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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