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 drug under the supervision of a doctor and other research professionals.
Clinical research studies must be reviewed by an institutional review board (IRB) or ethics committee (EC). An IRB or EC is a group of people that is responsible for helping to protect the rights and welfare of study participants. In addition, every study participant is monitored with medical tests and study-related 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. You will be asked to review and sign the informed consent document prior to your child participating. Your child’s medical history will be reviewed, and your child 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 your child’s research care with the study doctor 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 investigational drug being approved by the FDA or other regulatory health authorities, and may result in future developments of new drugs.
It is important to:
- Attend all scheduled visits with your child
- Help your child describe his or her feelings and well-being accurately and honestly to the study doctor
- Discuss any questions regarding the study with the study doctor
As a study participant, you (on behalf of your child) 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.
See If Your Child May Qualify