Every MTN study is designed according to the most rigorous international ethical standards and with the greatest concern for participant safety. A detailed informed consent process ensures that participants understand the procedures, risks and benefits of the study, and that they are not obliged to participate and may leave the study, without consequence, at any time. During the trial’s conduct, every possible measure is taken to protect the wellbeing of study participants. Strict national and international procedures for safety monitoring and reporting are followed, including regular reviews by a Protocol Safety Review Team and/or an independent Data and Safety Monitoring Board. Every MTN trial also includes on its team two physicians – one specializing in infectious diseases and HIV and the other in obstetrics and gynecology – whose sole responsibilities for that study are to ensure that everything possible is being done to monitor and protect the safety of participants.

Importantly, MTN researchers believe significant attention to safety should be paid before a trial even begins. They have developed a unique laboratory screening process designed to streamline product selection and move only the most effective and safest microbicides to testing in humans. Of great interest is whether these preclinical assays of potential biomarkers for safety can be validated with clinical findings of early-phase clinical trials, which could help accelerate the research and development of better microbicides. Moreover, by sharing laboratory results with industry partners and advocating for standardized screening across the field, MTN investigators can enable advances in research by other groups as well.