THE GEORGE WASHINGTON UNIVERSITY
Office of Human Research- Institutional Review Board
ohrirb@gwu.edu
Phone: 202-994-2715
http://humanresearch.gwu.edu/
Children Supplemental Checklist (HRP-292)
IRB # (if already assigned, otherwise leave blank--will be assigned upon submission):
STUDY TITLE:
PI NAME:
VERSION DATE, IF APPLICABLE:
1. RISK CATEGORIES FOR RESEARCH INVOLVING CHILDREN: Please select the
applicable categories of risk for the research involving children. If different categories of
children (e.g., transplant recipient versus transplant donor) will fall into different research
risk categories, provide a description of the population under the selected categories.
45 CFR 46.404 - Research not involving greater than minimal risk to the
individual child. For example, chart reviews, data analysis, certain blood draws.
Additional notes/comments:
45 CFR 46.405 - Research involving greater than minimal risk but presenting
the prospect of direct benefit to the individual subjects. For example, therapeutic trials,
transplant recipients.
a. Explain why the risks are justified by the anticipated direct benefit to the child:
b. Explain how the relationship between research risk and prospective benefit is at least as
favorable as presented by available alternative approaches:
Additional notes/comments:
45 CFR 46.406 - Research involving greater than minimal risk and no prospect
of direct benefit to the individual subjects, but likely to yield generalizable knowledge
about the subject’s disorder or condition.
a. Explain why the risk represents only a minor increase over minimal risk:
b. Explain how the procedures in this research are reasonably commensurate with
those inherent to the child’s situation outside research: (For instance, an oncology
patient would be expected to have more risky procedures than a flu patient).
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c. Explain what generalizable knowledge will be gained through the research and
why it is of vital importance (45 CFR 46.406.c) to the understanding or the
elimination of the subject’s underlying disease or condition:
d. What alternative methods were considered to gain the knowledge?
Additional notes/comments:
45 CFR 46.407 - Research not otherwise approvable which presents an
opportunity to understand, prevent, or alleviate a serious problem affecting the health
or welfare of children. Requires Director of Health and Human Services sign off – Call
OHR for assistance.
Additional notes/comments:
2. ASSENT PROCESS FOR CHILDREN: Please select all that apply and provide information
about the age range or description of the population for each selection, and justification for
each selection.
Requesting a waiver of assent:
Requesting a waiver of written assent (will obtain verbal assent):
Assent documented by signing a separate assent form:
Assent documented by signing the parental permission form (e.g. consent form) along
with parents or legal guardian:
3. PARENTAL OR GUARDIAN PERMISSION FOR CHILD PARTICIPATION: Please select
the way in which permission will be sought from parents or legal guardians to enroll their
children in research?
Only one parent or legal guardian will sign the parental permission form (e.g. consent
form). Applicable only for 45 CFR 46.404 and 45 CFR 46.405.
Additional notes/comments:
Both parents will sign the parental permission form (e.g. consent form) unless one
parent is deceased, unknown, incompetent, readily unavailable, or only one parent
has legal custody. Required for 45 CFR 46.406 and 45 CFR 46.407.
Additional notes/comments:
2
Children Supplemental Checklist (HRP-292)
V.04/23/15