Participating in a Diabetes Clinical Trial

Clinical trials, also called clinical studies, are research studies with people. Each trial seeks to answer specific scientific questions and to find better ways to prevent, detect, or treat diseases or to improve care.

Informed consent means you, as the patient, are given information so you can understand what is involved in a trial, including any potential benefits and risks, and then decide freely whether to participate or not participate.

You can ask any questions concerning the study, both before agreeing to be involved and during the course of the study. The list of questions you may want to as is provide for you in this brochure.

Your investigator will provide you a copy of the informed consent.

Yes, you can change your mind at any time after entering the trial. You may also refuse to take part in any aspect of the research. This decision will not affect your right to receive the care you would receive if you were not in the study.

In order for you to decide if the study is right for you, here are some questions you should ask before consenting to participate in the study.

• What is the purpose of the study?
• Why do researchers believe the new treatment being tested may be effective? Has it been tested before?
• What is the researcher's reason for doing the trial? Is he/she receiving payment for each research subject's participation?
• How long will the trial last?
• What tests and treatments does the study involve? Will I be hospitalized?
• What are the short-term and long-term risks and benefits of this trial? How will the trial affect my daily life?
• Could my condition become worse during the study? What will happen if it does?
• What do you do to monitor patient safety throughout the trial?
• What type of long-term follow up care is part of the study?
• Who will pay for the treatment and all other expenses related to the study?