What protections are in place for clinical trial participants?
Many steps are taken to ensure that research meets strict scientific guidelines and follows rules that protect you. Several groups who are not part of the research team examine both the scientific plan and procedures to protect the interests of participants before the research may begin. Each new study, including its provisions for the protection of study participants and its informed consent document, must be approved by an Institutional Review Board (IRB). IRB members are not a part of the research team and consist of medical and non-medical professionals. The IRB must follow strict federal guidelines when reviewing research to determine if it can be conducted.