Get Introduction We Invite You And Your Child To Take Part In A ... - Fda

The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines pediatric patients as persons aged 21 or younger at the time of their diagnosis or treatment. Pediatric subpopulations are further categorized as follows: Neonates - from birth through the first 28 days of life. Infants - 29 days to less than 2 years.

Requirements for parental permission serve the ethical obligation of investigators to respect and protect vulnerable individuals. Provisions for involving children in discussions about research participation and seeking their assent, when appropriate, attest to respect for children's developing autonomy.

Children should become a part of any studies that directly involve things that will have an impact on their life. A child's voice is just as important as the voice of the adults in their lives and the voice of the researcher.

For research that is FDA-regulated, a waiver of documentation of consent may be granted only: When the research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside the research context.

Key issues Many pharmaceutical agents are used off-label in children without guidance to clinicians for dosage initiation or adjustment. The lack of dosing guidance stems from ethical, pharmacological, statistical and economic challenges to studying pharmaceutical agents in children.

Clinical trials help provide reliable evidence needed when studying medical products to diagnose, prevent, treat, and sometimes even cure, childhood diseases. Children who participate in these research studies may also potentially benefit from the medical products under investigation.

PEDIATRIC RESEARCH EQUITY ACT3 The Pediatric Research Equity Act amends the federal Food, Drug, and Cosmetic Act to authorize the FDA to require pediatric studies of drugs or biologics when other approaches are insufficient to ensure that the products are safe and effective for use in children.

Because your child is a minor, you may be legally required to give informed consent allowing them to participate. Your child may also need to give their assent after having the trial explained to them in an age-appropriate manner.