• Clinicians knowledgeable in HIV/AIDS • Epidemiologists • Virologists • Immunologists • Social and behavioural scientists • Community representatives Terms of reference for the Data and Safety Monitoring Board The DSMB will: • Review the research protocol and the plans for data and safety monitoring. • Receive and review regular periodic progress reports from the investigators. • Have access to and review all data generated from the trial for quality and integrity. • Monitor data regarding safety (adverse reactions), immunogenicity and efficacy. • Receive and review unblinded results of interim analyses to determine continuation or termination of the trial. • Evaluate trial progress, including: – periodic assessments of data quality and timeliness – participant recruitment, accrual and retention – participant risk versus benefit – performance of trial sites – other factors that can affect study outcome such as scientific or therapeutic developments that may have an impact on the safety of the participants or the ethics of the study • Give recommendations to the sponsor, IRB, and investigators concerning 32