• 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 22

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