What you should know about clinical research studies.
What is a clinical research study?
A clinical research study, also known as a clinical trial, is a carefully designed study in which participants are asked to take an investigational medication under the supervision of a physician and other research professionals. An investigational medicine is one that is not approved by the US Food and Drug Administration (FDA).
Clinical research studies must be approved by an Institutional Review Board (IRB) or Ethics Committee (EC). An IRB or EC is a group that is responsible for helping to protect the rights and welfare of study participants. In addition, every study participant is monitored with study-related medical tests and exams before, during, and sometimes even after the study.
What should I expect for my child?
Before your child participates in a study, a detailed description of the study, as well as possible risks and benefits, will be provided in writing in an “Informed Consent Document” and discussed with you and your child. You will be asked to review and sign the parental or legal guardian Informed Consent Document prior to participating. Your child’s medical history will be reviewed, and he or she will be given a study-related physical exam and laboratory tests.
If your child qualifies, he or she may be enrolled in the study. Once enrolled, feel free to discuss his or her research care with the study physician or research staff members at any time during the course of the study. Information collected during a clinical research study may or may not ultimately lead to the study drug being approved by the FDA or other regulatory health authorities, and may result in future developments of new drugs.
It is important for your child to:
- Attend all scheduled visits
- Describe his or her feelings and well-being accurately and honestly to the study physician
- Use the investigational medication as prescribed
- Discuss any questions regarding the study with the study physician
As the parent or legal guardian of a study participant, you will have the right to contact the study’s IRB or EC representative regarding your child’s rights as a research participant. Your child will also have the right to leave the study at any time.