IRBs make sure participants are informed about the trial protocol, the benefits, and the risks of participating. An independent group of experts, called the Data and Safety Monitoring Committee, carefully watches over each clinical trial. These experts look for evidence of benefit or harm to the study participants during a clinical trial. A study can be stopped at any time to ensure the safety of participants. If you are thinking of participating in a trial, you should ask the researchers to confirm that each of these types of committees is in place and has reviewed the trial.
Informed consent is an important part of protecting people in clinical trials.
Informed consent means that as a participant in a clinical trial, you are given information so you can understand key facts about the study. These include why the study is being done, what will be done during the trial and for how long, possible risks and benefits, and other treatment options available to you. Any questions you ask should be answered to your satisfaction. If you decide to join a clinical trial, you will sign a consent form. But informed consent is more than signing this form.