Published online May 1, 2006
PEDIATRICS Vol. 117 No. 5 May 2006, pp. 1706-1711 (doi:10.1542/peds.2005-1233)
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Variation in Standards of Research Compensation and Child Assent Practices: A Comparison of 69 Institutional Review Board–Approved Informed Permission and Assent Forms for 3 Multicenter Pediatric Clinical Trials

Michael B. Kimberly, MBea,b, K. Sarah Hoehn, MD, MBec, Chris Feudtner, MD, PhD, MPHa,b,d, Robert M. Nelson, MD, PhDb,c,e and Mark Schreiner, MDc,f

a Pediatric Generalist Research Group
e Center for Research Integrity
f Children's Clinical Research Institute, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania
b Center for Bioethics
d Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania
c Department of Anesthesiology and Critical Care, Children's Hospital of Philadelphia and University of Pennsylvania, Philadelphia, Pennsylvania

OBJECTIVE. To systematically compare standards for compensation and child participant assent in informed permission, assent, and consent forms (IP-A-CFs) approved by 55 local institutional review boards (IRBs) reviewing 3 standardized multicenter research protocols.

METHOD. Sixty-nine principal investigators participating in any of 3 national, multicenter clinical trials submitted standardized research protocols for their trials to their local IRBs for approval. Copies of the subsequently IRB-approved IP-A-CFs were then forwarded to an academic clinical research organization. This collection of IRB-approved forms allowed for a quasiexperimental retrospective evaluation of the variation in informed permission, assent, and consent standards operationalized by the local IRBs.

RESULTS. Standards for compensation and child participant assent varied substantially across 69 IRB-approved IP-A-CFs. Among the 48 IP-A-CFs offering compensation, monetary compensation was offered by 33 as reimbursement for travel, parking, or food expenses, whereas monetary or material compensation was offered by 22 for subject inconvenience and by 13 for subject time. Compensation ranged widely within and across studies (study 1, $180–1425; study 2, $0–500; and study 3, $0–100). Regarding child participant assent, among the 57 IP-A-CFs that included a form of assent documentation, 33 included a line for assent on the informed permission or consent form, whereas 35 included a separate form written in simplified language. Of the IP-A-CFs that stipulated the documentation of assent, 31 specified ≥1 age ranges for obtaining assent. Informed permission or consent forms were addressed either to parents or child participants.

CONCLUSION. In response to identical clinical trial protocols, local IRBs generate IP-A-CFs that vary considerably regarding compensation and child participant assent.

Key Words: ethics • institutional review board • permission • assent • informed consent • research subjects • quasiexperimental design

Abbreviations: IRB—institutional review board • IP-A-CF—informed permission, assent, and consent form • CCRI—Children's Clinical Research Institute • PI—principal investigator • AHRF—acute hypoxemic respiratory failure

Accepted Nov 2, 2005.


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