HIV vaccine trials with adolescents will pose legal complexities for
all jurisdictions in which they will take place. Complexities may stem
from a lack of legal guidance, or a lack of tools for using legal
concepts, and some disharmony between ethical guidelines [22].
The legal complexities are not, however, insurmountable. Stakeholders
preparing for these trials in South Africa and other countries should
take on the following as a matter of urgency:
1. Investigators must plan for the complex consent processes that will be required including assessment of understanding
2. Investigators must compile the information necessary for RECs to
assess potential risks to child participants (both social and physical)
to establish if these meet national risk standards for child research
3. It must be determined whether adolescents have privacy rights to
their sexual risk information and HIV status and if so, whether these
will be waived or not
4. Trial site staff must be trained to recognize when adolescent
disclosures (e.g. of abuse or neglect) will trigger a mandatory
reporting response
5. RECs that will review adolescent protocols should begin to
network with one another to prepare for a coordinated response to
similar research protocols, and
6. The national regulatory authority should outline the data they
will need to allow adolescent trials and allow licensure of an
adolescent vaccine.
A journey of a 1000 miles starts with a single step.
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