•
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
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