The role of benefits in participants’ decisions to join and stay in studies
All respondents (participants, fieldworkers and researchers) talked of the various forms of study benefits, and the contribution of those benefits to making the research happen. Below we draw on the literature to categorise the benefits provided into direct benefits, indirect/collateral benefits and aspirational benefits.
Direct and indirect benefits to participants
In both case studies, the most common and immediate reason given for joining the study was the immediate access to high quality health care for participants, alongside describing varied depths of understanding of the research itself. This is unsurprising since both case studies provided health care as part of the direct and indirect study benefits to participants (see above) and KEMRI-WT is often thought of as a hospital.
“…they [researchers] told us that if the child becomes sick ‘we will come, take the child for treatment and if we are defeated we will send the child and the mother to another hospital and the child will be treated and the mother will be provided with food, then they will be transported by a vehicle up to here [hospital]. Oh! These are good things, the luggage is heavy on our head and someone wants to help. We were pleased and … I wished I had ten children I would release (consent) them all to go into the hands of KEMRI”, (P3/male/Malaria/FGD13).
Previous positive experiences of having been attended by KEMRI staff either at the health facilities or at the county hospital were narrated in many of the interviews in both case studies. Valued positive experiences included treatment of critically ill children or other family members by KEMRI doctors, the concern and attention those staff gave patients, and relatives being informed about what was going on even if the patient eventually died. These experiences were described as having positively contributed to consent and high retention rates in both case studies; retention rates of 78% (47/760) households in the RSV-study and 83% (748/900) participants in the Malaria-studyf.
I decided fast [to join the study] because of the situation of my child. He was ever sick and I was ever going to the hospital but did not seem to recover, so when the CHWs [community health worker] told me to come and try (join) KEMRI …I said its better I join and my child is now well and fine. So I am very grateful… (P2/female/Malaria/FGD14)
That study benefits facilitated retention of participants was especially clear in the RSV-study, a basic science non-therapeutic study involving a particularly unpopular and unfamiliar study procedure, taking a sample of nasopharyngeal mucus using a flocked swab. The study team realised early on in the study that meeting recruitment targets and retaining nearly 50 entire households in the study would be difficult given the discomfort of the procedure. Additional pressure for the study team to meet recruitment numbers was due to the relatively short duration of the RSV epidemic (five months), and the possibility that failure to carry out the study as designed would lead to extending it to the next epidemic season and to increased research costs. A comprehensive community engagement strategy to inform different constituencies about the study - community leaders, the entire population of the study area, household heads, and eligible household members - had been rolled out. This was perceived to have been well received in the community and facilitated participation. In addition, provision of relatively simple items such as sweets to children was highly praised by both FWs and participants for encouraging participation and helping calm children and their mothers during nasal swabbing.
Yes, like I don’t know whether to call them benefits or what but I think those sweets, they used to be seen like something very small but it contributed in a big way to the success of this project or this study. Because the children became calmer… later, I saw that the adults sometimes liked the sweets maybe even more than the children … (FW4/male/RSV/FGD06)
Indirect benefits to the wider community
KEMRI-WT was often highly praised for providing high quality health care compared with the perceived lacklustre services of the public health facilities in which trial activities were based.
“…probably a child is sick at the dispensary, and there is the KEMRI section and that of the government. So on the KEMRI section the child gets quick treatment and the treatment the child gets is that of high quality…and in our hospitals they do not investigate, you just tell the doctor how you are feeling and they just assume its malaria, and give you drugs…” (P5/male/Malaria/FGD13)
Due to the relative wealth of the research centre compared to the surrounding community, long lists of community needs were presented at community engagement meetings over the course of the study. While researchers’ and FWs’ general response was to re-explain study requirements and agreed benefits, they were sometimes able to assist in an emergency. For example in the RSV-study when a cholera epidemic broke out, researchers provided emergency aid to the community, including treating all communal water wells, setting up a temporary emergency ward at the local health facility, and providing clinical services, diagnosis kits, drugs, and ambulatory services for referrals to the county hospital. In explaining this assistance, one researcher noted:
“…you can’t see cholera affecting the place and you just sit back and yet you can do something about it. And you can’t also say now that only 3 of our participants have cholera we are only treating those ones. Then again, if the dispensary lacks paracetamol which is a very basic drug, and we have [it]; we can afford to get paracetamol for them, then it’s our social responsibility to them (community)” (R2/female/RSV/IDI05).
Although the Malaria-study was in a drier area of the county, with perennial food shortages, negotiations for different sorts of benefits were less often described in interviews, compared to the RSV-study. This could be because KEMRI-WT was new in the area of the Malaria-study, and hence expectations of what KEMRI-WT could offer were not as high. It also could be that informing and providing complete health care for participating children, and food and transport for participants and guardians for all clinic visits right from the outset of the study addressed (see Table 3) the immediate health care needs for this population. In addition, the intensity of interactions between FWs and households in the RSV-study (with between 2–4 hours per visit to each participating household twice a week in the RSV-study) could have generated different sorts of relationships and expectations (more kinship-like) which increased pressure for FWs to respond.
Aspirational benefits of the research
Though less often discussed, some participants described altruistic reasons for joining the studies, which seemed to refer to the eventual societal benefit should the research be ‘successful’. They saw their participation in research as contributing to better health for future generations.
“…malaria has disturbed so many people in this world, children have been dying at a young age, mothers miscarry or children die during delivery because of malaria. So after realizing that there was research being done for preventing malaria so that it does not affect us again, I was really pleased by that issue; and I said it was better to join so that we make a contribution for the vaccine to be found [discovered]…” (P1/male/Malaria/FGD13)
In the Malaria-study, these altruistic reasons for participation seemed to be in addition to expectations of immediate therapeutic benefit from the experimental vaccine. Thus, positive results of the research were anticipated to benefit both current and future generations, as explained by one FW:
“All children will benefit [if the study succeeds] but those who benefit first are the ones who are in the study, because it’s only when the research is proved to work, that’s when the others who are not in the study will benefit” (P6/Female/Malaria/FGD14).
Such high expectations, however, might also have been parents’ way of reassuring themselves that they made the right choice in enrolling their children in an experimental vaccine trial whose outcome was uncertain.
Expanding expectations and demand for more assistance from participants
There was some shifting of benefits given out over time in the RSV-study, in an effort to retain participants and in response to participants (and community) needs and concerns. Thus chairs were provided to facilitate the taking of nasal swabs, education materials were given to school going children, and insecticide treated bed-nets (ITNs) were distributed to pregnant mothers and all children aged less than five years in the participating households. Over time, it became apparent that the study teams’ provision of such benefits and compensations was feeding into expectations for more.
So with every other household we received very many expectations yah, even for some families, some would refuse to be swabbed and tell you, ‘I have a cold, I can’t make it to the dispensary, why don’t you bring me the drugs here at home so that you can swab me’. So that was really difficult for us (R2/female/RSV/IDI05).
Requests for additional benefits included requests for items that the Ministry of Health (MOH) should provide. For example, some parents threatened to withdraw from the study if pre-natal servicesg and male-child circumcision services were not provided in the RSV- and the Malaria-study respectively. It was difficult for fieldworkers and researchers in both case studies to know how to respond to participants’ requests and needs: re-emphasising study information, as described below, sometimes seemed inadequate.
There is another one [parent of a child participant] who withdrew the other day, she said that the moment a participant is recruited or taken by KEMRI we concentrate so much on the (participating) kid than the mother or other family members; so there are some other moments she wishes to be handled or taken care of herself, or given the attention the kid is given, but she never gets (FW2/male/Malaria/FGD08).
During our field visits at the end of the RSV-study, we noticed that many household members requested tokens of appreciation for having persevered with the study and possibly also in response to hints from FWs that additional tokens might be provided.
Negotiating study benefits: a challenge for FWs and frontline research staff
As already suggested above, despite the value placed on them by participants, the provision of study benefits appeared to present significant challenges for researchers and FWs. The study teams, including FWs, knew that they could not extend benefits without proper guidance from the research centre (through the community engagement advice team, or CAST), and from the national KEMRI ERC committee. Some participants’ requests for benefits such as food, school fees and uniforms, and shelter, went beyond what the study team, and the research programme, felt they could respond to. Feeling frustrated, fieldworkers sometimes responded in personal ways, including through using their own money to buy food for families. While this provided temporary relief for the participants, the unanswered issue for researchers and the research centre was whether there was a need for a more carefully considered and agreed approach to handle such emergencies for individual households.
With regards to extending benefits and emergency support to individuals, a contested area was whether those already participating in research could be unduly influenced through provision of more and different sorts of benefits. Some researchers felt strongly that enrolled participants could not be unduly influenced as they had already weighed up the risks and benefits for participation. They felt that undue inducement arguments were sometimes used to reduce or deny participants benefits:
“…if I were to decide for this study about the benefits to be given, having been at these households, I would have a very long list of cheap things we can give the households and they would appreciate. Although I know it would be like we are inducing them to participate in the study but they are already participating in the study, so I don’t think introducing extra benefits at this time would have much effect on their participation…” (R2/female/RSV/IDI02)
Some argued that given the relative wealth of the institution, the long-term presence of the research centre in this community, and the high poverty levels and unmet health needs among the community, studies should give more benefits to participants and communities.
“…but that issue (of additional benefits for participants) kept coming up, I think, in practically all of our meetings…and in the long run, each one of us who actually got into contact with those participants or within those households, I think we all felt that we did not give enough… This is a big study, they (participants) have made it succeed, it’s them who have made it a success, so we should also be able to give them something tangible” (R2/female/RSV/IDI05).
Other researchers felt that one way to avoid undue inducement was to give additional benefits to whole communities rather than individuals. A dilemma, where emphasis was placed on community-level benefits, is that participants might be unwilling to participate unless they also receive separate forms of benefits.
“…I believe the idea of balancing (risks and benefits) is trying to ensure that people don’t participate in your study just because of the benefits, but again you have to understand people cannot participate in the study if there are no benefits” (R1/male/RSV/IDI01).
One researcher in the RSV-study, who was also a member of the community engagement advisory team (CAST) for the study, strongly supported provision of more benefits to participants and the broader community. This researcher was the link between the FWs and the study PIs. She accompanied FWs to the field almost every day, and supported the clinical team during home visits. She was particularly frustrated by institutional limitations of what to offer the community, especially when the advice appeared misaligned with livelihood struggles for most households at a time of drought and famine. The field team estimated that nearly half of the community required some form of food aid over the study period, and requested to provide food items to participating households as part of study compensation for the considerable time taken in follow-up visits. After reviewing the situation, the CAST group advised against the request on the grounds that it was not within the overall mandate and focus of the research centre, and because of concerns of intra-community inequity if non-participating households were not also given food rations. Other arguments were that giving food rations in that context might unduly influence participants to join or stay in the study without a good understanding of the research, that future smaller studies could not provide similar levels of benefits, and that other current research in neighbouring areas may face similar demands that cannot be met at that time due to budgetary limitations. The researcher sounded particularly frustrated with these arguments:
“…we have tried to forward these (requests for additional benefits) to the CAST team and tried to justify every small thing we give, but every other time we do so in our CAST meeting, we are told again we can’t (give more benefits). You know, you go there wishing you could be allowed to take a packet of flour to the household, but again our hands are tied” (R2/female/RSV/IDI05).
Fieldworkers and frontline researchers as gatekeepers to benefits for community members
Based on study protocols and job descriptions, FWs were not expected to negotiate research benefits with participants. However, FWs were the immediate link between the participants and the researchers through which information and requests were communicated. In this intermediary role, FWs seemed to mediate the type and nature of information that was passed on, choosing how information was framed and what was emphasised. As FWs said, they were the ones who often delivered study benefits and tokens of appreciation to participants; they attended to participants at the health facility, helping them fill the various forms, manoeuvre through bureaucracies and ensure access to quick services. It was therefore inevitable that participants would perceive FWs as conduits for study benefits; the people they needed to talk to and negotiate with first. This was described in an FGD with FWs and repeated in other interviews:
FW5: You are the person who goes there handing over those things (benefits) to them. (FW3 interrupts)
FW3: And you give the information yourself and whenever they come here, when they want to get the benefit, it’s you they meet and it’s like whenever they meet you everything goes smoothly.
FW4: When they see us, it’s like they have met the benefits!
For some FWs, working for the research centre was a means by which they could help improve the livelihood of the community. During DK’s field observation, she reported that most FWs strongly felt that assisting participants and the community gain benefits, especially health care for the really poor households, was one way of helping those households; they seemed to view their role as helping these families alleviate some of their health care burdens. Convincing the researchers to provide additional benefits and to respond to other needs of these participants and the community was one way in which the Research Centre, and hence also the fieldworkers, could be seen to be valuable to the community. Given the daily livelihood struggles that fieldworkers encountered among some participants, the main issue for fieldworkers was not about undue inducement (which seemed abstract) but about responding to these needs.
While FWs were delighted when their requests to increase benefits for participants were accepted, they were also aware of intra-household and intra-community jealousies that could stem from unequal distribution of such benefits. Sometimes these tensions seemed to work in the FWs’ favour particularly where some ‘difficult’ participants later regretted refusing the study. This strengthened, at least temporarily, participants and FW status vis-a-vis non-participants. FWs were also concerned that complex impact of studies on social relations within households and communities might continue and shift after the study ends:
We don’t know what will happen (when the study ends), but what I think is that their relationship [participants and non-participants] at first may not be good, because if somebody had gotten used to being attended to quickly when they get here [dispensary], so their colleagues used to be jealous; now this time when they come and they all queue, there may be some exchange of words … (FW4/Male/RSV/FGD06)