Psychological screening of children for participation in nontherapeutic invasive research.
BACKGROUND
The need for children to participate in research has raised concerns about ethical issues surrounding their participation.


OBJECTIVE
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.


METHODS
Descriptive study carried out at The University of Iowa Hospitals and Clinics, Iowa City.


METHODS
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.


METHODS
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.
McCarthy
A M
AM
College of Nursing, Nursing Bldg, Room 430, 50 Newton Rd, The University of Iowa, Iowa City, IA 52242, USA. ann-mccarthy@uiowa.edu
Richman
L C
LC
Hoffman
R P
RP
Rubenstein
L
L
D000293:Adolescent; D001007:Anxiety / Q000209:etiology / Q000517:prevention & control; D002648:Child; D003863:Depression / Q000209:etiology / Q000517:prevention & control; D028744:Ethics Committees, Research; D004992:Ethics, Medical; D005260:Female; D006785:Hospitals, University; D006805:Human Experimentation; D006801:Humans; D007484:Iowa; D008297:Male; D018579:Patient Selection; D002666:Psychology, Child; D018570:Risk Assessment; D013315:Stress, Psychological / Q000209:etiology* / Q000517:prevention & control