Themes and Selected Illustrative Quotations

SubthemesParticipants’ Quotations and/or Authors’ ExplanationsContributing References
Centrality of community engagement
 Assisting in mobilizing community“If you don't get them involved, you may in the end implement something that will be strange or something that they will not embrace at all. So it is better to get them involved to be able to source some information from them, to be able to get their view about the project to move to the next stage, because they always have important contributions to make to the project, to improve on what you have.” (NHRC research officer)1614–16, 18–21, 24, 26, 31, 32, 34, 36, 37, 43, 61, 73
“Taking advantage of the structures that are already there is what makes it successful. It doesn't have to be capital-intensive or anything.” (NHRC research officer)16
 Recognizing the pivotal role of representatives and leaders“If one hadn't gone through the right procedure… that is, seeing the district authorities and the paramount chiefs and the subsection chiefs and so forth, there might have been a lot more suspicion about what was going on, why we were doing this, who we were, do we have permission to do this. Essentially, this study would not have been accepted.” (External researcher)1614–16, 18–20, 27, 32
“… we went to the meeting and the assistant chief said he doesn’t want to hear any rumors from anybody. He said he was an assistant chief and he had a child who was in the KEMRI study. He told people if they won’t enroll in the study they should just keep quiet and anybody who will be heard spreading rumours will be arrested … After the assistant chief called the meeting, rumours stopped and for us who had already joined, we felt a bit better because rumours had stopped.” (Female parent, late consenter)20
‘‘It was not difficult at all; it was difficult to convince them to join the program, but through the long time I stayed with them I got a special relation, an independent rapport with them, so that even if they do not want to join, they couldn’t say no..” (Fieldworker)46
 Managing community and research expectations“So as we went round he [CHW] used to say ‘you my colleagues earn but for me I go round and get nothing. You have bicycles and we have nothing but when we go, we go together. It’s like I am helping you in your work yet no one looks after us.’ So that is one of the challenges. But honestly if I look at it fairly its true; . . . if he had gone to work [he would have] earned something for a living . . . so it becomes hard because he wants something from there and you see I can’t help them.” (Fieldworker)1914–22, 26, 27, 34–36, 40, 42, 61, 73
“ should not say I think this is for research, when another person is dying and you have the medicines, I think it’s not fair. Even if you have the equipment for research, it can be used for diagnostics if it’s so needed.” (Researcher)25
 Retaining participation of community intermediaries “Those who stopped complained of money saying they are suffering for nothing . . .’ ‘. . . during the durbar the community agreed to give us (CHWs) some incentive but up to now nothing. . .’: ‘The Bible says we should love our neighbour like . . . we love ourselves, so whether the children vomit on me or not or I’m being paid or not I will still continue. . .’. ‘I have become so popular and respected by the people in the community. .’ …. ‘I have become a friend to all children and mothers in the village. That is my benefit from this work.’” (CHW)1317, 20, 23, 24, 27, 34
“The trial community became a web of everyday relations well beyond the necessities of the trial. “We are there daytime, night time, afternoon time, any time you think of. After the first trial, we do not leave but stay… we have good friends. We still visit them, and they come to us.” “By the end you become part of the community; you do everything together. It was sad…to leave.” (Fieldworker)46
“My father is the sufferer...He used to be the alternate imam of the village. Now half of the people do not want to stand behind him in the prayers. They say his daughters work for NGOs, which is not right for a religious person.” (CHW)12
Cognizance of vulnerability and poverty
 Therapeutic opportunity“What attracted us [was that] we knew our children will receive treatment for a whole year in every disease they suffer. If you have a problem and visit the people concerned, a call is made to the … [PI] he brings a vehicle and [the sick person] is carried away [to hospital]. In fact it’s something we should be happy about because nobody can bring you a vehicle that easily.” (Parent)2214, 15, 21, 22, 25–27, 29–32, 34, 36, 37, 39, 41, 70, 73
“One good thing about it is that, there is no money involved. The parents would also benefit from the treatment given. Drugs are so expensive and are not available in government hospitals.” (Mother)18
“I don’t see anything wrong with testing the vaccine on us . . . it’s us who are dying of AIDS.” (Female adolescent)42
‘‘Doctors will not give us anything that is harmful.” Another subject said, ‘‘Doctors are in a way godly. Who would know better than them?”18
 Medical mistrust“I don't trust experimental vaccines and moreover these vaccines brought here to Africa by scientists cannot be trusted. Because these Europeans know we are poor people and so accept any terms and conditions, they are using Africans like guinea-pigs and Africa as a dumping place for so much waste. I know it's true that experiments have to be carried out by researchers on human beings, but I don't want my child to be involved.” (Parent)4714, 15, 21, 22, 25–27, 29–34, 36, 37, 41, 70, 73, 75
“The sickness already reduces the blood so what if more is taken?” “Won’t that finish of the child?”27
“If I give them my child and the child dies, then they give money, that will not bring my child back. We had to explain to her until she understood. And in fact, some refused at that stage when they heard of KEMRI giving ‘fidia’ [compensation], they said ‘we don’t want our children in it. You want to take our child and give that child to the devils’…” (Male, fieldworker)20
Contending with power differentials
 Concerning potential for exploitationWhen asked, why the MRC had come to Africa, many said “to help.” “Because we Africans are vulnerable to diseases” and “because they can’t find these diseases in the UK,” or “because we are powerless people and they need to help us to know the diseases.” “….because Britain has more power than Africa,” “it will be easier here than there” or even “in UK people are not willing to participate in trials.”4614, 22, 27, 35, 40, 42, 61, 63
“......they might be doing something else also without you knowing. If they are drawing blood samples, they’re telling you we are doing it for Malaria, but do anybody have control over it, that those blood samples are not going out and they are doing some genetic testing or they are doing something else on it? /.../ that is my fear and concern...” (Institutional review board)25
“… village elders tended to be coercive sometimes … you could go with them [to homes] and you know that … [research] participation is voluntary. But then for a village elder, because he wants the [research] agenda fulfilled then he says, ‘we want everybody who has an eligible child to join the study, or else we will make sure you are removed even from other government projects that are brought here.’ So in such a place you [fieldworker] have to come back again and try to explain that this [research] is not a must, it’s voluntary.” (Male, fieldworker)20
 Fearing discrimination and stigmatization“This might have unintended outcomes where people might feel that they are used, understand, . . . unfortunately we have a long history of apartheid where blacks were exploited.” (Male educator)4215, 22, 26, 28, 29, 31, 33, 37, 38, 61
“. . . the community will ask . . . ‘what is it that we do not want it to know if there is no danger involved in this research?’ You try to explain that there are things in a family, family situation that . . . only family members should know . . . that is where people would begin to be suspicious; and . . . confidentiality is good in that it saves the lives of the people who are participating in research and at the same time it is retarding in the community that is being encouraged to participate.” (Community advisory board member)40
“The way [the FWs] are free with us; they can visit in the morning or evening to check on the kid. [So non-participants] have now started spreading rumours that they are not only KEMRI but our boyfriends.” (Mother)22
 Disempowerment hampering informed consentIf the husband says [in a household visit] ‘oh yeah you go listen and join the study,’ then they are more likely to … [since] they already have permission if I may say so. But if you just speak to them [women] in a baraza [public meeting] and then they go explain to their husbands, the response is not so good.” (Trial staff)2015, 19, 22, 23, 25, 29–32, 34, 36–39, 41, 43, 61, 71–74
“Research project? They build houses?” A translator for a woman whose child was in the placebo-controlled malaria trial explained, “She does not know what research is. She thought they have already done the research, and they are trying to implement the results of the research with these children.” (Stakeholder)38
“Your main concern is to get your child treated. They could even ask you to stand by a fire all day, and you’d do it!” (Mother)29
Translating research to local context
 Respecting beliefs and cultural practices“……..somewhere in the north, when a child is born it is not brought out until after one month or so. So if we are looking at a vaccine targeting children of four weeks or less, that can possibly be a barrier to such children getting access to the vaccine.” (Religious leader)1416, 22, 29, 31, 33, 37, 63, 70, 74
“...I was uncomfortable discussing topics like reproductive organs because according to our Shona culture it’s taboo.” (Teacher)50
This was illustrated in the breastfeeding study regarding the issue of random assignment of mother–infant dyads to breast- or bottle-feeding groups. Although randomization alone posed no ethical problems (assuming proper support of safe bottle-feeding was provided), such a procedure clearly clashed with prevailing cultural expectations that parents should choose an infant’s feeding method.17
“Time is such a big constraint because sometimes you go to inform the chief and he says, ‘Come back in 2 or 3 days.’…. you need to add about a month just to complete the community process.” (NHRC social scientist)
“It is part of our culture; whatever you are doing, if there is no tobacco, it is not proper.” (Elder)16
 Understanding resource constraintsIn addition, the Haitian custom of sharing food with needy neighbors and housemates would have to be respected and taken into account; thus, the provision of grain was recommended as a measure to discourage consumption of the infant formula by other family members.1729, 31, 33, 37, 42, 63, 70
“My children are also malnourished. I would share the supplements with them so they can also have good health.” (Mother)34
The pediatric wards at UTH during the conduct of this study were often congested. “Floor beds,” which were temporary beds, could be found on the wards due to the large number of patients and insufficient resources.49
However, it was acknowledged that: “being completely altruistic and participating in research that is [going to] benefit society and future generations, is sometimes a little hard to expect from people who’re struggling to keep their family fed.” (Site staff)40
 Ethical pluralism“Many of the people in the regulatory divisions in the US or the West have really conducted trials in the West. And they’re very good, but in resource-limited settings, they actually sometimes don’t understand the context of the patients being very sick, you as a researcher being their primary clinician so you’re dealing not only with the study component, but you’re also providing care and treatment. And so there are a lot more visits that go beyond the study visits that you have to take care of as a researcher. So there are a lot of severe, adverse events that are not related to the drug, but actually are severe, adverse events that are part and parcel of a child growing up in Africa with a high infant mortality rate, a lot of malaria and pneumonia, diarrhea. Just the common illnesses that all need to be reported as serious adverse events. 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)4815, 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.” (Investigator)48
“I said to them, ‘this is very good, but why are you giving a placebo to this other group? Do you know that the transmission is obviously proven. It’s there. So, can you really give placebo to this group?’ They said, ‘Yeah. But you know, in as far as we are concerned, there is no other study regarding this so we really want to give placebo to prove it.’ I said, ‘No way! There’s no way! You know that these mothers are at a disadvantage.
The children are at a disadvantage. How do you say you are going to give placebo? You are deliberately infecting those children!’ Right? So we refused and that group was given nevirapine and this other group received the new drugs. So they did the study…‘It’s the science and the ethics. Tell me in Sweden, in the States, in Canada, in France, would this research pass the ethics committee? Would American children, Canadian children, Swedish children, French, Norwegian children be deliberately exposed to milk that was HIV-infected and be given placebo? And compared with a group that was receiving anti-retroviral drugs? Would that pass your ethics committee?’” (Investigator)48
“Sometimes people don’t even look at the issues, you know, they might be interested in what they are going to get out of the trial in terms of money” (Research ethics committee). “…The problem is, if you start agonizing over inducements then you come out saying that if a person is poor we will give less to be in the trial than if they are rich.” (Sponsor)40
Advocating fair distribution of benefits
 Supporting health care and societal needs“...we want to ensure that if you are carrying research within a particular community, you need to give them something back for instance a hospital or something, even if you are doing clinical research. It can be anything else that can benefit the community. Some sort of infrastructure, so that they can at least see that they are benefiting. Once you have done that, actually they will feel that they are part of the process...” (Civil Society Organization)2616, 27, 44, 75
“... he likes to talk about ‘brain gain’ as opposed to ‘brain drain.’ I mean the fact is, we are being able to provide interesting research work for lots of scientists.... but there are a lot of doctors that are able to do what they want to do which is to stay in their own country and work in their own country.” (Public private partnership1)26
The effective and fast treatment offered to trial participants as well as nonparticipants “The death of children has been massively reduced in the paediatric ward.” (Health worker)44
“Even if the parents or guardians do not have money they still get quality health service, this project does not segregate between rich people and poor people…” (48-year-old Female)44
 Sponsor obligation“ the previous decade (the industry) was seen to just purely profit from human suffering and people had a very negative view of the pharmaceutical industry. And in the last 10 years, we are sort of re-modelling our self and trying to make sure we project our self in a very responsible manner...” (Pharmaceutical company 1)2516, 22, 35, 40
“... I think you should be realistic, that nobody is going to come back and you may not be there to enforce that somebody should give back to the community...and once they find what they are looking for, they may just take off...” (Institutional review board)25
 Collateral community benefits“We cannot serve the entire community, but neither can we only serve volunteers and leave out their wives and children… these people are all related—but where would we end?” (Fieldworker)4622, 27, 28, 32, 40
“We do not accept! We do not accept it at all! And if you do so, we will withdraw completely from the study! We want to be vaccinated: us, our children, our husbands and even our dogs!” “Maybe they [nonparticipants] are the ones that will be bitten by dogs and we will not get that vaccine . . .” (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 officer)30
  • CHW, community health worker; FW, fieldworker; MRC, Medical Research Council; NHRC, Navrongo Health Research Centre; UTH, University Teaching Hospital.