3. Research results 49
3.1. Description of emerging codes and theme 49
3.1.2. Challenges around child and adolescent consent 51
The issue of child and adolescent consent emerged from the data as one of the most important issues of informed consent for all the respondents. This theme addresses perceptions of the perceived capacity of children to give consent, as well as the risks and benefits around child participation. The age at which children should be able to consent to participation in HIV vaccine trials emerged as a contentious issue amongst respondents. Although the new South African Children‟s Act clearly sets the age at which children can consent to non-beneficial research as eighteen years, a number of respondents raised this as problematic considering the urgency of finding an HIV vaccine suitable for use on children. The scientific need for children to participate right from the start was evident in the following comment.
“I think there are four phases I think children should start participating in the first phase because if they do not begin in phase one then how are we going to determine the safety and immunogenicity of the vaccine in children” (Civ Soc).
53 Adolescent decision-making capacity was expressed as one of the main issues surrounding the inclusion of children and adolescents in HIV vaccine trials.
Respondents viewed the reluctance of parents to allow children to participate in the trials as stemming mainly from their inability to see the need for children to participate, the uncertainty of whether the vaccine would work and their objection to their children being exposed to perceived offensive sexual language.
“I suppose the very first thing is that you have to talk about sex to a child, which some people may even object to” and
“if you're talking bringing words like penis into the interview, is this going to upset people?” (Med).
Respondents speculated that conflict may develop between unwilling parents and adolescents who want to participate in the trials. Furthermore, conflict related to disclosure of an adolescent‟s sexual activities was likely to interfere with the decision making process. A respondent speculated that:
“[I]t is highly unlikely for a parent to give consent once they know that their daughters are sexually active. They probably, probably going to get an absolute fit or the daughter wont get parental consent because she is scared of disclosing to her mother that she is sexually active” (REC).
One of the challenges facing the informed consent process related to children‟s understanding of the material disclosed. Respondents expressed the need for appropriate information disclosure strategies that would address the issues of using language more suitable to their level of understanding.
Respondents argued that the evaluation of children‟s understanding of HIV vaccine research in Africa is incomparable to that of children in the West, however. On one hand, some respondents perceived children and adolescents as a vulnerable group who needed to be protected, while other respondents
54 argued that adolescents in Africa are not as vulnerable as people suspect, giving the impression that in general there was no real danger in the recruiting adolescents into the trials. Some respondents went as far as to use the different social demands that African children are exposed to as justification for re- evaluating them as more competent and capable of consenting to HIV vaccine trials than children in the west. A respondent explained:
“[T]his research is different from past research. We are re- evaluating the risk-benefit ratio in our context. We operate in a different social context, where our children are not as sheltered as children in the west. They come from vulnerable backgrounds where they sometimes need to grow up fast and be self-sufficient” (Civ Soc).
Despite this perceived invulnerability of African children, a number of different opinions emerged around who should consent to children and adolescents participation in HIV vaccine trials. One respondent was adamant that:
“The decision/choice should be given to the community. If the community says no, children should not participate”
(CAB).
Others argued that in many South African cultures it is customary for parents to make decisions and take responsibility for their children, which ought to include their children‟s participation in HIV vaccine trials:
“In our culture a child is under parents and they make decisions for him/her because once something goes wrong the parents will be responsible to correct it … As a parent you weigh advantages against disadvantages before giving your child permission no matter how old the child is”, and
“you don‟t want to get any old Tom, Dick and Harry to sign
55 your child, you want to get a legal, a legal guardian, and if
there is none, then you don‟t involve the children” (CAB).
Not all respondents agreed with parental consent, however, advocating the child as the decision-maker. Some argued that consenting to participate in HIV vaccine trials is no different to consenting to having an HIV test. There were also some unexpected issues raised. For example, parents could exploit their children for their own personal gains, for example.
“[B]ecause children can‟t give consent themselves …so that means they‟re dependent on their parents…and I don‟t know how you can ensure that the parents are not using this to for their own personal gains or needs versus that of the child…”
(Civ Soc).
“But then going back to the fact that these are, well helpless children, we, the mothers, could be drunkards, could be so desperate…I mean they could want this children to be involved in research just because they are looking at getting paid and not caring about the consequences to the child‟s life at all…” (CAB).
“…It may be easier for a parent to accept an incentives if they‟re not putting themselves in the risk but rather their child”
(CAB).