Making a Decision about Participation
Parents often wonder whether their child should be involved in a clinical trial or other research. In making this decision, it is very important to take the time you need to understand what's involved in the research and ask questions. The researcher or research staff member will explain what's involved in the research and answer your questions. You may also want to talk with your child's doctor or your family to help make your decision.
Protections in Place for Children who Participate in Research
Federal regulations and policies are in place to protect research participants. At the Advocate Children's Hospital, all of the research that is conducted at the Advocate Children's Hospital has been approved and is monitored by the Advocate Health Care Institutional Review Board to ensure the protection of human subjects. Industry-sponsored trials that have been developed by U.S. pharmaceutical and biotechnology companies to evaluate new treatments or devices for children must be reviewed by both the federal Food and Drug Administration (FDA) and the Advocate Health Care Institutional Review Board before they can begin. Further, if your child participates in a study, his or her health will be closely monitored throughout the study by one of Advocate's expert pediatric specialty clinicians, including physicians, nurses, and other research professionals. Additional information about children participating in clinical research can be found on the FDA website at http://www.fda.gov/consumer/updates/pediatrictrial101507.html.
Research as a Means to Advance Understanding and Treatments
Participation in research is vital to the children who entrust us with their lives. The National Heart Lung and Blood Institute (NHLBI), in partnership with other National Institutes of Health (NIH) institutes, has created a comprehensive award-winning website on Children & Clinical Studies that is designed to give parents and healthcare providers alike the information needed to understand clinical research in children and make informed decisions about participating in a study. Only through research can we discover the evidence-based information that ultimately enables us to improve the quality of healthcare that we provide to children. Clinical trials are conducted to test the safety and effectiveness of medications and devices in human subjects. You may be surprised to learn that many medications (70-80%) have not been studied in children. Therefore, in children, clinical trials may be used to test new medications or devices, or existing ones that have not been tested or approved for use in children. Through participation in clinical trials, children may receive some benefits for their condition, gain access to new medications or devices not yet approved, and contribute to future understanding and improved treatments for particular conditions.
At the Advocate Children's Hospital, clinician-investigators are engaged in both investigator-initiated research (that they design and conduct), as well as externally-sponsored clinical trials. Both types of research employ the same IRB review process and are governed by regulations that protect human subjects. If you are interested in learning about the clinical trials or other research being done at the Advocate Children's Hospitals, please contact us or view information on clinical studies currently recruiting.
Frequently Asked Questions and Additional Resources
Answers to frequently asked questions about participating in clinical trials or other research can be found in our FAQ section. Additional information regarding clinical trials can be found at http://www.clinicaltrials.gov/ and on The Center for Information and Study on Clinical Research Participation (CISCRP) website, http://www.ciscrp.org. Additionally, the US Department of Health and Human Services, Office for Human Research Protections has created a brochure "Becoming a Research Volunteer".