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This article outlines likely complexities for researchers and research ethics committees, including …

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- Enrolling adolescents in HIV vaccine trials: reflections on legal complexities from South Africa

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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