Understanding the benefits and burdens associated with a malaria human infection study in Kenya: experiences of study volunteers and other stakeholders

Abstract

Background Human infection studies (HIS) that involve deliberately infecting healthy volunteers with a pathogen raise important ethical issues, including the need to ensure that benefits and burdens are understood and appropriately accounted for. Building on earlier work, we embedded social science research within an ongoing malaria human infection study in coastal Kenya to understand the study benefits and burdens experienced by study stakeholders in this low-resource setting and assess the wider implications for future research planning and policy. Methods Data were collected using qualitative research methods, including in-depth interviews (44), focus group discussions (10) and non-participation observation. Study participants were purposively selected (key informant or maximal diversity sampling), including volunteers in the human infection study, study staff, community representatives and local administrative authorities. Data were collected during and up to 18 months following study residency, from sites in Coastal and Western Kenya. Voice recordings of interviews and discussions were transcribed, translated, and analysed using framework analysis, combining data- and theory-driven perspectives. Findings Physical, psychological, economic and social forms of benefits and burdens were experienced across study stages. Important benefits for volunteers included the study compensation, access to health checks, good residential living conditions, new learning opportunities, developing friendships and satisfaction at contributing towards a new malaria vaccine. Burdens primarily affected study volunteers, including experiences of discomfort and ill health; fear and anxiety around aspects of the trial process, particularly deliberate infection and the implications of prolonged residency; anxieties about early residency exit; and interpersonal conflict. These issues had important implications for volunteers’ families, study staff and the research institution’s reputation more widely. Conclusion Developing ethically and scientifically strong HIS relies on grounded accounts of volunteers, study staff and the wider community, understood in the socioeconomic, political and cultural context where studies are implemented. Recognition of the diverse, and sometimes perverse, nature of potential benefits and burdens in a given context, and who this might implicate, is critical to this process. Prior and ongoing stakeholder engagement is core to developing these insights.

Ethical considerations around volunteer payments in a malaria Human Infection Study in Kenya: An embedded empirical ethics study

“…During the malaria HIS in Kili , we conducted qualitative research before, during and after the volunteers' residency period (Chi, Owino, Jao, Olewe, et al, 2021;Jao et al, 2020;Njue et al, 2018). While observational data were collected during preliminary community engagement activities in Kili , the main data collection occurred during HIS residency (Period 1, T1), six weeks after leaving residency (Period 2, T2) and 12-18 months after residency (Period 3, T3).…”

“…Table A.1 describes participants' sociodemographic characteristics. (Chi, Owino, Jao, Olewe, et al, 2021). **Information on occupation for 5 volunteers is missing.…”

“…Some features of HIS may prompt higher levels of payment, including prolonged periods of residency and post-discharge study visits often involved as well as physical and other burdens associated with deliberate infection (e.g. restricted movements and regular blood draws for experimental and clinical/safety monitoring) (Chi, Owino, Jao, Olewe, et al, 2021;Kraft et al, 2019;Toto et al, 2021).…”

“…In our discussion, we draw on ndings from this and earlier publications to assess the nature of ethical concerns around study payments made to malaria HIS volunteers in Kili and implications for policy, with potential relevance to other similar settings. (Chi, Owino, Jao, Olewe, et al, 2021;Jao et al, 2020;Njue et al, 2018) 1.1 Ethical concerns around payments to HIS participants A fundamental ethical requirement in any research involving human participants is that there should be a favourable risk-bene t ratio, and that risks of burdens or harms are minimised and bene ts maximised (Council for International Organizations of Medical Sciences, 2016;Emanuel, Wendler, Killen, & Grady, 2004; National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979). In this respect, study bene ts -including some forms of payments -should account for costs, burdens and inconveniences linked to research participation and recognise existing structural inequities, including where made as forms of ancillary care (Hyder & Merritt, 2009;Richardson & Belsky, 2004).…”

“…Additional markers for study payments being 'too high' include: i) the encouragement of forms of deception by volunteers, including concealment of conditions that might preclude participation; ii) undermining of public trust (Lynch et al, 2021;Mngadi, Singh, Mansoor, & Wassenaar, 2017;Williams & Walter, 2015); iii) con icts emerging within communities and families; and iv) risks that the relationship between researchers and communities will become commercialised (Chi, Owino, Jao, Olewe, et al, 2021;Njue, Kombe, Mwalukore, Molyneux, & Marsh, 2014;Njue et al, 2015). Where payments are 'too low' on the other hand, concerns about exploitation centre on risks of disproportionately attracting economically vulnerable participants who may be willing to take on higher burdens or risks of harm to access even low payments; and the impact of being unable to recruit and retain su cient numbers of participants in studies of high social value (Largent & Lynch, 2017;Resnik, 2015).…”