title: Issues related to children participating in clinical research.
abstract: Research involving children is necessary to bridge the gap created by years of applying the findings of adult clinical trials to children. Given the mandate from the National Institutes of Health to include children in clinical trials, pediatric nurses will undoubtedly be asked to assist with pediatric research projects. Nurses working with children must consider the unique legal and ethical issues surrounding children as study participants. The purpose of this article is to examine issues related to children participating in clinical research. A review of pertinent literature is summarized, and practical approaches to the recommendations are discussed.
authors.affiliation: Kosair Children's Hospital, Louisville, KY, USA. christina.knox@nortonhealthcare.org
authors.forename: Christina A
authors.initials: CA
authors.lastname: Knox
authors.forename: Patricia V
authors.initials: PV
authors.lastname: Burkhart
mesh_terms: D000293:Adolescent; D002648:Child; D002651:Child Advocacy / Q000941:ethics / Q000331:legislation & jurisprudence / Q000523:psychology; D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence / Q000451:nursing / Q000523:psychology; D006805:Human Experimentation / Q000941:ethics / Q000331:legislation & jurisprudence; D006801:Humans; D016743:Mental Competency / Q000331:legislation & jurisprudence / Q000523:psychology; D033242:Minors / Q000331:legislation & jurisprudence / Q000523:psychology; D009316:National Institutes of Health (U.S.); D024802:Nurse's Role; D033282:Parental Consent / Q000941:ethics / Q000331:legislation & jurisprudence / Q000523:psychology; D010358:Patient Participation / Q000331:legislation & jurisprudence / Q000523:psychology; D018579:Patient Selection / Q000941:ethics; D010371:Pediatric Nursing / Q000941:ethics / Q000458:organization & administration; D000297:Psychology, Adolescent; D002666:Psychology, Child; D012307:Risk Factors; D014481:United States