Given the focus in this paper on giving an in-depth account of the nature of benefits and burdens experienced by HIS volunteers and other study stakeholders, we present the findings under broad themes related to these two main topics, which are summarised in Table 4.
3.1 Perceived ‘benefits’
A range of features or experiences of participation in the malaria HIS were valued, including social, economic, psychological and physical benefits. The cash payment provided as compensation for time and the residential conditions were most commonly discussed as benefits in ways that suggested their overall importance to volunteers.
3.1.1 Compensation for study participation
Across all three data collection periods, nearly all study participants talked about compensation as the main reason they decided to join this study, and those who described other more important reasons for joining had also been highly motivated to join by the lump-sum provided at the end of residency. Reflecting its value, many had planned how they would use this lump-sum beforehand. As described earlier, levels of compensation were tied to the number of days spent in residency during the mHIS, with early exits prompted by episodes of clinical malaria requiring treatment. Volunteers who did not develop malaria in response to the ‘challenge’ event or developed this later in the course of residency, generally received higher levels of compensation than those who exited the study earlier.
While a few seemed to feel that the cash payment was not particularly high, and some felt it should have been higher, the particular value attached to the cash payment was the certainty of its disbursement, given that many volunteers relied on uncertain or irregular livelihoods or were students (Table 2). Some volunteers described study participation as a form of employment or economic activity:
“…I have come to realize that many of them [volunteers] join…having in mind that in one way or the other, it’s an economic activity, because there is the reimbursement which you get after the research”. (Kilifi volunteer, male, IDI5, T3)
Across the data collection periods, several aspects of participants’ accounts reflected this high appreciation of the compensation provided, from their own and their families’ perspectives, including that: i) almost all participants described a sustained willingness (up to T3) to consider joining a similar challenge study in the future; ii) some had either drawn on the compensation payments to convince reluctant family members to support their decision to join, or had themselves been similarly convinced to join by family members:
“For me it was not a problem because my husband knows that I am a person who is always looking [for money]. He knows that wherever I go, whatever small thing I get, it will help the children in school. He told me ‘Aah that is a good chance and if you lose it you won’t get another one. So if you feel you are healthy you can go’.” (Kilifi volunteer, female, FGD6, T1)
3.1.2 Comprehensive health check
As part of the recruitment process for the HIS, all potential volunteers had agreed to a range of physical and laboratory tests in keeping with the overall inclusion and exclusion criteria of the study, summarised in Box A.
During all data collection periods, participants valued the health check during screening, including some who saw this as more important than the cash compensation. While the nature of the tests seemed not always to be fully understood, positive attitudes to testing were based on perceptions of thoroughness, high quality and accessibility, in contrast to tests outside the study.
“…I also liked it because you know these tests it’s hard for someone to go to a hospital to get tested…so to some point I count myself lucky because I know it will be costly to me if I decide to do it on my own. But at least if somebody somewhere did it for me and at least I was confirmed ok, I am happy about it” (Ahero volunteer, female, IDI17, T3)
As for the compensation provided, some volunteers drew on the health check to convince family members of the value of joining the study. Study fieldworkers felt that screening was generally seen as a positive experience, also pointing out that people screened out because of health conditions were often still positive, based on witnessing good progress amongst others subsequently referred for treatment. At the same time, the health check generated issues for volunteers, described in the later section on ‘burdens’.
3.1.3 Good residential living conditions
The HIS volunteers mainly described residential conditions as a valued aspect of participation, across all time periods, and some were particularly appreciative. The residential experience was described as a form of high quality paid-for vacation, with no work to do and time to rest. Specific aspects valued were the cleanliness of the environment, access to amenities like toiletries, “good” meals being served regularly and on time and access to games for entertainment. In this way, while the main concern around staying in the study for as long as possible was related to maximising the compensation for time that would generate, the residential facilities themselves also seemed to provide an incentive for some to ‘stay in the study’.
“…we were feeding well, sleeping well, the environment itself was ok. The food, hei! ...we used to eat so well and any kinds of food. You queue and serve whatever you feel like eating, the food was in plenty. Then the environment at XXXXX (name of place of residency), there were so many trees… there were some benches where you could go relax and chat with your friend, it was so nice.” (Ahero volunteer, female, IDI13, T3)
KEMRI Community Representatives and HIS field workers had a similar impression of how these facilities were valued, including very positive reports given by volunteers on returning home, around the accommodation, food and games for entertainment. KEMRI fieldworkers remembered positive stories from volunteers, and their expressed willingness to join another similar study in future, including a willingness to stay longer in the residence, if needed.
3.1.4 New learning opportunities
Several volunteers valued experiences of new learning during their in-patient stay, including learning about KEMRI and clinical research more broadly. A particularly appreciated activity during residency was a tour of the KEMRI laboratories, which also seemed to address concerns related to community-based rumours about the reasons for blood collection at the research organisation (30). Volunteers were shown the large-scale freezers where samples are stored and laboratory benches where tests are run, giving insights into real life research and researchers, in contrast to media representations. Volunteers valued learning about malaria control approaches in the home as well as the malaria vaccine to which the HIS aimed to make a contribution. Some Kilifi-based volunteers appreciated learning about a science attachment programme at KWTRP as relevant to their own families[1]:
“… for example when a student …has excelled in…sciences and chemistry… they get an opportunity with KEMRI people…I thought that it’s my responsibility…as a parent…to encourage my child to work hard in school so that when they get the qualifications needed to do research, then it will be luck to me” (Kilifi volunteer, male, IDI5, T3)
3.1.5 Developing new friendships
A feature of residency that strongly coloured volunteers’ experiences was the opportunity provided to meet new people, including from different parts of the country. This was largely seen as an enjoyable aspect of participation, and in some cases these relationships developed into good friendships and even romantic relationships. At least one such relationships seemed to involve a serious commitment that the couple hoped could lead to marriage; the young man in this case intended to talk to his father on return home to take this plan forwards.
“But my father knew I have come for a study, but not to get a girl to go back with! Maybe if I go back, I can tell him “Well, things happened there…what do you say?”… I am now of age and can be able to start my life” (Ahero volunteer, male, FGD5, T1)
Volunteers drew strength and encouragement from friendships made during residency, especially during difficult periods. Activities enjoyed included ball games and faith-based groups, which kept spirits high and countered boredom. While we later describe challenges around interpersonal relations during residency, 12-18 months later, many former volunteers were still in touch with friends made at that time from other parts of the country.
3.1.6 Personal satisfaction in contributing to a new malaria vaccine
Volunteers described pride in contributing towards developing a malaria vaccine, an important public health need in their communities, as one of the most fulfilling aspects of participation and acting as an encouragement to stay in the study. At least one volunteer recognised complexities in the move from research to policy:
“…if probably this vaccine is developed and it’s out, I would only maybe suggest or recommend… let it be at an affordable rate.” (Ahero volunteer, female, IDI14, T3)
3.2 Challenges (burdens) experienced in relation to malaria HIS participation
Challenges around involvement in the mHIS were described by a range of stakeholders, primarily for HIS volunteers themselves, but also for their families and wider communities. Additionally, study staff experienced important challenges through their work, and, taken together, we note the emergence of risks for the research institution itself.
3.2.1 Challenges for study participants and their families
Across this section, challenges experienced by volunteers are discussed in approximate chronological order across study-related activities, noting their nature as physical, economic, social and psychological challenges and assessing their perceived importance where possible. Some challenges reflected the ‘flip side’ of a benefit; that is, quite severe concerns and anxieties were often related to the risk of losing anticipated benefits, and some benefits also had perverse implications, as described across the following sections.
i) Anxieties around health screening
While mHIS volunteers had met the eligibility criteria during health screening, this group shared fears and worries they had experienced around screening processes, including the implications of being found to have a previously unknown health condition.
“…so I was worried, and I thought “will I really succeed?” because they were testing blood, all the tests, and you know nowadays there are a lot of diseases, so I was worried ” (Ahero volunteer, female, IDI6, T3)
The period of worrying about the findings of health screening as prolonged by the staggered process (see Fig 2), with a second screening immediately before the start of the malaria HIS. The main concern was a new diagnosis of HIV infection, including the direct implications for health and fears of stigmatisation by others in future. Although the research team made clear that people might be ‘screened out’ for many different reasons – to counter risks of community stigmatisation around HIV – this risk still appeared real to many volunteers. Some choose not to disclose their involvement in the study outside their immediate household until their enrolment had been confirmed. In relation to the health check, an additional concern was a lack of gender sensitivity, commented on by a woman who was uncomfortable being examined by a male clinician.
ii) Preparing to take up residency at the in-patient study facility
Stress in meeting family needs before leaving: As study participants prepared to take up residency at the in-patient facility, many described the stress and practical difficulties involved in ensuring their families’ daily needs could be met over the residency period, especially those who were the main ‘breadwinners’ for their families. These needs included money for food, school fees and medical costs, and ways of maintaining normal income-generating activities, such as small-scale businesses. Many participants, particularly from Ahero, felt more time should have been given for this preparation. Others were challenged to secure the needs of their families for such a long period of residency ahead of time, irrespective of the time given to prepare. Worrying about families at home was a major burden for volunteers throughout residency.
Insecurity, long travels and reception upon arrival: Study participants from Ahero met challenges in travelling to Kilifi for re-screening and residency, given the distance involved and post-presidential election turmoil in this opposition stronghold, when some roads were unofficially blocked by protestors and an overall feeling of insecurity prevailed.
“The journey was difficult. That day there were gunshots here at Ahero ...So even leaving the house, the journey was difficult, but we just went until we reached. Even the bus that we had boarded, some of the windows were broken. So, we were worried because of the chaos.” (Ahero volunteer, female, IDI08, T3)
Before study activities were temporarily halted, security concerns were heightened by the juxta positioning of study recruitment and the presidential elections since both required access to potential volunteers’ identity cards and travel allowances were given to Ahero volunteers, leading to rumours that the study was recruiting young people for a politically-related activity in Kilifi. Study staff in Ahero were also concerned about being targeted by angry protesters:
“… there was a certain age [group] that we wanted…mostly youths so they [community members] could say they are taking our youths to Kilifi for maybe elections and … they thought that we are giving this one a thousand [travel costs] because we are convincing them to go Kilifi …to get numbers… we became worried … they could come and attack us” (Field officer Ahero, female, IDI1, T3)
Given issues with travel, some Ahero participants were annoyed not to be given more time to recover between arrival in Kilifi and starting the re-screening process, an issue still talked about 18 months after the study. During re-screening on arrival in Kilifi, a few individuals were found to have been exposed to malaria, so were excluded from the study and had to return home. While this late form of ineligibility was unplanned, being generated by the delay caused by political events, the anxiety, inconvenience and disappointment caused to a few was considerable.
iii) Mandatory use of an effective contraceptive
Several women participants, especially from Ahero, described shock and concern about the enforcement of a study requirement to use an effective contraceptive to prevent pregnancy during the study; an issue that remained live 18 months later. According to the study protocol, an effective contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly, in accordance with the product label (5). While this requirement had been part of study information-giving processes, many had apparently not taken this seriously. Lack of previous use and the experience of unwanted side effects made this a difficult action. Volunteers’ reactions included regret at having joined the study, feeling forced to use a contraceptive against their will, and later non-adherence to this requirement:
“…it slipped me on the first day of explanation…I was even trying to tell that lady “Why don’t we just write ‘condom’? Just write anything.” And then she said “No, they don’t agree with the condom, you have to have the real, you see, family planning.”…when you have no choice, is that a motivation really?” (Ahero volunteers, female, FGD4, T1)
“…since birth I hadn’t used that thing (contraceptive), so I was being forced to use it and I also didn’t know why we were being forced to use it …so I said that I would get sick here and I won’t survive, if I take this thing twice I will hurt myself, so I took it once and stopped using it” (Ahero volunteer, female, IDI18 T3).
iv) The challenge event, subsequent study procedures and long-term health issues
The challenge event: Physical and psychological burdens
As described in earlier publications, the challenge event was accompanied by important physical and psychological burdens, including physical discomfort involved in the intravenous injection of malaria sporozoites, the subsequent frequent venous and capillary blood sampling over time and, for some, the experience of developing a malaria infection (10, 17). These burdens were increased by (generally short-lived) doubts about the truthfulness, motivation and professional standards of researchers, reflecting trust issues around this unfamiliar form of research (10). A recurring example was sometimes quite marked worry about the nature of the challenge injection, including that it might contain a more ‘deadly’ pathogen like HIV or be contaminated, particularly as the injection was drawn up in a side room. Some volunteers expressed worries about contamination of the syringe. Other concerns related to long term consequences, including that the parasites would not be completely cleared by antimalarial treatment at the end of the study, reinforced by a study requirement for a post-study follow-up visit at day 35.
“… suppose we get treated, but then there is some kind of resistance?... now I’m just wondering, suppose this resistance is there after day 35 who will take care of- of me? That is my main concern.” (Ahero volunteer, male, FGD5, T1)
Other volunteers continued to worry about experiences of ill health long after participation, described a year later:
“At times I feel like, especially my arms… they don’t want to be subjected to any strenuous work…they are fatigued…at times they are numb…[and] I can’t do anything… I’m just thinking could it be that those things that we were injected is what is affecting us this way? At times I just keep thinking, I’m just scared…” (Ahero volunteer, female, IDI5, T3)
v) Family relations: Missing and being unable to support families during residency
Being away from their families weighed heavily on many volunteers, especially women who had left young children at home. Worries included that children were suffering from neglect, lack of parental support and poor health, linked to difficulties experienced in finding a fully trusted caregiver for this period. One volunteer left the residency (and study) early for this reason, within the last three days of antimalarial treatment. In the study protocol, compensation payments for time in residency were to be given to volunteers on leaving the facility, as it was not possible to predict the duration of stay and a lumpsum payment was thought to be preferred by volunteers. But this lack of ‘cash in hand’ over the period compounded emotional experiences of missing family and familiar surroundings. Even where a trusted caregiver was in place, volunteers worried about providing basic necessities such as food and school fees at home, made worse by difficulties in maintaining mobile phone communication given the costs involved. Volunteers also felt the lack of cash in relation to their own ongoing needs that were not covered by the study, such visiting a barber. A few participants asked contacts at home to send money. Many HIS volunteers recommended that earlier disbursements of compensation payments should be made, rather than providing a lumpsum at the end.
“I am the overall breadwinner and my family depends on me. So while I am away, I’m not happy to be eating well while I don’t know whether they got something or not, yeah. … and I cannot say that… I left something enough for them” (Ahero volunteer, male, FGD5, T1)
Family relations had in some cases been challenged by volunteers’ decisions to join the study and withdraw from other responsibilities, which added to worries for some:
“What I was talking about earlier about that hotel, it belongs to my sister. So, she said you just go, but if you go, we’ll never be in good terms again…because… I am the one who runs that hotel … So, from that date [of leaving home] up to today, she has never called me again. Even when I call her, she doesn’t receive my calls.” (Ahero volunteer, male, FGD5, T1)
vi) Worry about and actual impacts of residency on livelihoods and commitments
During residency, some volunteers expressed anxiety about the security of their prior livelihoods. Amongst these were individuals who had not informed their employers about joining the study and self-employed people with small businesses, who worried whether they would have businesses to return to, for example, whether regular clients would have found alternative suppliers:
“One is my business. I have a business… I have chairs and tents. It is seriously affected because I’m not there. Secondly is … church issues…and I’m the chairperson. So… they seriously need me even now…it has really affected the organization. So that again I think it has affected me in a way because there was a duty that I was to perform.” (Ahero volunteer, male, FGD5, T1)
Others were concerned about the impact on farming activities at that time, in relation to the year’s eventual harvest. While some were worried about their businesses and other activities at home, others were already receiving ‘bad’ news from home about mismanaged businesses while in residence.
Overall, in the long term, volunteers’ reports on livelihoods suggest that many participants found ways of using the compensation payments to enhance their lives in modest ways, including paying off debts, as we will describe in more detail in a future publication. Others did not appear to have benefitted and some described being ‘worse off’ in ways that reflected their concerns during residency. For example, at least one participant later lost their job because of the long absence while participating in the study.
vii) Challenges during residency including interpersonal conflicts
While residency conditions were generally highly appreciated, a number of challenges were also associated with this aspect of participation. A common but short-term issue was the experience of boredom associated with restricted movement during this period, set up to promote compliance with scheduled study procedures and minimise the risks of volunteer’s developing new malaria infections. Many study participants described this confinement as very burdensome, especially young men, who made frequent requests for more freedom:
“And even staying for those 21 days in that place, it’s not easy, it is hard….if we could go out for a walk a bit and come back, that would be better. But there is no leaving completely. It becomes so difficult that even the legs can get swollen.” (Kilifi volunteer, male, FGD7, T1)
Underlining the extent to which some volunteers valued residency conditions, volunteers described worries about being forced to leave early (for volunteers who developed malaria soon after the deliberate infection) and more subtle concerns that the ‘comfortable’ residential living conditions would make settling back to demanding home routines difficult, highlighting the often physically arduous nature of ‘normal’ life:
“I don’t know whether I’ll be having the strength which I’ve been having because with me I used to cook. So I don’t know if I’ll get that strength again [softly with voice trailing, sounding upset]”. (Ahero volunteer, female, FGD4, T1).
The most important but relatively uncommon challenge related to residency was the emergence of interpersonal conflict amongst volunteers, as social relations within the facility were not always smooth. Several complaints were made by participants who were offended or inconvenienced by the apparent development of intimate relations between study participants. We described one such relationship in the section on benefits, in which the individuals involved made a serious commitment to each other. There were reportedly other instances that caused offence to participants, in which behaviours were judged immoral.
In the residency, sleeping arrangements involved two participants of the same sex sharing a room with two beds, which meant that any form of heterosexual intimacy would be difficult to keep private. One well-discussed incident involved rumours of an affair between two volunteers, an angry visit to the residency by the husband of the woman implicated and an altercation between this woman and another woman volunteer around accusations of rumour-mongering. Several weeks later (at T2), we learned that the couple involved had made a complaint to their village elder, and the second woman was fined for ‘assault’. An important point arising from this incident is that the second woman, who was interviewed at T2, felt very unfairly treated and was clear that she would not participate in a residential study again, unless all accommodation was single sex. In addition, this incident was well known within the residence at the time, and many participants noted an associated reputational risk for the KWTRP.
The form that social relations might take in residency seems to have been a concern in some of the communities where volunteers lived. During FGDs, community stakeholders described worries amongst men in their community that their wives might become involved in extramarital affairs during residency. Some clinical staff found it difficult – describing ‘choosing words carefully’ – to explain the study requirement for women volunteers to use contraception during study participation, as this might be interpreted as a tacit acknowledgement and even approval of sexual activities during residency. At the same time, HIS field workers also gave positive accounts of the ways that some families worked together around this potential ‘opportunity’, including one in which a husband and wife both joined the study, at different times, while the other supported the family and wider domestic responsibilities.
From later discussions with community stakeholders, the study had been perceived as contributing to the separation of families in some cases, based on rumours of inappropriate social relations in residency or family disagreements on how to spend compensation payments. mHIS fieldworkers similarly described instances of being confronted by community members whose relationships, including marriages, had deteriorated (including leading to separation) following the participation of one partner in mHIS; in these cases, they described bearing the brunt of the resulting acrimony in families and the wider community. In some cases, an intervention by the KWTRP Community Liaison Group (CLG) was needed to resolve the issue by engaging directly with the community member(s) involved. Reports of these adverse impacts of the compensation payment on families seem to relate to underlying issues of trust or gender inequity:
“Also, this issue of money in some households, it had caused conflicts, you’ll find people have had misunderstandings, the husband has...left the in-patient facility and he doesn’t go home, he goes and spend the whole night in a bar, and stays for almost 2 days before reaching home, by the time he gets home he has finished the money, so the conflict now starts between him and his wife. Also, if it’s the wife, she has gotten the money, you see, that is her money now and she says, “I’m starting my own business, my own personal project,” so the husband becomes furious.” (Kilifi fieldworker, male, PI3, T3)
3.2.2 Wider challenges: Community, field workers and research institution
In addition to challenges experienced by volunteers and their families, a range of issues arose with implications for field workers (who are also local residents), the wider community from which mHIS volunteers had been drawn and the research institution and its work.
Challenges for fieldworkers
In addition to risks of being blamed when research-related issues emerge for individuals and their families within the community, KWTRP field workers experienced blame for unfairness around study recruitment processes, including accusations of favouring their own families and friends. A fieldworker (and other stakeholders) described being barred from research-related activities in a household where he had earlier assessed a family member as ineligible for the mHIS. Given field workers’ roles as the interface between the research institution and the community, individual issues of trust and blame have clear implications for research institutions.
Community concerns
During early community engagement activities, concerns were raised about safety in deliberately infecting volunteers with a disease-causing parasite, related to perceptions of risk and issues around trust in the research process. Specific issues raised at meetings included the severity of illness that might result from deliberate infection, possible future effects on fertility, including infertility or damage to future babies, and concerns that ‘new diseases’ could emerge in the community when volunteers returned home. The relatively high rates of compensation generated by the long residential period fuelled community concerns that the study included high but hidden risks.
As described earlier, the inclusion of HIV testing during screening generated risks of community stigmatisation for volunteers who ‘failed’ to join the study following a health check. This phenomenon illustrates both high levels of awareness across the community about research processes and the stigmatising ways these may be interpreted locally.
“…they [community] used to say …you couldn’t join the study, which disease disqualified you? Having in mind HIV/AIDS [giggles]….that’s what disqualified you, and in our community there, HIV/AIDS is not a disease that people are happy about…so whoever will come back, even if its high blood pressure or any other diseases that caused them not to continue with the research, others say it’s HIV” (Kilifi community leader, male, IDI5, T3)
Institutional harm
KWTRP, as an institution, was implicated by many of the tensions described for families of HIS volunteers, KWTRP field workers and wider communities in Kilifi and Ahero. Negative experiences and rumours around the study carried a risk of undermining trust and generating rumours around the programme’s aims and ways of working. At a practical level, one important challenge concerns the implications of the unusually high levels of compensation given to volunteers in the HIS for recruitment into other community-based studies at KWTRP, and potentially for other research organisations in the area.
“First, it brought in challenges to the other studies because of reimbursement…so even now any project or study that is initiated there, someone will ask you, “Is that the one where you’ll be admitted at X [guest house used for mHIS]? …if it’s that one then I have no problem but if it’s a different one, ask someone else,”…[or] somebody will tell you, “If I participate in this study, will I also be able to participate in the HIS?” So, if you tell the person that I feel this won’t be possible, then they refuse…” (Kilifi field worker, female, PI3, T3)
As described earlier, issues of public trust have been long recognised as a risk for the introduction of HIS in Kenya in general, and Kilifi and Ahero in particular, given the novel and potentially counterintuitive idea that research should involve deliberately giving healthy volunteers with an infection. Earlier papers from KWTRP have described the political and public engagement activities undertaken over many years to assess whether and how these studies should proceed (24). Similarly, extensive community engagement activities had been undertaken in Kilifi and Ahero prior to the start of HIS in Kilifi in 2017. The issues of individual and community trust in the HIS and KWTRP more widely, has largely been anticipated and community and public engagement strategies developed earlier in the process of planning. One example was the publication of an article in a national newspaper, following completion of Phase 1, describing high payments given to volunteers (34). KWTRP was subsequently inundated with requests from the general public to join the study, prompting a crisis-management response within KWTRP and the KEMRI headquarters in Nairobi, to develop an appropriate response (35).
Table 4: A summary of reported benefits and burdens for volunteers and other stakeholders in the malaria HIS
Area
|
HIS volunteers: Benefits/aspects of participation valued
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HIS volunteers: Burdens/aspects of participation seen as problematic
|
Spread of individual benefits/burdens to community, research staff and institution
|
Preparation and travel to study site for residency
|
None described
|
Tiredness and anxiety associated with long distance travelled, perceptions of safety (political situation) and of inadequate time to prepare for travel to take up residence.
|
Loss of trust and reputational damage to institution, particularly in relation to political tensions
|
Access to a health check
|
Physical and psychological benefits
- Health check valued particularly if found to be ‘normal’
- Potential benefit from detection of underlying health problems and referral for care
|
The possibility of ‘failing’ a health check caused anxiety related to loss of opportunity to participate (and benefit from compensation) and risks of stigma, where latter widely seen as linked to HIV status
|
Rumours/stigma related to perceptions that people who are excluded from the malaria HIS on the health test are HIV positive
|
The malaria challenge and follow up ‘clinical’ processes
|
None described
|
Physical and psychological burdens:
- Pain and discomfort caused by intravenous injection of malaria sporozoites and later blood sampling
- Anxiety (sometimes severe) about risks involved in short and longer term, linked to issue of trust in research and researchers (generally but not always temporary)
|
Issues of trust around researchers’ intentions and short and long term effects of research procedures can spread to community as rumours (positive or negative); negative attitudes towards research staff (including field workers who are based in the community); potential institutional reputational damage; and impact on other studies
|
Compensation
|
Social & economic benefits
Compensation highly valued & in practice generally used in ways that promoted individual or family wellbeing in long term, often in modest ways.
|
Social & psychological burdens
- Anxiety (sometimes severe) about minimisation of compensation in the event of early study exit
- Family conflicts over decision to join study (to gain compensation)
- Family conflicts over the way compensation should be used, with gendered dimension
|
Conflicts in families are likely to generate issues within the wider community, potentially leading to community conflict, community-researcher trust issues and risks to institutional reputation and other studies.
|
Residential experience
|
Social & psychological benefits
- Facilities enjoyed as ‘paid for vacation’
- New friendships valued, sometimes long lasting
- Other opportunities for learning during residency valued e.g. tour of labs
|
Social and psychological burdens:
- Families missed and worried about, particularly in relation to their economic and health status while volunteer away, particularly if had role as main ‘breadwinner’
- Offence to other residents and family/community conflict caused through development of relationships seen as ‘inappropriate’
- Boredom and frustration experienced
|
Being forced to use contraceptives
|
None reported
|
Psychological burdens for women volunteers - disliked as ‘not normal’ practice, fears about safety and concerns about being forced to use.
|
Opportunity to contribute to new vaccine development
|
A valued opportunity given the nature of malaria as a well-recognised and serious illness in local communities
|
As above, anxiety (sometimes severe) about risks involved in short and longer term, linked to issue of trust in research and researchers (generally but not always temporary)
|