How are clinical research trial participants/volunteers protected?

There are several procedures in place, as part of the protocols, to protect the safety of the people who participate. Two groups that oversee the safety procedures are:

• The organization sponsoring a trial also monitors the safety of volunteers. Depending on the type of sponsor, there may be a monitoring board or a monitor that reviews all study records.
  
  
• The MetroHealth System's Institutional Review Board (IRB). The IRB includes physicians, other health care providers, consumers, and community members who do not have any personal interest in the results of the trial. As neutral reviewers, they try to ensure that the trial is conducted fairly and that participants are not likely to be harmed. All clinical trials require approval from the IRB before the trial may begin. The IRB reviews clinical trials on no less than an annual basis and conducts thorough, random audits to insure that patient's rights are being protected.