• If the vaccine is effective participants should have the opportunity to develop protective immunity to HIV 11. Guiding principal 11: Control group. As long as there is no known effective HIV vaccine, a placebo controlled arm should be considered ethically acceptable in a phase 111 trail. 12. Guiding principal 12: Informed consent. Independent and informed consent based on complete, accurate and appropriately conveyed and understood information should be obtained from each individual while being screened for eligibility for participation in an HIV prevention or treatment vaccine trial and before enrolment. • A process of consultation will be used to design an effective informed consent strategy and process. Issues such as literacy, language cultural barriers and decreased personal automatism should be addressed • The use of free and informed consent is of foremost importance. • Consent should be obtained by a trained professional in an environment that respects the dignity of each individual. The wording of the consent should be understandable, taking into account the participants’ language, culture and circumstances;. 13. Guiding principal 13:Informed consent-special measures. Special measures should be taken to protect persons who may be limited in their ability to provide informed consent due to their social and legal status. The following persons or groups should be given special consideration with regards to their ability to provide informed consent in HIV vaccine trails 25

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