4. Guiding principal 4: Research protocols and study populations. In order to conduct research in an ethically acceptable manner, the research protocol should be scientifically appropriate and the desired research outcome should potentially benefit the population from which research participants are drawn. • In order to be ethical, clinical vaccine trials should be based on scientifically valid research protocols and the scientific question should be rigorously formulated and capable of providing valid and reliable responses. • Protocols should justify the selection of the research population, outline how risks taken by the population are balanced by benefits in that population, address the particular needs of the research population and establish safeguards for the protection of research participants from potencial harm arising from the research. 5. Guiding Principal 5: Community participation. To ensure the ethical and scientific quality of the proposed research, it relevance to the affected community, community representatives should be involved in an early and sustained manner in the design, development, implementation and distribution of results of HIV vaccine research. • The orientation and community involvement should be one of the partnerships towards mutual education and consensus building regarding all aspects of the vaccine development programme. • There should be establishment of a continued forum of communication and problem solving on all aspects of the vaccine development programme from phase 1 to phase 111 trials and beyond. 21

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