As you get more involved in the care for yourself or your child who has been diagnosed with CHD or acquired heart disease, you may learn about research to study these conditions. You may read about or be asked about clinical trials in many ways. A member of the research team may contact you, or your primary care doctor may speak with you about a study. You may learn about a study from seeing information on a community post or from others who have participated. You may see a brochure or information sheet that gives some details about a study. This will help identify what studies might be out there, but to learn if one is right for you or your child, you will want to talk to your or your child’s doctor as well as a study coordinator, and read the consent form carefully.
Before you decide whether to participate in a clinical study, be sure to know your rights and responsibilities.
This form is required by law to explain:
Your rights are protected through laws in the United States, Canada and the European Union. These laws have been created over time and exist to protect study subjects and help them understand the details about a study. Additional legal protections are given for pregnant women, human fetuses, neonates and children. The rights these laws protect are outlined below.
If you decide to leave the study, talk with a member of the study team before you do so. Your child may need to be placed on a different medicine or need a certain test so you can leave the study safely. On the Children and Clinical Studies website, watch the video “Leaving a Study” for more information.
The Children and Clinical Studies website provides important information to help you decide whether a clinical study is right for your family. Check out the following topics: