Participating in Clinical Trials

Frequently Asked Questions

27. What organizations exist to protect participants in clinical trials?

If you have concerns about your safety being protected by someone other than the research team, there are outside organizations that protect trial participants. They will stop a trial if they find that the experimental product is harming the participants or not having any effect. These organizations include Institutional Review Boards and Data and Safety Monitoring Committees.

Before starting a trial, researchers must get permission from their organization's Institutional Review Board or IRB. IRB members are independent of the study and do not have an interest in how it turns out. The IRB reviews the trial's protocol, or study plan, to look for possible benefits and risks to human subjects.

Data and Safety Monitoring Committees are independent of the study and look at data collected during studies comparing different drugs. They pay special attention to treatment trials for life threatening diseases. If a committee finds the experimental product is harming participants or is not working, it will stop the study.