title: Protection of children's rights to self-determination in research.
abstract: Federal guidelines require that informed consent be obtained from participants when they are enrolled in a research study. When conducting research with children, the guidelines utilize the term permission to describe parents' agreement to enroll their children in a study. The basic components of consent and permission are well described and identical, with the exception of the person for whom the decision to participate is being made (i.e., oneself as opposed to one's child). Beyond permission, when enrolling minor participants in research, affirmative agreement to participate in research or assent must be obtained from the child participants themselves. The concept of children's assent to research, however, is poorly defined, resulting in inconsistency in its pursuit and consequently, in its utility. The interface between cognitive development, emotional, and social development must be examined as its pertains to this special situation of decision making. For this process to meaningfully protect minors, the assent process must be clarified, decisions regarding parental veto power must be more convincingly justified, and researchers must be better educated and held accountable for the valid execution of this process. Strategies for implementing the assent process more effectively are presented.
authors.affiliation: Department of Pediatrics, Hackensack University Medical Center, 30 Prospect Avenue, Hackensack, NJ 07601, USA. csterling@humed.com
authors.forename: Cheryl M
authors.initials: CM
authors.lastname: Sterling
authors.forename: Gary A
authors.initials: GA
authors.lastname: Walco
mesh_terms: D002648:Child; D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence; D003657:Decision Making; D035082:Federal Government; D033161:Government Regulation; D006805:Human Experimentation / Q000941:ethics / Q000331:legislation & jurisprudence; D006801:Humans; D007258:Informed Consent; D016743:Mental Competency; D033242:Minors; D033282:Parental Consent; D014481:United States