“Informed Consent” is a process of information exchange before an adult agrees to participate in research. Potential research participants will be asked to read and sign an informed consent document, but will also be given instructions, verbally and in writing, question/answer sessions and other reading materials to assure the potential study participants understanding and willingness to voluntarily enroll in the research.   Before you agree to volunteer for the study, the study doctor or staff is required to explain all the details of the study, which will include the risks and benefits, and address your questions. After all of your questions have been answered, and if you wish to participate, then you will sign a document called the informed consent form to ensure: You agree to volunteer You understand the study, including the study procedures, risks and potential side effects of the investigational medication You understand that you can leave the study at any time, for any reason If you don’t understand what is expected of you or the document, you should continue to ask questions and talk with the study doctor, your family or others that you trust, until you feel you understand.