Evaluating the Safety of Vaginal Microbicides: The Fundamentals

Scientists are developing vaginal microbicides as an important new female-initiated HIV prevention tool. Before they can be licensed, candidate microbicides must go through a series of tests to evaluate their safety. This brief is part of a series intended to serve as a resource for non-scientists to fur-ther understand the questions that scientists hope to answer when they conduct safety evaluations of microbicides; including how safety is evaluated as well as the strengths and limitations of vari-ous evaluation methods. Subsequent briefs in the series will discuss the additional research criteria required to evaluate the safety of using microbicides rectally and new safety considerations in light of the development of microbicides which contain anti-retroviral compounds. What is safety? Product developers tend to think about safety as a person’s ability to use a product without negative impact on the body. While communities share this concern, community members sometimes conceptualize “safety ” more broadly. When asked about their safety concerns regarding an upcoming microbicid