Will I have a chance to talk with the clinical investigator about the study before I sign the informed consent form?

Signing the informed consent document should not be the first or the only step in the informed consent process. The signing of the consent form should only occur when you believe you have the information you need to make an informed decision. Prior to providing your signature, the clinical investigator or study staff member should sit down with you to discuss the study in detail and give you an opportunity to ask any questions you may have. That discussion should include a review of the information contained in the informed consent form itself. You may be asked to take the informed consent form home with you so that you have an opportunity to think about participation in the research study or to talk the matter over with your loved ones or friends. You should consider including a relative or friend in your discussions with the clinical investigator or study staff member if you believe their inclusion will help you with the decision making process.

The informed consent process extends throughout the study, well after the signing of the document. This means that you will be told about new information learned during the course of the study if it is decided that the information could have an impact on your decision to participate in the study. It also means that you can ask questions of the clinical investigator and study staff at any time during the study or after it is completed.