How are study volunteers protected?
Volunteers are protected through extensive scrutiny of the study before it is implemented, extensive briefing to ensure they understand the study and all of their rights as volunteers, and careful monitoring both during and after the study period. All study plans and materials have been extensively reviewed by the Institutional Review Boards (IRBs) at IMPACTA in Peru, the University of San Francisco de Quito in Ecuador, the University of California San Francisco Committee on Human Research, Fenway, Cape Town University Institutional Review Board and the Fundacao Oswaldo Cruz Ethics Committe, ethic committes at the University of Sao Paulo, the Federal University of Rio de Janeiro and the University of Chiang Mai. These institutional review boards meet all applicable international standards. The study was also reviewed and approved by the Ministries of Health of Peru, Ecuador and Thailand, the U.S. National Institutes of Health, the U.S. Food and Drug Administration, the Medical Research
