Informed consent is a critically important and mandatory process of communication and the goal of informed consent is to ensure that you fully understand all of the requirements, implications, risks and benefits about participating in a clinical trial.
 
Informed consent is a process, and it involves an important document called an Informed Consent Form.
 
An Informed Consent Form is reviewed and approved by an Ethics Committee before it can be presented to and reviewed with research subjects.  There are specific requirements for the content of Informed Consent Forms that are described in federal regulations.  In addition they must be written in a language that is easy to understand.
 
The Informed Consent Form provides a summary of the clinical trial (including its purpose, the treatment procedures and schedule, potential risks and benefits, alternatives to participation, etc.) and explains your rights as a participant. It is designed to begin the informed consent process, which consists of conversations between you and the research team. If you then decide to enter the trial, you give your official consent by signing the document. You must keep a copy and use it as an information resource throughout the course of the trial.
 
The informed consent process provides you with ongoing explanations that will help you make educated decisions about whether to begin or continue participating in a trial. A written document alone may not ensure that you fully understand what participation means. Therefore, before you make your decision, the research team will discuss with you the trial’s purpose, procedures, risks and potential benefits, and your rights as a participant. If you decide to participate, the team will continue to update you on any new information that may affect your situation. Before, during, and even after the trial, you will have the opportunity to ask questions and raise concerns. Thus, informed consent is an ongoing, interactive process, rather than a one-time information session.