Download Child Checklist - Johns Hopkins University

Johns Hopkins University
Homewood Institutional Review Board (HIRB)
Child Checklist
This form must be attached to ALL Applications for Expedited/Full Board Review that include children as
participants.
STUDY ID
Study Title:
Principal Investigator:
Signature of PI:
Date:
ALLOWABLE CATEGORIES OF RESEARCH WITH CHILDREN
Indicate which one of the following four categories applies to your study and provide any additional
information requested.
1. Research involving no greater than minimal risk:
The probability and magnitude of harm or discomfort anticipated in the research are not greater
in and of themselves than those ordinarily encountered in daily life or during the performance of
routine physical or psychological examinations or tests. Assent of the child and permission of at
least one parent or guardian are required. [45 CFR 46.404]
2. Research involving greater than minimal risk with the prospect of direct benefit to
individual participants:
(a) Anticipated benefits to research participants justify the risks, and (b) anticipated benefits are
at least as favorable as any available alternative approaches. Assent of the child and permission
of at least one parent or guardian are required. [45 CFR 46.405]
Explain how the study meets criterion (b) for approval.
3. Research of greater than minimal risk with no prospect of direct benefits to individual
participants that is likely to yield generalizable knowledge about participants’ disorder
or condition:
(a) there is only a minor increase over minimal risk; (b) the intervention or procedure presents
experiences to participants that are reasonably commensurate with those in participants’ actual
or expected medical, dental, psychological, social, or educational situations; and (c) the
intervention or procedure is likely to yield generalizable knowledge about the participants’
disorder or condition that is of vital importance for the understanding or amelioration of the
disorder or condition. Assent of the child and permission of both parents or guardian(s)
generally are required. [45 CFR 46.406]
Explain how the study meets criterion (c) for approval.
Child Checklist (11/05)
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4. Other research that presents a reasonable opportunity to further the understanding,
prevention, or alleviation of a serious problem affecting the health or welfare of children
but does not fit in one of the three allowable categories above.
If HIRB approves the research, it must then forward the application to the Secretary of DHHS
for possible approval after consultation with a panel of experts in pertinent disciplines (e.g.,
science, medicine, education, ethics, law) and following publication and public comment. Assent
of the child and permission of both parents or guardian(s) generally are required. [45 CFR
46.407]
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Child Checklist (11/05)
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