Informed consent is needed before you may be enrolled in clinical research trials. The purpose of informed consent in this setting is to allow you to learn enough about the study and your rights as a potential participant to decide whether or not to participate. Informed consent for a research study should include the following information:

• That the study involves research
• The purpose of the study
• How long the study is expected to last
• A description of what will be done during the study
• Which parts experimental
• Possible risks and/or discomforts to you from participation in the study
• The benefits that you can expect from participation in the study
• The study records will be kept confidential to the extent required by law
• What will happen in the event of an injury or side effect, including whether any compensation and or medical treatment are available
• An explanation of whom to ask for information about the research (questions or complaints), subjects’ rights, and questions about injuries related to the research
• Other treatments that are available if you decide not to participate in the study
• A statement that participation is voluntary you have the right to leave the study at any time, and that standard medical care will be provided without penalty if you choose to withdraw from the study