– Serious and unexpected adverse events – Periodic and final reports – New information that may affect risk-to-benefit ratio • Receive and consider recommendations from the Data and Safety Monitoring Board (DSMB) and where necessary, make recommendations to the DSMB. • Work closely with the WHO ethical review committee, the WHO-UNAIDS Vaccine Advisory Committee and other relevant bodies on HIV/AIDS vaccine research and development. Data safety and monitoring board (DSMB) (indentified by MRCZ for each trial) In each trial, the establishment of a data safety and monitoring board (DSMB) to evaluate data from HIV vaccine research studies conducted in Zimbabwe is manditory. These boards should be multidisciplinary, with the participation of individuals unrelated to the study, the researchers or the sponsors. For international multi centre trials, there is the additional recommendation to establish an international DSMB, with appropriate representation from research institutions and national and international regulatory agencies. The DSMB should be multidisciplinary with appropriate representation from all scientific disciplines needed to interpret the data and ensure patient safety, including: • Clinical trial experts • Biostatisticians • Bioethicists 31