title: When neonatal ICU infants participate in research: special protections for special subjects.
abstract: Neonatal ICU research poses unique concerns for infants and parents. Children are considered a vulnerable research population. Federal regulations specify special protections when children participate in research. These regulations determine the types of research approvable for children based on the balance of risks and benefit. Risk also determines whether one or both parents' consent is required for their infant's participation in research.
authors.affiliation: Department of Family and Child Nursing, University of Washington, 1959 NE Pacific Street, Seattle, WA 98195, USA. kthomas@u.washington.edu
authors.forename: Karen A
authors.initials: KA
authors.lastname: Thomas
mesh_terms: D002651:Child Advocacy / Q000941:ethics / Q000331:legislation & jurisprudence*; D028744:Ethics Committees, Research; D055317:Evidence-Based Practice / Q000941:ethics / Q000331:legislation & jurisprudence; D035082:Federal Government; D033161:Government Regulation; D006805:Human Experimentation / Q000941:ethics / Q000331:legislation & jurisprudence*; D006801:Humans; D007231:Infant, Newborn; D015931:Intensive Care, Neonatal / Q000941:ethics / Q000331:legislation & jurisprudence*; D017283:Neonatal Nursing / Q000941:ethics / Q000331:legislation & jurisprudence*; D024802:Nurse's Role; D033282:Parental Consent / Q000941:ethics / Q000331:legislation & jurisprudence; D035842:Research Subjects / Q000331:legislation & jurisprudence*; D012307:Risk Factors; D014481:United States; D035862:Vulnerable Populations / Q000331:legislation & jurisprudence