Definition: Before enrolling a person in a clinical trial, researchers must obtain informed consent. In informed consent, the person must understand the purpose of the trial, the potential risks and benefits of the trial and the goals of the research. It should also be clear that a study participant can quit the trial at any time (and for any reason) and is free to ask questions about the research. The informed consent document is a signed, legal document and should be read carefully and fully understood.
In an MS trial, it is important the all participants understand what medications or treatments they may receive. Often participants assume that they will receive the medication being tested, but a group of study participants, called the control group, must receive either standard care or a placebo and study participants will not know which one they are receiving until the trial is over.
