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).
Health Law and Ethics Section Editors: Lawrence
O. Gostin, JD, Center for Law and the Public's Health at Georgetown University,
Washington, DC, and the Johns Hopkins University, Baltimore, Md; Helene M.
Cole, MD, Contributing Editor, JAMA.
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.
Shah S, Whittle A, Wilfond B, Gensler G, Wendler D. How Do Institutional Review Boards Apply the Federal Risk and Benefit Standards for Pediatric Research?. JAMA. 2004;291(4):476-482. doi:10.1001/jama.291.4.476