Strict federal guidelines safeguard clinical trial participants by requiring that independent committees called Institutional Review Boards (IRBs) oversee the trials. There are more than 3,000 IRBs in the United States that are? made up? of a mix of physicians, scientists, patient advocates, ethicists and administrators. IRBs are responsible for:

• Reviewing and approving? study plans-of-action, or protocols
• Closely monitoring trials after they are approved to ensure that participants are not exposed to excessive or unnecessary risks

In addition to IRB's, all Phase III clinical trials supported or performed by the National Cancer Institute (NCI) require monitoring by a Data Safety Monitoring Board (DSMB), and most other Phase III studies use DSMB's as well.? DSMB's are independent committees, composed of community representatives and clinical research experts.? DSMB's are responsible for:

• Reviewing data and monitoring safety trends while a clinical trial is in progress to ensure that participants are not exposed to unnecessary risk
• Recommending that a clinical trial be stopped if there are safety concerns or if the trial objectives have been achieved