – including but not limited to those related to community engagement – are identified and addressed.

Underlying challenges and dilemmas linked to stigma and discrimination of men who have sex with men in Africa raise special responsibilities for researchers. Community engagement is an important way of identifying responses to these challenges and responsibilities but itself presents important ethical challenges.

Molyneux S., Sariola S, Allman D., Dijkstra M., Gichuru E., Graham S., Kamuya D., Gakii G., Kayemba B., Kombo B., Maleche A., Mbwambo J. Marsh V., Micheni M., Mumba N., Parker M., Shio J., Yah C., van der Elst E. and Sanders E. (2016) Public/community engagement in health research with men who have sex with men in sub-Saharan Africa: challenges and opportunities, Health Research Policy and Systems, 2016, 14:40

There is a growing literature documenting the complex realities of consent processes in the field, and the negotiations and ethical dilemmas involved. Much has also been written about how gender and power shape household decision-making processes. However, these bodies of literature have rarely been brought together to inform research theory and practice in low-income settings. In this paper, qualitative research (observation, focus group discussions and interviews) were used alongside large clinical community-based studies conducted on the Kenyan Coast to explore how gender and power relations within households and communities and between fieldworkers and communities shape consent processes and interactions. This exploration is embedded in relevant literature and the implications for community-based health research policy and practice are considered. Across diverse forms of households, we observed significant consultation on whether or not to participate in research. Although men are typically described as household decision-makers, in practice, decision-making processes are often far more nuanced, with many women using their agency to control, sometimes subtly, the decisions made. Where decisions are made without adequately consulting women, many find strategies to exercise their choice, in ways that safeguard important relationships within households in the longer term. We also found that the gender of field staff who typically conduct research activities in the field, including consent processes, can influence household dynamics and decision-making processes with important implications for the science and ethics of research. It is essential that frontline field staff and their supervisors are aware of the complex and gendered realities of consent processes at household level, and their implications, and that they develop appropriate context-informed approaches that support ethical practice.

Kamuya D.M., Molyneux C. and Theobald S. (2017) Gendered negotiations for research participation in community-based studies: implications for health research policy and practice, BMJ Glob Health 2017;2:e000320

Benefit sharing in health research has been the focus of international debates for many years, particularly in developing countries. Whilst increasing attention is being given to frameworks that can guide researchers to determine levels of benefits to participants, there is little empirical research from developing countries on the practical application of these frameworks, including in situations of extreme poverty and vulnerability. In addition, the voices of those who often negotiate and face issues related to benefits in practice – frontline researchers and fieldworkers (FWs) – are rarely included in these debates. Against this background, this paper reports on experiences of negotiating research participation and benefits as described by fieldworkers, research participants and researchers in two community based studies.

The findings reported here are from a broader social science study that explored the nature of interactions between fieldworkers and participants in two community based studies on the Kenyan Coast. Between January and July 2010, data were collected using participant observation, and through group discussions and in-depth interviews with 42 fieldworkers, 4 researchers, and 40 study participants.

Participants highly appreciated the benefits provided by studies, particularly health care benefits. Fieldworkers were seen by participants and other community members as the gatekeepers and conduits of benefits, even though those were not their formal roles. Fieldworkers found it challenging to ignore participant and community requests for more benefits, especially in situations of extreme poverty. However, responding to requests by providing different sorts and levels of benefits over time, as inadvertently happened in one study, raised expectations of further benefits and led to continuous negotiations between fieldworkers and participants.

Fieldworkers play an important intermediary role in research; a role imbued with multiple challenges and ethical dilemmas for which they require appropriate support. Furthermore specific empirical research is needed to inform the development of guidance for researchers on benefit sharing, and on responding to emergency humanitarian needs for this and other similar settings.

Kamuya D.M., Marsh V., Njuguna P., Munywoki P., Parker M. and Molyneux S. (2014) “When they see us, it’s like they have seen the benefits!” experiences of study benefits negotiations in community-based studies on the Kenyan Coast, BMC Medical Ethics, 2014, 15:90

Data fabrication, incorrect collection strategies and poor data management, are considered detrimental to high-quality scientific research. While poor data management have been occasionally excused, fabrication constitutes a cardinal sin and scientific misconduct. Scholarly examinations of fabrication usually seek to expose and capture its prevalence and, less frequently, its consequences and causes. Most accounts centre on high-income countries, individual senior researchers and scientists who are portrayed as irrational, immoral or deceptive. We argue that such accounts contain limitations in overlooking data collected in ‘the field’, in low income countries, by junior researchers and non-scientists. Furthermore, the processes and motivations for fabrication and subversive practices are under-examined. Drawing on two separate ethnographies, conducted in 2004 and 2009 in medical research projects in sub-Saharan Africa, this paper investigates fabrication among fieldworkers using data from observations and informal conversations, 68 interviews and seven Focus Group Discussions involving diverse stakeholders. Based on an interpretative approach, we examined fieldworkers’ accounts that fabrications were motivated by irreconcilable moral

concerns, faltering morale resulting from poor management, and inadequate institutional support. To fieldworkers, data fabrication constituted a ‘tool’ for managing their quotidian challenges. Fabrications ranged from active to passive acts, to subvert, resist and readdress tensions deriving from employment inequalities and challenging socio-economic conditions.

We show that geographical and hierarchical distance between high-ranking research actors and fieldworkers in contemporary configurations of international medical research can compartmentalise, and ultimately undermine, the relationships necessary to produce high-quality data. In focusing on fieldworkers, we argue for the inclusion of wide-ranging perspectives in examinations of data fabrication.

Kingori P. and Gerrets R. (2016) Morals, morale and motivations in data fabrication: Medical research fieldworkers views and practices in two Sub-Saharan African contexts, Soc Sci Med. 2016 Oct;166:150-159.