The South African Medical Research Council's Guidelines on Ethics for Medical Research--implications for HIV-preventive vaccine trials with children.

Children are at risk of HIV infection, stand to benefit from the development of HIV preventive vaccines, and therefore should be enrolled in trials of HIV vaccines in order to generate relevant safety, immunogenicity and efficacy data. In South Africa, the national vaccine initiative is considering the future conduct of trials involving children; this requires an analysis of the current ethical framework, including elements that facilitate or constrain the conduct of such trials. In this article, we examine the Medical Research Council (MRC)'s Guidelines on Ethics for Medical Research: General Principles (Book 1), and their provisions on research involving children. We argue that this set of influential guidelines includes provisions on research with children that are conceptually problematic and may prohibit critical research with healthy (but at-risk) child participants, including trials of HIV-preventive vaccines. We recommend that Book 1 provisions should be redrafted to reflect a balance between protecting children from research-related risks and testing interventions critical to their health.