Benefits and payments for research participants: Experiences and views from a research centre on the Kenyan coast

Abstract

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.

Stakeholder Views of Clinical Trials in Low- and Middle-Income Countries: A Systematic Review

“…You know, we're not denying that they should be reported, but there is a heavy load on the staff that are doing the studies." (Investigator) 48 15, 22,27,30,35,36,42,43,72 "My opinion is that we should use the standard of care here. Because it makes more sense if you are investigating whether something is useful, you should compare it with what is being done here rather than what is being done in the US, which will take a long time actually to be done here."…”

“…40 For example, in Kenya, the secondary benefits of a malaria vaccine trial included improved local health facilities, provision of medical equipment, and upskilling of medical personnel. 30 Community members perceived that the primary role of sponsors was to provide access to treatment and better quality medical care. 26,46 Reimbursement of out-of-pocket trial expenses and providing ancillary medical care were considered distinct to sharing benefits arising from the research.…”

“…22 Disempowerment Hampering Informed Consent: Stakeholders believed that disempowerment, poor education, and difficulty in translating scientific concepts were barriers to informed decisionmaking. 30,38,39 They recommended that consent forms be simplified and presented in a culturally and linguistically appropriate format with verification of parental comprehension. 17 Parents' implicit trust in physicians was a concern because the physician's recommendation of the trial could be misinterpreted as endorsement that the intervention is effective.…”

“…(Mothers) 23 "Even with fares; a study will give exact fare, another one will give extra-like one and a half the amount that people are charged, so sometimes it brings problems and you know sometimes they are in one study when they complete then maybe another child is in another study, so they are like, 'why is it that I was given double fare and now you are giving me only one way.'" (Clinical offi cer) 30 CHW, community health worker; FW, fi eldworker; MRC, Medical Research Council; NHRC, Navrongo Health Research Centre; UTH, University Teaching Hospital.…”

“…45 Tensions emerged when benefits differed between studies or when there was poor clarity or disagreements on eligibility for reimbursement. 30 Researchers proposed that direct collateral community benefits should be primarily medical rather than monetary and should be maximized through engagement of the country's ministry of health.…”