TheAmericanAcademyofPediatrics(AAP)isastrong.docVIP

The American Academy of Pediatrics (AAP) is a strong advocate for including children as subjects in appropriate research studies. The Academy believes that children should be afforded the potential benefit from studies that could offer direct benefit, such as drug trials, as well as those that have the potential to benefit all children (as a group). Limiting participation, even for concerns of increased vulnerability, could discriminate against children while adults benefit from the tremendous gains in clinical research. The AAP argues that in the absence of research, practitioners will be forced to administer new drugs to children either off-label or with inadequate information about dosing and toxicities. Policies that unduly restrict the participation of children in research will slow the acquisition of knowledge that could potentially benefit children. What are the basic tenets of research advocated by the AAP? Children need to be involved in research so that advances can continue to be made and so that children can enjoy equal access to beneficial medical treatments. Children comprise an especially vulnerable population therefore added protection against violation of their rights and exposure to inappropriate and unnecessary risk is required. Local Institutional Review Boards (IRBs) are capable of protecting the rights of children, but it is imperative that these IRBs have proper pediatric expertise and adequate institutional support. We Rank how much risk there is in a study as: minimal, minor increase over minimal, or greater than minimal. When can children be subjects in research protocols that present greater than minimal risk? The first principal that applies here is usually referred to as equipoise, that is a balance between the potential for benefit compared to the potential for harm (45 CFR §46.405; 21 CFR §50.52). Children can participate in research with greater-than-mnimal-risk as long as the balance of potential direct benefit to them results in a f