title: Safety: when infants and parents are research subjects.
abstract: Patient safety is a central concern in nursing. Unlike other areas of patient safety, safety in research is particularly important because research is not part of standard care and participation is voluntary. Issues related to safety in research are especially pertinent to high-risk infants, because of the nature of parental (or legal guardian) consent and because children are considered a vulnerable group requiring special protection from research risks. Nurses must be aware of safety in research whether independently conducting research, employed by a research project, or caring for patients who are research subjects. This article reviews safety issues and policies, processes, and ethical guidelines designed to protect infants and children who are research subjects.
authors.affiliation: Department of Family and Child Nursing, University of Washington, Seattle, WA 98105, USA. kthomas@u.washington.edu
authors.forename: Karen A
authors.initials: KA
authors.lastname: Thomas
mesh_terms: D000328:Adult; D003219:Confidentiality; D028744:Ethics Committees, Research; D032984:Ethics, Research; D006801:Humans; D007231:Infant, Newborn; D007258:Informed Consent / Q000941:ethics; D017283:Neonatal Nursing / Q000379:methods; D024802:Nurse's Role; D018579:Patient Selection / Q000941:ethics; D035842:Research Subjects / Q000331:legislation & jurisprudence; D017751:Safety Management / Q000941:ethics* / Q000331:legislation & jurisprudence / Q000592:standards*; D014481:United States