Your Rights as a Study Participant
What are your rights once you have made the decision to participate in a clinical trial?
You will first need to sign an Informed Consent Document. The form includes:
- Detailed explanation of the study protocol
- Types of treatment being studies
- Known risks and benefits of each treatment
- Expected costs related to the study that you might have to pay
- Contact information if you have further questions
- Your Safety as a Study Participant
As a study participant your safety comes first!
So you might ask, how is my safety protected?
Before any trial can begin the enrollment process for their study, the study protocol and Informed Consent must go through many approvals.
Where does the study get the approval to begin enrollment?
- Food and Drug Administration (FDA)-Nationally
- Institutional Review Board (IRB)-Locally at Indiana University
- The IRB includes medical and non-medical professionals who ensure a clinical trial is ethical and the rights of study participants are protected.
What should you do to ensure your safety before you agree to participate in a research study?
Be sure you understand the study clearly.
Talk to your personal doctor who knows your medical history and will help you decide whether or not to participate in the research study. Your doctor may also know potential risks and benefits of the projected treatment(s).
Know what your current health status is. Although you will be presented with the side effects and other health risks associated with the treatment by the research staff, not all risks may be known at the time you decide to participate in the study.