The rigorous requirements for safety imposed by regulatory groups involve a complete briefing, a comprehensive consent form, full medical history and physical examination, and one on one counseling for risk behavior and HIV infection avoidance. After being briefed on the HIV epidemic and the protocol requirements, the volunteers will receive a complete physical examination. Research trials may last up to a year, with as many as 14 visits during this time period. Potential volunteers are absolutely free to enter or renounce their participation before committing themselves. Volunteers enter of their own free will and will not suffer any loss of benefit should they have to drop out for any reason.
Blood is drawn at most visits.
Blood volume drawn varies with the type of visit and the study. Urine is also required for safety testing. Immunization of experimental vaccine is never administered without proof of a negative pregnancy test on women of childbearing potential. Because of the lack of knowledge on possible risks to a fetus, women must use birth control methods and men must not father a child during the immunization period. Volunteers are reimbursed.