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. 33

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