For Parents - Deciding to Participate
At Johns Hopkins All Children's Hospital, we understand that it is difficult being a parent of a child with a medical problem, and even more difficult to decide whether it is in the best interest of your child to participate in a medical research study. We also know that clinical research is the only means that we have to evaluate treatments for illnesses and diseases
Taking part in a study is entirely voluntary. It is never required and choosing not to take part will not change the standard procedures of care that your child will receive. If your child has an illness or disease where there is no known cure, participation in a research study may not provide a benefit to your child, but may help researchers learn more about the illness or disease, or ways to diagnose and treat the illness or disease. Your child is free to withdraw from a study at any time without affecting on-going or future medical care.
The National Institutes of Health (NIH) has developed a web based information resource for families entitled Children & Clinical Studies. This site features an award-winning video of children, parents, and healthcare providers discussing the participation of children in research. Tambien en Espanol.
Clinical Trials Q&A
What are clinical trials?
A clinical trial is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the safest and fastest way to find treatments that work in people, and new ways to improve health.
Where can people find out about clinical trials?
People can find information about clinical trials being conducted now by searching www.clinicaltrials.gov. ClinicalTrials.gov is an online database, managed by the National Library of Medicine. It provides information about both federally and privately supported clinical research in human volunteers.
Are clinical trials safe?
The Food and Drug Administration, Department of Health and Human Services, and children's hospital/university Institutional Review Boards work to protect participants in clinical trials and to ensure that children and their parents have reliable information as they decide whether to join a clinical trial. The federal government has regulations and guidelines for clinical research to protect participants from unreasonable risks.
Although efforts are made to control the risks to clinical trial participants, some risks may be unavoidable because of the uncertainty inherent in medical research studies involving new medical treatments.
Q & A source: www.FDA.gov