How is “child” defined?
A “child” is a person who has not attained the legal age for consent to treatments or procedures. Please see your state and local law for accurate age in your area.
Does research involving children include special requirements?
Yes the biggest difference with research involving children is the use of an assent form. The parent of a minor must sign the research consent form and the minor signs the assent form.
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 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.
We all know that children are not "little adults" when it comes to treating their health problems. They need medications, devices and treatments designed especially for their unique medical conditions, not to mention their developing brains and bodies. Clinical research in children is the best way to determine which therapies are safe and effective for children, but all too often children must rely instead on hand-me-downs from adult clinical research. The site is formatted to many educational levels by combining text, graphics and documentary film footage of experts, parents and children themselves discussing their experiences in clinical research.
This site can assist healthcare providers as they answer questions from parents and families about the consent process. For more information, see http://www.nhlbi.nih.gov/childrenandclinicalstudies/index.php