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Psychological Screening of Children for Participation in Nontherapeutic Invasive Research
Ann Marie McCarthy, PhD, RN, PNP;
Lynn C. Richman, PhD;
Robert P. Hoffman, MD;
Linda Rubenstein, PhD
Arch Pediatr Adolesc Med. 2001;155:1197-1203.
Background The need for children to participate in research has raised concerns
about ethical issues surrounding their participation.
Objectives To describe a protocol of preresearch psychological screening and postresearch
outcomes and to present the results of the screening process for a nontherapeutic,
invasive research study.
Design and Setting Descriptive study carried out at The University of Iowa Hospitals and
Clinics, Iowa City.
Participants Twenty-eight children (mean age, 10.6 years) were screened, with 4 not
completing the research study and another 4 unavailable for psychological
follow-up.
Main Outcome Measures Prescreening interviews with parent and child and screening measures
of appropriate child cognitive abilities and behavior; postscreening parent
and child questionnaires.
Results Of the 4 children who did not complete the research study, 3 were identified
with increased anxiety during the screening and were advised to not participate
in the study. The primary motivator for participation was monetary reimbursement
(14 parents [82%]; 15 children [75%]), followed by altruistic reasons (10
parents [59%]; 4 children [20%]). Before participating, none of the children
reported concerns related to participating in the study. However, on follow-up,
9 (45%) of the children reported that they had had concerns before participating.
Follow-up assessment showed that parents underestimated their children's concerns
related to sexual development assessment and intravenous insertion.
Conclusions Children with increased anxiety may not be appropriate participants
in potentially anxiety-provoking research. Children's reports of concerns
may change from preparticipation to postparticipation, and discrepancies may
exist between parent and child reports of concerns with research participation.
Further research is needed to ensure children's safe participation in research.
From the College of Nursing (Drs McCarthy and Rubenstein) and Divisions
of Pediatric Psychology (Dr Richman) and Pediatric Endocrinology (Dr Hoffman),
Department of Pediatrics, College of Medicine, The University of Iowa, Iowa
City. Dr Hoffman is now with the Department of Pediatrics, Columbus Children's
Hospital, Columbus, Ohio.
Corresponding author and reprints: Ann Marie McCarthy, PhD, RN, PNP,
College of Nursing, Nursing Bldg, Room 430, 50 Newton Rd, The University of
Iowa, Iowa City, IA 52242 (e-mail: ann-mccarthy{at}uiowa.edu).
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