•
Community representation must be present in committees charged with
review, approval and monitoring of HIV vaccine research.
6.
Guiding principal 6: Scientific and ethical review. HIV preventive and
treatment trials should only be carried out in communities that have the
capacity to conduct appropriate, independent and competent scientific and
ethical reviews
•
Proposed HIV vaccine research protocols should be reviewed by ethical
review committees that include the community where the research is
proposed to be taken.
•
Where capacity does not exist, the sponsor should be responsible for
ensuring adequate structures are developed for scientific and ethical
review prior to the start of the research.
7.
Guiding principal 7: Vulnerable populations. Where relevant, the research
protocol should describe the social context of the proposed research
population that create conditions for possible exploitation and create
vulnerability among potential research participants, as well as the the steps
that will be taken to overcome these and protect the dignity, safety and
welfare of participants.
•
The following may increase vulnerability and the nature and level of risk
of harm to participants and should be considered;
i. Government, institutional or social stigmatization and
discrimination on the basis of HIV status
ii. Inadequate ability to protect HIV related human rights
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