How are volunteers protected?
In the United States, the U.S. Food and Drug Administration (FDA) must authorize a drug companys research proposal before a drug study begins. Years of laboratory research are required before an investigational drug is approved for research in people. An Ethics or Institutional Review Board (ERB/IRB) must also independently review and approve the study before it begins. These review boards are comprised of healthcare professionals and non-healthcare members whose goal is to protect the safety and rights of study participants. Participants in research studies are followed closely during studies through lab and other diagnostic testing, physical examinations, and evaluation of symptoms and general health. Centralized study drug safety information is regularly sent out to research investigators to keep study teams up-to-date on current findings. Any significant information is communicated to study participants as indicated during the study period.