continuation or conclusion of the trial(s).
• Ensure confidentiality of trial data and monitoring results.
Other monitoring agencies
Multidisciplinary community advisory board (CAB)
In each trial, the implementation of multidisplinary community advisory and follow-up
board is recommended. These boards should participate in the research process,
especially in the community sensitization, ethical aspects and the human rights of
the volunteers. They must be independent both from researchers and sponsors.
Selection of vaccine candidate products
The National HIV Vaccine Committee, together with the MCAZ, will review all
preclinical data and previous results of trials involving human subjects and
recommend (or not) a vaccine product for evaluation. The decision will be based on
the research’s relevance for the country, the evidence of safety and immunogenicity,
on the report of the vaccine antigen with the HIV strains circulating in the country
and on the potential effectiveness.
Setting up and maintaining cohorts
In order to assess the incidence of HIV infection, for behavioral studies, counseling
and discussion about free and informed participation in vaccine candidate products
trials, cohorts epidemiologically compatible with the research objectives should be
set up.
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