How are participants protected and what is informed consent?

During clinical trials, the safety of patients is very important. This includes making sure that patients fully understand what will happen during any study in which they participate.  All individuals have the right to know exactly why a study is being conducted, and what is expected of them upon participation.

Informed consent is the process in which potential subjects learn the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information to participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant’s native language is not English, translation assistance can be provided. The information provided to potential participants includes details such as: the purpose of the study, the duration of the study, required procedures, and key contact people involved in the study. Risks and benefits of participating are included in the informed consent document that all participants sign PRIOR to beginning the study. Informed consent is not a contract, and the participant may withdraw from the study at any time.