Federal regulations ensure that people are told about the benefits, risks and purpose of research before they agree to participate. Federal regulations also require oversight of the trial by an Institutional Review Board (IRB). An IRB is a neutral group of physicians, healthcare providers and ordinary citizens not involved in healthcare. This group reviews all protocols and consent forms and oversees the trial to make sure it is conducted fairly and safely.

Protecting Patients Before a Trial
The IRB makes sure that the informed consent form defines each of the following about the clinical trial:

• Purpose
• Procedures
• Risks and potential benefits
• Individual rights

The IRB and the study sponsor conduct a scientific review to make sure each study has a valid scientific design and minimizes risk for study volunteers

Protecting Patients During a Trial
Strict guidelines are set up to minimize risk to study volunteers. Physicians and research nurses explain the risks of the trial. They also closely monitor study volunteers to identify any changes in their condition. The IRB oversees the trial to make sure it is conducted safely and fairly. Data and safety monitoring boards:

• Ensure that risks are minimized
• Ensure data integrity
• Stop a trial if safety concerns arise or objectives have been met