Informed Consent

Informed consent is the process of learning and understanding the key facts about a clinical research trial before you enroll. It is also a continuing process throughout the clinical research trial to provide you with information about the study.

To help you decide whether or not to participate, the study team will explain all details of the clinical research trial, including:

• Why the study is being done
• What the researchers are hoping to accomplish
• The treatments being tested and how they are thought to work
• Any potential risks and benefits to the participant.

You will then receive a Consent Form that describes how the study is designed, whether or not a placebo is to be used, and what kind of tests will be required.

Review the Consent Form carefully to make sure you have a full understanding of the clinical research trial. If something is not clear or if you don't understand a term, ask the study team to explain it to you. If you still feel uncomfortable, ask your personal doctor to review the form.

Once you are satisfied, you can sign the Consent Form. Your signature indicates your agreement to participate in the research trial. However, informed consent is not a contract; you can withdraw from the research trial at any time.