Clinical research is a way for doctors and scientists to answer questions about healthcare. Research can find better ways to prevent, diagnose or treat diseases and disorders. There are many kinds of clinical research. For example, some studies test new medicines or devices. Other studies use interviews to learn about health problems.
Drugs and medical devices must be proven safe and effective in people before the U.S. Food and Drug Administration (FDA) will approve them for general use. A clinical trial is a study that tests a drug or medical device to see if it is safe and effective for treating people. The government has strict rules for clinical trials. These rules help to ensure that study participants are safe.
Many types of people are needed to participate in research studies. Some studies need healthy persons. Other studies need persons with certain health problems. Persons of all ages and from all ethnic groups are needed. Why do people participate in research studies?
Every study is different, and the reasons people participate are different. Some reasons people take part in a study are:
The risks for each study are different. Some possible risks of taking part in a research study are:
What is informed consent? Before taking part in a study, each participant will receive a consent form that contains important written information about the study. It is important to read and understand the information in this form. The researcher or member of the research team will also talk to the person about the information contained in the form. The person should be sure all of his or her questions are answered before signing the consent form. A signed consent form is not a contract -a participant can leave a study at any time.
These methods of protection do not eliminate all possibility of risk. But they do help to ensure study participants will be as safe as possible.
Before you decide to participate, you should ask as many questions as you need to in order to be sure you understand the study. Some questions you might want to ask are: