What are the safeguards?
Safeguards have been built in so that you are told everything that is known about the procedures, including possible risks. No one can take part in a medical study without giving informed consent—reading a description of the actual test and signing a document to show that he or she understands it. You will be given all the facts about what is being done and why, because it’s important that you fully understand the procedures. The FDA must approve all vaccine trials before they are tested in humans. The Institutional Review Board at the universities or the Ministry of Health where vaccines are being tested monitors the participation and safety of volunteers. Community representatives, scientists, physicians, ethicists and others make sure participants understand what is involved. The safety and results of the trials are overseen by a Data and Safety Monitoring Board made up of experts in medicine, ethics, statistics, virology, immunology and AIDS clinical research. In addition, Communit
