What is a Clinical Research Study?
A clinical research study is a carefully designed scientific evaluation of an investigational medication conducted by physicians. Clinical research studies help to answer important medical questions, such as:
Is the investigational medication safe?
How does it impact your body?
How does it effect certain diseases or conditions?
The safety of the study participants is always the primary concern of everyone involved in a research study. In order to provide reliable information, clinical research studies require the participation of research volunteers.
What is Informed Consent?
Before you decide whether or not to take part, you should know why the research is being done and what it involves. The study doctor or nurse will describe all of the possible benefits and risks of taking part in the study that are known at that time. You should ask the study doctor (or his or her staff) any questions you may have. This process is meant to help you decide whether or not participating in the study is right for you.
If you decide that you want to participate in the study, a member of the study team will review a detailed document about the study with you, called the “Informed Consent Form.” This document provides you with important information about a clinical research study and documents your agreement to participate.
You may take an unsigned copy of this form home with you to read again or to discuss with family, friends or your personal doctor before making your decision. Even after signing the form you may withdraw from the study at any time without any consequences.
The purpose of “Informed Consent” is to make sure that:
You understand what participating in the study will involve, including the potential side effects and other risks associated with the investigational medication or the study procedures
You understand your responsibilities as a study participant
It addresses all the questions you may have