title: Assessment of children's capacity to consent for research: a descriptive qualitative study of researchers' practices.
abstract: BACKGROUND
  In Canadian jurisdictions without specific legislation pertaining to research consent, the onus is placed on researchers to determine whether a child is capable of independently consenting to participate in a research study. Little, however, is known about how child health researchers are approaching consent and capacity assessment in practice. The aim of this study was to explore and describe researchers' current practices.
  
  
  METHODS
  The study used a qualitative descriptive design consisting of 14 face-to-face interviews with child health researchers and research assistants in Southern Ontario. Transcribed interviews were analysed for common themes.
  
  
  RESULTS
  Procedures for assessing capacity varied considerably from the use of age cutoffs to in-depth engagement with each child. Three key issues emerged from the accounts: (1) requirements that consent be provided by a single person thwarted researchers' abilities to support family decision-making; (2) little practical distinction was made between assessing if a child was capable, versus determining if study information had been adequately explained by the researcher; and (3) participants' perceived that review boards' requirements may conflict with what they considered ethical consent practices.
  
  
  CONCLUSIONS
  The results suggest that researchers' consent and capacity knowledge and skills vary considerably. Perceived discrepancies between ethical practice and ethics boards' requirements suggest the need for dialogue, education and possibly ethics board reforms. Furthermore we propose, where appropriate, a 'family decision-making' model that allows parents and their children to consent together, thereby shifting the focus from separate assent and consent procedures to approaches that appropriately engage the child and family.
authors.affiliation: Department of Physical Therapy, University of Toronto, 160-500 University Avenue, Toronto, ON Canada. barbara.gibson@utoronto.ca
authors.forename: Barbara E
authors.initials: BE
authors.lastname: Gibson
authors.forename: Elaine
authors.initials: E
authors.lastname: Stasiulis
authors.forename: Shawna
authors.initials: S
authors.lastname: Gutfreund
authors.forename: Maria
authors.initials: M
authors.lastname: McDonald
authors.forename: Lauren
authors.initials: L
authors.lastname: Dade
mesh_terms: D002648:Child; D002669:Child Welfare; D032882:Comprehension; D003657:Decision Making; D040261:Harm Reduction; D006801:Humans; D033181:Information Dissemination / Q000379:methods; D057828:Informed Consent By Minors / Q000941:ethics* / Q000331:legislation & jurisprudence; D010287:Parent-Child Relations; D026684:Personal Autonomy; D036301:Qualitative Research