HighlightsPlacebo controls may be acceptable even when an efficacious vaccine exists, in the following four possible situations:When developing a locally affordable vaccine.When evaluating the local safety and efficacy of an existing vaccine.When testing a new vaccine when an existing vaccine is not considered appropriate locally.When determining the local burden of disease.
Researchers and the REC did not adequately address the inter-related ethical and regulatory issues pertaining to HBMs. There was a lack of congruence between the ethical guidelines of developed countries and their actions which are central to the access to HBMs in collaborative research. HBMs may be leaving South Africa without EPs and MTAs during the process of international collaborative research.
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