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Seema Shah, BA; Amy Whittle, BA; Benjamin Wilfond, MD; Gary Gensler, MS; David Wendler, PhD

JAMA. 2004;291:476-482.

Context  Federal regulations allow children in the United States to be enrolled in clinical research only when the institutional review board (IRB) determines that the risks are minimal or a minor increase over minimal, or that the research offers a prospect of direct benefit. Despite this reliance on IRBs, no data exist on how IRBs apply the risk and benefit categories for pediatric research.

Objective  To determine how IRB chairpersons apply the federal risk and benefit categories for pediatric research.

Design, Setting, and Participants  Telephone survey, conducted between May and August 2002 of 188 randomly selected chairpersons of IRBs in the Unites States. The survey consisted of 21 questions to assess the application of federal risk standards to research procedures, whether certain interventions offer a prospect of direct benefit to participating children, and the extent to which IRBs use the federal definition of minimal risk when categorizing the risks of research procedures in children.

Main Outcome Measures  Responses regarding categorization of the risk level and direct benefits of pediatric research procedures.

Results  A single blood draw was the only procedure categorized as minimal risk by a majority (152 or 81%) of the 188 respondents. An electromyogram was categorized as minimal or a minor increase over minimal risk by 100 (53%) and as more than a minor increase over minimal risk by 77 (41%). Allergy skin testing was categorized as minimal risk by 43 IRB chairpersons (23%), a minor increase over minimal risk by 81 (43%), and more than a minor increase over minimal risk by 51 (27%). Regarding benefits, 113 chairpersons (60%) considered added psychological counseling to be a direct benefit, while participant payment was considered a direct benefit by 10% (n = 19).

Conclusions  Application of the federal risk and benefit categories for pediatric research by IRB chairpersons is variable and sometimes contradicted by the available data on risks and the regulations themselves. To protect children from excessive risks while allowing appropriate research, IRB chairpersons need guidance on applying the federal risk and benefit categories and also need data on the risks children face in daily life and during routine physical or psychological tests.

Author Affiliations: Department of Clinical Bioethics (Mss Shah and Whittle and Drs Wilfond and Wendler) and Human Genome Research Institute (Dr Wilfond), National Institutes of Health, Bethesda, Md; and Emmes Corporation, Bethesda, Md (Mr Gensler).

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