As children should be recipients of future HIV preventive vaccines, children should be included in clinical trials in order to verify safety, immunogenicity and efficacy from their standpoint. The development of HIV vaccines for children in South Africa must address specific scientific, ethical, and legal considerations relevant to children, so that their welfare is safeguarded and promoted.
18.1 The Constitution defines a child as someone younger than 18 years.
18.2 Children, including infants and adolescents in many communities throughout South Africa, are at high risk of HIV infection. Infants born to HIV-infected mothers may be at risk of becoming infected during birth or during the postpartum period through breast-feeding. Adolescents are also at high risk of infection because of sexual activity, and/ or lack of access to HIV prevention means.
18.2.1 As children are at risk of HIV infection, children stand to benefit from the development of HIV preventive vaccines. Therefore, children should be included in clinical trials in order to verify safety, immunogenicity and efficacy from their standpoint.
18.2.2 The participation of children in research also honours their right to equal consideration by enabling their access to safe and efficacious products.
18.3 Before undertaking research in children, investigators must satisfy research ethics committees of the points detailed below7.
18.4 The research could not be carried out equally well with less vulnerable participants: Ethical justification of the involvement of children in research requires that the research would not be equally informative if carried out on less vulnerable participants, and there is a specific need to perform the research on children (see Book 1, 18.104.22.168). According to this reasoning, the participation of children in HIV vaccine research should be considered only if their participation is indispensable to establish safety, immuno-genicity and efficacy data relevant to children.
18.5 The purpose of the research is to obtain knowledge relevant to the health needs of children: Ethical justification for the involvement of children in research requires that the purpose of the research is to obtain knowledge relevant to the health needs of children. That is, the research is intended to obtain knowledge that will lead to the improved prevention or treatment of diseases or health problems characteristic of children, either to actual child participants or children as a class.
18.6 The risks presented by research interventions are reasonable and justifiable in relation to expected benefits:
18.6.1 The risk from research interventions and procedures that do not hold out the prospect of direct health-related benefits for the individual participant should be no more likely and no greater than the risk attached to routine medical or psychological examination of children, or the risk that is normally encountered in the daily lives of people in a stable society (see Book 1, 22.214.171.124.1 and 126.96.36.199.1).
188.8.131.52 Slight increases above such risk may be permitted when there is an over-riding scientific or medical rationale. The research should be designed to be responsive to the disease affecting the prospective participants or to conditions to which they are particularly susceptible, and the objective of the research must be sufficiently important to justify exposure of the participants to the increased risk.
18.6.2 The risks of research interventions or procedures that do hold out the prospect of direct health-related benefits should be justified by the anticipated benefit to participants.
18.6.3 In making these determinations, research ethics committees should consult with experts, including persons with expertise in paediatric and child health.
18.7 Legal and ethical requirements for informed consent will be met:
18.7.1 In South Africa, the Constitution states that no person shall be subject to experimentation without informed consent. Persons above the age of 18 years, who are of sound mind, are generally considered capable of giving independent informed consent for participation in research (see Point 12.7) 8,9. When persons below the age of 18 are to be involved in research, proxy consent from a parent or legal guardian must be obtained.
184.108.40.206 Therefore, the enrolment of children in HIV vaccine research in South Africa requires informed consent from a parent or legal guardian, and assent from the child, according to his or her evolving capabilities.
18.7.2 Because the Child Care Act specifies that South African children who are 14 years and older may give consent to medical treatment of themselves (see Book 1, 220.127.116.11.1), such children are considered (by implication) able to give consent to "therapeutic research".
18.104.22.168 If a research ethics committee classifies an entire HIV vaccine trial protocol as "therapeutic research" 10 it is possible that independent consent for participation could be secured from children who are 14 years and older. However the permission of the parents or legal guardian is still highly desirable. The participation of children who are under 14 years would require parental consent as well as assent from the child according to his or her evolving capabilities.
18.7.3 If a research ethics committee classifies an entire HIV vaccine trial protocol as "non-therapeutic research", parents must provide proxy consent for participation and the child must assent (according to his or her evolving capabilities), provided that the risks are no more likely and no greater than the risk attached to routine medical or psychological examination of children, or the risk that is normally encountered in the daily lives of people in a stable society (see Point 18.6.1). Where there is an over-riding medical or scientific rationale, such risks may be slightly increased (see Point 22.214.171.124).