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Why We Don't Need a Relative Risk Standard for Adolescent HIV Vaccine Trials in South Africa

Snyder and colleagues (2011) underscore the need to enroll adolescents in HIV prevention trials in order to realize much-needed interventions for this deserving group. However, they argue at several points that adolescents might be excluded from HIV vaccine trials unless something is done about the allowable levels of risk in child research. On the contrary, while continued preparation is needed to enroll adolescents in HIV vaccine trials, (Slack et al. 2007), this need not require a reformulation of allowable risk levels. South Africa hosts many trials of HIV prevention products. Current ethical guidelines governing child trials generally (Department of Health 2006), and HIV vaccine trials specifically (MRC 2003) assert that procedures that do not hold out the prospect of direct benefit should approximate minimal risk, or a minor increase over that. Minimal risk is anchored to risks encountered in daily life or during routine medical or psychological examinations (Department of Health 2006). Procedures that hold out the prospect of direct benefit are not expressly capped but must be reasonable in relation to the benefits (Department of Health 2006; MRC 2003). Adolescent HIV vaccine trials could conceivably fit these requirements. Many procedures in HIV vaccine trials will likely be classed as holding out the prospect of direct benefit (for example, physical examinations; medical historytaking; sexually transmitted infection [STI] testing; HIV testing; pregnancy testing; contraceptive provision; and circumcision assessments) and will therefore not be held to minimal risk/minor increase over minimal risk, but will be held to a sound risk–benefit ratio and concerted efforts to minimize foreseeable risks.